ISO11135-2014中文翻译版

ISO 11135-2014

Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine

control of a sterilization process for medical devices

医疗保健产品灭菌—— 环氧乙烷——

医疗器械灭菌过程开发、确认和常规控制要求

1 Scope范围

1.1 Inclusions 包含内容

This International Standard specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications.

本标准规定了医疗器械产品在工业与医疗保健机构的环氧乙烷灭菌过程的开发、验证和常规控制的要求，并承认这两个领域之间灭菌过程开发、确认的常规控制的异同。

NOTE 1. Among the similarities are the common need for quality systems, staff training, and proper safety measures. The major differences relate to the unique physical and organizational conditions in health care facilities, and to the initial condition of reusable medical devices being presented for sterilization.

注1．其中, 相同之处在于质量体系、人员培训及适当的安全措施的通用要求。主要的区别涉及到医疗保健机构的独特的硬件环境

和组织条件，以及供灭菌的可重复使用医疗器械的初始条件。

NOTE 2. Health care facilities differ from medical device manufacturers in the physical design of processing areas, in the equipment used, and in the ISO 11135-2014 availability of personnel with adequate levels of training and experience. The primary function of the health care facility is to provide patient care; medical device reprocessing is just one of a myriad of activities that are performed to support that function.

注2．医疗器械制造商与医疗机构的主要不同点在于灭菌区域的硬件设计、所使用的设备，以及有技能和经充分培训的人员的可用

性方面。卫生保健机构的基本功能是为病人提供医疗保健;医疗器械的再处理仅是支持医疗保健功能的无数活动之一。

NOTE 3. In terms of the initial condition of medical devices, medical device manufacturers generally sterilize large numbers of similar medical devices that have been produced from virgin material. Health care facilities, on the other hand, must handle and process both new medical devices and reusable medical devices of different descriptions and with varying levels of bioburden. They are therefore faced with the additional challenges of cleaning, evaluating, preparing and packaging a medical device prior to sterilization. In this International Standard, alternative approaches and guidance specific to health care facilities are identified as such.

注3．就医疗器械的初始条件而言，医疗器械制造商通常灭菌大量的从原始材料开始生产的类似的医疗器械。另一方面，卫生保健

机构必须同时处理和加工有着不同生物负载水平的新的医疗器械和再次使用的医疗器械。因此，医疗保健机构的灭菌产品面临着在灭菌前清洗、评估、准备和包装医疗器械的额外挑战。在本标准，确定了针对医疗保健机构的灭菌过程开发、确认和控制的方法或指南。

NOTE 4. EO gas and its mixtures are effective sterilants that are primarily used for heat- and/or moisture-sensitive medical devices that cannot be moist heat sterilized.

注4. EO气体及其混合物是一种主要用于对湿热敏感而不能用湿热进行灭菌的医疗器械灭菌的有效的灭菌剂。

NOTE 5. Although the scope of this International Standard is limited to medical devices, it specifies requirements and provides guidance that can be ISO 11135-2014 applicable to other health care products.

注5 尽管本标准限定于医疗器械，但标准规定的要求和提供的指南同样适用于其他医疗保健产品。

1.2 Exclusions 不适用

1.2.1 This International Standard does not specify requirements for the development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.

本标准没有对海绵状脑病的致病因子(如痒病、牛绵状脑病和克-雅病)的灭活过程的开发、确认和常规控制作出规定。有些国家已有了处理可能受此类因子污染的材料的推荐资料。

NOTE， See ISO 22442-1, ISO 22442-2 and ISO 22442-3.

注，见ISO 22442-1, ISO 22442-2 和 ISO 22442-3

1.2.2 This International Standard does not detail a specified requirement for designating a medical device as sterile. 本标准未详细论述确定医疗器械为无菌的规定要求。

NOTE Attention is drawn to national or regional requirements for designating medical devices as “sterile”. See for example EN 556–1 or ANSI/AAMI ST67.

须注意国家和地区确定医疗器械‘无菌’的要求，见如EN556-1或ANSI/AAMI ST67。

1.2.3 This International Standard does not specify a quality management system for the control of all stages of production of medical devices.

本标准未对医疗器械生产各个阶段的控制的质量管理体系作出规定。

NOTE The effective implementation of defined and documented procedures is necessary for the development, validation and routine control of a ISO 11135-2014 sterilization process for medical devices. Such procedures are commonly considered to be elements of a quality management system. It is not a requirement of this International Standard to have a full quality management system during manufacture or reprocessing. The necessary elements are normatively referenced at appropriate places in the text (see, in particular, Clause 4). Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production or reprocessing of medical devices. National and/or regional regulations for the provision of medical devices might require the implementation of a full quality management system and the assessment of that system by a third party.

建立医疗器械灭菌过程的开发、确认和常规控制的文件化的，并能有效实施的程序是必需的，这样的程序文件通常被认为是质量管理体系的要素。在制造和再加工期间有一个充分的质量管理体系不是本标准的要求，必需的要素在接下来的适当地方(见第4章)被规范性引用。须注意控制医疗器械生产和再加工各个过程的质量管理体系的标准(见ISO13485)。国家和/或地区的法规可能对医疗器械质量管理体系及其第三方评价作出了规定。

1.2.4 This International Standard does not specify requirements for occupational safety associated with the design and operation of EO sterilization facilities.

本标准没有对与环氧乙烷灭菌机构的设计和与操作有关的职业安全要求作出规定。

NOTE 1 For further information on safety, see examples in the Bibliography. National or regional regulations may also exist.

注1，有关安全性的进一步的信息，请参阅‘参考文献’。国家或地区性法规也可能有明确规定。

NOTE 2 EO is toxic, flammable and explosive. Attention is drawn to the possible existence in some countries of regulations giving safety requirements for handling EO and for premises in which it is used.

注2，EO有毒，易燃，易爆。需注意，有些国家的法规可能对EO处理和使用场所的安ISO 11135-2014全要求作出了规定。

1.2.5 This International Standard does not cover sterilization by injecting EO or mixtures containing EO directly into packages or a flexible chamber.

本标准未覆盖用直接注射环氧乙烷或其混合气体到产品包装或活动柜室中的灭菌。

NOTE See ISO 14937 for these types of EO processes.

注，这些类型的EO灭菌过程见ISO 14937

1.2.6 This International Standard does not cover analytical methods for determining levels of residual EO and/or its reaction products.

本标准未覆盖测定EO残留和/或其反应物水平的分析方法。

NOTE 1 For further information see ISO 10993-7.

注1，EO残留的分析方法的进一步信息见ISO 10993-7

NOTE 2 Attention is drawn to the possible existence of national or regional regulations specifying limits for the level of EO residues present on or in medical devices.

注2，应注意,国家或地区的法规可能对医疗器械产品中环氧乙烷残留极限量作出了规定。

2 Normative references引用标准

The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

以下参考标准,全部或部分，对本标准的应用是必不可少的。注明日期的标准，其引用版本适用；不注明日期的标准，其最新版本（包括修订）适用。

ISO 10012, Measurement management systems — Requirements for measurement processes and measuring equipment

ISO10012，测量管理系统——测量程序和测量设备的要求 ISO 11135-2014 ISO 10993-7, Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals

ISO10993-7医疗器械的生物学评价--第7部分:环氧乙烷灭菌残留量

ISO 11138-1:2006, Sterilization of health care products — Biological indicators — Part 1: General requirements ISO11138-1：2006 医疗保健产品灭菌生物指示物第1部分：通则

ISO 11138-2:2009, Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes

ISO11138-2：2009 医疗保健产品灭菌生物指示物第2部分：环氧乙烷灭菌用生物指示物

ISO 11140-1, Sterilization of health care products — Chemical indicators — Part 1: General requirements

SO11140-1 医疗保健产品灭菌化学指示剂第1部分：总要求

ISO 11737-1, Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products

ISO11137-1医疗保健产品灭菌微生物方法第1部分：产品微生物数量的测定

ISO 11737-2, Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

ISO 11737-2, 医用器械的灭菌微生物学方法第二部分：确认灭菌过程的无菌试验

ISO 13485:2003/Cor 1:2009, Medical devices — Quality management systems — Requirements for regulatory purposes — Technical Corrigendum 1

ISO 13485:2003/Cor 1:2009, 医疗器械质量管理体系常规要求技术勘误

3 Terms and definitions 术语和定义

For the purposes of this document, the following terms and definitions apply.ISO 11135-2014本标准使用以下术语和定义

3.1 Aeration 通风

part of the sterilization process during which ethylene oxide and/or its reaction products desorb from the medical device until predetermined levels are reached

灭菌过程的一部分，环氧乙烷和/或其反应产物从医疗器械解吸附至预定水平的过程。

Note 1 to entry: This can be performed within the sterilizer and/or in a separate chamber or room.

注1，可在灭菌器中进行，也可在单个柜室或房间内进行。

3.2 aeration area 通风区

either a chamber or a room in which aeration occurs

发生通风的柜室或房间。

3.3 Bioburden 生物负载

population of viable microorganisms on or in product and/or sterile barrier system

[SOURCE: ISO/TS 11139:2006, definition 2.2]

产品和/或无菌屏障系统表面或内部的活的微生物数量。

[依据: ISO/TS11139：2006，定义2.2]

3.4 biological indicator 生物指示剂

test system containing viable microorganisms providing a defined resistance to a specified sterilization process [SOURCE: ISO/TS 11139:2006, definition 2.3]

对特定灭菌过程具有确定抗力的染菌测试系统。

[依据: ISO/TS11139：2006，定义2.3] ISO 11135-2014 3.5 Calibration 校准

set of operations that establish, under specified conditions, the relationship between values of a quantity indicated by a measuring instrument or measuring system, or values represented by a material measure or a reference material, and the corresponding values realized by standards

[SOURCE: ISO/TS 11139:2006, definition 2.4]

用已知精度(可追溯到国家标准)的测量系统或器具与未知精度的测量系统或器具进行比较，以检测、对比、报告或通过调整来消除未检定测量系统或器具对所要求的性能极限的任何偏差。

[VIM1993，定义6.11]

3.6 chemical indicator 化学指示剂

test system that reveals a change in one or more pre-defined process variables based on a chemical or physical change resulting from exposure to a process

[SOURCE: ISO/TS 11139:2006, definition 2.6]

根据暴露于某过程后发生的化学或物理变化，反映一个或多个预定过程变量变化的测试系统。

[ISO/TS11139：2006，定义2.6]

3.7 Conditioning 处理

treatment of product within the sterilization cycle, but prior to ethylene oxide admission, to attain a predetermined temperature and relative humidity

在加入环氧乙烷之前，对灭菌周期内的产品进行处理，以达到预定温度和相对湿度。

Note 1 to entry: This part of the sterilization cycle can be carried out either at atmospheric pressure or under vacuum. 注1，该部分灭菌周期可在大气压下或真空下进行。

Note 2 to entry: See 3.27, preconditioning 见3.27, 预处理 ISO 11135-2014

3.8 D value D值

D10 value D10值

time or dose required to achieve inactivation of 90 % of a population of the test microorganism under stated conditions [SOURCE: ISO/TS 11139:2006, definition 2.11]

在设定条件下，灭活90%测试微生物所需的时间或辐射剂量。

Note 1 to entry: For the purposes of this International Standard, the D value is the exposure time required to achieve 90 % inactivation of the population of the test organism.

注：本标准中的D值是指灭活90%测试微生物所需的暴露时间。

3.9 Development 开发

act of elaborating a specification

确定某规范的行为。

[SOURCE: ISO/TS 11139:2006, definition 2.13]

3.10 dew point 露点

The temperature at which the saturation water vapour pressure is equal to the partial pressure of the water vapour in the atmosphere

大气中的水蒸汽由于温度下降，水蒸气的压力等于饱和蒸汽压而凝结时的温度

Note 1 to entry: Any cooling of the atmosphere below the dew point would produce water condensation.

任何露点以下的大气的冷却会产生水凝。

3.11 Establish 建立

determine by theoretical evaluation and confirm by experimentation

[SOURCE: ISO/TS 11139:2006, definition 2.17] ISO 11135-2014通过理论评价与试验确认进行确定。

3.12 ethylene oxide (EO) injection time 环氧乙烷注入时间

duration of the stage beginning with the first introduction of the EO (mixture) into the chamber to the completion of that injection

从环氧乙烷最初进入灭菌柜开始至环氧乙烷气体或环氧乙烷混合气体加入结束阶段的时间。

3.13 exposure time 暴露时间

period for which the process parameters are maintained within their specified tolerances

[SOURCE: ISO/TS 11139:2006, definition 2.18]

过程参数保持在规定公差内的持续时间

Note 1 to entry: For the purpose of calculation of cycle lethality, it is the period of sterilization between the end of EO injection and the beginning of EO removal.

