FDA 21 CFR 177.1520-2007

21 CFR Ch. I (4–1–07 Edition) §177.1520

(which has been held in a vacuum des-iccator over anhydrous calcium sulfate until constant weight has been at-tained) and carefully evaporated to dryness. The weight of the solid residue is determined by difference after hold-ing in a vacuum desiccator over anhy-drous calcium sulfate until constant weight has been attained. The percent of solids extracted is calculated by di-viding the weight of the solid residue by the weight of the sample and multi-plying by 100.

(5) Viscosity number (VN). (i) The vis-cosity number (VN) for Nylon 6/12 resin in a 96 percent sulfuric acid solution (5 milligrams resin per milliliter) shall be determined at 25 °C (77 °F) by method ISO 307–1984(E), ‘‘Plastics-Polyamides- Determination of Viscosity Number,’’ which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS–200), Food and Drug Administra-tion, 5100 Paint Branch Pkwy., College Park, MD 20740, or available for inspec-tion at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: https://www.wendangku.net/doc/155981759.html,/ federal l register/

code l of l federal l regulations/

ibr l locations.html.

(ii) The viscosity number (VN) for Nylon 6/69 and Nylon PA–6–3–T resins in a 99 percent cresol solution (5 milli-grams resin per milliliter) shall be de-termined at 25 °C (77 °F) by method ISO 307–1984(E), ‘‘Plastics-Polyamides-De-termination of Viscosity Number,’’ which is incorporated by reference. The availability of this incorporation by reference is given in paragraph (d)(5)(i) of this section.

[42 FR 14572, Mar. 15, 1977]

E DITORIAL N OTE: For

F EDERAL R EGISTER ci-tations affecting §177.1500, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.

§177.1520Olefin polymers.

The olefin polymers listed in para-graph (a) of this section may be safely used as articles or components of arti-cles intended for use in contact with food, subject to the provisions of this section.

(a) For the purpose of this section, olefin polymers are basic polymers manufactured as described in this para-graph, so as to meet the specifications prescribed in paragraph (c) of this sec-tion, when tested by the methods de-scribed in paragraph (d) of this section.

(1)(i) Polypropylene consists of basic polymers manufactured by the cata-lytic polymerization of propylene.

(ii) Propylene homopolymer consists of basic polymers manufactured by the catalytic polymerization of propylene with a metallocene catalyst.

(2)(i) Polyethylene consists of basic polymers manufactured by the cata-lytic polymerization of ethylene.

(ii) Fumaric acid-grafted poly-ethylene (CAS Reg. No. 26877–81–6) con-sists of basic polymers manufactured by the catalytic polymerization of ethylene followed by reaction with fu-maric acid in the absence of free rad-ical initiators. Such polymers shall contain grafted fumaric acid at levels not to exceed 2 percent by weight of the finished polymer.

(3) Olefin basic copolymers consist of basic copolymers manufactured by the catalytic copolymerization of:

(i) Two or more of the 1-alkenes hav-ing 2 to 8 carbon atoms. Such olefin basic copolymers contain not less than 96 weight-percent of polymer units de-rived from ethylene and/or propylene, except that:

(a)(1) Olefin basic copolymers manu-factured by the catalytic copolym-erization of ethylene and hexene-1 or ethylene and octene-1 shall contain not less than 90 weight-percent of polymer units derived from ethylene;

(2) Olefin basic copolymers manufac-tured by the catalytic copolymeriza-tion of ethylene and hexene-1 shall con-tain not less than 80 but not more than 90 weight percent of polymer units de-rived from ethylene.

(3) Olefin basic copolymers manufac-tured by the catalytic copolymeriza-tion of ethylene and pentene-1 shall contain not less than 90 weight-percent of polymer units derived from ethyl-ene.

(4) Olefin basic copolymers manufac-tured by the catalytic polymerization of ethylene and octene-1 shall contain not less than 50 weight-percent of poly-mer units derived from ethylene.

Food and Drug Administration, HHS §177.1520

(b ) Olefin basic copolymers manufac-tured by the catalytic copolymeriza-tion of ethylene and 4-methylpentene-1 shall contain not less than 89 weight- percent of polymer units derived from ethylene; (c )(1) Olefin basic copolymers manu-factured by the catalytic copolym-erization of two or more of the mono-mers ethylene, propylene, butene-1, 2- methylpropene-1, and 2,4,4-

trimethylpentene-1 shall contain not less than 85 weight-percent of polymer units derived from ethylene and/or pro-pylene;

(2) Olefin basic copolymers manufac-tured by the catalytic copolymeriza-tion of propylene and butene-1 shall contain greater than 15 but not greater than 35 weight percent of polymer units derived from butene-1 with the remainder being propylene.

(d ) Olefin basic terpolymers manufac-tured by the catalytic copolymeriza-tion of ethylene, hexene-1, and either propylene or butene-1, shall contain not less than 85 weight percent poly-mer units derived from ethylene.

(e ) Olefin basic copolymers manufac-tured by the catalytic polymerization of ethylene and octene-1, or ethylene,

octene-1, and either hexene-1, butene-1,

propylene, or 4-methylpentene-1 shall contain not less than 80 weight percent of polymer units derived from ethyl-ene.

(ii) 4-Methylpentene-1 and 1-alkenes having from 6 to 18 carbon atoms. Such olefin basic copolymers shall contain not less than 95 molar percent of poly-mer units derived from 4-

methylpentene-1, except that copoly-mers manufactured with 1-alkenes hav-ing from 12 to 18 carbon atoms shall contain not less than 97 molar percent

of polymer units derived from 4-

methylpentene-1; or

(iii) E thylene and propylene that may contain as modifiers not more than 5 weight-percent of total polymer units derived by copolymerization with one or more of the following mono-mers:

5-Ethylidine-2-norbornene. 5-Methylene-2-norbornene.

(iv) Ethylene and propylene that may contain as a modifier not more than 4.5 weight percent of total polymer units derived by copolymerization with 1,4- hexadiene. (v) Ethylene and butene-1 copolymers (CAS Reg. No. 25087–34–7) that shall contain not less than 80 weight percent of polymer units derived from ethyl-ene.

(vi) Olefin basic copolymers (CAS Reg. No. 61615–63–2) manufactured by

the catalytic copolymerization of

ethylene and propylene with 1,4- hexadiene, followed by reaction with fumaric acid in the absence of free rad-ical initiators. Such polymers shall contain not more than 4.5 percent of polymer units deriving from 1,4- hexadiene by weight of total polymer prior to reaction with fumaric acid and not more than 2.2 percent of grafted fu-maric acid by weight of the finished polymer.

(vii) Ethylene and 2-norbornene (CAS Reg. No. 26007–43–2) copolymers that shall contain not less than 30 and not more than 70 mole percent of polymer units derived from 2-norbornene.

(4) Poly(methylpentene) consists of basic polymers manufactured by the catalytic polymerization of 4- methylpentene-1.

(5) Polyethylene graft copolymers consist of polyethylene complying with item 2.2 of paragraph (c) of this section which subsequently has 3a,4,7,7a-

tetrahydromethyl-4,7- methanoisobenzofuran-1,3-dione graft-ed onto it at a level not to exceed 1.7 percent by weight of the finished co-polymer.

(6) E thylene-maleic anhydride co-polymers (CAS Reg. No. 9006–26–2) con-taining no more than 2 percent by weight of copolymer units derived from maleic anhydride.

(b) The basic olefin polymers identi-fied in paragraph (a) of this section may contain optional adjuvant sub-stances required in the production of such basic olefin polymers. The op-tional adjuvant substances required in the production of the basic olefin poly-mers or finished food-contact articles

may include substances permitted for such use by applicable regulations in

parts 170 through 189 of this chapter, substances generally recognized as safe

in food and food packaging, substances used in accordance with a prior sanc-tion or approval, and the following:

21 CFR Ch. I (4–1–07 Edition)

§177.1520

Substance Limitations

Aromatic petroleum hydrocarbon resin, hydrogenated (CAS Reg. No. 88526–47–0), produced by the catalytic polym-erization of aromatic-substituted olefins from distillates of cracked petroleum stocks with a boiling point no greater than 220 °C (428 °F), and the subsequent catalytic hydrogenation of the resulting aromatic petroleum hydrocarbon resin, hav-ing a minimum softening point of 110 °C (230 °F), as deter-mined by ASTM Method E 28–67 (Reapproved 1982), ‘‘Standard Test Method for Softening Point by Ring-and-Ball Apparatus,’’ and a minimum aniline point of 107 °C (225 °F), as determined by ASTM Method D 611–82, ‘‘Standard Test Methods for Aniline Point and Mixed Aniline Point of Petro-leum Products and Hydrocarbon Solvents,’’ both of which are incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the American Society for Testing and Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or from the Center for Food Safety and Applied Nutrition (HFS– 200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: https://www.wendangku.net/doc/155981759.html,/ federal l register/code l of l federal l regulations/

ibr l locations.html..For use only as an adjuvant at levels not to exceed 25 percent by weight in blends with polypropylene complying with para-graph (c), item 1.1 of this section. The finished polymer may be used in contact with food Types I, II, IV-B, VI-A through VI-C, VII-B, and VIII identified in table 1 of §176.170(c) of this chapter and under conditions of use B through H de-scribed in table 2 of §176.170(c) of this chapter; and with food Types III, IV-A, V, VII-A, and IX identified in table 1 of §176.170(c) of this chapter and under conditions of use D through G described in table 2 of §176.170(c) of this chap-ter.

Colorants used in accordance with §178.3297 of this chapter.

2,5-Dimethyl-2,5-di(tert-butylperoxy)hexane (CAS Reg. No. 78– 63–7).For use as an initiator in the production of propylene homopolymer complying with §177.1520(c), item 1.1 and olefin copolymers complying with §177.1520(c), items 3.1 and 3.2 and containing not less than 75 weight percent of polymer units derived from propylene, provided that the max-imum concentration of tert-butyl alcohol in the polymer does not exceed 100 parts per million, as determined by a method titled ‘‘Determination of tert-Butyl Alcohol in Polypropylene,’’ which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS– 200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http:// https://www.wendangku.net/doc/155981759.html,/federal l register/

code l of l federal l regulations/ibr l locations.html.

Methyl methacrylate/butyl acrylate-grafted polypropylene co-polymer containing methyl methacrylate/butyl acrylate-grafted polypropylene (CAS Reg. No. 121510–09–6), methyl meth-acrylate/butyl acrylate copolymer (CAS Reg. No. 25852–37– 3), methyl methacrylate homopolymer (CAS Reg. No. 9011– 14–7), and polypropylene (CAS Reg. No. 9003–07–0), re-sulting from the reaction of a mixture of methyl methacrylate and butyl acrylate with polypropylene. The finished product contains no more than 55 percent by weight of polymer units derived from methyl methacrylate and butyl acrylate as de-termined by a method entitled, ‘‘Determination of the Total Acrylic in PP-MMA/BA Polymers,’’ which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Office of Premarket Approval, Center for Food Safety and Applied Nutrition (HFS–200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or may be exam-ined at the Center for Food Safety and Applied Nutrition’s Li-brary, 5100 Paint Branch Pkwy., College Park, MD 20740, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: https://www.wendangku.net/doc/155981759.html,/ federal l register/code l of l federal l regulations/

ibr l locations.html..For use only at levels not to exceed 6 percent by weight of olefin polymers complying with paragraph (c) of this section, items 1.1, 3.1a, 3.2a, and 3.2b, where the copolymers com-plying with items 3.1a, 3.2a, and 3.2b contain not less than 85 weight-percent of polymer units derived from propylene.

