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 moistu
re-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 devel
opment, 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
documented翻译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、、缓解；
- 伤残的诊断、监护、、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

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