出于周期杀伤力计算的目的，是指环氧乙烷注入时间结束至环氧乙烷去除开始之间的灭菌周期

3.14 Fault 故障

one or more of the process parameters lying outside of its/their specified tolerance(s)

[SOURCE: ISO/TS 11139:2006, definition 2.19]

一个或多个过程参数超出其规定的公差。

3.15 Flushing 换气

procedure by which the ethylene oxide is removed from the load and chamber by either multiple alternate admissions of filtered air, inert gas or steam and evacuations of the chamber or continuous passage of filtered air, inert ISO 11135-2014 gas or steam through the load and chamber

通过以下方法之一去除物品或柜室内环氧乙烷的过程:

a）多次交替将经过滤的空气或惰性气体加入柜室，然后再抽空柜室内气体，或

b）不断将经过滤的空气或惰性气体通过被灭菌物品或柜室。

3.16 fractional cycle 短周期

a cycle in which the exposure time to EO gas is reduced compared to that specified in the sterilization process

与灭菌过程规定的EO作用时间相比，作用时间减少的灭菌周期。

3.17 half cycle 半周期

a cycle in which the exposure time to EO gas is reduced by 50 % compared to that specified in the sterilization process

与灭菌过程相比，EO作用时间减少50%的灭菌周期。

3.18 health care facility 医疗保健机构 HCF

governmental and private organizations and institutions devoted to the promotion and maintenance of health, and the prevention and treatment of diseases and injuries

致力于促进和维护健康，以及疾病和伤害的预防和治疗的政府和私人组织和机构

EXAMPLE A health care facility can be a hospital, nursing home, extended care facility, free-standing surgical centre, clinic, medical office, or dental office.

例：一个医疗保健机构可以是医院，疗养院，延长护理设施，独立的手术中心，诊所，医务室，或牙科办公室

3.19 health care product 医疗保健产品

medical device(s), including in vitro diagnostic medical device(s), or medicinal product(s), including biopharmaceutical(s) ISO 11135-2014

[SOURCE: ISO/TS 11139:2006, definition 2.20]

医疗器械，包括在体外诊断试剂，或药用产品，包括生物药品

3.20 installation qualification 安装验证IQ

process of obtaining and documenting evidence that equipment has been provided and installed in accordance with its specification

[SOURCE: ISO/TS 11139:2006, definition 2.22]

证明并记录设备已按照规范提供和安装的过程。

3.21 medical device 医疗器械

any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of

— diagnosis, prevention, monitoring, treatment or alleviation of disease,

— diagnosis, monitoring, treatment, alleviation of, or compensation for an injury,

— investigation, replacement or modification or support of the anatomy or of a physiological process,

— control of conception,

— disinfection of medical devices,

— providing information for medical purposes by means of in vitro examination of specimens derived from the human body, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means

[SOURCE: ISO 13485:2003, definition 3.7] ISO 11135-2014

为以下目的应用于人体的，单独使用或联合使用的任何仪器、设备、器具、植入物、体外试剂、软件、材料或其他物品：- 疾病的诊断、预防、监护、治疗、缓解；

- 伤残的诊断、监护、治疗、缓解或修补；

- 人体结构或生理过程的研究、替代或调节；

- 妊娠的控制；

- 医疗器械的消毒；

- 通过人体样本体外检查方式提供医疗信息

其对于人体内或人体上的主要预期作用不是用药理学、免疫学或代谢的手段获得，但可以在这些手段的应用中起辅助作用。

3.22 microorganism 微生物

entity of microscopic size, encompassing bacteria, fungi, protozoa and viruses

包括细菌、真菌、原生生物、病毒在内的个体微小的实体。

Note 1 to entry: A specific standard might not require demonstration of the effectiveness of the sterilization process in inactivating all types of microorganisms, identified in the definition above, for validation and/or routine control

of the sterilization process.

[SOURCE: ISO/TS 11139:2006, definition 2.26]

注1：特定的标准可能不要求为灭菌过程确认和常规控制证实灭菌过程灭活以上定义规定的全部类型微生物的有效性。

3.23 operational qualification 操作验证OQ

process of obtaining and documenting evidence that installed equipment operates within predetermined limits when used in accordance with its operational procedures

[SOURCE: ISO/TS 11139:2006, definition 2.27] ISO 11135-2014

证明并记录，按操作程序进行使用时，已安装设备能在预定范围内进行运行。

3.24 overkill approach过度杀灭方法

approach using sterilization process that delivers a minimum of 12 Spore Log Reduction (SLR) to a biological indicator having a resistance equal to or greater than the product bioburden

证明具有与产品生物负载相等或较大抗力的生物指示物孢子对数下降值（SLR）至少为12的灭菌过程的方法。

3.25 parametric release 参数放行

declaration that product is sterile, based on records demonstrating that the process parameters were delivered within specified tolerances

[SOURCE: ISO/TS 11139:2006, definition 2.29]

根据过程参数在规定公差内的记录，决定产品无菌。

Note 1 to entry: This method of process release does not include the use of biological indicators.

注：本过程放行方法不涉及使用生物指示物。

3.26 performance qualification 性能验证PQ

process of obtaining and documenting evidence that the equipment, as installed and operated in accordance with operational procedures, consistently performs in accordance with predetermined criteria and thereby yields product meeting its specification

[SOURCE: ISO/TS 11139:2006, definition 2.30]

获得并出具书面证明的过程，已安装设备按操作程序进行操作时，能持续按预定准则发挥性能并生产合格产品。

3.27 Preconditioning 预处理

treatment of product, prior to the sterilization cycle, in a room or chamber ISO 11135-2014

to attain specified conditions for temperature and relative humidity

灭菌周期开始前，在一房间或柜室内先对产品进行处理，以达到预定的温度和相对湿度。

3.28 process challenge device 过程挑战器具PCD

item designed to constitute a defined resistance to a sterilization process and used to assess performance of the process [SOURCE: ISO/TS 11139:2006, definition 2.33]

设计成对灭菌过程具有确定的抗力，用于评估过程性能的器具。

Note 1 to entry: For the purpose of this International Standard, a PCD can be product, simulated product or other device that is inoculated directly or indirectly. See 7.1.6 and D.7.1.6.

就本标准而言，PCD可以是产品、模拟产品、或直接或间接被接种的其他器具，见7.1.6和D7.1.6

Note 2 to entry: In this International Standard, a distinction is made between an internal PCD and an external PCD. An internal PCD is used to demonstrate that the required product SAL is achieved. A PCD located within the confines of the product or product shipper case is an internal PCD, whereas a PCD located between shipper cases or on the exterior surfaces of the load is an external PCD. An external PCD is an item designed to be used for microbiological monitoring of routine production cycles.

注2 本标准中有内部PCD和外部PCD之分。内部PCD被用来证明指定的产品已达到无菌保证水平。放置于产品内部或销售包装内的PCD 是一个内部的PCD，而放置于产品销售包装之间或装载的外表面上的PCD是外部PCD。外部PCD只是用来日常生产过程的微生物监测。

3.29 process parameter 过程参数

specified value for a process variable ISO 11135-2014

过程变量的规定值。

Note 1 to entry: The specification for a sterilization process includes the process parameters and their tolerances. [SOURCE: ISO/TS 11139:2006, definition 2.34]

注：灭菌过程规范包括过程参数和其公差。

3.30 process variable 过程变量

condition within a sterilization process, changes in which alter microbicidal effectiveness 灭菌过程的条件，它的变化会改变微生物的效力。

EXAMPLE，Time, temperature, pressure, concentration, humidity, wavelength.

[SOURCE: ISO/TS 11139:2006, definition 2.35]

如：时间、温度、压力、密度、湿度、波长?。

3.31 processing category 加工组

collection of different product or product families that can be sterilized together

能一起灭菌的不同产品或产品族的组合

Note 1 to entry: All products within the category have been determined to present an equal or lesser challenge to the sterilization process than the process challenge device for that group.

该组合内的所有产品的灭菌过程挑战力已被确定为与该组PCD呈现相等或更低。

3.32 Product 产品

result of a process 过程的结果

[SOURCE: ISO 9000:2005, definition 3.4.2]

Note 1 to entry: For the purposes of sterilization standards, product is ISO 11135-2014

tangible and can be raw material(s), intermediate(s), sub-assembly(ies) and health care products.

注: 本标准所说的产品是指实物，可以是原材料、媒介、集合或医疗保健产品。

3.33 product family 产品族

group of product possessing characteristics that allow them to be sterilized using defined process conditions

可以用规定的过程条件灭菌的，类似加工特性的产品系列。

3.34 product load volume产品装载容积

defined space within the usable chamber volume occupied by product

产品在灭菌柜中占用的规定的空间。

3.35 recognized culture collection 认可的培养物存储机构

depository authority under the Budapest Treaty on The International Recognition of the Deposit of

Microorganisms for the Purposes of Patent and Regulation

[SOURCE: ISO/TS 11139:2006, definition 2.38]

3.36 reference microorganism 基准微生物

microbial strain obtained from a recognized culture collection

从认可的培养物存储机构获得的微生物菌种

3.37 Requalification 重新验证

repetition of part of validation for the purpose of confirming the continued acceptability of a specified process 为证实规定过程持续认可而进行的部分确认的重复；

3.38 reusable medical device 可重复使用医疗器械

medical device designated or intended by the manufacturer as suitable for ISO 11135-2014

reprocessing and re-use

制造商设计或规定的作为适合于重新加工或重复使用的医疗器械

Note 1 to entry: This is not a medical device that is designated or intended by the manufacturer for single use only. 注，并不是指制造商设计或规定的一次性使用的医疗器械

3.39 Services 服务

supplies from an external source, needed for the correct function of equipment

EXAMPLE Electricity, water, compressed air, drainage.

[SOURCE: ISO/TS 11139:2006, definition 2.41]

3.40 single use medical device 一次性使用医疗器械

medical device designated or intended by the manufacturer for one-time use only

3.41 Specify 规定

stipulate in detail within an approved document

在批准的文件内详细指定

3.42 Spore-log-reduction 孢子对数下降值SLR

log of initial spore population, N0, minus the log of the final population, Nu

描述生物指示物在暴露于规定条件下后孢子数下降值的系数，该系数为10的对数。

[SOURCE: ISO 14161:2009, definition 3.19]

Note 1 to entry: Describing the reduction in the number of spores on a biological indicator or inoculated item produced by exposure to specified conditions.

SLR计算方式为生物指示物的初始孢子数的对数减最终孢子数的对数。 ISO 11135-2014

For Direct Enumeration公式:

SLR = log N?0 log Nu

where

N0 is the initial population初始数;

Nu is the final population最终数.

For Fraction Negative:

SLR = log N0 – log [ln (q/n)]

where

N0 is the initial population;

q is the number of replicate samples tested;

n is the number of samples negative for growth.

If there are no survivors, the true SLR cannot be calculated. The SLR can be reported as “greater than” log N0 if one surviving organism is used.

如没有存活微生物，则无法计算实际SLR。如果一个微生物呈阳性或存活，则SLR表述为“大于”logNo。

3.43 Sterile 无菌

free from viable microorganisms 无存活微生物

[SOURCE: ISO/TS 11139:2006, definition 2.43]

3.44 sterile barrier system无菌屏障系统

minimum package that prevents ingress of microorganisms and allows aseptic presentation of the product at the point of use

[SOURCE: ISO/TS 11139:2006, definition 2.44]

3.45 Sterility 无菌状态 ISO 11135-2014

state of being free from viable microorganisms 保持无存活微生物的一种状态

Note 1 to entry: In practice, no such absolute statement regarding the absence of microorganisms can be proven.

实际上，不存在此类绝对的声明，证明微生物存在与否。

Note 2 to entry: See 3.47, sterilization.

[SOURCE: ISO/TS 11139:2006, definition 2.45]

3.46 sterility assurance level 无菌保证水平SAL

probability of a single viable microorganism occurring on an item after sterilization

灭菌后，在单位产品上检出存活微生物的概率。

Note 1 to entry: The term SAL takes a quantitative value, generally 10-6 or 10-3. When applying this quantitative value to assurance of sterility, an SAL of 10-6 has a lower value but provides a greater assurance of sterility than an SAL of 10-3.

注：SAL为定量值，通常为10-6或10-3。将此定量值用于无菌保证时，10-6SAL数值比10-3SAL小，但高于10-3SAL的无菌保证。[SOURCE: ISO/TS 11139:2006, definition 2.46]

3.47 Sterilization 灭菌

validated process used to render product free from viable microorganisms

已确认的使产品无存活微生物的过程。

Note 1 to entry: In a sterilization process, the nature of microbial inactivation is exponential and thus the survival of a microorganism on an individual item can be expressed in terms of probability. While this probability can be reduced to a very low number, it can never be reduced to zero. ISO 11135-2014

注：灭菌过程中，微生物的死亡规律用指数函数表示，因此，任何单件产品上微生物的存在可用概率表示。概率可减少到最低，但不可能到零。

Note 2 to entry: See 3.46, sterility assurance level.