Food and Drug Administration, HHS §177.1520

Substance Limitations

Petroleum hydrocarbon resins (cyclopentadiene-type), hydro-

genated (CAS Reg. No. 68132–00–3) produced by the ther-

mal polymerization of dicyclopentadiene and cyclodiene

codimers (consisting of a mixture of cyclopentadiene, methyl

cyclopentadiene, and C4-C5acyclic dienes), followed by hy-

drogenation and having a ring-and-ball softening point of 119 °C minimum as determined by ASTM Method E 28–67 (Re-approved 1982), ‘‘Standard Test Method for Softening Point

by Ring-and-Ball Apparatus,’’ and a minimum viscosity of

3,000 centipoise, measured at 160 °C, as determined by

ASTM Method D 3236–88, ‘‘Standard Test Method for Ap-

parent Viscosity of Hot Melt Adhesives and Coating Mate-

rials,’’ both of which are incorporated by reference in accord-

ance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are

available from the American Society for Testing and Mate-

rials, 100 Barr Harbor Dr., West Conshohocken, Philadel-

phia, PA 19428-2959, or from the Center For Food Safety

and Applied Nutrition (HFS–200), Food and Drug Administra-

tion, 5100 Paint Branch Pkwy., College Park, MD 20740, or

may be examined at the National Archives and Records Ad-

ministration (NARA). For information on the availability of this

material at NARA, call 202–741–6030, or go to: http://

https://www.wendangku.net/doc/155981759.html,/federal l register/

code l of l federal l regulations/ibr l locations.html..For use only as an adjuvant at levels not to exceed 30 percent by weight in blends with: (1) Polypropylene complying with paragraph (c), item 1.1 of this section, or (2) a copolymer of propylene and ethylene containing not less than 94 weight percent propylene and complying with paragraph (c), item 3.2 of this section. The average thickness of the food-con-tact film is not to exceed 0.1 millimeter (0.004 inch). The fin-ished polymer may be used in contact with (1) Food types I, II, IV-B, VI-A, VI-B, VII-B, and VIII identified in table 1 of §176.170(c) of this chapter and under conditions of use C through G described in table 2 of §176.170(c) of this chap-ter; and (2) food types III, IV-A, V, VI-C, VII-A, and IX identi-fied in table 1 of §176.170(c) of this chapter and under con-ditions of use D through G described in table 2 of §176.170(c) of this chapter.

Polymethylsilsesquioxane (CAS Reg. No. 68554–70–1)............For use only as a surface lubricant or anti-blocking agent in

films.

Poly(vinylidene fluoride) homopolymer (CAS Reg. No. 24937– 79–9), having a melt viscosity of 6 to 37 kilopoise at a shear rate of 100￥1seconds at 232 °C as determined by ASTM Method D 3835–79 (Reapproved 1983), ‘‘Standard Test Method for Rheological Properties of Thermoplastics with a Capillary Rheometer’’ using a capillary of 15:1 L/D, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Center for Food Safety and Applied Nutrition (HFS–200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the Na-tional Archives and Records Administration (NARA). For in-formation on the availability of this material at NARA, call 202–741–6030, or go to: https://www.wendangku.net/doc/155981759.html,/ federal l register/code l of l federal l regulations/

ibr l locations.html..For use only as a processing aid in the production of olefin polymers complying with paragraph (c) of this section at lev-els not to exceed 1.0 percent by weight of the polymer. The finished polymers may be used only under the conditions de-scribed in §176.170(c) of this chapter, table 2, under condi-tions of use B though H.

Polyoxyethylene-grafted polydimethylsiloxane (CAS Reg. No. 68937–54–2).For use as an extrusion aid in the production of extruded olefin polymers that comply with §177.1520(c) at levels not to ex-ceed 0.3 percent by weight of the polymer. The finished polymer is used in contact with foods under conditions of use B through H described in table 2 of §176.170 of this chapter.

Triisopropanolamine (CAS Reg. No. 122–20–3)........................For use as a Zeigler-Natta-type catalyst deactivator and anti-

oxidant in the production of olefin polymers complying with

§177.1520(c), items 2.1, 2.2, and 2.3, and having a min-

imum density of 0.94 grams per cubic centimeter, and co-

polymers complying with §177.1520(c), items 3.1 and 3.2,

for use in contact with all foods under the following condi-

tions of use: (a) films with a maximum thickness of 0.102

millimeter (0.004 inch) may be used under conditions A

through H defined in table 2 of §176.170(c) of this chapter;

and (b) articles with thickness greater than 0.102 millimeter

(0.004 inch) may be used under conditions C through G de-

fined in table 2 of §176.170(c) of this chapter.

Trimethylpyridine and dimethylpyridine mixture having percent by weight composition as follows: 2,4,6-trimethylpyridine (CAS Reg. No. 108–75–8), not less than 60 percent; 2,3,6- trimethylpyridine (CAS Reg. No. 1462–84–6), not more than 27 percent; 3,5-dimethylpyridine (CAS Reg. No. 591–22–0), not more than 12 percent; and other dimethylpyridines, not more than 6 percent.For use only as an adjuvant substance in the production of propylene homopolymers complying with items 1.1, 1.2, and 1.3, and propylene copolymers complying with items 3.1, and 3.2 of paragraph (c) of this section provided that the ad-juvant is used at a level not to exceed 20 parts per million by weight of the olefin polymers.

21 CFR Ch. I (4–1–07 Edition)

§177.1520

Substance Limitations

Vinylidene fluoride-hexafluoropropene copolymer (CAS Reg. No. 9011–17–0) having a fluorine content of 65 to 71 per-cent and a Mooney viscosity of at least 28, as determined by a method entitled ‘‘Mooney Viscosity,’’ which is incorporated by reference in accordance with 5 U.S.C. 552(a). Copies are available from the Center for Food Safety and Applied Nutri-tion (HFS–200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or may be exam-ined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: https://www.wendangku.net/doc/155981759.html,/ federal l register/code l of l federal l regulations/

ibr l locations.html..For use only as an extrusion aid in the production of extruded olefin polymers at levels not to exceed 0.2 percent by weight of the polymer. The finished polymers may be used only under the conditions described in §176.170(c) of this chap-ter, table 2, under conditions of use B through H.

Vinylidene fluoride-hexafluoropropene copolymer (CAS Reg. No. 9011–17–0), having a vinylidene fluoride content of not less than 87 percent but less than 100 percent by weight and a melt viscosity of 12 to 27 kilopoise at a shear rate of 100￥1seconds at 232 °C as determined by ASTM Method D 3835–79 (Reapproved 1983), ‘‘Standard Test Method for Rheological Properties of Thermoplastics with a Capillary Rheometer’’ using a capillary of 15:1 L/D, which is incor-porated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Center for Food Safety and Applied Nutrition (HFS–200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: https://www.wendangku.net/doc/155981759.html,/federal l register/ code l of l federal l regulations/ibr l locations.html..For use only as a processing aid in the production of olefin polymers complying with paragraph (c) of this section at lev-els not to exceed 1.0 percent by weight of the polymer. The finished polymers may be used only under the conditions de-scribed in §176.170(c) of this chapter, table 2, under condi-tions of use B though H.

(c) Specifications:

Olefin polymers Density

Melting Point

(MP) or softening

point (SP) (De-

grees Centi-

grade)–

Maximum extract-

able fraction (ex-

pressed as per-

cent by weight of

the polymer) in N-

hexane at speci-

fied temperatures

Maximum soluble

fraction (ex-

pressed as per-

cent by weight of

polymer) in xy-

lene at specified

temperatures

1.1a. Polypropylene described in para-graph (a)(1)(i) of this section 0.880–0.913 MP:

160°–180 °C 6.4 pct at reflux

temperature

9.8 pct at 25 °C

1.1b. Propylene homopolymer described in paragraph (a)(1)(ii) of this section 0.880–0.913– MP:

150°–180 °C 6.4 pct at reflux

temperature

9.8 pct at 25 °C

1.2. Polypropylene, noncrystalline; for use

only to plasticize polyethylene described

under items 2.1 and 2.2 of this table, pro-

vided that such plasticized polymers meet

the maximum extractable fraction and max-

imum soluble fraction specifications pre-

scribed for such basic polyethylene

0.80–0.88

1.3. Polypropylene, noncrystalline, for use

only: To plasticize polypropylene described

by item 1.1 of this table, provided that such

plasticized polymers meet the maximum ex-

tractable fraction and maximum soluble

fraction specifications prescribed for such

basic polypropylene, and further provided

that such plasticized polypropylene contacts

food only of the types identified in

§176.170(c) of this chapter, table 1, under

Types I, II, IV-B, VI-B, VII-B, and VIII; and

for use at levels not to exceed 50 pct by

weight of any mixture employed as a food-

contact coating provided such coatings con-

tact food only of the types identified in

§176.170(c) of this chapter, table 1, under

Types I, II, IV-B, VI-B, VII-B, and VIII

0.80–0.88 SP:115°–138 °C.

2.1. Polyethylene for use in articles that con-

tact food except for articles used for pack-

ing or holding food during cooking

0.85–1.00 ............................. 5.5 pct at 50 °C 11.3 pct at 25 °C

Food and Drug Administration, HHS §177.1520

Olefin polymers Density

Melting Point

(MP) or softening

point (SP) (De-

grees Centi-

grade)–

Maximum extract-

able fraction (ex-

pressed as per-

cent by weight of

the polymer) in N-

hexane at speci-

fied temperatures

Maximum soluble

fraction (ex-

pressed as per-

cent by weight of

polymer) in xy-

lene at specified

temperatures

2.2. Polyethylene for use in articles used for

packing or holding food during cooking

0.85–1.00 ............................. 2.6 pct at 50 °C Do.

2.3. Polyethylene for use only as component

of food-contact coatings at levels up to and

including 50 percent by weight of any mix-

ture employed as a food-contact coating

0.85–1.00 .............................53 pct at 50 °C 75 pct at 25 °C

2.4. Olefin polymers described in paragraph

(a)(2)(ii) of this section, having a melt flow

index not to exceed 17 grams/per 10 min-

utes as determined by the method de-

scribed in paragraph (d)(7) of this section,

for use in blends with other polymers at lev-

els not to exceed 20 percent by weight of

total polymer, subject to the limitation that

when contacting food of types III, IV-A, V,

VI-C, VII-A, and IX identified in §176.170(c)

of this chapter, Table 1, the polymers shall

be used only under conditions of use C, D,

E, F, and G, described in §176.170(c) of

this chapter, Table 2.

3.1a. Olefin copolymers described in para-

graph (a)(3)(i) of this section for use in arti-

cles that contact food except for articles

used for packing or holding food during

cooking; except olefin copolymers described

in paragraph (a)(3)(i)(a)(3) of this section

and listed in item 3.1c of this table and

olefin copolymers described in paragraph

(a)(3)(i)(e) of this section and listed in item

3.1b of this table

0.85–1.00 ............................. 5.5 pct at 50 °C 30 pct at 25 °C

3.1b. Olefin copolymers described in para-

graph (a)(3)(i)(e) of this section for use in

contact with food only under conditions of

use D, E, F, G, and H described in

§176.170(c) of this chapter, table 2

0.9–1.00 .............................Do Do.

3.1c. Olefin copolymers described in para-

graph (a)(3)(i)(a)(3) of this section for use in

contact with food only under conditions of

use B, C, D, E, F, G, and H described in

§176.170(c) of this chapter, table 2; except

that such copolymers when used in contact

with food of the types identified in

§176.170(c), table 1, under types III, IVA,

V, VIIA, and IX, shall be used only under

conditions of use D, E, F, and G described

in §176.170(c) of this chapter, table 2

Not less than 0.92

21 CFR Ch. I (4–1–07 Edition) §177.1520

Olefin polymers Density

Melting Point

(MP) or softening

point (SP) (De-

grees Centi-

grade)–

Maximum extract-

able fraction (ex-

pressed as per-

cent by weight of

the polymer) in N-

hexane at speci-

fied temperatures

Maximum soluble

fraction (ex-

pressed as per-

cent by weight of

polymer) in xy-

lene at specified

temperatures

3.2a. Olefin copolymers described in para-

graph (a)(3)(i) of this section for use in arti-

cles used for packing or holding food during

cooking; except olefin copolymers described

in paragraph (a)(3)(i)(c)(2) of this section

and listed in item 3.2b of this table; except

that olefin copolymers containing 89 to 95

percent ethylene with the remainder being

4-methyl-pentene-1 contacting food Types

III, IVA, V, VIIA, and IX identified in

§176.170(c) of this chapter, table 1, shall

not exceed 0.051 millimeter (mm) (0.002

inch (in)) in thickness when used under

conditions of use A and shall not exceed

0.102 mm (0.004 in) in thickness when

used under conditions of use B, C, D, E,

and H described in §176.170(c) of this

chapter, table 2. Additionally, olefin copoly-

mers described in (a)(3)(i)(a)(2) of this sec-

tion may be used only under conditions of

use B, C, D, E, F, G, and H described in

§176.170(c) of this chapter, table 2, in con-

tact with all food types identified in

§176.170(c) of this chapter, table 1

0.85–1.00 ............................. 2.6 pct at 50 °C Do.

3.2b. Olefin copolymers described in para-

graph (a)(3)(i)(c)(2) of this section have a

melt flow index no greater than 10 grams

per 10 minutes as determined by the meth-

od described in paragraph (d)(7) of this sec-

tion, and the thickness of the finished poly-

mer contacting food shall not exceed 0.025

mm (0.001 in). Additionally, optional adju-

vants permitted for use in olefin copolymers

complying with item 3.2a of this table may

be used in the production of this copolymer

Do.

3.2c. Olefin copolymers described in para-

graph (a)(3)(i)(a)(4) of this section have a

melt flow index no greater than 50 grams

per 10 minutes as determined by the meth-

od described in paragraph (d)(7) of this sec-

tion. Articles manufactured using these

polymers may be used with all types of food

under conditions of use C through H as de-

scribed in table 2 of §176.170(c) of this

chapter

0.85–0.92

3.3a. Olefin copolymers described in para-

graph (a)(3)(ii) of this section and manufac-

tured with 1-alkenes having from 6 to 10

carbon atoms

3.3b. Olefin copolymers described in para-

graph (a)(3)(ii) of this section, provided that

such olefin polymers have a melt tempera-

ture of 220 °C to 250 °C (428 °F to 482 °F)

as determined by the method described in

paragraph (d)(8) of this section and min-

imum intrinsic viscosity of 1.0 as determined

in paragraph (d)(9) of this section.

Food and Drug Administration, HHS §177.1520

Olefin polymers Density

Melting Point

(MP) or softening

point (SP) (De-

grees Centi-

grade)–

Maximum extract-

able fraction (ex-

pressed as per-

cent by weight of

the polymer) in N-

hexane at speci-

fied temperatures

Maximum soluble

fraction (ex-

pressed as per-

cent by weight of

polymer) in xy-

lene at specified

temperatures

3.4. Olefin copolymers, primarily non-crys-

talline, described in par. (a)(3) (iii) of this

section provided that such olefin polymers

have a minimum viscosity average molec-

ular weight of 120,000 as determined by the

method described in par. (d)(5) of this sec-

tion and a minimum Mooney viscosity of 35

as determined by the method described in

par. (d)(6) of this section, and further pro-

vided that such olefin copolymers contact

food only of the types identified in

§176.170(c) of this chapter, table 1, under

Types I, II, III, IV-B, VI, VII, VIII, and IX

0.85–0.90

3.5. Olefin copolymers, primarily non-crys-

talline, described in paragraph (a)(3)(iv) of

this section, provided that such olefin poly-

mers have a minimum viscosity average

molecular weight of 95,600 as determined

by the method described in paragraph

(d)(5) of this section, and further provided

that such olefin polymers are used only in

blends with olefin polymers described under

items 1.1, 2.1, and 2.2 of this table at a

maximum level of 25 pct by weight, and

provided that such olefin copolymers con-

tact food only of the types identified in

§176.170 (c) of this chapter, table 1, under

Types I, II, IV-B, VI, VII-B, and VIII at tem-

peratures not exceeding 190 °F

0.85–0.90

3.6.Olefin copolymers described in para-

graph (a)(3)(v) of this section for use in

blends with olefin polymer resins have a

melt flow index no greater than 5 grams/10

minutes as determined by the method de-

scribed in paragraph (d)(7) of this section

and the thickness of the finished blends

shall not exceed 0.1 millimeter (0.004 inch).

The ethylene/butene-1 copolymer may be

used subject to the following conditions: (1)

For use at a level not to exceed 20 weight

percent in polypropylene as described

under item 1.1 of this table. (2) For use at a

level not to exceed 40 weight percent in

polyethylene as described under items 2.1

and 2.2 of this table. (3) For use at a level

not to exceed 40 weight percent in olefin

copolymers as described under items 3.1

and 3.2 of this table

Not less than 0.88

21 CFR Ch. I (4–1–07 Edition) §177.1520

Olefin polymers Density

Melting Point

(MP) or softening

point (SP) (De-

grees Centi-

grade)–

Maximum extract-

able fraction (ex-

pressed as per-

cent by weight of

the polymer) in N-

hexane at speci-

fied temperatures

Maximum soluble

fraction (ex-

pressed as per-

cent by weight of

polymer) in xy-

lene at specified

temperatures

3.7. E thylene/propylene copolymers, meeting

the identity described in paragraph (a)(3)(i)

of this section, containing not less than 80

mole-percent of polymer units derived from

ethylene and having a minimum viscosity

average molecular weight of 95,000 as de-

termined by the method described in para-

graph (d)(5) of this section, and a minimum

Mooney viscosity of 13 as determined by

the method described in paragraph (d)(6) of

this section. E thylene/propylene copolymers

described in this item 3.7 are to be used

only in blends with other olefin polymers

complying with this section, at levels not to

exceed 30 percent by weight of the total

polymer blend, and in contact with food only

of types identified in §176.170(c) of this

chapter, Table 1, under Types I, II, III, IV-B,

VI, VII, VIII, and IX. Additionally, optional

adjuvants permitted for use in olefin copoly-

mers complying with item 3.4 of this table

may be used in the production of this

copolymer

Not less than 0.86

3.8. Olefin polymers described in paragraph

(a)(3)(vi) of this section, having a melt flow

index not to exceed 9.2 grams per 10 min-

utes as determined by the method de-

scribed in paragraph (d)(7) of this section,

for use in blends with other polymers at lev-

els not to exceed 8 percent by weight of

total polymer, subject to the limitation that

when contacting food of types III, IV-A, V,

VI-C, VII-A, and IX, identified in

§176.170(c) of this chapter, Table 1, the

polymers shall be used only under condi-

tions of use C, D, E, F, and G, described in

§176.170(c) of this chapter, Table 2.

3.9. Olefin copolymers described in paragraph

(a)(3)(vii) of this section may only be used

in contact with dry foods, Type VIII, as iden-

tified in §176.170(c) of this chapter, Table 1

Not less than 1.0

4. Poly(methylpentene) 0.82–0.85 MP: 235°–250 °C 6.6 pct at reflux

temperature

7.5 pct at 25 °C 5. Polyethylene copolymer described in para-

graph (a)(5) of this section and having a

melt index not to exceed 2, for use, either

alone or in blends with other olefin poly-

mers, subject to the limitation that when

contacting foods of types III, IV-A, V, VI-C,

VII-A, VIII, and IX identified in §176.170(c)

of this chapter, table 1, the thickness of the

film (in mils) containing the polyethylene

graft copolymer times the concentration of

the polyethylene graft copolymer shall not

exceed a value of 2

Not less than 0.94 .............................0.45 pct at 15 °C 1.8 pct at 25 °C

6. E thylene-maleic anhydride copolymers de-

scribed in paragraph (a)(6) of this section

for use as the adhesive component in multi-

laminate structures, or as the sealant layer

in flexible packaging, in contact with food at

temperatures not exceeding 49 °C (120 °F)

0.92 or greater ........................ 1.36 pct at 50 °C 2.28 pct at 25 °C

(d) The analytical methods for deter-mining whether olefin polymers con-form to the specifications prescribed in this section are as follows, and are ap-plicable to the basic polymer in film form not exceeding 4 mils in thickness.

Food and Drug Administration, HHS §177.1520

The film to be tested shall be cut into approximately 1-inch squares by any convenient method that avoids con-tamination by dust, dirt, or grease (N OTE: Do not touch samples with bare fingers—use forceps to hold or transfer samples).

(1) Density. Density shall be deter-mined by ASTM method D1505–68 (Re-approved 1979), ‘‘Standard Test Method for Density of Plastics by the Density- Gradient Technique,’’ which is incor-porated by reference. Copies may be obtained from the American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be examined at the National Archives and Records Ad-ministration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http:// https://www.wendangku.net/doc/155981759.html,/federal l register/

code l of l federal l regulations/

ibr l locations.html.

(2) Melting point or softening point—(i) Melting point. The melting point shall be determined by ASTM method D2117– 82, ‘‘Standard Test Method for Melting Point of Semicrystalline Polymers by the Hot Stage Microscopy Method,’’ which is incorporated by reference. The availability of this incorporation by reference is given in paragraph (d)(1) of this section.

(ii) Softening point. The softening point shall be determined by ASTM method E28–67 (Reapproved 1982), ‘‘Standard Test Method for Softening Point by Ring-and-Ball Apparatus,’’ which is incorporated by reference. The availability of this incorporation by reference is given in paragraph (d)(1) of this section.

(3) Maximum extractable fraction in n- hexane—(i) Olefin copolymers described in paragraph (a)(3)(ii) of this section, polypropylene, and poly(methylpentene).

A sample is refluxed in the solvent for

2 hours and filtered at the boiling point. The filtrate is evaporated and the total residue weighed as a measure of the solvent extractable fraction.

(a) Apparatus. (1) E rlenmeyer flasks, 250-milliliter, with ground joint.

(2) Condensers, Allihn, 400-millimeter jacket, with ground joint.

(3) Funnels, ribbed 75-millimeter di-ameter, stem cut to 40 millimeters.

(4) Funnels, Buchner type, with coarse-porosity fritted disc, 60-milli-meter diameter.

(5) Bell jar for vacuum filtration into beaker.

(b) Reagent. n-Hexane, commercial grade, specific gravity 0.663–0.667 (20 °C/ 20 °C), boiling range 66 °C-69 °C, or equivalent.

(c) Procedure. Weigh 1 gram of sample accurately and place in a 250-milliliter E rlenmeyer flask containing two or three boiling stones. Add 100 milliliters of solvent, attach the flask to the con-denser (use no grease), and reflux the mixture for 2 hours. Remove the flask from the heat, disconnect the con-denser, and filter rapidly, while still hot, through a small wad of glass wool packed in a short-stem funnel into a tared 150-millimeter beaker. Rinse the flask and filter with two 10-milliliter portions of the hot solvent, and add the rinsings to the filtrate. E vaporate the filtrate on a stream bath with the aid of a stream of nitrogen. Dry the res-idue in a vacuum oven at 110 °C for 2 hours, cool in a desiccator, and weigh to the nearest 0.0001 gram. Determine the blank on 120 milliliters of solvent evaporated in a tared 150-milliliter beaker. Correct the sample residue for this blank if significant. Calculation:

Grams of residue Grams of sample Percent extractable with

×

=

100

n-hexane.

(ii) Olefin copolymers described in para-graph (a)(3)(i) of this section and poly-ethylene. A preweighed sample is ex-tracted at 50 °C for 2 hours and filtered. The filtrate is evaporated and the total residue weighed as a measure of the solvent extractable fraction. Alter-natively, the sample is reweighed after the extraction period to give a measure of the solvent extractable fraction. The

21 CFR Ch. I (4–1–07 Edition) §177.1520

maximum n-hexane-extractable frac-tion may be determined by the meth-ods set forth in paragraphs (d)(3)(ii)(a) through (d)(3)(ii)(i) of this section.

(a) Extraction apparatus. Two-liter, straight-walled, Pyrex (or equivalent) resin kettles, fitted with three-hole ground-glass covers are most conven-ient for this purpose. The cover is fitted with a thermometer, a gas-tight stirrer driven by an air motor or explo-sion-proof electric motor, and a reflux condenser. The kettle is fitted with an electric heating mantle of appropriate size and shape, which is controlled by a variable-voltage transformer.

(b) Evaporating apparatus. Rapid evaporation of large volumes of solvent requires special precautions to prevent contamination by dust. This is facili-tated by a special ‘‘gas’’ cover con-sisting of an inverted flat Pyrex crys-tallizing dish of an appropriate size (190 millimeters × 100 millimeters) to fit a 1-liter beaker. Through the center of the dish are sealed an inlet tube for preheated, oxygen-free nitrogen, and an outlet tube located 1 inch off center. Nitrogen is fed from the supply source through a coil of 1?4-inch stainless steel tubing immersed in the same steam bath used to supply heat for solvent evaporation. All connections are made with flexible tetrafluoroethylene tub-ing.

(c) Reagents—(1) n-Hexane. Spectro-grade n-hexane.

(2) Nitrogen. High-purity dry nitrogen containing less than 10 parts per mil-lion of oxygen.