[SOURCE: ISO/TS 11139:2006, definition 2.47]

3.48 sterilization cycle 灭菌周期

treatment in a sealed chamber, which includes air removal, conditioning (if used), injection of ethylene oxide, inert gas (if used), exposure to ethylene oxide, removal of ethylene oxide and flushing (if used), and air/inert gas admission 在一密闭的柜室内，包括进行去除空气、处理（若采用）、加入EO、EO作用、去除EO和换气（若采用）、及加入空气/惰性气体的一系列处理的步骤。

3.49 sterilization load 被灭菌产品（灭菌装载）

product to be, or that has been, sterilized together using a given sterilization process

用同一灭菌过程一起灭菌或已灭菌的产品

[SOURCE: ISO/TS 11139:2006, definition 2.48]

3.50 sterilization process 灭菌过程

series of actions or operations needed to achieve the specified requirements for sterility

[SOURCE: ISO/TS 11139:2006, definition 2.49]

为达到规定无菌要求所需的一系列动作或操作。

Note 1 to entry: This series of actions or operations includes preconditioning (if necessary), exposure to the ethylene oxide under defined conditions and any necessary post-treatment required for the removal of ethylene oxide and its by-products. It does not include any cleaning, disinfection or packaging operations that precede the sterilization process. ISO 11135-2014

注：这一系列动作或操作包括预处理（若采用）、在规定条件下暴露于EO和任何去除EO及其产物所需的后处理。但不包括灭菌过程之前的任何清洗、消毒或包装操作。

3.51 sterilization specialist 灭菌专家

person with technical knowledge of the sterilization technology being utilized and its effects upon materials and microorganisms

3.52 sterilizing agent 灭菌剂

physical or chemical entity, or combination of entities having sufficient microbicidal activity to achieve sterility under defined conditions

具有充分杀死微生物能力的在规定条件下能够达到无菌的物理或化学物质或物质组合。

[SOURCE: ISO/TS 11139:2006, definition 2.50]

3.53 survivor curve 存活曲线

graphical representation of the inactivation of a population of microorganisms with increasing exposure to a microbicidal agent under stated conditions

[SOURCE: ISO/TS 11139:2006, definition 2.51]

在规定条件下，微生物灭活与暴露于微生物杀灭剂的时间之间的图状说明。

3.54 test for sterility 无菌试验

technical operation defined in a Pharmacopoeia performed on product following exposure to a sterilization process [SOURCE: ISO/TS 11139:2006, definition 2.53]

3.55 test of sterility 无菌检查

technical operation performed as part of development, validation, or requalification to determine the presence or absence of viable microorganisms on product or portions thereof

开发、确认或重新确认的一部分，确定产品上是否存在存活微生物的技术操作。 ISO 11135-2014

[SOURCE: ISO/TS 11139:2006, definition 2.54]

3.56 usable chamber volume 柜室可用体积

defined space within the sterilizer chamber, which is not restricted by fixed or mobile parts and which is available to accept the sterilization load

灭菌器柜室内不受固定或可移动部件限制的，可容纳被灭菌物品的空间。

Note 1 to entry: The volume allowed for gas circulation around the load inside the chamber is not included as usable space.

注：用于循环的空间不计算在可用空间内

3.57 Validation 确认

documented procedure for obtaining, recording and interpreting the results required to establish that a process will consistently yield product complying with predetermined specifications

[SOURCE: ISO/TS 11139:2006, definition 2.55]

对获得的结果进行整理和记录的书面程序，证明某过程可持续生产符合预定规格的产品。

3.58 virgin material 新材料

material that has not been previously used, or subjected to processing other than for its original production

没被使用过的或被

4 Quality management systems 质量管理体系

4.1 Documentation 文件

4.1.1 Procedures for development, validation, routine control and product release from sterilization shall be specified. 应规定灭菌开发、确认、常规控制和产品放行的程序。

4.1.2 Documents and records required by this International Standard shall be reviewed and approved by designated personnel (see 4.2.1). Documents and ISO 11135-2014

records shall be controlled in accordance with the applicable clauses of ISO 13485.

本标准所要求的文件和记录应由指定人员进行审核和批准（见4.2.1）。文件和记录应按照ISO13485的适用条款进行控制。

4.2 Management responsibility 管理职责

4.2.1 The responsibility and authority for implementing and meeting the requirements described in this International Standard shall be specified. Responsibility shall be assigned to competent personnel in accordance with the applicable clauses of ISO 1348

5.

应规定实施和满足本标准要求的职责和权限。职责应按ISO13485的适用条款分配给能胜任的人员。

D.4.2.1 Requirements for responsibility and authority are specified in ISO 13485:2003, 5.5, and requirements for human resources are specified in ISO 13485:2003, 6.2.

ISO13485：2003中的5.5条款规定了职责和权限的要求, 6.2条款规定了人力资源的要求。

In ISO 13485, the requirements for management responsibility relate to management commitment, customer focus, quality policy, planning, responsibility, authority and communication, and management review.

ISO13485的管理职责涉及到管理承诺，顾客焦点，质量方针，策划，职责、权限与沟通，及管理评审。

Each organization should establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities.

每个机构应建立规定培训要求的程序，以确保所有人员都能胜任他们的职责。

4.2.2 If the requirements of this international standard are undertaken by organizations with separate quality management systems, the responsibilities and authority of each party shall be specified. ISO 11135-2014

如果本标准的要求由具有独立质量管理体系的机构承担，则各方的职责和权限应加以规定。

When a HCF contracts out the sterilization of reusable medical devices, it is the HCF’s responsibility for validation and release of the sterilized product.

当医疗保健机构将可重复使用医疗器械的灭菌外包时，灭菌产品的确认和放行是医疗保健机构的职责。

D.4.2.2 The development, validation and routine control of a sterilization process can involve a number of separate parties, each of whom is responsible for certain elements. It is important that the respective procedures clearly outline the responsibilities for meeting the requirements of this International Standard. This is especially important where contractors are engaged to carry out specific functions.

灭菌过程的开发、确认和日常控制能分成许多独立的环节，每个环节对某些要素负责。为满足本标准的要求，各自职责明确的流程是十分重要的；如果由承包商来完成某些项目，这尤其重要。

Even where elements of the sterilization process are contracted out it is important to note that the medical device manufacturer is ultimately responsible for validation, release and distribution of sterilized product to the market. When a health care facility contracts out the sterilization of reusable medical devices, it is the health care facility’s responsibility for validation and release of the sterilized product

无论灭菌过程的哪个要素被分包，应注意，确认、灭菌产品的放行和分发到市场仍是医疗器械制造商的职责。当医疗机构将可重复使用医疗器械的灭菌过程外包时，灭菌产品的确认和放行是医疗机构的职责。

Further guidance is available in ISO 14937:2009, E.4.2.2.

4.3 Product realization 产品实现 ISO 11135-2014

D.4.3 NOTE In ISO 13485, the requirements for product realization relate to the product lifecycle from the determination of customer requirements, design and development, purchasing, control of production, and calibration of monitoring and measuring devices.

产品实现的要求涉及到产品生命周期，产品生命周期取决于顾客要求、设计开发、采购、过程控制和监视和测量器械的校验。

4.3.1 Procedures for purchasing shall be specified. These procedures shall comply with the applicable clauses of ISO 1348

5.

应规定采购程序。这些程序应符合ISO13485适用条款的要求。

D.4.3.1 Requirements for purchasing are specified in ISO 13485:2003, 7.4. In particular, it should be noted that the requirements in ISO 13485:2003, 7.4 for verification of purchased product apply to product and services, that impact on process quality, received from outside the organization.

ISO13485：2003中的7.4条款规定了采购的要求。特别要注意，ISO13485：2003中的7.4条款的针对应用于产品和服务的、影响过程质量的、来自外部机构的采购产品的验证的要求。

Purchasing procedures in a health care facility should ensure that reusable medical devices are supplied with validated instructions for cleaning, disinfection, sterilization and aeration as specified in ISO 17664.It should also be verified that the prescribed procedure for cleaning, disinfection, sterilization and aeration can be performed in the health care facility.

根据ISO17444的要求，医疗机构的采购程序应确保重复使用医疗器械按已验证的清洗、消毒、灭菌和通风的规范要求来供应。应证明医疗机构实施了规定的清洗、消毒、灭菌和通风的流程。

4.3.2 Procedures for identification and traceability of product shall be specified. These procedures shall comply with the applicable clauses of ISO 1348

5. ISO 11135-2014

应规定产品标识和可追溯性程序。这些程序应符合ISO13485适用条款的要求。

D.4.3.2 Requirements for identification and traceability are specified in ISO 13485:2003, 7.5.3.

在ISO13485：2003的7.5.3中规定了标识和可追溯性的要求；

For those facilities that do not fully comply with ISO 13485, such as health care facilities, procedures for identification of product and maintenance of traceability should include the labelling of each item or package prior to sterilization with a lot control identifier that includes the following information:

对那些并不完全符合 ISO 13485的机构，如医疗机构，其产品标识和可追溯性程序应包括灭菌前的每一单件或每一包装件的批控

制标识，并包括下列信息:

a) the sterilizer ID or code;灭菌器的ID或代码；

b) the date of sterilization;灭菌日期

c) the cycle number (i.e. the cycle run of the day or sterilizer);

周期编号(如，当天的或灭菌柜的运行序号)

d) the identity of the person who assembled the pack.

操作人的身份

Including the identity of the person who assembled the pack allows for further investigation if a problem should arise. Lot identification information enables personnel to retrieve items sterilized in a specific cycle in the event of a recall and to trace problems to their source.

如出现问题时，可以调查到更详细的操作人的身份。批标识信息可以使人员在召回事件中更容易取回问题灭菌产品，以及追溯问题的根源。

4.3.3 A system complying with the applicable clause(s) of ISO 13485 or ISO 10012 shall be specified for the calibration of all equipment, including instrumentation for test purposes, used in meeting the requirements of this ISO 11135-2014 International Standard.

应规定所有设备(包括用于满足本标准要求的测试仪器)校准的体系，体系应符合ISO13485或ISO10012适用条款的要求。

D.4.3.3 Requirements for calibration of monitoring and measuring instrumentation are specified in ISO 13485:2003, 7.6. ISO 13485:2003中的7.6条规定了监视和测量装置的校验要求。

4.4 Measurement, analysis and improvement — Control of nonconforming product测量、分析和改进——不合格产品的控制Procedures for control of product designated as nonconforming and for correction, corrective action and preventive action shall be specified. These procedures shall comply with the applicable clauses of ISO 1348

5.

应规定被判定为不合格品的控制程序，及其纠正、纠正措施和预防措施的程序。这些程序应符合ISO13485适用条款的要求。

D.4.4 Procedures for control of non-conforming product and corrective action are specified in ISO 13485:2003, 8.3 and

8.5.2, respectively.

ISO 13485:2003中的8.3 和8.5.2条分别规定了不合格品的控制和纠正措施的要求。

5 Sterilizing agent characterization 灭菌剂特性

5.1 General通则

The purpose of this activity is to define the sterilizing agent, demonstrate its microbicidal effectiveness, identify the factors that influence microbicidal effectiveness, assess the effects that exposure to the sterilizing agent has on materials, and identify requirements for safety of personnel and protection of the environment. This activity may be undertaken in a test or prototype system. Where this occurs, the final equipment specification (see 6.3) shall be relatable to the results of experimental studies undertaken in the test or prototype equipment. For the purposes of this International Standard, the sterilizing agent is EO. ISO 11135-2014

本章节是为了定义灭菌剂，指明它的灭菌效果，识别影响灭菌效果的因素，评价灭菌剂对材料的影响，识别人员安全和环境防护的要求。这些活动可以由试验或样机系统来承担。无论在哪里进行，最终设备规范(见6.3)应与试验或样机设备的研究结果一致。本标准所指的灭菌剂是EO.

5.2 Sterilizing agent 灭菌剂

The sterilizing agent specification shall include, if appropriate, conditions of storage to maintain the EO within its specification for the duration of the stated shelf life.

如果适用，灭菌剂规范应当包括，为保证声称的保质期所规定的EO储存条件。

D.5.2 EO is a highly penetrative gas that will permeate most packaging materials and polymeric materials. Widely recognized compositions include pure EO and mixtures with carbon dioxide or nitrogen.

EO 是高穿透性气体，可穿透绝大多数包装材料和聚合材料。广泛认同的成份包括纯EO和EO与二氧化碳或氮气的混合物。

NOTE，For EO gas mixtures with carbon dioxide, nitrogen or other inert gas blends, EO molecular diffusion rates into polymer materials can be affected by the volume percent of EO gas molecules within the sterilant, which can result in longer EO exposure times to achieve the desired microbiological spore log reduction.

与二氧化碳、氮气或其他惰性气体混合的EO混合物，EO分子进入聚合材料的扩散速率可能会受灭菌剂中EO分子体积百分比的影响，这样可能导致达到规定的微生物孢子对数下降需更长EO暴露时间。

The storage conditions and shelf life for EO should be in accordance with the EO manufacturer’s recommendations and all applicable regulations. This is particularly important with premixed gas mixtures where stratification might be an issue.

EO 的储存条件和有效期应符合 EO生产商的建议和所有适用的规定。不管是否产生分ISO 11135-2014

层，混合气体的预先混合尤其重要。

5.3 Microbicidal effectiveness 杀灭微生物效果

Microbicidal effectiveness data shall be developed if it is proposed to use the EO outside of the range of compositions that are widely recognized or if a novel diluent is to be used.

如果使用的环氧乙烷超出公认的成分范围或使用新的稀释物，则应开发杀灭微生物的有效性数据。

NOTE The inactivation of microorganisms by EO has been comprehensively documented in literature. This literature provides knowledge of the manner in which the process variables affect microbial inactivation. Reference to these general studies on microbial inactivation is not required by this International Standard.

注：环氧乙烷对微生物的灭活性能已在文献中作全面记录，这个知识提供了过程变量影响微生物灭活的手段。本标准未对有关这些微生物灭活的普遍性研究作出要求。

5.4 Material effects材料影响

The effects of EO on a wide variety of materials used to manufacture medical devices have been comprehensively documented and such documentation is of value to those designing and developing medical devices that are to be sterilized by EO. This International Standard does not require the performance of specific studies on material effects, but does require performance of studies of the effects of EO on product (see Clause 7).

环氧乙烷对用于医疗器械制造的一系列材料的影响已得到全面记录，这些记录对使用环氧乙烷灭菌的医疗器械设计和开发具有一定价值。本标准不要求进行对具体材料影响的研究，但要求进行EO对产品影响的研究（见第7条）。

5.5 Safety and the environment安全和环境

5.5.1 Either a material safety data sheet (MSDS) or analogous safety information shall be made available for EO and its diluents (if any). Measures ISO 11135-2014

necessary to protect the health and safety of personnel shall be identified.