(d) Procedure. Transfer 2.5 grams (ac-curately weighed to nearest 0.001 gram) of the polymer to the resin kettle. Add 1 liter of solvent and clamp top in posi-tion. Start water flowing through jack-

et of the reflux condenser and apply air pressure to the stirring motor to produce vigorous agitation. Turn on heating jacket with transformer set at a predetermined voltage to bring the temperature of the contents to 50 °C within 20–25 minutes. As the thermom-eter reading approaches 45 °C–47 °C, re-duce the voltage to the predetermined setting that will just maintain the temperature at 50 °C. Do not overshoot the prescribed temperature. Should this occur discard the test and start afresh. E xactly 2 hours after the sol-vent temperature has reached 50 °C, disconnect the heater, remove the resin kettle from the heating jacket, and de-cant the solvent, while still warm, through a coarse filter paper placed on top of a fritted-glass funnel, collecting the filtrate in a tared, glass-stoppered E rlenmeyer flask of 1-liter capacity. Determine the weight of the filtrate re-covered to the nearest gram. Recovery should be at least 90 percent of the original solvent. Losses due to evapo-ration during heating and filtering have been found not to exceed 10 per-cent. Transfer about half of the solvent filtrate to a 1-liter beaker placed on an opening in the steam bath and imme-diately cover with the special ‘‘gas’’ cover, the inlet tube of which has been attached with flexible tetrafluoro-ethylene tubing to a source of high-pu-rity nitrogen in series with a stainless steel heating coil immersed directly in the body of the steam bath. Maintain a positive flow of warm nitrogen gas throughout the evaporation of the sol-vent, adding the remainder of the fil-trate from the Erlenmeyer flask as the evaporation proceeds. When the volume of the solvent has been reduced to about 50 milliliters, transfer the con-centrated liquid to a previously tared weighing dish of suitable size. Wash the beaker twice with 20–30 milliliter por-tions of warm solvent, adding the washings to the weighing dish while continuing to evaporate the remainder of the solvent under the gas cover with its flow of warm nitrogen directed to-ward the center of the dish. In the event that an insoluble residue that cannot be removed with warm solvent remains in the beaker, it may be nec-essary to heat with a small amount of a higher boiling solvent such as ben-zene or toluene, transferring these washings to the weighing dish before final evaporation to dryness. Transfer the weighing dish with its residue to a vacuum desiccator, and allow it to re-main overnight (at least 12 hours), after which the net weight of the dry residue is determined to the nearest 0.0001 gram. Correct the result for any solvent blank equivalent to the non-volatile matter determined to be con-tained in the amount of solvents used in the test.

Food and Drug Administration, HHS §177.1520

(e) Extraction apparatus for alternate

method. Two-liter extraction vessel,

such as a resin kettle or round bottom

flask, fitted with an Allihn condenser

(size C), a 45/50 male joint with a Teflon

sleeve, and a Teflon coated stir bar.

Water bath maintained at 49.5 °C ±0.5 °C containing a submersible magnetic stirrer motor with power supply. Other

suitable means of maintaining tem-

perature control, such as electric heat-

ing mantles, may be used provided that

the temperature range can be strictly

maintained.

(f) Sample basket (Optional). A per-

forated stainless steel cylindrical bas-

ket that is approximately 1.5 inches in

diameter, 1.6 inches high, and has per-

forations of 0.125 inches in diameter for

33 holes/in2, or 40 percent open area.

The basket should pass freely through

the 45/50 female joint of the extraction

flask. A No. 6–32 stainless steel eye-

bolt is attached to the lid for posi-

tioning the basket in the extraction

vessel. The positioning rod, approxi-

mately 18 inches long and made from 1/

16 inch outside diameter 316 stainless

steel welding rod or equivalent and

hooked at both ends, is used to position

the basket in the extraction apparatus.

(g) Vacuum oven. Capable of main-

taining 80 °C ±5 °C and a minimum of

635 millimeters of mercury pressure.

(h) Reagents. n-Hexane, reagent or

spectrograde, aromatic free (less than 1

milligram per liter), minimum 85 per-

cent n-hexane. This reagent may be re-

used until it contains a maximum of 1.5

grams polyolefin extractables or has

been used for 12 determinations.

(i) Procedure. Assemble the extraction

vessel, condenser, and magnetic stir

bar. Add n-hexane (1 liter) to the ex-

traction vessel and clamp the assembly

into a water bath set at 49.5 °C ±0.5 °C.

Start the water flowing through the

jacket of the reflux condenser. Adjust

the air flow through the stirring motor

to give a smooth and uniform stir rate.

Allow the n-hexane to preheat for 1

hour to bring the temperature to 49.5 °C±0.5 °C. Temperature is a critical fac-tor in this analysis and it must not vary more than 1 °C. If the temperature exceeds these limits, the test must be discontinued and restarted. Blown, compression molded, or extrusion cast films can be tested. Ideally, the film should be prepared by the same process as will be used with the production resin. Using gloves and metal tweezers to avoid sample contamination, cut about 2.7 grams of the prepared film (4 mils or less in thickness) into about 1- inch squares using clean sharp scissors. Proceed with Option 1 or 2.

Option 1. Using tweezers and noting the number of film pieces, transfer 2.5 grams (accurately weighed to 0.1 milli-gram) of polymer to the extraction ves-sel. E xtract the film sample for 2 hours. Allow the vessel to cool and fil-ter the contents through a fritted por-celain funnel. Wash the film pieces with fresh n-hexane, aspirate to dry-ness, and transfer, using tweezers, to a beaker. Recount the film pieces to verify that none were lost during the transfer. Place the beaker in the vacu-um oven for 2 hours at 80 °C ±5 °C. After 2 hours, remove and place in a desic-cator to cool to room temperature (about 1 hour). After cooling, reweigh the film pieces to the nearest 0.1 milli-gram. Calculate the percent hexane- extractables content from the weight loss of the original sample. Multiply the result by 0.935 and compare with extraction limits in paragraph (c) of this section. Repeat the above proce-dure for successive samples.

Option 2. Transfer 2.5±0.05 grams of the prepared 1-inch film sections into a tared sample basket and accurately weigh to the nearest 0.1 milligram. Carefully raise the condenser until the hook on the positioning rod is above the neck of the 2-liter extraction ves-sel. The basket should be totally below the level of n-hexane solvent. E xtract the sample resin film for 2 hours and then raise the basket above the solvent level to drain momentarily. Remove the basket and rinse the contents by immersing several times in fresh n- hexane. Allow the basket to dry be-tween rinsings. Remove the excess sol-vent by briefly blowing the basket with a stream of nitrogen or dry air. Place the basket in the vacuum oven for 2 hours at 80 °C ±5 °C. After 2 hours, re-move and place in a desiccator to cool to room temperature (about 1 hour). After cooling, reweigh the basket to the nearest 0.1 milligram. Calculate

21 CFR Ch. I (4–1–07 Edition)

§177.1520 the percent hexane extractables con-tent from the weight loss of the origi-nal sample. Multiply the result by 0.935 and compare with extraction limits in paragraph (c) of this section. Repeat the above procedure for successive samples. The same solvent charge should remain clear and can be used for at least 12 determinations. Applica-tions of solvent reuse should be con-firmed for each resin type before use. (4) Maximum soluble fraction in xy-lene —(i) Olefin copolymers described in paragraph (a )(3)(ii ) of this section, poly-propylene, and poly (methylpen-tene ). A sample is dissolved completely in xy-lene by heating and stirring in a bottle with little free space. The solution is allowed to cool without stirring, whereupon the insoluble portion pre-cipitates and is filtered off; the total solids content of the filtrate is then de-termined as a measure of the soluble fraction.

(a ) Apparatus. (1) Pyrex (or equiva-lent) reagent bottle, 125-milliliter, glass-stoppered.

(2) Heating mantle of size for 150-mil-liliter beaker (or suitable aluminum block to fit the 125-milliter bottle de-scribed in paragraph (d)(4)(i)(a )(1) of this section.

(3) Magnetic stirrer for use under the heating mantle (combination magnetic stirrer and hotplate may be used if alu-minum block is used in place of heat-ing mantle).

(4) Variable-voltage transformer, 7.5 amperes.

(5) Tetrafluoroethylene-resin-coated stirring bar, 1-inch long.

(6) Constant temperature water bath maintained at 25 °C ±0.5 °C.

(7) Aluminum dishes, 18 millimeters × 60 millimeters, disposable.

(8) Funnel, Buchner type, with coarse-porosity fritted disc, 30–60 milli-meter diameter.

(b ) Reagent. Xylene with antioxidant. Dissolve 0.020 gram of phenyl-b - naph-thylamine in 1 liter of industrial grade

xylene having specific gravity 0.856– 0.867 (20 °C/20 °C) and boiling range 123 °C–160 °C. (c ) Procedure. Weigh 1 to 2 grams of sample to the nearest 0.001 gram and place in a 125-milliliter Pyrex reagent bottle containing a 1-inch long tetra-fluoroethylene-resin-coated stirring

bar. Add 100 milliliters of solvent, set

the stopper in lightly, and place the bottle in the heating mantle or alu-minum block maintained at a tempera-ture of 120 °C, and stir with a magnetic stirrer until the sample is completely dissolved. Remove the bottle from the heat and allow it to cool 1 hour in the air, without stirring. Then place the bottle in a water bath maintained at 25

°C ±0.5 °C, and allow to stand 1 hour without stirring. Next, remove the bot-tle from the water bath, shake, and

pour part of the contents into the

coarse-porosity fritted-glass funnel. Apply suction, and draw 30–40 milli-liters of filtrate through, adding more

slurry to the funnel, and catching the filtrate in a large test tube. (If the slurry is hard to filter, add 10 grams of

diatomaceous earth filter aid to the bottle and shake vigorously just prior

to the filtration.) Pipet a suitable ali-quot (preferably 20 milliliters) of the filtrate into a tared aluminum dispos-able dish. Place the dish on a steam

bath covered with a fresh sheet of alu-minum foil and invert a short-stemmed 4-inch funnel over the dish. Pass nitro-gen (heated if desired) down through the funnel at a rate sufficient to just

ripple the surface of the solvent. When the liquid has evaporated, place the

dish in a vacuum oven at 140 °C and less than 50 millimeters mercury pres-sure for 2 hours. Cool in a desiccator and weigh. (Note: If the residue value seems high, redry in the vacuum oven

for one-half hour to ensure complete removal of all xylene solvent.) Calcula-tion:

Grams of r Percent so esidue Grams of sample

milliters

volume of aliquot in milliliters

luble in xylene

×

×=100100

Food and Drug Administration, HHS §177.1520

(ii) Olefin copolymers described in para-graph (a )(3)(i ) of this section and poly-ethylene. A sample is extracted in xy-lene at reflux temperature for 2 hours and filtered. The filtrate is evaporated and the total residue weighed as a measure of soluble fraction. (a ) Apparatus —(1) Extraction appa-ratus. Two-liter, straight-walled Pyrex (or equivalent) resin kettles, fitted with ground-glass covers, are most con-venient for this purpose. The cover is equipped with a thermometer and an efficient reflux condenser. The kettle is fitted with an electric heating mantle of appropriate size and shape which is controlled by a variable-voltage trans-former. (2) Constant temperature water bath. It must be large enough to permit immer-sion of the extraction kettle and set to maintain 25 °C ±0.1 °C. (3) Evaporating apparatus. Gas cover consisting of a flat Pyrex crystallizing dish (190 millimeters × 100 millimeters) inverted to fit over a 1-liter beaker with 8-millimeter gas inlet tube sealed through center and an outlet tube 1 inch off center. The beaker with gas cover is inserted in an electric heating mantle equipped with a variable-volt-age transformer. The outlet tube is at-tached to an efficient condenser mounted on a receiving flask for sol-vent recovery and having an outlet for connection to an aspirator pump. The heating mantle (with the beaker) is mounted on a magnetic stirring device. An infrared heat lamp is mounted vertically 3–4 inches above the gas cover to prevent condensation of the solvent inside the cover. Make all con-nections with flexible tetrafluoro-ethylene tubing. (b ) Reagents —(1) Xylene. American Chemical Society reagent grade that has been redistilled through a fractionating column to reduce the nonvolatile residue. (2) Nitrogen. High-purity dry nitrogen containing less than 104parts per mil-lion oxygen. (c ) Procedure. Transfer 5 grams ±0.001 gram of sample to the resin kettle, add 1,000 milliliters (840 grams) of xylene, and clamp top in position after insert-ing a piece of glass rod to prevent bumping during reflux. Start water flowing through the jacket of the reflux condenser and apply full voltage (115 volts) to the heating mantle. When the xylene starts to boil, reduce the voltage to a level just sufficient to maintain reflux. After refluxing for at least 2 hours, disconnect the power source to the mantle, remove the ket-tle, and allow to cool in air until the temperature of the contents drops to 50 °C, after which the kettle may be rap-idly cooled to 25 °C–30 °C by immersing in a cold water bath. Transfer the ket-tle to a constant temperature bath set to maintain 25 °C ±0.1 °C, and allow to equilibrate for a least 1 hour (may be left overnight if convenient). Break up any precipitated polymers that may have formed, and decant the xylene so-lution successively through a fast filter paper and then through a fritted-glass

filter into a tared 1-liter E rlenmeyer flask, collecting only the first 450 mil-liliters—500 milliliters of filtrate (any attempt to collect more of the xylene solution usually results in clogging the filter and risking losses). Reweigh the E rlenmeyer flask and calculate the weight of the filtrate obtained to the nearest 0.1 gram. Transfer the filtrate, quantitatively, from the E rlenmeyer flask to the 1-liter beaker, insert the beaker in its heating mantle, add a glass-coated magnetic stirring bar, and mount the gas cover in place, con-necting the inlet tube to the nitrogen source and the outlet to the condenser of the receiving flask. Start a flow of nitrogen (2 to 3 liters per minute) into the gas cover and connect an aspirator to the receiver using a free-flow rate equivalent to 6–7 liters of air per minute. With the infrared lamp on, ad-just the voltage to the heating mantle to give a distillation rate of 12–13 milli-liters per minute when the magnetic stirrer is revolving just fast enough to promote good boiling. When the vol-ume of solvent in the beaker has been reduced to 30–50 milliliters, transfer the concentrated extractive to a suit-able weighing dish that has been pre-viously tared (dry). Rinse the beaker twice with 10–20 milliliter portions of fresh xylene, adding the rinsings to the weighing dish. E vaporate the remain-der of the xylene on an electric hotplate set at low heat under the gas cover with a stream of nitrogen di-rected toward the center of the dish.

21 CFR Ch. I (4–1–07 Edition) §177.1520

Avoid any charring of the residue. Transfer the weighing dish to a vacu-um desiccator at room temperature and allow to remain under reduced pressure for at least 12 hours (over-night), after which determine the net weight of the residue to the nearest 0.0001 gram. Correct the result for non-volatile solvent blank obtained by evaporating the equivalent amount of xylene under identical conditions. Cal-culate the weight of residue originally present in the total weight of solvent (840 grams), using the appropriate fac-tor based on the weight of filtrate evaporated.

(5) Viscosity average molecular weight olefin copolymers described in paragraphs (a)(3) (iii) and (iv) of this section. The viscosity average molecular weight shall be determined from the kine-matic viscosity (using ASTM method D445–74, ‘‘Test for Kinematic Viscosity of Transparent and Opaque Liquids’’ (Revised 1974), which is incorporated by reference; copies are available from American Society for Testing and Ma-terials (ASTM), 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or available for inspection at the National Archives and Records Ad-ministration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http:// https://www.wendangku.net/doc/155981759.html,/federal l register/

code l of l federal l regulations/

ibr l locations.html.) of solutions of the copolymers in solvents and at tempera-tures as follows:

(i) Olefin polymers described in para-graph (a)(3)(iii) of this section in decahydronaphthalene at 135 °C.

(ii) Olefin polymers described in paragraph (a)(3)(iv) of this section in tetrachloroethylene at 30 °C.

(6) Mooney viscosity—olefin copolymers described in paragraph (a)(3)(iii) of this section. Mooney viscosity is determined by ASTM method D1646–81, ‘‘Standard Test Method for Rubber—Viscosity and Vulcanization Characteristics (Mooney Viscometer),’’ which is incorporated by reference (the availability of this in-corporation by reference is given in paragraph (d)(1) of this section), using the large rotor at a temperature of 100 °C, except that a temperature of 127 °C shall be used for those copolymers whose Mooney viscosity cannot be de-termined at 100 °C. The apparatus con-taining the sample is warmed for 1 minute, run for 8 minutes, and vis-cosity measurements are then made. (7) Melt flow index. The melt flow index of olefin polymers described below shall be determined by ASTM method D–1238–82, ‘‘Standard Test Method for Flow Rates of Thermo-plastics by E xtrusion Plastometer,’’ which is incorporated by reference in accordance with 5 U.S.C. 552(a). The availability of this incorporation by reference is given in paragraph (d)(1) of this section. The olefin polymers and test conditions and procedures are as follows:

List of polymers Conditions/procedures Olefin copolymers described in para-

graph (a)(3)(i)(c)(2) of this section.

Condition L, proce-

dure A.

Olefin copolymers described in para-

graph (a)(3)(v) of this section.

Condition E, proce-

dure A.

Olefin polymers described in para-

graph (a)(2)(ii) of this section.

Condition E, proce-

dure A.

Olefin polymers described in para-

graph (a)(3)(vi) of this section.

Condition E, proce-

dure A.

(8) Melting peak temperature. The melt temperature of the olefin polymers de-scribed in paragraph (a)(3)(ii) of this section shall be determined by ASTM method D 3418–82, ‘‘Standard Test Method for Transition Temperatures of Polymers by Thermal Analysis,’’ which is incorporated by reference in accord-ance with 5 U.S.C. 552(a). The avail-ability of this incorporation by ref-erence is given in paragraph (d)(1) of this section.

(9) Intrinsic viscosity. The intrinsic viscosity of the olefin polymers de-scribed in paragraph (a)(3)(ii) of this section shall be determined by ASTM method D 1601–78, ‘‘Standard Test Method for Dilute Solution Viscosity of Ethylene Polymers,’’ which is incor-porated by reference in accordance with 5 U.S.C. 552(a). The availability of this incorporation by reference is given in paragraph (d)(1) of this section.

(e) Olefin copolymers described in paragraph (a)(3) (i) of this section and polyethylene, alone or in combination, may be subjected to irradiation bom-bardment from a source not to exceed 2.3 million volts intensity to cause mo-lecular crosslinking of the polymers to impart desired properties, such as in-creased strength and increased ability to shrink when exposed to heat.

Food and Drug Administration, HHS

§177.1550

(f) The olefin polymers identified in and complying with this section, when used as components of the food-contact surface of any article that is the sub-ject of a regulation in parts 174, 175, 176, 177, 178, and §179.45 of this chapter, shall comply with any specifications and limitations prescribed by such reg-ulation for the article in the finished form in which it is to contact food.

(g) The provisions of this section are not applicable to olefin polymers iden-tified in §175.105(c) (5) of this chapter and used in food-packaging adhesives complying with §175.105 of this chapter.

[42 FR 14572, Mar. 15, 1977] E DITORIAL N OTE : For F EDERAL R EGISTER ci-tations affecting §177.1520, see the List of

CFR Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access. §177.1550Perfluorocarbon resins.

Perfluorocarbon resins identified in this section may be safely used as arti-cles or components of articles intended

to contact food, subject to the provi-sions of this section: (a) Identity. For the purpose of this section, perfluorocarbon resins are

those produced by: (1) The homopolymerization and/or copolym-erization of hexafluoropropylene and

tetrafluoroethylene, and (2) the co-polymerization of perfluoropropylvinylether and tetra-fluoroethylene (CAS Reg. No. 26655–00–

5). The resins shall meet the extrac-tives limitations in paragraph (d) of this section.

(b) Optional components. The

perfluorocarbon resins identified in

paragraph (a) of this section as well as

articles or coating made from these

resins may include the following op-tional components except that the resin identified in paragraph (a)(2) of this section may not be used with the optional component, lithium

polysilicate, mentioned in paragraph (b)(4) of this section.

(1) Substances generally recognized as safe (GRAS) in food or food pack-aging subject to any limitations cited on their use.

(2) Substances used in accordance

with a prior sanction or approval, sub-ject to any limitations cited in the prior sanction or approval.

(3) Substances authorized under ap-plicable regulations in this part and in parts 175 and 178 of this chapter and subject to any limitations prescribed therein.

(4) The following substances, subject to any limitations prescribed:

List of substances

Limitations

Lithium polysilicate containing not more than 20 weight per-cent silica, not more than 2.1 percent lithium oxide and having a maximum mole ratio of Si02/Li 20 of 8.5 to 1.For use only as a compo-nent of repeated-use coatings not exceeding 0.030 millimeter (0.0012 inch) in thickness where the coatings are thermally

cured at minimum sinter-ing temperatures of 371

°C (700 °F). Lithium ex-tractives shall not exceed 1.55 milligrams per square decimeter (0.1

milligram per square inch) of coating surface when tested in accordance with

paragraph (e)(2) of this section. Naphthalene sulfonic acid formaldehyde condensate, sodium salt.For use only:

1. As a component of re-peated-use coatings,

based on the perfluorocarbon resin identified in paragraph

(a)(1) of this section, not to exceed 0.030 milli-meter (0.0012 inch) in thickness, and at a level

not to exceed 0.4 weight percent of the coating. 2. As a component of re-peated-use coatings, based on the

perfluorocarbon resin identified in paragraph (a)(2) of this section, not to exceed 0.10 millimeter

(0.004 inch) in thickness,

and at a level not to ex-ceed 0.4 weight percent of the coating. (c) Optional processing. Poly- tetra-fluoroethylene resins may be irradi-ated by either a cobalt-60 sealed source, at a maximum dose of gamma radiation not to exceed 7.5 megarads, or an electron beam at energy levels

not to exceed 2.5 million electron volts with a maximum dosage of 7.5

megarads, to produce lubricant pow-ders having a particle diameter of not more than 20 microns for use only as components of articles intended for re-peated use in contact with food. (d) Specifications —(1) Infrared identi-fication. Perfluorocarbon resins can be identified by their characteristic infra-red spectra.

21 CFR 820 美国FDA,质量体系(QS)法规医疗器械良好生产规范(中文),2020年5月最新版

标题21-食物和毒品 第一章-食品和药物管理局 卫生和人类服务部 第h章-医疗设备 第820部分质量体系监管 A部分----一般规定 秘书。820.1范围。 (a)适用性。（1）本质量体系条例规定了现行良好制造做法要求。本部分的要求指导所有用于人类使用的成品设备的设计、制造、包装、标签、储存、安装和维修所使用的方法以及所使用的设施和控制。本部分的要求旨在确保成品设备将是安全和有效的，否则符合联邦食品、药品和化妆品法案（该法案）。本部分确立了适用于成品医疗器械生产厂家的基本要求..如果制造商只从事符合本部分要求的某些操作，而不是其他操作，则该制造商只需遵守适用于其所从事操作的要求。关于I类设备，设计控制只适用于820.30(A)（2）中列出的设备。本条例不适用于部件制造商或成品设备部件制造商，但鼓励这些制造商使用本条例的适当规定作为指导。用于输血或进一步制造的血液和血液成分的制造商不受本部分的限制，但受本章F节的限制。本章第1271.3(d)段所界定的人体细胞、组织、细胞和组织产品制造商，即医疗设备（根据该法的设备规定提交的申请或根据《公共卫生服务法》第351节提交的生物产品许可证申请，须接受市场前审查或通知，或免于通知），均须遵守本章第1271节C部分所规定的供者资格程序适用本章第1271节D部分现行良好做法程序。如果第1271部分和本章其他部分中的适用条例发生冲突，则具体适用于该装置的条例应取代较一般的条例。 （2）本部分的规定适用于在美国任何州或领土、哥伦比亚特区或波多黎各自由邦制造、进口或提供进口的本部分所界定的供人类使用的任何成品装置。 （3）本条例多次使用“酌情”一词。如果一项要求被“酌情”限定，则被认为是“适当的”，除非制造商可以另有证明。如果合理地预期不实施会导致产品不符合其规定的要求或制造商无法采取任何必要的纠正行动，则要求是“适当的”。 (b)本部分的质量体系条例补充了本章其他部分的规定，但另有明确说明的除外。如果本部分的适用法规与本章其他部分发生冲突，则具体适用于该装置的法规应取代任何其他普遍适用的要求。 (c)权力。第820部分是在该法第501、502、510、513、514、515、518、519、520、522、701、704、801、803节的授权下设立和发布的(21U.S.C。351、352、360、360c、360d、360e、360h、360i、360j、360l、371、374、381、383)。未能遵守本部分的任何适用规定，使设备在该法第501(H)节中掺假。这种装置以及任何不遵守规定的责任人都要受到管制。 (d)外国制造商。如果提供进口到美国的设备的制造商拒绝允许或允许完成食品和药物管理局(FDA)对外国设施的检查，以确定是否符合这一部分，则为该法第801(a)条的目的，应表明该法中使用的方法以及用于设计、制造、包装、标签、储存、安装的设施和控制，或维修在该设施生产的任何设备，而这些设备是提供进口到美国的，不符合该法第520(F)节和本部分的要求，以及该设施制造的设备是根据该法第501(H)节掺假的。 (e)豁免或差额。（1）任何人如欲申请豁免或更改任何设备质量体系要求，须遵守该法第520(f)（2）条的规定。豁免或差异的申请应按照本章第10.30条规定的程序，即FDA的行政程序提交。可从食品和药物管理局、设备和放射卫生中心、小制造商司、国际和消费者援助司、新罕布什尔州大道10903号，Bldg获得指导。66，RM。4613，银弹簧，MD20993-0002，1-800-638-2041或301-796-7100，传真：301-847-8149。 （2）当机构确定这种差异符合公共卫生的最佳利益时，林业发展局可根据任何设备质量系统的要求提出和批准差异。只有在公共卫生对该装置仍有需要的情况下，而且在没有这种差异的情况下不可能充分提供该装置，这种差