EO及其稀释剂应有材料安全清单(MSDS)或类似的安全报告。应规定人员安全和健康保护的必要措施。

D.5.5.1 EO is toxic, flammable and explosive; therefore, extreme caution should be used during its handling and use. The explosive limits are 2,6 % to 100 % EO by volume in air.

EO是有毒、易燃、易爆物质，因此，在使用时要格外的小心。其爆炸极限是空气中含有2.6%～100%的EO。

Where practical, EO sterilization cycles should operate within the non-flammable region throughout the complete sterilization cycle in order to minimize the risk of explosion. This requires the removal of air from the chamber prior to the introduction of EO gas. For 100 % EO sterilization processes this can be achieved by pulling a deep vacuum or by pulling several partial vacuums, each of which is followed by injection of an inert gas, e.g. nitrogen. This purges air from the chamber allowing EO gas to be injected into the chamber in a safe manner. On completion of the EO gas exposure phase it is necessary to remove the EO gas from the chamber until the level of gas is below the 2,6 % explosive limit. This is achieved by pulling several post-vacuums, each of which is followed by a nitrogen backfill.

不管怎样，为了使爆炸风险最小化，整个灭菌周期应在不易燃烧的区域内运行。这要求在EO导入前将灭菌柜室内的空气去除。对于使用100%EO的灭菌过程，可以通过抽深度真空或部分真空的方法来达到，不管哪个方法都可以用注入惰性气体如氮气的方法来排除空气。这样将柜室内的空气去除，使得EO安全地注入柜室。当EO暴露阶段结束时，必须将灭菌柜室内的EO气体浓度抽至2.6%的爆炸极限以下。可以通过多抽几次过真空然后回填氮气来完成。

The use of non-flammable sterilant blends can improve safety by decreasing the risk of fire or explosion. They can also facilitate compliance with country-specific equipment safety requirements. Nonflammable blends are ISO 11135-2014 produced by mixing the highly flammable EO gas with one or more inert gases. The flammability of such a mixture can be assessed by measuring the relative proportions of EO, air, diluent gas (e.g. CO2, etc.), inert gas (e.g. nitrogen) and water vapour in the sterilizer. Caution should be exercised to ensure no separation of the EO blend can occur as this might lead to safety and quality issues.

使用非可燃性混合灭菌剂，降低着火或爆炸的风险来提高安全性。这也容易符合国家特种设备安全要求。非可燃性混合灭菌剂由高可燃性EO气体与一种或多种惰性气体混合而成。这种混合气体的可燃性可以通过测定灭菌柜室内的EO、空气、稀释气体(如二氧化

碳等)、惰性气体(如氮气)和水蒸汽的比例来评估。应注意，混合气体的分层可能导致安全和质量事故。

Ethylene oxide sterilizers should be installed in a dedicated room. The operating controls for the sterilization equipment should be mounted outside the room so that operators can set or change program parameters without entering the sterilization room. All airflow from the sterilizer access area should be exhausted to the outdoors and comply with applicable requirements.

环氧乙烷灭菌柜应安装在专用房间内。灭菌柜的操作控制应安装在灭菌柜房间外，使操作者在不进入灭菌间就可以设定或调整项目参数。用适当的设备，将来自灭菌柜区域的全部空气排出户外。

Prior to removing product from a sterilizer, precautions should be taken to ensure that operators are not exposed to levels of EO above relevant worker exposure limits [permissible exposure limit (PEL)/short term exposure limit STEL)] due to the outgassing of the load. When products sterilized with inert EOgas mixtures are not immediately removed from the sterilizer at the end of a cycle the EO concentrations in the sterilizer might result in personnel safety issues. 在将产品移出灭菌柜前，应采取预防措施，以确保操作员工不会处于由于产品解析EO而超过安全极限的环境里。如果用混合气体灭菌，当周期结束后，未马上将产品从灭菌柜内移出时，灭菌柜内的EO浓度可能导致人员安全事故。 ISO 11135-2014

5.5.2 The potential effect on the environment of the operation of the sterilization process shall be assessed and measures to protect the environment shall be identified. This assessment, including potential impact and measures for control, shall be documented.

应评估灭菌过程对环境的潜在影响，并规定保护环境的措施。应记录所进行的评估，包括潜在危害和控制措施。

D.5.5.2 Principles of an environmental management system can be applied to the EO sterilization process. ISO 14001 provides a specification for an environmental management system. ISO 14040 provides guidance on designing a life cycle assessment study.

环境管理体系的原则可以应用于EO灭菌过程。ISO14001提供了环境管理体系的规定。ISO14040提供了关于生设计命周期评估研究的指南。

5.5.3 Users of EO shall comply with applicable local, national and international requirements regarding the emission and disposal of EO and its diluents as well as any by-products.

对于EO和稀释剂及其副产物的排放和处理，EO使用者应符合适当的地区、国家和国际的要求。

D.5.5.3 Effluent gas should be discharged through an EO gas treatment system, such as a catalytic oxidizer, wet acid scrubber or thermal oxidizer in compliance with local permit requirements or emission control legislation.

废气应通过一个EO气体处理系统排放，如，符合当地许可要求或排放控制法规的催化氧化器，湿酸洗涤器或热氧化器。

When choosing a diluent, the ozone depleting potential of the diluent as well as the disposal of any byproducts should be taken into consideration.

选择稀释剂时，应考虑稀释剂及其副产物的臭氧消耗潜力。

6 Process and equipment characterization 过程和设备特征

D.6 In health care facilities, process and equipment characterization are ISO 11135-2014

generally the responsibility of the sterilizer manufacturer. The management of the health care facility should have controls in place to ensure that the equipment it purchases conforms to national, regional and local regulations and is suitable for use to sterilize products that require EO sterilization. The management of the health care facility should ensure that the facility has the infrastructure necessary to correctly operate the sterilizing equipment and to achieve effective sterilization of medical devices.

在医疗机构，过程和设备特征通常是制造商的职责。医疗机构的管理应控制到位，以确保采购的设备符合国家、地区和地方法规的要求，并适用于产品的EO灭菌过程。医疗机构的管理应确保机构具有必要的基础设施，以完成灭菌设备的正确操作，并能达到有效的医疗器械灭菌过程。

6.1 General 通则

6.1.1 The purpose of this activity is to define the entire sterilization process and the equipment necessary to deliver the sterilization process safely and reproducibly.

这一活动的目的是定义整个灭菌过程及可提供安全和可重复灭菌过程所必需的设备。

6.1.2 If an existing process has been used to sterilize product this activity is not required, however, the process and equipment should be reviewed to ensure the identified variables in 6.2 and 6.3 have been included in the process specification for routine production.

如果目前的过程已被用于灭菌产品，这一活动不是必需的，然而，应对灭菌过程和设备进行评审，以确保在6.2和6.3所定义的变量已包含在日常生产的过程规范中。

6.2 Process characterization过程特征

6.2.1 Process characterization, at a minimum, shall include:

过程特征，至少应包含：

a) identifying the phases that are necessary for an EO sterilization process;

识别EO灭菌过程所必需的阶段； ISO 11135-2014

b) identifying the process variables for each phase;

识别每个阶段的过程变量

c) documenting the process variables.

记录过程变量

NOTE The data developed in product definition (see Clause 7) can impact the characterization of the sterilization process.

注，在产品定义(见7)时开发的数据可能影响灭菌过程特征

6.2.2 The phases of the sterilization process include:

灭菌过程的阶段包括:

a) preconditioning (if used);预处理(如采用)

b) the sterilization cycle;灭菌周期

c) aeration (if used).通风(若采用)

D.6.2.2 The resistance of microorganisms to deactivation by EO is affected by their moisture content. At low levels of humidity, below 30 %, microbial resistance may increase with decreased humidity for some products. For this reason it is common practice to control and monitor the humidity of the atmosphere to which the product is exposed in order to attempt to equilibrate the moisture content of the microorganisms with the local conditions. Consideration should be given to the packaged product to ensure that excessive relative humidity will not impact the product functionality and package integrity. One of the ways to assist in addressing the humidity in the product is to precondition product at a defined temperature and humidity. Such preconditioning can reduce the duration of the sterilization cycle. For health care facilities, excessive moisture content can also be caused by inadequate drying after cleaning.

微生物对EO的抵抗力受他们的水分含量的影响。在较低的湿度水平下，低于30%,有些ISO 11135-2014

产品微生物的抵抗力会增加。由于上述原因，通常测定和控制与产品接触的空气湿度，促使微生物的水分含量与当地条件一致；应考虑到过高的相对湿度对已包装产品的产品性能和产品包装完整性的影响。帮助提高产品湿度的方法之一是在规定的温度和湿度下预处理产品。这样的预处理能减少灭菌周期的时间。对医疗机构而言，清洗后未充分干燥可能引起过高的水分含量。

Product heating and humidification are used to establish reproducible product temperature and moisture content prior

to EO exposure. Studies establishing minimum residence time in preconditioning cells/rooms ensure that the required conditions are attained in the sterilization load. Precautions should be taken to prevent excessive water condensation on the sterilization load.

产品的加热和加湿可以使EO暴露前的产品的温度和水分含量达到规定的范围内。在预处理室/房的最短滞留时间确保灭菌产品内达到规定的条件。应注意灭菌产品内水的凝结。

Although it is common practice to perform preconditioning in a separate chamber, room or cell, sterilization cycles can be designed to attain the required temperature and humidity ranges within the load during a conditioning phase in the sterilization chamber. To minimize the risk of excessive condensation, it is recommended that the load temperature should be maintained above the process environmental dewpoint temperature during the preconditioning and conditioning phases of the sterilization process.

尽管在专用的柜、房间或室内进行预处理十分普遍，但也可在灭菌柜内，在处理过程期间，使灭菌产品内的温度和湿度达到规定的范围内。为降低水凝结的风险，在灭菌过程的预处理和处理阶段，将产品(装载)的温度保持在加工环境的露点温度之上。

The actual temperature and humidity ranges within the sterilization load at the end of preconditioning should be demonstrated during PQ.

PQ时应证明预处理结束时灭菌产品(装载)内的实际温度和湿度范围。

Where applicable, a maximum time between removal of the load from preconditioning and the start of the sterilization cycle needs to be ISO 11135-2014

established. A transfer time of 60 min or less is common practice.

在适用情况下，应规定产品(装载)从预处理移出到灭菌周期开始的最大时间。

一般情况下，转移时间不超过60分钟。

a) When product enters the sterilization chamber without preconditioning, consideration should be given to the possibility of excessive condensation in product and packaging.

当产品未经预处理进入灭菌柜时，要考虑产品和包装中水凝结的可能性。

b) Residues of EO and its reaction products can be hazardous. It is essential for the manufacturer of the product to be sterilized to be aware of the possible occurrence of residues in the product. Temperature, dwell time, forced heated air circulation, load characteristics, product and packaging _materials all affect the efficiency of aeration, and the set points and tolerances should be taken into account when evaluating residual levels as outlined in ISO 10993-7. Aeration can be performed within the sterilizer, in a separate area(s), or in a combination of both. For health care facilities it is usual to perform aeration in a chamber rather than in a room due to the hazards of exposure to EO. In health care facilities, reprocessed items sterilized with EO need to be thoroughly aerated prior to handling or use, according to the medical device and the rigid sterilizer container manufacturer’s recommendations. Inadequately aerated items and packaging will release EO, which can injure patients and health care facility personnel.

EO及其产物的残留可能是有危害的。就灭菌产品的制造商而言，应关注产品内产生残留的可能性。温度、时间、强热风循环、装载特征、产品及其包装材料都可能影响通风的效果。当按ISO10993-7的要求评估残留水平时，应先设定残留物的值及其公差。通风可以在灭菌柜室内或专门的区域内进行，或二者相结合。医疗机构通常在灭菌柜内通风。在医疗机构，用EO灭菌的再加工物品在处理和使用前，应根据医疗器械和灭菌柜室的制造商的建议，对产品进行彻底的通风。通风不足的物品或包装可能释放EO,而导致病人和操作人员的伤害。 ISO 11135-2014

6.2.3 The process variables for preconditioning (if used) include at a minimum:

预处理(若采用)的过程变量至少应包含:

a) time;时间

b) temperature;温度

c) humidity;湿度

d) transfer time.转移时间

D.6.2.3 Transfer time refers to each transfer step during preconditioning and final transfer of product into the sterilizer to the start of cycle.

转移时间参考预处理期间的每一转移步骤和产品最后进入灭菌柜周期开始的转移。

6.2.4 The process variables for the sterilization cycle include:

灭菌周期的过程变量包含:

a) exposure time; 暴露时间

b) temperature;温度

c) humidity;湿度

d) EO concentration;EO浓度

e) pressure.压力

D.6.2.4 The following is a list of phases that can be included in a sterilization cycle along with the performance factors that might be considered for each phase:

下列是灭菌周期是可能需考虑的每个阶段的性能因素的清单:

a) air removal:空气去除

1) depth (ΔP or terminal pressure) and rate (ΔP/time) of attainment of vacuum; ISO 11135-2014

真空深度(ΔP或终端压力)和抽真空的速率(ΔP/时间)

b) chamber leak test (performed either under vacuum for subatmospheric cycles or under vacuum and at pressure for superatmospheric cycles), if applicable:

柜室泄漏试验(低于大气压或真空状态下和在高于大气压状态下二都之一),如适当:

1) stabilization period and/or hold time;稳定期限和/或保持时间

2) pressure change;压力变化；

c) inert gas addition (if used);惰性气体的加入(若采用)

1) pressure (ΔP or terminal pressure) and rate (ΔP/time) of attainment of pressure on admission of the inert

gas.