FDA医疗器械质量体系手册

FDA医疗器械质量体系手册 When finished device manufacturers produce components specifically for use in medical devices they produce, whether in the same building or another location, such production of components is considered part of the device manufacturing operations, and the production should comply with the QS regulation. 当成品制造商生产专门用于其产品的零件时，不管是在同一楼内或另外地点，这样的零件生产是视为器械生产作业的一部分，并且其生产应顺从QS法规的要求。 Accessory devices [807.20(a)(5)] such as hemodialysis tubing or major diagnostic xray components, that are packaged, labeled, and distributed separately to a hospital, physician, etc., for healthrelated purposes are sometimes inappropriately referred to as components. However, FDA considers them finished devices because they are suitable for use or capable of functioning and are distributed for health-related purposes; and the QS regulation applies to their manufacture. Similarly, a device or component including software that is sold as an addition to a finished medical device to augment or supplement its performance is also termed an accessory. An accessory to a medical device is considered a finished device and, therefore, is subject to the QS regulation. 附件器械[807.20(a)(5)]，诸如血透仪管或X光诊断仪的主零件，这些包装了的，标志了的，并且分开销往医院或医生的用于健康目的，有时被不正确地作为零件对待。然而，FDA认为它们是成品器械因为它们可以使用于或作用于并且销售来为健康相关的目的；并且QS法规要应用When finished device manufacturers produce components specifically for use in medical devices they produce, whether in the same building or another location, such production of components is considered part of the device manufacturing operations, and the production should comply with the QS regulation. 当成品制造商生产专门用于其产品的零件时，不管是在同一楼内或另外地点，这样的零件生产是视为器械生产作业的一部分，并且其生产应顺从QS法规的要求。 Accessory devices [807.20(a)(5)] such as hemodialysis tubing or major diagnostic xray components, that are packaged, labeled, and distributed separately to a hospital, physician, etc., for healthrelated purposes are sometimes inappropriately referred to as components. However, FDA considers them finished devices because they are suitable for use or capable of functioning and are distributed for health-related purposes; and the QS regulation applies to their manufacture. Similarly, a device or component including software that is sold as an addition to a finished medical device to augment or supplement its performance is also termed an accessory. An accessory to a medical device is considered a finished device and, therefore, is subject to the QS regulation. 附件器械[807.20(a)(5)]，诸如血透仪管或X光诊断仪的主零件，这些包装了的，标志了的，并且分开销往医院或医生的用于健康目的，有时被不正确地作为零件对待。然而，因为它们可以使用于或作用于并且销售来为健康相关的目的，FDA认为它们是成品器械；并且QS法规要应于其生产。同样的，装置或零件包括软件是作为成品医疗器械的附加部分销售的，以增加或补充其性能，也作为附件器械对待。既然医疗器械的附件是作为成品来对待，因而受QS法规制约。

美国FDA_医疗器械体系法规QSR820中英文版

美国FDA 医疗器械体系法规QSR820中文版Part 820——质量体系法规——目录 Subpart A- 总则 820.1 范围 820.3 定义 820.5 质量体系 Subpart B –质量体系要求 820.20 管理职责 820.22 质量审核 820.25 人员 Subpart C- 设计控制 820.30 设计控制 Subpart D- 文件控制 820.40 文件控制 Subpart E- 采购控制 820.50 采购控制 Subpart F- 标识与可追溯性 820.60 标识 820.65 可追溯性 Subpart G - 生产和过程控制 820.70 生产和过程控制 820.72 检验、测量和试验设备 820.75 过程确认 Subpart H - 验收活动: 820.80 进货、过程和成品器械检验 820.86 检验状态 Subpart I –不合格品 820.90 不合格品 Subpart J - 纠正和预防措施 820.100 纠正和预防措施 Subpart K –标识和包装控制 820.120 设备标签 820.130 设备包装

Subpart L –搬运/储存/分销和安装 820.140 搬运 820.150 贮存 820.160 分销 820.170 安装 Subpart L –记录 820.180 记录的通用要求 820.181 设备主要记录 820.184 设备历史记录 820.186 质量体系记录 820.198 投诉文件 Subpart M –服务 820.200 服务 Subpart N –统计技术 820.250 统计技术 Subpart A——总则 Subpart A--General Provisions Sec.820.1 范围 Sec. 820.1 Scope. （a）适用性Applicability。 （1）本质量体系法规阐明了当前良好制造法规Current good manufacturing practice （CGMP）的要求。本标准适用于所有预期用于人类的成品器械的设计、制造、包装、标识、储存、安装和服务中所使用的管理方法、设施和控制。本标准的目的是保证成品器械的安全性和有效性，并符合联邦食品、药品和化妆品法案Federal Food, Drag and Cosmetic Act （the act）。本法规适用于所有的医疗器械成品制造商。如果制造商仅从事本部分有要求服从的某些过程而未从事其它过程，则只需符合其实施的过程的要求。对于Ⅰ类设备，设计控制仅适用于Sec.820.30（a）（2）中列出的设备。本法规不适用于成品器械的部件或零件制造商，但鼓励这类制造商把本法规的适当规定作为指南来使用。人血和血液成分制造商不受本部分法规的限制，但应遵循本章606部分法规的要求。 Current good manufacturing practice (CGMP) requirements are set forth in this quality system regulation. The requirements in this part govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. The requirements in this part are intended to ensure that finished devices will be safe and effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act (the act). This part establishes basic requirements applicable to manufacturers of finished medical devices. If a manufacturer engages in only some operations subject to the requirements in this part, and not in others,

美国FDA-医疗器械体系法规QSR820中英文版

培训教材 美国FDA 医疗器械体系法规 QSR820中文版

Part 820——质量体系法规——目录 Subpart A- 总则 范围 定义 质量体系 Subpart B –质量体系要求 管理职责 质量审核 人员 Subpart C- 设计控制 设计控制

Subpart D- 文件控制 文件控制 Subpart E- 采购控制 采购控制 Subpart F- 标识与可追溯性 标识 可追溯性 Subpart G - 生产和过程控制 生产和过程控制 检验、测量和试验设备 过程确认 Subpart H - 验收活动: 进货、过程和成品器械检验 检验状态 Subpart I –不合格品 不合格品 Subpart J - 纠正和预防措施 纠正和预防措施 Subpart K –标识和包装控制 设备标签 设备包装 Subpart L –搬运/储存/分销和安装 搬运 贮存 分销 安装 Subpart L –记录 记录的通用要求 设备主要记录 设备历史记录 质量体系记录 投诉文件 Subpart M –服务 服务 Subpart N –统计技术 统计技术

Subpart A——总则 Subpart A--General Provisions 范围 Sec. Scope. （a）适用性Applicability。 （1）本质量体系法规阐明了当前良好制造法规Current good manufacturing practice （CGMP）的要求。本标准适用于所有预期用于人类的成品器械的设计、制造、包装、标识、储存、安装和服务中所使用的管理方法、设施和控制。本标准的目的是保证成品器械的安全性和有效性，并符合联邦食品、药品和化妆品法案Federal Food, Drag and Cosmetic Act （the act）。本法规适用于所有的医疗器械成品制造商。如果制造商仅从事本部分有要求服从的某些过程而未从事其它过程，则只需符合其实施的过程的要求。对于Ⅰ类设备，设计控制仅适用于（a）（2）中列出的设备。本法规不适用于成品器械的部件或零件制造商，但鼓励这类制造商把本法规的适当规定作为指南来使用。人血和血液成分制造商不受本部分法规的限制，但应遵循本章606部分法规的要求。 （2）本部分的规定适用于本部分定义的预期用于人体的所有成品器械，不论其在美国(包含:美国任何州或领土,哥伦比亚特区,波多黎各联邦)本土制造还是进口,提供进口的产品。 （3）在本法规中“适用时”（where appropriate）出现过多次。当要求根据“where appropriate”被认为是合格时，其要求应被认为是“适用的”（appropriate），除非组织能提供文件证明其理由。如果不执行预期结果会导致产品不符合其特定的要求，或组织不需要执行任何必要的纠正措施，那么要求就是适用的（appropriate）。 （b）限制。除非特别规定，则本部分质量体系法规是本章其它部分法规的补充要求。在不能符合所有适用的法规，包括本章此部分和其它部分的情况，特别是对讨论中的设备，此法规应取代其它通用要求。 （c）权限。PART820是在（法令351、352、360、360c、360d、360e、360h、360i、360j、360l、370、374、381、383中）501、502、510、513、514、515、518、519、520、522、701、704、801、803下建立并发布的。不符合本部分（Part 820）的任何适用的规定，依据法令section 501（h）条款，可判定该产品为伪劣产品。这类产品及对此不符合负责的任何个人，将依法被起诉。 （d）外国制造商。如果把器械进口到美国的制造商拒绝允许或同意FDA对其外国工厂履行为确定器械是否符合本法规（Part 820）所进行的检查，可按section 801（a）条款对其提出诉讼。即准备出口到美国的设备，其设计、生产、包装、标签、贮存或服务中使用的方法和设备控制不符合本法令section 520（f）和本部分（Part 820）的要求，可按本法令section 501（h）条款判定在此条件下制造的产品为伪劣产品。 （e）豁免或特别许可/ Exemptions or variances （1）任何人希望得到任何医疗器械质量体系要求的豁免或特别许可，应符合法令section 520（f）（2）的要求。根据本章即FDA行政程序，来提交豁免或特别许可的申请。可以从

美国FDA医疗器械法规解读第一部分

mds 美国FDA医疗器械法规解读 第部分 第一部分 MEDevice Services, LLC 美德思咨询公司（美国） https://www.wendangku.net/doc/155981759.html,

美国FDA是什么机构 美国食品药品监督管理局（FDA，U.S. Food and Drug Administration）为直属美国健 康及人类服务部（DHHS）管辖的联邦政府机 康及人类服务部（）管辖的联邦政府机 构，其主要职能为负责对美国国内生产及进 口的食品、膳食补充剂、药品、疫苗、生物 口的食品膳食补充剂药品疫苗生物 医药制剂、血液制剂、医学设备、放射性设 备、兽药和化妆品进行监督管理，同时也负 责执行公共健康法案(the Public Health Service Act)的第361号条款，包括公共卫 生条件及州际旅行和运输的检查、对于诸多 生条件及州际旅行和运输的检查对于诸多 产品中可能存在的疾病的控制等等。 2 MEDevice Services, LLC

美国FDA是什么机构（续） 美国健康及人类服务部（DHHS）（相当于卫生部） 国家卫生研究院（NIH） 卫生资源与服务管理局(HRSA) 保健研究与质量局(AHRQ) 印第安人卫生服务(IHS) 药品滥用及精神健康服务管理局(SAMHSA) 疾病控制及预防中心(CDC) 食品药品监督管理局(FDA) 3 MEDevice Services, LLC

美国FDA的各个部门 该管理局由若干个部门组成，每个部门都负 责一个相关领域的监管工作： ?食品安全和应用营养中心（CFSAN） ?生物制品审评和研究中心（CBER） ?药品审评和研究中心（CDER） ?设备仪器与放射健康中心（CDRH） ?兽药中心（CVM） ?国家毒理学研究中心（NCTR） ?监管事务办公室（ORA） ?另外，美国食品药品监督管理局也同包括农 业部、联邦禁毒署、美国海关和美国消费品 安全委员会等联邦部门以及州政府展开了频 繁而广泛的合作 繁而广泛的合作。 4 MEDevice Services, LLC

医疗器械法规培训试题(答案)

医疗器械法律法规及文件体系培训试题 部门：______________ 姓名：___________________ 分数：__________________ 一、填空题 1、为了加强对医疗器械的监督管理，保证医疗器械的安全、有效，保障人体健康和生命安全，制定《医疗器械监督管理条例》。 2、为规范医疗器械分类，根据《医疗器械监督管理条例》制定《医疗器械分类规则》，及局令15 号。 3、医疗器械是指：单独或者组合使用于人体的仪器、设备、器具、材料或者其他物品，包括所需的软件。 4、《医疗器械生产企业许可证》分正本和副本，正本、副本具有同等法律效力________ ，有效期为 5 年。 5、《医疗器械生产企业许可证》变更分为许可事项变更和登记事项变更。 6自2011年_7_月—1_日起，生产企业申请无菌医疗器械首次注册和重新注册时，应当按要求提交经检查合格的《医疗器械生产管理规范检查结果通知书》—，其他医疗器械的质量管理体系检查按现有规定进行。 7、为规范医疗器械的注册管理，保证医疗器械的安全、有效，根据《医疗器械监督管理条例》，制定《医疗器械注册管理办法》。 8、医疗器械标准分为国家标准、行业标准和注册产品标准。 9、医疗器械临床验证的范围：同类产品已上市，其安全性、有效性需要进一步确认的医疗器械。 10、公司质量手册代码为QM ，程序文件代码为PR ，记录文件代码为 JL __ 。 二、简答题： 1、公司管理文件总共有几类，分别为哪些？ 8类：组织结构与人员管理；厂房设施设备管理，物料管理，卫生管理，验证管

30理，生产管理，质量管理，销售管理 2、医疗器械注册证书中哪些内容发生变化，生产企业应当自发生变化之日起日内申请变更重新注册？有五种内容发生变化，1型号规格、2 生产地址；3 产品标准；4产品性能结构及组成； 5 产品适用范围 3、《医疗器械监督管理条例》第五条国家对医疗器械实行分类管理。请简述第一类、第二类和第三类医疗器械各指的是哪类医疗器械？ 第一类：常规管理，足以保证其安全性，有效性的医疗器械第二类：对其安全性，有效性应加以控制的医疗器械第三类：植入人体用以支持维持生命对人体具有潜在危险，对其安全性，有效性必须严格控制的医疗器械。

一文读懂各国医疗器械法规框架

一文读懂各国医疗器械法规框架 1. 入门：各国GMP法规综述 1）中国医疗器械监管历程 CFDA负责负责食品、药品、医疗器械、化妆品的监督管理。 2013年3月22日，"国家食品药品监督管理局"(SFDA)改名为"国家食品药品监督管理总局"(CFDA) 历任领导 局长杨寿山1978.7-1979.8 局长胡昭衡1979.8-1982.9 局长郑筱萸(1944-2007) 1994.5--2005.6死刑副局长张敬礼2003.10--2010.6 有期徒刑17年 局长邵明立2005.6--2012.2 局长尹力2012.2--2013.3 局长张勇2013.3--2015.1 局长毕井泉2015.1至今 CFDA在2014年之前并没有医疗器械全生命周期的监管思路，而是有点无面零散地发布了一些法规。在国务院650号令之后，开始系统性地按照GxP的架构发布法规。所发布的法规分为以下几个层级： 条例：650号令国务院 办法：7号令生产监督管理办法 规范：64号令GMP/附录 原则：现场检查指导原则

医疗器械全生命周期监管已进入4G时代，还缺一个GLP (Good Laboratory Practice) GCP:Good Clinical Practice |医疗器械临床试验质量管理规范 GMP:Good Manufacturing Practice |医疗器械生产质量管理规范 GSP: Good Supply Practice|医疗器械经营质量管理规范 GUP: Good Use Practice |医疗器械使用质量管理规范 与ISO13485相比，国内器械GMP的主要差异有 ?GMP是法规具有强制性，ISO是标准 ?GMP不强调“以客户关注为焦点”，不强调客户抱怨的处理要求 ?GMP要求生产和质量负责人不得兼任 ?GMP强调生产/技术/质量管理部门的负责人应当掌握法规，有能力对实际问题作出处理?GMP里没有关于顾客财产的要求 ?GMP不强调对内部审核的要求 ?GMP对不良事件报告的要求比ISO更具体 ?GMP里要求产品必须有合格证 ?GMP强调供应商审核制度，ISO偏重外包控制要求 2）新版ISO13485：2016简介 ISO13485名称：Medical devices-Quality managementsystems-Requirements for regulatory purposes 医疗器械-质量管理体系-用于法规的要求 适用对象：医疗器械设计和制造商/经营商/供应商 发布单位：医疗器械质量管理和通用要求技术委员会即ISO/TC 210 ISO13485的历史 第一版ISO13485：1996（必须与ISO9001：1994一同使用）

国内外医疗器械政策法规及标准

软科学研究项目报告 国内外医疗器械政策法规及标准 比较研究专题报告 深圳市医疗器械行业协会 2013年12月

前言 医疗器械直接关系到人民的生命安全和身体健康，为此，世界各个国家和地区都将医疗器械行业列为重点监管对象。为了确保医疗器械的安全性和有效性，各个国家和地区都制定了严格的医疗器械市场准入制度和相关的法规体系，这些法规既有相通之处，又存在许多差异。 开展国内外医疗器械政策法规及标准的对比研究，一直是医疗器械产业界及政府监管部门十分关注的热点问题，一方面有助于现代产业体系的建设与完善，促进产业结构的调整，帮助创新型自主品牌企业在国际市场中把握技术性贸易壁垒的变化发展趋势，及早采取应对措施；另一方面，从政府监管的角度来讲，也可为监管部门提供意见和建议，为进一步完善中国医疗器械法规体系提供科学的参考依据。 由于各国家和地区相关法规、标准众多，使得此类研究工作的开展十分困难。基于此，深圳市科技创新委员会和深圳市医疗器械行业协会特邀请业内资深人士、企业代表，组织研究并编写了《国际医疗器械法规研究专题报告》。这些人员均具有多年从事医疗器械法规事务方面的丰富工作经验，对各个国家和地区的法规和标准体系有着深刻的认识和理解。 本报告对国内外医疗器械监管政策法规及产品标准的现状、差异及未来的发展趋势进行对比研究，一共十二章，第一章为法规综述；第二章至第十三章分别从监管模式、医疗器械分类、标准、检测模式、临床要求、质量体系及生产监管、上市准入模式、流通监管模式、上市后监督模式，以及体外诊断试剂法规要求等方面进行对比、分析，形成专项报告。

本报告在编撰过程中得到了深圳市科技创新委员会的大力支持和指导。参加本项目的研究单位有：深圳市科技创新委员会、深圳市药品监督管理局、深圳市医疗器械行业协会、深圳迈瑞生物医疗电子股份有限公司、深圳市理邦精密仪器股份有限公司、业聚医疗器械（深圳）有限公司、先健科技（深圳）有限公司、奥咨达医疗器械咨询机构、深圳市龙德生物科技有限公司，具体撰写人员有：蔡翘梧、胡辉、黄进、乐秋红、李玲、李秀兰、柳永英、施小立、谭传斌、杨龙、张强、张晓华、张艳红、钟志辉（按姓氏排列）等。在此一并表示感谢。 本报告仅代表参加项目研究人员的个人意见，由于水平有限，时间仓促，难免有遗漏和错误之处，恳请读者批评指正，以便在今后修订完善。若读者对本报告的观点有不同看法，欢迎提出商榷。

美国医疗器械法规体系--QSR820介绍

美国的医疗器械法规体系--QSR820 美国食品药品监督管理局(FDA)是负责医疗器械管理的政府机构。其根据各相关法律授权而制定的各类法规性的文件编号为21CFRxxxx(xxxx为阿拉伯数字)。 其中21CFR820是FDA根据《联邦食品,药品和化妆品法案》第501, 502, 510, 513, 514, 515, 518, 519, 520, 522, 701, 704, 801, 803条款的授权而制定的规范医疗器械企业质量体系要求的法规,即Quality System Regulation,简称QSR或QSR820。 谁要遵守QSR820? 21QSR820。1规定,所有在美国和波多黎各境内的,或者有产品出口到美国和波多黎各境内的医疗器械企业必须按QSR820的要求建立质量体系。各企业可以根据实际情况,满足QSR中与自己活动相关的条款。 QSR820不适用于医疗器械零件生产商,但FDA鼓励这类企业以QSR820中适用的条款为指导。 QSR820不适用于人血和血制品生产商。这类企业应遵循21CFR606的规定。 谁来检查企业是否符合QSR820? FDA下属的CDRH(器械与放射健康中心)是专职负责医疗器械企业管理的政府机构,其根据FDA的授权安排检查员到个企业进行工厂检查。对美国境内企业一般每两年检查一次,境外企业不定期检查。所有检查费用由FDA承担。 在欧洲和美国本土,FDA也授权TUV等第三方机构进行工厂检查,扥企业要支付相应费用。 无论谁来检查,都只是一个符合性检查,不颁发任何证书,不属于【信息咨询】活动。 如何检查企业是否符合QSR820? QSIT(质量体系检查技术)是FDA检查员的必修课程,也是FDA Quality Systems Inspection Reengineering Team专门编制的检查员手册。该文件详细介绍了检查方法,关注点,无论对FDA检查员还是企业内审员/供应商审核员都具有参考价值。

美国FDA-医疗器械体系法规QSR820中英文版2015.06

培训教材 美国FDA 医疗器械体系法规QSR820中文版 2015.06

Part 820——质量体系法规——目录 Subpart A- 总则 820.1 范围 820.3 定义 820.5 质量体系 Subpart B –质量体系要求 820.20 管理职责 820.22 质量审核 820.25 人员 Subpart C- 设计控制 820.30 设计控制

Subpart D- 文件控制 820.40 文件控制 Subpart E- 采购控制 820.50 采购控制 Subpart F- 标识与可追溯性 820.60 标识 820.65 可追溯性 Subpart G - 生产和过程控制 820.70 生产和过程控制 820.72 检验、测量和试验设备 820.75 过程确认 Subpart H - 验收活动: 820.80 进货、过程和成品器械检验820.86 检验状态 Subpart I –不合格品 820.90 不合格品 Subpart J - 纠正和预防措施 820.100 纠正和预防措施 Subpart K –标识和包装控制 820.120 设备标签 820.130 设备包装 Subpart L –搬运/储存/分销和安装 820.140 搬运 820.150 贮存 820.160 分销 820.170 安装 Subpart L –记录 820.180 记录的通用要求 820.181 设备主要记录 820.184 设备历史记录 820.186 质量体系记录 820.198 投诉文件 Subpart M –服务 820.200 服务 Subpart N –统计技术 820.250 统计技术

医疗器械+质量管理体系+用于法规的要求

医疗器械质量管理体系用于法规的要求医疗器械质量管理体系用于法规的要求 0 引言 0.1总则 本标准规定了质量管理体系要求，组织可依此要求进行医疗器械的设计和开发、生产、安装和服务以及相关服务的设计、开发和提供。 本标准也可用于内部和外部(包括认证机构)评定组织满足顾客和法规要求的能力。注:是理解或说明有关要求的指南。 值得腔调的是，本标准所规定的质量管理体系要求是对产品技术要求的补充。 采用质量管理体系应当是组织的一项战略性决策，一个组织的质量管理体系的设计和实施受各种需求、具体目标、所提供的产品、所采用的过程以及该组织的规模和结构的影响。统一质量管理体系的结构或文件不是本标准的目地。 医疗器械的种类很多，本标准中所规定的一些专用要求只适用于指定的医疗器械类别。本标准第3章规定了这些类别的定义。 0.2过程方法 本标准以质量管理的过程方法为基础。 任何得到输入并将其转化为输出的活动均可视为过程。 为使组织有效运作，必须识别和管理众多相互关连的过程。 通常，一个过程的输出将直接形成下一个过程的输入。 组织内诸过程的系统的应用，连同这些过程的识别和相互作用及其管理，可称之为“过程方法”。 0.3与其他标准的关系 0.3.1与GB/T19001的关系 本标准是一个以GB/T19001为基础的独立标准。