压力(ΔP或终端压力)和惰性气体进入的压力变化速率(ΔP/time)。

d) conditioning (if used);处理(若使用)

1) during the conditioning phase, pressure rise (ΔP or terminal pressure) or % relative humidity and rate (Δ

P/time) of attainment of pressure on injection of steam;

处理阶段，压力上升或相对湿度，以及蒸汽注入时压力变化速率(ΔP/time)。

2) number of steam pulse/vacuum stages, if applicable;

蒸汽加入和抽出的次数，如适用；

e) EO injection:EO注入

1) pressure, pressure rise (ΔP) and rate (ΔP/time) of attainment of specified pressure on admission of EO and

correlation of methods used to monitor EO concentration;

压力，压力上升，和注入EO时规定的压力速率(ΔP/time)，以及监测EO浓度的方法

2) pressure, pressure rise (ΔP) and rate (ΔP/time) of attainment of specified pressure on admission of any inert

gasses (if used); ISO 11135-2014

压力，压力上升，和注入惰性气体的规定的压力速率(ΔP/time)

f) maintenance of specified conditions for the exposure time:

EO暴露时间的规定条件的保持

1) pressure differential used to apply sterilant or inert gas make-ups (if used);用灭菌剂或惰性气体补偿(若采用)

的压力变化。

2) chamber temperature;柜室温度

g) EO removal:EO去除

1) depth (ΔP or terminal pressure) and rate (ΔP/time) of attainment of vacuum to remove EO;EO去除时的压力和

压力变化速率

h) flushing (if used):清洗

1) pressure rise and rate of attainment of pressure;压力上升和压力变化速率。

2) depth (ΔP or terminal pressure) and rate (ΔP/time) of attainment of vacuum to remove EO;去除EO的真空深度

和真空速率

3) number of times of repetition and any variations in successive repetitions;重复次数和连续重复时的任何变化。

i) air/inert gas admission:空气或惰性气体的进入。

1) pressure (ΔP or terminal pressure) and rate (ΔP/time) of attainment of pressure on admission of the inert

gas or air;

压力和进入惰性气体或空气的压力变化速率

2) number of times of repetition and any variations in successive repetitions;

重复次数和连续重复时的任何变化。

3) equilibration to atmospheric pressure using air admission.

使用空气与大气压平衡。 ISO 11135-2014

6.2.5 The process variables for aeration (if used) include at a minimum:

通风(若采用)的过程变量至少包含:

a) time;时间

b) temperature.温度

NOTE In aeration these parameters are considered process variables only if aeration is considered to contribute to ensuring the microbicidal effectiveness of the sterilization process (See AAMI TIR16:2009, clause 5.1.3.3)

如果通风只是用于协助确保灭菌过程杀灭微生物效果，通风时上述参数应是过程变量。

D.6.2.5 Recirculation velocity should be specified when assessing product residual levels.

当评估产品残留量水平时，应规定空气循环速度。

6.3 Equipment characterization 设备特征

6.3.1 The specification for the equipment to be used shall be developed and documented. This specification shall include: 应开发和记录所用设备的规范。规范应包含：

a) the preconditioning area (if used);预处理区域(若采用)

b) the sterilizer;灭菌器

c) the aeration area (if used).通风区域(若采用)

NOTE Some aspects of the equipment design may be influenced by national or regional regulatory requirements or standards. 注：一些设备设计因素可能受国家或地区法规要求和标准的影响。

D.6.3.1 The following factors should be considered when characterizing the equipment: ISO 11135-2014

当表征设备时应考虑下列因素:

a) Preconditioning area characterization.预处理区的特征

Preconditioning can be performed in a separate preconditioning area (chamber, cell or room). Humidification by steam is necessary because humidifiers that operate by dispersion of unheated water as an aerosol (e.g. spinning disc humidifiers and nebulizers) can be a potential source of microbial contamination.

预处理可以在专门的预处理区（柜室，室或房间）进行。应使用蒸汽来加湿，如使用加湿器(被分散的水未经加热处理,如旋转盘加湿器和雾化器）来加湿，可能导致微生物的污染潜。

The preconditioning area (if used) should have the following performance and monitoring capabilities:

预处理区(若采用)应有下列性能和监视能力:

adequate air circulation to ensure the uniformity of temperature and humidity in the usable space, and to ensure that uniformity is maintained in a loaded room or chamber;

充足的空气循环，以确保可用空间的温度和湿度的均匀性，并确保在装载间或柜室内保持均匀性。

airflow detection equipment, alarm systems or indicators monitoring the circulation system to ensure conformance to predetermined tolerances;

测试空气流动的设备，警报系统或监视循环系统的指示，以确保规定公差的一致性。

means of recording time of load entry into and removal from the preconditioning area;

装载进入和移出预处理区的记录时间的手段。

means of monitoring cell/room temperature and humidity;

ISO 11135-2014

监视室/房间的温度和湿度的手段

— means of controlling cell/room temperature and humidity.

控制室/房间的温度和湿度的手段

b) Sterilizer characterization.灭菌柜特征

The sterilization chamber should have the following performance and monitoring capabilities:

灭菌柜应具备下列性能和监视能力:

means of monitoring time, chamber pressure, temperature and humidity (if humidity additions are controlled by sensor readings);

监视时间、柜室压力、温度和湿度的手段(如果加湿是靠传感器读数控制的);

means of controlling time, chamber pressure, temperature and humidity, if humidity additions are controlled by sensor readings (when sensors are fixed on the equipment, ensure that a correlation is made during IQ or OQ to the pressure

rise);

控制柜室压力、温度和湿度的手段, 如果加湿是靠传感器读数控制的; [如果传感器是装在设备上的，要确保在安装鉴定或操作鉴定时压力上升具有关联性];

if humidity is not controlled by sensor readings, means to monitor and control steam additions;

如果湿度不是由传感器读数控制的，监视和控制蒸汽加入的手段。

if parametric release is used, analytical instrumentation for the direct analysis of humidity during conditioning and EO concentration during EO exposure time (also see 9.5.5 and D.9.5.5);

如果采用参数放行，在处理期间直接测定湿度和在EO暴露时间直接测定EO浓度的分析仪器(也可见9.5.5和D9.5.5)

— a system controlling the admission of gaseous EO to the chamber; ISO 11135-2014

— 控制EO气体导入柜室的系统；

— means to demonstrate that gaseous EO is injected into the chamber. This can be done by measuring the temperature of the EO gas flowing from the vaporizer to the sterilizer chamber. This system can control EO concentration during EO exposure time.

证明EO气体已进入柜室的手段。可采用测量从汽化器流入灭菌柜室的EO气体温度的手段。这一系统可控制EO曝露期间的EO浓度。— means to detect and alert deviations to cycle parameters so that remedial action can be taken in a timely fashion.

测量和警报周期参数偏差的手段，以及时采取补救措施。

c) Aeration area characterization.通风区特征

An aeration area (chamber, cell or room) can be used to remove EO residuals from product/packaging. Temperature uniformity, fresh air make-up and air re-circulation throughout the area are important to ensure consistent and reproducible results. The aeration area should have the following performance and monitoring capabilities:

通风区用于去除产品/包装中的EO残留。整个区域的温度均匀性、新鲜空气补充和空气再循环对确保一致的和可再现的结果是非常

重要的。通风区应具备下列性能和监视能力:

— airflow detection equipment, alarm systems or indicators monitoring the air handling system to ensure that it operates within predetermined tolerances and maintains adequate airflow in a loaded room or chamber;

具备空气流量检测设备、报警系统或空气处理系统监测显示器，以保证空气处理系统在满载的房间或柜室内在规定的参数范围内运行，并保持充裕的空气流量;

— equipment to re-circulate air;空气再循环设备;

— means of monitoring room temperature;监测室温的手段 ISO 11135-2014

— means of controlling room temperature.控制室温的手段

6.3.2 At a minimum, the specification shall include:

规范至少应包含:

a) description of the equipment, together with any necessary ancillary items, including materials of construction; 设备及其附件，包括组成材料的描述；

b) description of the means by which the sterilizing agent is delivered to the chamber;

灭菌剂进入柜室的方式的描述；

c) description of the means by which any other gas(es), including steam, are delivered to the chamber;

其他气体，包括蒸汽，进入柜室的方式的描述；

d) description of instrumentation for monitoring, controlling and recording the sterilization process, including sensor characteristics and their locations;

用于监视、控制和记录灭菌过程的仪表的描述，包括传感器的特性及其位置

e) fault(s) recognized by the sterilizing equipment;

灭菌设备认可的故障；

f) safety features, including those for personnel and environmental protection;

安全特性，包括人员安全和环境防护；

g) installation requirements, including specifications for required services and requirements for the control of emissions.

安装要求，包括必需的服务和排放控制要求的规范；

D.6.3.2 The equipment specification should be reviewed to ensure that ISO 11135-2014

regulatory and safety requirements are met, technical specifications are appropriate, and services and infrastructure necessary to operate the equipment are available.

设备规范应经审核，以确保规范已满足法规和安全的要求，技术规范是适当的，服务和设备操作所必要的基础设施是适宜的。

The following items should be considered when preparing the equipment specification:

编制设备规范时，应考虑下列内容:

a) If the EO supply to the sterilizer is from a bulk storage tank that is periodically replenished, then the tank should be equipped with a means of removing samples for analysis, a means of emptying the tank of EO and a provision for cleaning in the event of contamination or excessive accumulation of polymers.

如果EO是从定期补充的大体积储存罐内导入灭菌柜的，那么，储存罐就有一个能提取用于分析样品的装置，清空罐内EO的手段，以及在污染或聚合物过度积聚情况下的清洗规范。

b) The system for admission of EO to the sterilizer should be equipped with a vaporizer to prevent liquid EO from being admitted to the sterilizer chamber.

EO导入系统应装配一个汽化器，以防止EO以液态状态进入灭菌柜。

c) The temperature of the EO gas flowing from the vaporizer to the sterilizer chamber should be measured to demonstrate that gaseous EO has been produced.

应测量EO气体从汽化器进入灭菌柜时的温度，以证明进入是气体EO。

d) Steam is utilized to humidify the load and is not intended to be a sterilant. The consistency of steam supply can be determined by the periodic analysis of the boiler feed water or condensate.

蒸汽是用于加湿产品[装载]而不是当作灭菌剂。可通过定期对锅炉加水或冷凝水的分析来确定蒸汽供应的一致性。 ISO 11135-2014 e) A minimum of two probes to measure chamber temperature should be used. Large volume chambers can be fitted with more than two probes so as to ensure that the monitoring/control system captures data that reflects the temperature throughout the chamber during use.

至少有二个可以测定柜室温度的探头。大容积的柜室可以安装多于二个探头，以确保监视/控制系统可获得反映柜室工作温度的数据。

NOTE The purpose of two separate probes is to prevent the failure of one sensor from causing an out-of specification process from being erroneously accepted. Comparing two separate temperature sensors will detect that one of the sensors has failed. A dual element temperature probe can be used to meet this need.

注，二个独立的探头是为了防止探头故障而不符合规范的过程被错误地接受。比较二个独立的温度传感器将可以检测其中一个传感器已故障。二个探头可以满足这个需要。

f) It is important to maintain uniform conditions within the sterilizer chamber during processing. This can be achieved by forced gas circulation. If used, a gas circulation system should be equipped with a monitoring device to indicate when circulation is ineffective as devices that solely monitor “power on” to the fan or pump are not sufficient. 在灭菌期间灭菌柜内保持均衡的条件是十分重要的。这可以通过迫使气体循环来达到。如果使用，安装一个带监视装置的气体循环系统，当循环无效或泵力的不足时，监视装置显示器闪动‘power on’。

g) Areas used for storage of cylinders, tanks or cartridges of EO or EO gas mixtures should be secured and ventilated. 用于EO或EO混合气体钢瓶、罐或盒储存的区域应独立和通风。

h) Where ambient conditions are subject to temperature variation greater than the range recommended by the supplier, storage areas for the containers of EO should include provision for temperature control. ISO 11135-2014

如果环境条件可能导致大于供应商推荐的温度变化范围，那么，EO容器的贮存区域应包含一个控制温度的防护措施。

It might not be possible to calibrate controlling and monitoring instruments under actual processing conditions, e.g. humidity sensors. Calibration results for these instruments should be correlated against qualification studies. Processing conditions can have a detrimental effect on some types of sensors, e.g. humidity sensors. Sensors might require replacement after repeated exposure to processing conditions due to irreversible deterioration of materials currently used as sensing elements. It might be necessary to implement a program of more frequent maintenance for these sensors than that recommended by the sensor manufacturer/supplier.

在实际工作条件下，去校验控制和监视仪器也许是不可能的，如湿度传感器。这些仪器的校验结果对验证研究有关联。加工条件可能对一些传感器有不利的影响，如，湿度传感器。反复暴露于加工条件后导致传感元素的材料不可逆的老化后，可以更换传感器。以高于制造商或供应商推荐的保养频率去保养这些传感是必要的。

6.3.3 Software used to control and/or monitor the process shall be prepared and validated in accordance with the elements of a quality system that provides documented evidence that the software meets its design specification.

按质量体系元素的要求，用于过程控制和/或监视的软件应经准备和确认，以提供书面证据证明软件符合其设计规范。

NOTE For further information, attention is drawn to ISO/IEC 90003.

注：进一步信息见ISO/IEC90003。

6.3.4 The means of monitoring and controlling the process variables shall be determined and specified.

应确定和规定监视和控制过程变量的手段

6.3.5 Means shall be provided to ensure that failure in a control function does not lead to failure in recording of process variables such that an ISO 11135-2014

ineffective process appears effective.

应提供适当的手段，以防止某控制功能失效而导致过程参数记录失效，从而致使无效的过程显得有效的。

NOTE This may be achieved either by the use of independent systems for control and monitoring or by a cross-check between control and monitoring which identifies any discrepancies or indicates a fault.

注：可通过使用独立的控制和监视系统或控制和监视之间的相互校验实现该目的，发现矛盾并指出故障。

D.6.3.5 If there is an undetected failure of a control or monitoring function, a sterilization load could be released without having met its required processing parameters. To prevent this from happening, it is general practice to have redundant sensors for many critical process parameters. The common options for utilizing these redundant sensors include:

如果有一个未被发现的控制或监视功能的故障，灭菌产品可能在未满足规定的加工参数的情况下被放行。为了防止此类事件的发生，通常是备用一个那些重要参数的传感器。利用这些备用的传感器的选项包括:

a) use one sensor for control, and another sensor for monitoring and reporting;

用一个传感器用于控制，另一个传感器用于监视和报告。

b) use two sensors, or their average value, for both monitoring and control; this system needs to generate an automatic fault condition if the difference between the two sensors exceeds a defined value;

用二个传感器，或他们的平均值，都用于监视和控制。如果二个传感器的差异超过了规定的限值，系统需产生一个自动的故障条件。

c) use dual element sensors for both monitoring and control; this system needs to generate an automatic fault condition if the difference between the two elements exceeds a defined value.

使用双重的监视和控制传感器。如果二个传感器的差异超过了规定的限值，系统需产ISO 11135-2014

生一个自动的故障条件。

7 Product definition产品定义

7.1 General通则

7.1.1 The purpose of this activity is to define the product to be sterilized, including the microbiological quality of the product prior to sterilization and the manner in which product is packaged and presented for sterilization. 对需灭菌的产品进行定义，包括灭菌前产品微生物质量，及产品包装和提供灭菌的方式。

D.7.1.1 Product definition involves documentation of essential information about the medical device to be sterilized (i.e. the new or modified product).

产品定义涉及到被灭菌医疗器械的必要的信息文件[如是新产品还是改造过产品]

Product definition for a medical device includes the medical device itself, the sterile barrier system containing the device, and any accessories, instructions, or other items included in the packaging system. It also includes a description of the intended functionality of the medical device, and the available manufacturing and sterilization processes. The product definition process should also consider whether this is a new design, or whether it is part of an existing product family.

作为医疗器械的产品定义包括医疗器械本身，装有产品的无菌屏障系统，以及包装系统内的任何附件、说明书或其他部件。也包含医疗器械预期功能和适当的制造和灭菌过程的描述。产品定义过程也应考虑产品是否是新设计的，或者是否是目前产品族的一部分。The following should be considered as part of product definition:

下列应考虑为产品定义的部分:

a) physical attributes of the medical device (composition and configuration);医疗器械的物理属性[组成和结构] ISO 11135-2014

b) intended use of the medical device;医疗器械的预期用途

c) whether the medical device is intended for single use or for multiple use;医疗器械预期是一次性使用还是多次使用。

d) design characteristics that would affect the choice of sterilization process (e.g. batteries, fibreoptics, computer chips);可能影响灭菌过程选择的设计特征[如，电池、光纤、计算机芯片]

e) raw materials/manufacturing conditions that could affect microbiological quality (e.g. materials of natural origin); 可能影响微生物质量的原材料/制造条件[如天然材料]

英国合同法复习资料

英国合同法复习资料 -CAL-FENGHAI-(2020YEAR-YICAI)_JINGBIAN

Lecture 1 Offer and acceptance I What is an offer? Key principles: An offer is a statement which objectively indicates that the offeror is prepared 900 pounds”P:“We agree to buy for the sum of 900 pounds asked by you” D refused to sell. Held: D is not b ound. P’s first telegram asked two questions and D answered only the second. D had made no promise, express or implied to sell. A statement of the minimum price at which a sell the house to you” and invited Gibson to fill in a form. Gibson filled in but council refused to sell. Held: No contract. The words “may be prepared to sell” are fatal to this. The Council did not make an offer but only invited offers and the tenant made a firm offer which was rejected by the Council. The tenant’s application was an offer rather than an acceptance. Recognized instances of invitations to treat Advertisements Key principles: Advertisements are normally invitations to treat because it is clear that the each. No details as to quantity. Held: The ad did not amount to an offer to sell. after using the smoke ball as directed and that to show its sincerity it had deposited ￡1000 in a bank account. P used the smoke ball, but nevertheless caught flu. Held: the ad was an offer to the world which was accepted by P when she used the smoke ball as directed. She was entitled to the ￡100. Shop displays Key principles: the display of goods for sale on a supermarket shelf is an invitation to treat, and Held :As a general rule, display of flick knife in a shop window is an invitation to treat and not supervision of a registered pharmacist. In this shop, the pharmacist could refuse to allow the purchase at the cash desk.

最新中文地址如何翻译成英文(精)

5栋 Building No.5 ----------- 请看相关资料 翻译原则:先小后大。 中国人喜欢先说小的后说大的,如 **区 **路 **号 而外国人喜欢先说大的后说小的,如 **号 **路 **区,因此您在翻译时就应该先写小的后写大的 . 中文地址的排列顺序是由大到小, 如:X 国 X 省 X 市 X 区 X 路 X 号, 而英文地址则刚好相反, 是由小到大。如上例写成英文就是:X 号, X 路, X 区, X 市, X 省, X 国。掌握了这个原则,翻译起来就容易多了! X 室 Room X X 号 No. X X 单元 Unit X X 号楼 Building No. X X 街 X Street X 路 X Road X 区 X District X 县 X County X 镇 X Town

X 市 X City X 省 X Province 请注意:翻译人名、路名、街道名等,最好用拼音。 中文地址翻译范例: 宝山区示范新村 37号 403室 Room 403, No. 37, SiFang Residential Quarter, BaoShan District 虹口区西康南路 125弄 34号 201室 Room 201, No. 34, Lane 125, XiKang Road(South, HongKou District 473004河南省南阳市中州路 42号李有财 Li Youcai Room 42 Zhongzhou Road, Nanyang City Henan Prov. China 473004 434000湖北省荆州市红苑大酒店李有财 Li Youcai Hongyuan Hotel Jingzhou city Hubei Prov. China 434000 473000河南南阳市八一路 272号特钢公司李有财

委托翻译合同样本(官方版)

编号：QJ-HT-0465委托翻译合同样本(官方版) In order to clarify their rights and obligations, sign contracts to ensure that their legitimate rights and interests are not harmed. 甲方：_____________________ 乙方：_____________________ 日期：_____________________ --- 专业合同范本系列下载即可用---

委托翻译合同样本(官方版) 说明：该合同书适用于甲乙双方为明确各自的权利和义务，经友好协商签署合同，在合同期限内按照合同规定或者依照法律规定履行义务，保证权利双方合法权益不受损害，文档可下载收藏或打印使用（使用时请先阅读条款是否适用）。 委托翻译合同范文一 甲方:xx 乙方:xx 经甲乙双方友好协商，现就甲方委托给乙方完成的xx申报中文材料翻译成英文材料事项签订如下合同。 一、翻译稿件名称：xx材料。具体包括：1、拟建xx考察报告(含建设发展规划及规划图册);2、xx申报书;3、xx申报自评报告;4、xx风光片解说词。 二、工作时间：甲方于x年x月日前将需翻译的中文定稿材料交付乙方。乙方应于x年x月x日前将翻译好的英文成稿交付甲方。 三、交稿方式：乙方应向甲方提供英文成稿打印件及电子文本(文件格式：coredraw9.0排版)各一份。

四、合同总金额：合同全部工作任务总费用为xx元，大写人民币xx元整。甲方在签订合同之日起向乙方支付x万元，余款在乙方交付成稿并经甲方验收后一次性结清。 五、翻译质量：乙方保证翻译成稿质量，做到忠实原文、翻译准确、语句通顺、行文流畅，达到甲方提供给乙方的《xx综合报告》(英文版)的翻译水平。如双方对译文水平发生争议，由双方共同认可的第三方进行评判。 六、其它事项：乙方负责为甲方在xx申报国际评审会上作英文陈述，陈述费用不再另付。乙方在申报材料的英文翻译稿进行电脑排版时，需就排版格式等有关问题与甲方提供的印刷厂技术员进行联系沟通，以保证英文成稿的电子文本符合甲方印刷要求。 七、本合同自签订之日起具有法律效力，双方应共同遵守，否则由违约方赔偿对方由此造成的一切损失。 八、本合同未尽事宜，由双方友好协商解决。 九、本合同壹式肆份，甲乙双方各执贰份，具有同等法律效力。 甲方(签章)：乙方(签章)： 委托翻译合同范文二

唯美的中文翻译成英文

唯美的中文翻译成英文 Abandon 放弃 Disguise 伪装 Abiding 持久的，不变的~friendship Indifferent 无所谓 Forever 最爱 I know what you want 我知道你想要什么 See you forget the breathe 看见你忘了呼吸 Destiny takes a hand.命中注定 anyway 不管怎样 sunflower high-profile向日葵，高姿态。 look like love 看起来像爱 Holding my hand, eyes closed you would not get lost 牵着我的手，闭着眼睛走你也不会迷路 If one day the world betrayed you, at least I betray the world for you! 假如有一天世界背叛了你，至少还有我为你背叛这个世界! This was spoiled child, do not know the heart hurts, naive cruel. 这样被宠惯了的小孩子，不知道人心是会伤的，天真的残忍。

How I want to see you, have a look you changed recently, no longer said once, just greetings, said one to you, just say the word, long time no see. 我多么想和你见一面，看看你最近的改变，不再去说从前，只是寒暄，对你说一句，只说这一句，好久不见。 In fact, not wine, but when the thought of drinking the unbearable past. 其实酒不醉人，只是在喝的时候想起了那不堪的过去。 The wind does not know clouds drift, day not know rain down, eyes do not understand the tears of weakness, so you don't know me 风不懂云的漂泊，天不懂雨的落魄，眼不懂泪的懦弱，所以你不懂我 Some people a lifetime to deceive people, but some people a lifetime to cheat a person 有些人一辈子都在骗人，而有些人用一辈子去骗一个人 Alone and lonely, is always better than sad together 独自寂寞，总好过一起悲伤 You are my one city, one day, you go, my city, also fell 你是我的一座城，有一天，你离开了，我的城，也就倒了。

合作协议(中英文翻译)

编号：_______________本资料为word版本，可以直接编辑和打印，感谢您的下载 合作协议(中英文翻译) 甲方：___________________ 乙方：___________________ 日期：___________________ 说明：本合同资料适用于约定双方经过谈判、协商而共同承认、共同遵守的责任与 义务，同时阐述确定的时间内达成约定的承诺结果。文档可直接下载或修改，使用 时请详细阅读内容。

Technical Cooperation Agreement 甲方：XX油脂化学有限公司 Party A: XX Grease Chemical Co. , Ltd. 地址：XX高新技术工业园 Address: XXHigh-tech Industrial Park 法定代表人：XXX Legal Representative: XXX 乙方： Party B: 地址： Address: 本协议合作双方就组建技术研发团队事项，经过平等协商，在真实、充分地 表达各自意愿互惠互利的基础上，根据《中华人民共和国合同法》的规定，达成如下协议，并由合作各方共同恪守。 This Agreement, concerning the setting up of a technical research and development team, is made according to the Contract Law of PRC regulations and entered into through equal negotiation by both Parties as the free and full expression of their own wishes to mutual benefits, and to this end both Parties shall abide by this Agreement as following. 第一条、甲方同意雇用乙方为新产品研发技术顾问。乙方同意为甲方提供技术顾问服务。 Article 1: Party A hereby agrees to employ party B as the technical consultant for the new product research and development. Party B hereby agrees to offer technical consultation service to Part A. 第二条、甲方同意每月支付乙方的研究费用，包括：薪资、办公费、检测费、差旅费以及其他相关费用。 Article 2: Party A hereby agrees to pay Party B for the research each month, including salaries, administrative expenses,detection cost, traveling expenses and other cost associated. 第三条、乙方有责任为甲方提供相关国内外技术及市场信息，并及时答复甲方技术上所遇到的问题。 Article 3 : Party B is responsible to provide relevant technical and market information home and abroad and is ready to answer any technical problem frequently asked by Party A. 第四条、乙方有义务向甲方提供有关个人简历和相关证明材料，甲方要尊重乙方个人隐私，有义务妥善保管相关材料。 Article 4: Party B shall has the obligation to provide Party A with any relevant personal resume and reference documents as necessary.Party A shall respect the personal privacy of Party B and has the obligation to properly keep those materials. 第五条、乙方同意所研发的产品所有知识产权归甲方所有，乙方不得将相关技术信息泄露给任何第三方，否则需要承担一切法律后果。