那些从GB/T19001中不加更改而直接引用的章或条采用宋体字表示，这些未作更改的条见附录B。 本标准的文本与GB/T19001的文本不同，文本中包含的变化的句子或排版全部以黑色宋体字标准，更改内容的性质和原因见附录B。 0.3.2与ISO/TR14969的关系 ISO/TR14969是一个旨在为YY/T0287的应用提供指南的技术报告。 0.4 与其他管理体系的相容性 为了方便医疗器械行业的使用者，本标准遵循了GB/T19001的格式。 本标准不包括针对其他管理体系的要求，如环境管理、职业卫生与安全管理或财务管理的特定要求。 然而本标准使组织能够将其自身的质量管理体系与相关的管理体系要求结合或整合。组织为了建立符合本标准要求的质量管理体系，可能会改变现行的管理体系。 1 1.范围 1.1总则 本标准为需要证实其有能力提供持续满足顾客要求和适用于医疗器械和相关服务的法规要求的医疗器械和相关服务的组织规定了质量管理体系要求。 本标准的主要目地是便于实施协调的质量管理体系的法规要求。因此，本标准包含了一些医疗器械的专用要求，删减了GB/T19001中不适于作为法规要求的某些要求。由于这些删减，质量管理体系符合本标准的组织不能声称符合GB/T19001标准，除非其质量管理体系还符合GB/T19001中所有的要求。(见附录B) 1.2应用 本标准的所有要求是针对提供医疗器械的组织，不论组织的类型或规模。

美国医疗器械FDA认证流程

美国医疗器械FDA认证流程 一、美国医疗器械FDA认证介绍 FDA对医疗器械的管理通过器械与放射健康中心进行的,中心监督医疗器械的生产、包装、经销商遵守法律下进行经营活动。医疗器械范围很广,小到医用手套,大至心脏起博器,均在FDA监督之下,根据医疗用途和对人体可能的伤害,FDA将医疗器械分为Ⅰ、Ⅱ、Ⅲ类,越高类别监督越多. 如果产品是市场上不曾存在的新颖发明,FDA要求厂家进行严格的人体实验,并有令人信服的医学与统计学证据说明产品的有效性和安全性。 医疗器械的FDA认证,包括:厂家在FDA注册、产品的FDA登记、产品上市登记(510表登记)、产品上市审核批准(PMA审核) 医疗保健器械的标签与技术改造、通关、登记、上市前报告,须提交以下材料:(1)包装完整的产成品五份,(2)器械构造图及其文字说明,(3)器械的性能及工作原理;(4)器械的安全性论证或试验材料,(5)制造工艺简介,(6)临床试验总结,(7)产品说明书. 如该器械具有放射性能或释放放射性物质,必须详细描述. 医疗器械的工厂和产品注册FDA对医疗器械有明确和严格的定义,其定义如下:“所谓医疗器械是指符合以下条件之仪器、装置、工具、机械、器具、插入管、体外试剂及其它相关物品,包括组件、零件或附件:明确列于National Formulary或the Unite States Pharmacopeia或前述两者的附录中者;预期使用于动物或人类疾病,或其它身体状况之诊断,或用于疾病之治愈、减缓与治疗者;预期影响动物或人体身体功能或结构,但不经由新陈代谢来达到其主要目的者”。 只有符合以上定义的产品方被看作医疗器械,在此定义下,不仅医院内各种仪器与工具,即使连消费者可在一般商店购买之眼镜框、眼镜片、牙刷与按摩器等健身器材等都属于FDA 之管理范围。它与国内对医疗器械的认定稍有不同。 根据风险等级的不同,FDA将医疗器械分为三类(Ⅰ,Ⅱ,Ⅲ),Ⅲ类风险等级最高。FDA将每一种医疗器械都明确规定其产品分类和管理要求,目前FDA医疗器械产品目录中共有1,700多种。任何一种医疗器械想要进入美国市场,必须首先弄清申请上市产品分类和管理要求。 FDA针对医疗器械制订了许多法案,并不时地进行修改和补充,但根本的法案并不多,主要包括:联邦食品、药品与化妆品法案(FD&C Act,根本法案);公众健康服务法案;公正包装和标识法案;健康和安全辐射控制法案;安全医疗器械法案;现代化法案。对这些法案,FDA给予了非常详细的解释,并配套有具体的操作要求。企业在计划进入美国市场前,需仔细评估针对自己产品相关的法规和具体要求(包括不同的美国产品标准要求)。 在明确了以上信息后,企业就可以着手准备有关的申报资料,并按一定程序向FDA申报以获取批准认可。对于任何产品,企业都需进行企业注册(Registration)和产品列名(Listing)。对Ⅰ类产品(占47%左右),实行的是一般控制(General Control),绝大部分产品只需进行注册、列名和实施GMP规范,产品即可进入美国市场(其中极少数产品连GMP也豁免,极少数保留产品则需向FDA递交510(K)申请即PMN(Premarket Notification));对Ⅱ类产品

2017年最新医疗器械法规汇总

目录

《医疗器械监督管理条例》（国务院令第650号） 2014年03月07日发布 《医疗器械监督管理条例》已经2014年2月12日国务院第39次常务会议修订通过，现将修订后的《医疗器械监督管理条例》公布，自2014年6月1日起施行。 总理李克强 2014年3月7日 医疗器械监督管理条例 （2000年1月4日中华人民共和国国务院令第276号公布 2014年2月12日国务院第39次常务会议修订通过） 第一章总则 第一条为了保证医疗器械的安全、有效，保障人体健康和生命安全，制定本条例。 第二条在中华人民共和国境内从事医疗器械的研制、生产、经营、使用活动及其监督管理，应当遵守本条例。

第三条国务院食品药品监督管理部门负责全国医疗器械监督管理工作。国务院有关部门在各自的职责范围内负责与医疗器械有关的监督管理工作。 县级以上地方人民政府食品药品监督管理部门负责本行政区域的医疗器械监督管理工作。县级以上地方人民政府有关部门在各自的职责范围内负责与医疗器械有关的监督管理工作。 国务院食品药品监督管理部门应当配合国务院有关部门，贯彻实施国家医疗器械产业规划和政策。 第四条国家对医疗器械按照风险程度实行分类管理。 第一类是风险程度低，实行常规管理可以保证其安全、有效的医疗器械。 第二类是具有中度风险，需要严格控制管理以保证其安全、有效的医疗器械。 第三类是具有较高风险，需要采取特别措施严格控制管理以保证其安全、有效的医疗器械。 评价医疗器械风险程度，应当考虑医疗器械的预期目的、结构特征、使用方法等因素。 国务院食品药品监督管理部门负责制定医疗器械的分类规则和分类目录，并根据医疗器械生产、经营、使用情况，及时对医疗器械的风险变化进行分析、评价，对分类目录进行调整。制定、调整分类目录，应当充分听取医疗器械生产经营企业以及使用单位、行业组织的意见，并参考国际医疗器械分类实践。医疗器械分类目录应当向社会

医疗器械法律法规试题-答案

法律法规试题 一、单选题（15题，每题1分） 1、省、自治区、直辖市(食品)药品监督管理部门应当在受理之日起( )个工作日内作出是否核发《医疗器械经营企业许可证》的决定。 A、10 B、15 C、20 D、30 答案： D 2、从事医疗器械生产活动，非必须具备的条件是：( ) A、有与生产的医疗器械相适应的生产场地、环境条件、生产设备以及专业技术人员； B、有对生产的医疗器械进行质量检验的机构或者专职检验人员以及检验设备； C、产品标准 D、有保证医疗器械质量的管理制度； 答案：C 3、第一类医疗器械产品备案和申请第二类、第三类医疗器械产品注册，不用提交的资料( ) A、仓库地址的地理位置图、平面图、房屋产权证明（或租赁协议）复印件产品、技术要求； B、产品检验报告； C、注册产品标准 答案：A 4、医用中心制氧系统按医疗器械的结构特征、使用状态分类，为( ) A、有源医疗器械、接触或进入人体器械 B、有源医疗器械、非接触人体器械 C、无源医疗器械、接触或进入人体器械 D、无源医疗器械、非接触人体器械 答案：B 5、涂改、倒卖、出租、出借医疗器械注册证书，或者以期货形式非法转让医疗器械注册证书的，由县组以上（食品）药品监督管理部门责令改正，可以并处( )罚款。 A、5000元以上10000万以下 B、5000元以上20000万以下 C、3万元以下 答案： C 6、医疗器械注册产品标准的法律责任主体是( ) A、医疗器械制造商 B、技术监督管理部门 C、医疗器械注册产品标准复核备案部门 答案： A 7、医疗器械使用状态可分为接触或进入人体器械和非接触人体器械，属于非接触人体器械的内容是：( ) A、对医疗效果的影响，其程序分为：基本不影响；有间接影响；有重要影响 B、使用时限分为：暂时使用；短期使用；长期使用

中文版FDA质量体系规范-

FDA 质量体系规范-中文版(QSR820 1.1 概述 §820.1 范围 (a 适用性 (1 在这个质量体系规范中描述了现行的生产管理规范的要求(CGMP. 本规范要求 规定了所有医用器械成品在设计,制造,包装,标签,贮存,安装和服务中使用的方法, 设施和控制.这些要求是为了确保医疗器械成品的安全和有效,并遵从美国食品,药品 和化妆品法.本规范提出了适用于医疗器械成品制造商的基本要求.如果某制造商只进行本规范规定的一部分操作,而不进行其他操作,则该制造商仅需执行适用于他所进行操作的那些要求.有关Ⅰ类器械,设计控制仅按在§820.30(a(2中列出的要求进行.这个规范不适用于成品组件和零件的制造商,但鼓励这样的制造商使用规范的适当规定作为指导.人类血液制品和血液成分的制造商不属于本规范的管理范围,但属于606的管理范围. (2 这一规范的规定适用于本规范定义的医疗器械成品,即使用的对象是人的,在美 国各州或领地,哥伦比亚特别区或波多黎哥联邦制造,进口或出口的器械成品. (3 在本规范中,几次使用了短语”适当的地方”.当要求以”适当的地方”来限制时,如果制造商没有合理的理由来证明不适宜,就认为此要求是”适当的”.如果不 贯彻”适当的”要求,就会导致产品达不到要求或制造商不能采取某些必要的正确措施. (b 范围 这一的质量体系规范和增补在这一规范其他节的条文明确注明用于其他方面的条文除外. 在不可能执行全部适用条文(包括这一节的和这一规范其他节的条文的情况下,特定的运用于有问题器械的条文将取代其他一般的适用条文.

(c 权威性根据联邦法501, 502, 510, 513, 514, 515, 518, 519, 520, 522, 701, 704, 801, 803, (21U.S.C.315, 352, 360, 360c,360d,360e,360h,360i,360j, 360l, 371, 374, 381, 383 建立和提出了820规范的权威性. 如果没能执行适用规 范,可能会导致产生伪劣器械, 根据法规501(h, 对这样的器械和未能执行规范的 人都要进行处罚. (d 外国制造商如果某制造商提供给美国的进口器械,拒绝接受FDA 对外国设备进行是否执行本规范的检查,就会出现法规的801(a节中的后果. 用这样的设备生产出的任何器械,在设计,制造,包装, 标签,贮存,安装或服务方面,使用方法,设备和控制都未遵从法规的 520(f节和本规范的要求. 根据法规501(h, 用这样的设备制造 出来的器械都属于伪劣产品. (e 豁免或更改 (1 任何希望豁免或更改执行某些器械质量体系要求的申请,都要遵从法规 520(f(2的要求. 申请豁免或更改的过程将依据这一规范§10.30的程序进行,即FDA 的管理程序. 以下地址可提供指导: 器械和放射卫生中心, 小制造商处 (HFZ-220, 1350 Picca rd Dr.,Rockville,MD20850, U.S.A. 电话: 1-800-638- 2041或1-301-443-6597, FAX 301-443-8818. (2 当FDA判定某种更改有益于公众健康时, 就会起草并认可这项更改. 这种更改仅能在一段时间内维持有效, 即当器械仍能满足公众健康需要, 并且如果没有更改, 器械不可能制造得非常有效的一段时间内. §820.3 定义 (a法指的是美国食品,药品和化妆品法修正案(secs.201~903, 52Stat.1040et seq., 修正版21U.S.C.321~394.在法201中的全部定义都适用于本规定.