中文地址翻译成英文地址的方法和技巧

中文地址翻译成英文地址的方法和技巧 中文地址的排列顺序是由大到小，如：Ｘ国Ｘ省Ｘ市Ｘ区Ｘ路Ｘ号，而英文地址则刚好相反，是由小到大。如上例写成英文就是：Ｘ号，Ｘ路，Ｘ区，Ｘ市，Ｘ省，Ｘ国。 1.各部分写法 ●Ｘ室：Room Ｘ ●Ｘ号：No. X ●Ｘ单元：Unit Ｘ ●X楼/层：X/F ●Ｘ号楼：Building No. Ｘ ●住宅区/小区：ResidentialQuater ●Ｘ街：ＸStreet ●Ｘ路：ＸRoad East/Central/West东路/ 中路/ 西路 芙蓉西二路/ West 2nd Furong Road Central Dalian Rd. /大连中路 芙蓉中路的“中”可以用Central，也有用Middle的，一般用Mid比较简洁。 ●Ｘ区：ＸDistrict ●Ｘ镇：ＸTown ●Ｘ县：ＸCounty ●Ｘ市：ＸCity ●Ｘ省：ＸProvince ●国家（State）中华人民共和国：The People’s Republic of China、P.R.China、P.R.C.、 China ●X信箱：M ailbox X 请注意：翻译人名、路名、街道名等，最好用拼音。 各地址单元间要加逗号隔开。

2.英文通信地址常用翻译 201室/房Room 201 二单元Unit 2 马塘村MatangVallage 一号楼/栋Building 1 华为科技公司Huawei Technologies Co., Ltd.

xx公司xx Corp. / xx Co., Ltd. 宿舍Dormitory 厂Factory 楼/层Floor 酒楼/酒店Hotel 住宅区/小区Residential Quater 县County 甲/乙/丙/丁A/B/C/D 镇Town 巷/弄Lane 市City 路Road（也简写作Rd.，注意后面的点不能省略）一环路1st Ring Road 省Province(也简写作Prov.） 花园Garden 院Yard 街Street/Avenue 大学College/University 信箱Mailbox 区District A座Suite A 广场Square 州State 大厦/写字楼Tower/Center/Plaza 胡同Alley（北京地名中的条即是胡同的意思） 中国部分行政区划对照 自治区Autonomous Region 直辖市Municipality 特别行政区Special Administration Region 简称SAR 自治州Autonomous Prefecture

英国合同法中文翻译版

本法旨在对第三方履行合同条款做出规定。（1999年11月11日） 以下条款根据本届议会上议院神职和非神职议员以及下议院的建议并由本届议会规定与同意通过，以女王陛下之名义颁布： 1．第三方实施合同条款的权利。 （1）根据本法规定，非合同当事方（第三人）也可享有实施合同条款的权利，如果: （a）该合同明示规定其享有这样的权利，或 （b）根据下文第（2）款的规定，该合同有关条款赋予第三人以某种权益。 （2）如果基于适当基础之上的合同，其当事人没有将合同条款扩展适用于第三方的意思，则以上第一款（b）项不予适用。 （3）第三方名称必须在合同中明示加以界定，或确定其为某群体的一员，或表述出其为特定的种类，但在缔约时其不必实际存在。 （4）本条规定并不授予第三方以实施合同条款的权利，但根据本合同其他相关条款规定授予第三方该权利的除外。 （5）为实践其履行合同条款的权利，如果第三方在自己已经作为合同一方当事人的情况下遭遇他方违约行为，则第三方享有对他自己来说是可行的救济的权利（相应地，和有关损失、法院禁令、具体履行以及其他救济相关的规则也将适用）。 （6）当某一合同条款排斥或限制与本法中涉及第三方实施合同条款有关事项的责任，该合同条款应做使其利用这种限制或排斥的解释。 （7）在本法中，涉及第三方可实施的合同条款时， “缔约方”表示由第三方而非由其负责合同条款实施的一方合同当事人，且 “受约人”表示相对于缔约方，由其负责合同条款实施的另一方合同当事人。 2．合同的变更与撤消。 （1）根据本条的规定，第三方拥有第1条中实施合同条款的权利，根据协议，合同双方不可撤消合同，或没有经第三方同意而以消灭或改变给予该项权利的条件的方式变更之，如果（a）第三方已对缔约方及合同条款表示同意， （b）缔约方意识到第三方已信赖该条款，或者 （c）缔约方可以合理预见到第三方将信赖且实际上第三方已信赖该条款。 （2）前款第a项所述的“同意”是指： （a）可以用语言或行为表达，并且 （b）如果是以邮递或其他方式传递给缔约方，那么直到缔约方收到时，才视为已知晓。（3）第（1）款服从于合同的明示条款，在该明示条款中 （a）合同双方可协商撤消或变更合同而无须第三方的同意，或 （b）合同中具体规定需要由第三方同意而非依上述第（1）款第a项至第c项的规定。（4）当根据第（1）款或第（3）款，需要取得第三方的同意时，法庭或仲裁庭依据合同当事方的要求，在以下情形下可以免除其同意： （a）由于不能合理确定第三方下落而无法得到其同意，或 （b）因第三方的精神状况而无法给出其同意。 （5）法庭或仲裁庭依照合同当事方的要求，可以免除第（1）款第c项中所要求的同意，如果无法合理确定是否第三方实际上已信赖该条款的话。 （6）如果法庭或仲裁庭免除第三方同意的话，那么其可以提出其认为适当的条件，包括要求支付对第三方赔偿的条件等。 （7）高等法院和县法院均可行使第（4）款至第（6）款规定的授予法院的权限。 3．缔约方享有的抗辩事由等。 （1）基于对以上第1条的信赖，在为了执行合同条款而由第三方提起的诉讼程序时，以下

英文翻译成中文

第四部分翻译 Part Ⅰ英译汉 练习： Unit 1 1.年轻时，他对学业漫不经心，加之他一直不愿考虑运动员以外的职业，到这时候，这一切终于给他带来了不幸。 2.护士们对不得不日复一日地参与欺骗病人的做法也许深恶痛绝，但要抵制却感到无能为力。 3.我不会在初版的《失乐园》上乱写乱画，就像我不会把一幅伦勃朗的原作连同一套蜡笔交给我的婴儿任意涂抹一样。 4.只有假设地球表面呈曲线状，这一现象才能得到解释。 5.鹿减少生存所需的能耗以增加越冬生存的机会，从生物学的角度看是合情合理的。 6.不论好坏，不论是何结果，美国人不仅会一概接受，还要去铲除那些反对者，尽管对于成千上万的人来说，这决定与自己的意愿背道而驰。 7.你可曾为了接电话在洗澡时从浴室冲出来，或是嚼着饭从饭桌旁站起来，或是昏昏沉沉的从床上爬起来，而结果却是有人打错了。 8.实际上，大把花钱的满足感大于商品本身带给他们的乐趣。 9.但是蓝色也可以表示伤感（我很伤感），白色常代表纯洁，尽管在中国，人们在婚礼上穿白的，在葬礼上穿黑的。 10. 晚上十点到十二点，美国处在权力真空状态——除了纽约广播公司总部和两家大的新闻机构之外，全国范围内就再没有别的信息中心。 Unit 2 1) 1800年英国与法国之间将爆发一场持续15后的大战。 2) 我相信，到1816年，英国将在滑铁卢村附近赢得一场伟大战役的胜利。 3) 然而，到1870年，对于英国来说，德国将成为一个比法国更具危险性的国家。 4) 在20世纪初，俄国、美国和日本将成为大国，而英国将不再是世界上最强大的国家了。 5) 反过来，农民的业绩大小取决于农业的组织形式，经济环境，市场结构这些与之息息相关的因素。 6) 他被接回来时，不停地跟人讲，一些可怕的怪物瞪着眼睛盯着他，把他带到了一个宇宙飞船上。 7) 烫伤大多数发生在老人和孩子身上，往往是由于浴室里水温太高而造成的。 8) 尽量多地了解可能发生的事情，这样你可以提前做好准备。 9) 市场的变化迫使很多网站关闭，而其它网站也仅是勉强维持。 10）因为在农民生产率低下的国家，需要劳动人口中大多数人种粮食，因此就没有多少人从事投资货物的生产或进行经济增长所必须的其它活动。 Unit 3 1. 在牛顿之前，亚里士多德已经发现物体的自然状态是静止的，除非有力作用于物体。所以运动着的物体会停下来。 2．人们在家中或是类似家的地方感觉最为亲密——和一个或几个亲近的人呆在一起——也就是在私人交谈的时候。 3．当一个人长时间在干道或高速公路上驾车行驶，就会存在两个问题：一是如何保持稳定的车速；二是如何确保他不撞上前面的车。 4．这个系统尤其适用于汽车拥挤的情况，因为电脑不仅能够控制车速，与前面车子的距离，还能够控制方向。

涉外合同(完整版)

合同编号：YT-FS-6977-11 涉外合同(完整版) Clarify Each Clause Under The Cooperation Framework, And Formulate It According To The Agreement Reached By The Parties Through Consensus, Which Is Legally Binding On The Parties. 互惠互利共同繁荣 Mutual Benefit And Common Prosperity

涉外合同(完整版) 备注：该合同书文本主要阐明合作框架下每个条款，并根据当事人一致协商达成协议，同时也明确各方的权利和义务，对当事人具有法律约束力而制定。文档可根据实际情况进行修改和使用。 随着中国加入wto，国际货物的买卖也开始频繁起来。而这种买卖，总是以签订国际货物买卖合同的方式来进行。国际货物买卖合同，也是一种合同，因此，合同法之原理原则，如契约自由，当事人意思自治，对国际货物买卖合同同样应当适用。在国际货物买卖中，合同成立的一般要件也要求当事人应具有完全权利能力和行为能力，当事人的意思表示应该一致且不存在瑕疵，而国际货物买卖合同区别于一般合同之处就在于：它是有形货物买卖的合同，货物的买卖要进行跨越国界的流动，其双方当事人的营业地一定是在不同的国家，而对于当事人的国籍或合同的民事或商业性质，则不予考虑。国际货物买卖合同具有国际因素，在特定国家看来就是具有涉外的因素，为了保证国际货物买卖的顺利进行，国际上制定了一系列

的规则与法律，以规范合同的形式，以保障交易的公平与安全。 就合同的形式而言，无论是以非立法的方式统一和协调法律的《国际商事合同通则》还是以示范法形式约束当事人行为的《联合国国际货物销售合同公约》都对国际货物买卖合同的形式有着明确的规定。 《国际商事合同通则》的目标是要制定一套可以在世界范围内使用的均衡的规则体系，而不论在它们被适用的国家的法律传统和政治经济条件如何。这一目标在《通则》正式文本中和这些规则所反映出的总的指导方针中都能得到体现。它还可作为国内和国际立法者在一般合同法领域或是针对一些特殊类型的交易起草立法时的范本。就国内立法而言，《通则》对有些国家可能更为有用，尤其是对象我国这样的缺乏完善的合同法规则体系，但又力图使其法律达到现代国际水准的国家，借鉴《通则》的规定可以对我国的法律至少是有关对外经济关系方面的法律更符合国际趋势。

投资合同中英文

竭诚为您提供优质文档/双击可除 投资合同中英文 篇一：委托投资协议中英文 委托投资协议 entrustedInvestmentAgreement 甲方（委托人）： partyA(Thegrantor): 身份证号IDno.： 乙方（受托人）： partyb(thetrustee): 身份证号IDno.： 根据《中华人民共和国合同法》、《中华人民共和国公司法》以及英国证券相关法律法规，甲、乙达成如下协议。 subjecttocontractLawofpeoplesRepublicofchina,compan yLawofpeoplesRepublicofchinaandrelevantlawsandregul ationsrelatingtouKsecurities,partyAandpartybenterin tothefollowingagreement

一、委托事项 entrustedmatters 甲方将全权委托李忠全先生收购其英国雅惠生态农业 集团pLc（YAhuIAgRIcuLTuRepLc）的英国股票股，其股票认购投资款共计人民币元，每笔交易不低于500股，每股价格按照前2个交易日的平均价（在20XX年5月9号挂牌当天，认购其股票，将享受每股折合人民币7元/股的股原始股配 售价，每人仅限10000股）计算。现甲方将该股 票投资款全部委托给乙方管理，委托乙方严格按照英国天富资本（英国保荐商）的要求，在海外进行股权登记、过户等交割手续，使其持有英国农业集团pLc（AgRIcuLTuRepLc）股份。 partyAwillfullyauthorizemr.ZhongquanLitosubscribefo r………https://www.wendangku.net/doc/6212633742.html,sharesofYAhuIAgRIcuLTuRepLc.Totalinvestm entofsharesubscriptionisRmbYuan,witheachtransaction notlessthan500shares.Thepriceofeachshareistheaverag epriceof2priortradingdays(onthelistingdate-9thmay,2 0XX,theinvestorwillenjoythepriceoforiginalshare7Yua n/shareandeachinvestorislimitedtosubscribe10,000sha resthatday).nowpartyAisauthorizingpartybtomanagethe investmentinsharesubscription,tocompletetheregistra

中文名字的英文写法

中文名字最标准的英文写法就是直接翻译成汉语拼音：Li Leyang或Lee Yeyang 西方人的习惯是名字在前，姓在后，二者间如果有中间名（Middle name），Middle name一般用简写，中国人如果有英文名字，在正式的场合可以参照这种格式。比如，搜狐创始人、董事局主席张朝阳的英文名字就写成：Charles CY. Zhang. 搜狐所有英文正式文件中张朝阳的名字都是这样写的。 如果没有英文名字，那么应该按照中国人的习惯（姓在前名字在后）直接把中文名字翻译成汉语拼音作为英文写法！很典型的例子，奥运会上，所有中国运动员的名字在运动衣上都是这样翻译的（以前不是，后来国家颁布了《汉语拼音方案》，并解释到《汉语拼音方案》是拼写中文人名地名唯一标准后，统一改过来了），所以，中国人名字的英文写法，就是汉语拼音：姓在前，名在后，姓和名分开写，姓和名的开头字母均大写！ 两个字的是：比如：张三就应该写：Zhang San 三个字的是：1.单姓,比如：李小言就应该写：Li Xiaoyan 2.复姓,比如：诸葛亮就应该写：Zhuge Liang 四个字的是：1.单姓,比如：李雨中生就应该写：Li Yuzhongsheng 2.复姓,比如：司马相如就应该写：Sima Xiangru 1. Last Name就是姓，First Name就是名，請勿混淆。 2. "國語羅馬拼音對照表" 乃外交部護照科所採用的中英文姓名翻譯原則，為了保持所有文 件的統一，建議同學根據此表來翻譯姓名及地址。 3. 同學的英文姓名，應由中文姓名音譯，並與大學英文畢業證書、英文成績單、TOEFL / GRE / GMAT考試及申請學校、辦理護照及簽證時所用的英文姓名完全一致，如姓名不 一致，將造成申請學校、辦護照、簽證時身份的困擾，徒增麻煩。 4. 如果有英文別名 (如John、Mary...等)，可以將別名當做Middle Name。 [例] 王甫平有一個英文別名STEVE，其英文姓名可以下列方式列出： WANG FUPING S Last Name First Name M.I. 5. 如果沒有英文別名，M.I. 處不要填。 6. 如非必要，英文別名最好不要用，只用中文姓名的英譯最為單純。 7. 在國外使用英文姓名的建議：外國人習慣將名放在前面，姓放在後；而中國人的姓名， 則是姓在前名在後，有時在國外填寫資料時常會搞錯，建議在打履歷表、印名片或處理 資料時，如果填寫姓名的地方沒有註明Last Name時，英文姓名正確表達方法可以如： Fuping Wang 或 Wang, Fuping

翻译版权许可合同 (中英文)

CONTRACT OF COPYRIGHTS PERMISSION ON WORK’S TRANSLATION 本合同系中译英，翻译：张云军 This contract translated from Chinese to English by Mr. Chang Yunejune. 说明：这个合同适用于直接从外国出版社购买翻译版权，由被许可方负责制作的情形。付款按 约定的印数一次性支付。 This contract concluded on the date of 合同签订日期： 本合同于年月日由（中方出版社名称、地址，以下简称为：出版者）与（外国出版社名称、地址，以下简称：版权所有者）双方签订。 版权所有者享有（作者姓名，以下简称作者）所著（书名）第版的版权（以下简称作品）， 现双方达成合同如下： This contract is concluded and ente red into by and between ( the name and address of a China’s publishing company, hereinafter referred to as publisher) and (the name and address of a foreign publishing company, hereinafter referred to as proprietor of copyrights) on the date of . Proprietor enjoy the copyrights of the edition (book name) written by (the author name，hereinafter referred to as author ). NOW THEREFORE, it is hereby agree as bellow: 律师观点：序言部分给出了合同双方的名称和地址，以及翻译作品的详细资料。对于一部很快会被修订的非小说作品，西方出版社通常会将版权许可仅限于当前版本。 1．根据本合同，版权所有者授予出版者独家许可，准许其以该出版社的名义，以图书形式 （简/精装）翻译、制作、出版该作品中文（简体）版册（以下简称翻译本），限在中华人民 共和国大陆发行，不包括香港和澳门和台湾。未经版权所有者的书面同意，出版者不能复制版 权所有者对该作品的封面设计，也不能使用版权所有者的标识、商标或版权页。本合同授予的 权利不及于该作品的其他后续版本。

翻译作品出版合同范本

合同订立原则 平等原则： 根据《中华人民共和国合同法》第三条：“合同当事人的法律地位平等，一方不得将自己的意志强加给另一方”的规定，平等原则是指地位平等的合同当事人，在充分协商达成一致意思表示的前提下订立合同的原则。这一原则包括三方面内容：①合同当事人的法律地位一律平等。不论所有制性质，也不问单位大小和经济实力的强弱，其地位都是平等的。②合同中的权利义务对等。当事人所取得财产、劳务或工作成果与其履行的义务大体相当；要求一方不得无偿占有另一方的财产，侵犯他人权益；要求禁止平调和无偿调拨。③合同当事人必须就合同条款充分协商，取得一致，合同才能成立。任何一方都不得凌驾于另一方之上，不得把自己的意志强加给另一方，更不得以强迫命令、胁迫等手段签订合同。 自愿原则： 根据《中华人民共和国合同法》第四条：“当事人依法享有自愿订立合同的权 利，任何单位和个人不得非法干预”的规定，民事活动除法律强制性的规定外，由当事人自愿约定。包括：第一，订不订立合同自愿；第二，与谁订合同自愿，；第三，合同内容由当事人在不违法的情况下自愿约定；第四，当事人可以协议补充、变更有关内容；第五，双方也可以协议解除合同；第六，可以自由约定违约责任，在发生争议时，当事人可以自愿选择解决争议的方式。 公平原则： 根据《中华人民共和国合同法》第五条：“当事人应当遵循公平原则确定各方的权利和义务”的规定，公平原则要求合同双方当事人之间的权利义务要公平合理具体包括：第一，在订立合同时，要根据公平原则确定双方的权利和义务；第二，根据公平原则确定风险的合理分配；第三，根据公平原则确定违约责任。诚实信用原则：根据《中华人民共和国合同法》第六条：“当事人行使权利、履行义务应当遵循诚实信用原则”的规定，诚实信用原则要求当事人在订立合同的全过程中，都要诚实，讲信用，不得有欺诈或其他违背诚实信用的行为。

中文名字翻译成英文

中文名字翻译成英文 一般就是把中文名字用拼音方式写出即可，注意大小写规定和前后顺序要求。 例如：张三 Zhang San 或者 San Zhang 根据英文习惯，名在前，姓在后，所以第二种更符合外国人习惯，但是第一种现在也很常见，也算对。 张三四 Zhang Sansi 或者 Sansi Zhang 如果遇到三个字的，第三个字的拼音不用大写，但是要和第二个字的拼音连着写不能有空格。 此外，如果有必要，您能够自己起个有意义的或者发音相似的外国名字来用，一般像香港人都会有两个名字，一个中文名，一个外文名。 中文翻译英文其它实用方法 首先不要翻译姓，不要翻译姓，不要翻译姓！把姓放在名字的最后面用拼音写就好了。 按照音译的方式来取名字的话也能够不过有两个问题需要注意一下，第一很多人都会有一样的名字（因为英文里Y等字母开头的名字很有限）第二有些音英语几乎没有所以选出的名字会也许会有点古怪/ 非主流。 我举个例子吧： 黄晓明如果音译的话= 晓明 +Huang/ Wong = Seamus, Shane, Sean, Shayne, Sheldon, Sherman,(sigmund, simon) 这些名字当中 Seamus 是苏格兰名比较粗，Sheldon，Sherman， Sigmund 比较过时。所以要

么 Simon Huang, Sean Huang, Shane Huang.(或者Wong- 对于英国人来说粤语拼音更熟悉）按照名字的意义来翻译不错，不过有的名字不 好翻译，尤其是男人的名字，为什么？因为在英国像‘阳/晓/春/月/ 夏/天’等词更多是用在女孩子的名字，男人用得少。之外觉得我得提 醒大家千万不要直接翻译，千万不要直接翻译，千万不要直接翻译而 且千万不要自己乱起， Sun, Star, Red, Spring, King, Morning，Moon， Green 等词不能够做名字的，几乎所有名词/形容词不能够当 作名字的，需要查‘Name Dictionary' 才能找出名字来。比如晓明：与日出/日光相关，搜一下于相关的名字，名字的意思和来源即可。 中文翻译英文起名注意事项 问题1：所起英文名太常见 第一种问题是起的英文名太常见，如：Henry, Jane, John, Mary. 这就像外国人起名叫赵志伟、王小刚、陈*一样，给人牵强附会的感觉。虽然起名字并无一定之规，但给人的感觉很重要。 问题2：不懂文化差异而犯忌 此外，因为文化差异，有些名字引申义不雅，如：Cat, Kitty，在英 语俚语中，它们指的是女性的阴部。Cat 宜改为Cathy，Kitty 宜改为Kate。 问题3：改名又改姓 一般来说，非英语国家的人到了美国，都可能改名，但没有改姓的。 这关系到家族荣誉，将来还会关系到遗传基因。所以，无论自己的姓 多么难读，都要坚持。常见有人起英文名时连姓也改了，如司徒健Ken Stone，肖燕Yan Shaw。下列英文姓尚可接受，但也不用，如：Young 杨，Lee李。 问题4：英文名与姓谐音

英文合同口语

入门级： 1、孙万彪的《英汉法律翻译教程》和《汉英法律翻译教程》，涉及的内容都是最基本的，书写得比较严谨，孙老师应该是语言专业出身，对一些词（比如说threatened ）的处理比较好。 2、中文版的《合同法》和《公司法》以及英文版的《合同法》和《公司法》，中文版的不必管哪个出版社的，想来都差不多。英文版的至少有两个版本，我在书店里见过，但现有手头没有，也不方便找。 3、《2000年国际贸易术语解释通则》，有中英文对照版，算是做得比较精致的一本书。这本书不厚，但可以让你明白好的翻译作品应该是什么样的。 4、香港的双语资料库，至少可以利用一下香港联合交易所的双语《上市规则》。香港的词法和句法与大陆有所不同，但值得借鉴。 中级篇： 1、《法律文本与法律翻译》，作者之一是李克兴，他最近还写了一本书，也不错，可以看看。书名记不得了，但如果你在百度搜索栏敲入“李克兴”、“法律翻译”，逐页翻页，应该可以找到。 2、《法律翻译-从实践出发》，这本书有多名作者，既有宏观的论述，又有微观的剖析，作者基本上都是圈内高人。 3、《美国1933年证券法》和《美国1934年证券交易法》，著名的两部美国法律，主译是张路老师，这一系列的书还有，与律所的实战翻译风格比较接近。 4、利用互联网，直接查阅相关法律，如美国的《特拉华州普通公司法》。至于具体查阅哪部法律，看个人的兴趣。每本书后面都有参考书目，可以利用这个作为线索。 高级篇 1、《国际商法教学案例英文选编》，对外经济贸易大学考研用的“灰皮书”，不知现在是不是这样？先读懂这本书，加深对法律知识的了解。 2、《英美商事组织法》，对外经济贸易大学丁丁老师著，同一系列的书还有很多。 3、陈忠诚老师的《词语翻译漫谈》及其续篇、《法窗译话》以及相关的词语翻译书，加强“炼字”功夫。 4、其他中文或英文原版著作。 三、法律翻译的前途 外资律所法律翻译的月薪大概在一万到五万之间，看个人能力和机遇。 目前外资所扩张得厉害，法律翻译供不应求，薪水应该看涨。 应聘我所的法律翻译候选人的测试稿，我看过十多份，真正好的有四份，有几份根本不合格，剩下的就是可用但需要修改的了。感觉招个好法律翻译挺难的，上面说的做得好的那四个人，都是从别的所挖过来的。

中文名字最标准的英文写法就是直接翻译成汉语拼音

中文名字最标准的英文写法就是直接翻译成汉语拼音：；西方人的习惯是名字在前，姓在后，二者间如果有中间；如果没有英文名字，那么应该按照中国人的习惯（姓在；两个字的是：比如：张三就应该写：ZhangSan；三个字的是：1.单姓,比如：李小言就应该写：Li；2.复姓,比如：诸葛亮就应该写：ZhugeLia；四个字的是：1.单姓,比如：李雨中生就应该写：L；2.复姓, 中文名字最标准的英文写法就是直接翻译成汉语拼音： Li Leyang或 Lee Yeyang 西方人的习惯是名字在前，姓在后，二者间如果有中间名（Middle name），Middle name一般用简写，中国人如果有英文名字，在正式的场合可以参照这种格式。比如，搜狐创始人、董事局主席张朝阳的英文名字就写成：Charles CY. Zhang. 搜狐所有英文正式文件中张朝阳的名字都是这样写的。 如果没有英文名字，那么应该按照中国人的习惯（姓在前名字在后）直接把中文名字翻译成汉语拼音作为英文写法！很典型的例子，奥运会上，所有中国运动员的名字在运动衣上都是这样翻译的（以前不是，后来国家颁布了《汉语拼音方案》，并解释到《汉语拼音方案》是拼写中文人名地名唯一标准后，统一改过来了），所以，中国人名字的英文写法，就是汉语拼音：姓在前，名在后，姓和名分开写，姓和名的开头字母均大写！ 两个字的是：比如：张三就应该写：Zhang San 三个字的是：1.单姓,比如：李小言就应该写：Li Xiaoyan 2.复姓,比如：诸葛亮就应该写：Zhuge Liang 四个字的是：1.单姓,比如：李雨中生就应该写：Li Yuzhongsheng 2.复姓,比如：司马相如就应该写：Sima Xiangru 1. Last Name就是姓，First Name就是名，請勿混淆。 2. "國語羅馬拼音對照表" 乃外交部護照科所採用的中英文姓名 翻譯原則，為了保持所有文