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Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices 1 Scope 1.1 Inclusions This document specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices during manufacture, and it is applicable to medical devices adopting EO for sterilization. Note 1: There are similarities and differences in the development, validation and routine control of an ethylene oxide sterilization process in both the product manufacturing process and health care facilities, please refer to this document for EO sterilization process in health care facilities. 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. Note 2: Health care facilities differ from medical device manufacturers in the physical design of processing areas, in the equipment used, and in the 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. 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, shall handle and process both new medical devices and reusable medical devices 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 document, alternative approaches and guidance on the development, validation and control of sterilization process specific to health care facilities are recommended. 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. Note 5: Although the scope of this document is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other health care products. 1.2 Exclusions 1.2.1 This document 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. Note: See YY/T 0771.1, YY/T 0771.2 and YY/T 0771.3. 1.2.2 This document does not detail a specified requirement for designating a medical device as sterile. 1.2.3 This document does not specify a quality management system for the control of all phases of production of medical devices. Note: The effective implementation of defined and documented procedures is necessary for the development, validation and routine control of a 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 document to have a full quality management system during manufacture or reprocessing. The necessary elements are normatively referenced at appropriate places in this document (see, in particular, Clause 4). Attention is drawn to the standards for quality management systems (see YY/T 0287-2017) that control all phases of production or reprocessing of medical devices. 1.2.4 This document does not specify requirements for occupational safety associated with the design and operation of EO sterilization facilities. Note: EO is toxic, flammable and explosive. For further information on safety, see examples in the Bibliography. 1.2.5 This document does not cover sterilization by injecting EO or gas mixtures directly into packages or a flexible chamber. 1.2.6 This document does not cover analytical methods for determining levels of residual EO and/or its reaction products. Note: For further information, see GB/T 16886.7-2015. 2 Normative references The following documents contain requirements which, through reference in this text, constitute provisions of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. GB 18281.1-2015 Sterilization of health care products - Biological indicators - Part 1:General requirements (ISO 11138-1: 2006, IDT) GB 18281.2-2015 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2: 2006, IDT) GB 18282.1 Sterilization of health care products - Chemical indicator - Part 1:General requirements (GB 18282.1-2015, ISO 11140-1: 2005, IDT) 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 aeration part of the sterilization process during which ethylene oxide and/or its reaction products desorb from the medical device until predetermined levels are reached Note: This may be performed within the sterilizer and/or in a separate chamber or room. 3.2 aeration area either a chamber or a room in which aeration occurs 3.3 bioburden population of viable microorganisms on or in product and/or sterile barrier system [Source: GB/T 19971-2015, definition 2.2] 3.4 biological indicator test system containing viable microorganisms providing a defined resistance to a specified sterilization process [Source: GB/T 19971-2015, definition 2.3] 3.5 calibration 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: GB/T 19971-2015, definition 2.4] 3.6 chemical indicator test system that reveals change in one or more pre-defined process variables based on a chemical or physical change resulting from exposure to a sterilization process [Source: GB/T 19971-2015, definition 2.6] 3.7 conditioning treatment of product within the sterilization cycle, but prior to ethylene oxide admission, to attain a predetermined temperature and relative humidity Note 1: This phase may be carried out either at atmospheric pressure or under vacuum. Note 2: See 3.26 “Preconditioning”. 3.8 D value D10 value time or dose required to achieve inactivation of 90% of a population of the test microorganism under stated conditions Note: For the purposes of this document, the D value is the exposure time required to achieve 90% inactivation of the population of the test organism. [Source: GB/T 19971-2015, definition 2.11] 3.9 development act of elaborating a specification [Source: GB/T 19971-2015, definition 2.13] 3.10 dew point temperature at which the saturation steam pressure is equal to the partial pressure of the steam in the atmosphere Note: Any cooling of the atmosphere below the dew point would produce water condensation. 3.11 establish determine by theoretical evaluation and confirm by experimentation [Source: GB/T 19971-2015, definition 2.17] 3.12 ethylene oxide injection time duration of the phase beginning with the first introduction of the EO (or gas mixture) into the chamber to the completion of that injection 3.13 exposure time period for which the process parameters are maintained within their specified tolerances Note: 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 in this document. [Source: GB/T 19971-2015, definition 2.18] 3.14 fault one or more of the process parameters lying outside of its/their specified tolerance(s) [Source: GB/T 19971-2015, definition 2.19] 3.15 flushing procedure by which the ethylene oxide is removed from the load and chamber by a) multiple alternate admissions of filtered air, inert gas or steam and evacuations of the chamber, or b) continuous passage of filtered air, inert gas or steam through the load and chamber 3.16 fractional cycle a cycle in which the exposure time is reduced compared to that specified in the sterilization process 3.17 half cycle a cycle in which the exposure time is reduced by 50% compared to that specified in the sterilization process 3.18 health care facility; HCF governmental and private organizations and institutions devoted to the promotion and maintenance of health, and the prevention and treatment of diseases and injuries Example: A health care facility may be a hospital, nursing home, extended care facility, free-standing surgical center, clinic, medical office, or dental office. 3.19 health care product medical device(s), including in vitro diagnostic medical device(s), or medicinal product(s), including biopharmaceutical(s) [Source: GB/T 19971-2015, definition 2.20] 3.20 installation qualification; IQ process of obtaining and documenting evidence that equipment has been provided and installed in accordance with its specification [Source: GB/T 19971-2015, definition 2.22] 3.21 microorganism entity of microscopic size, encompassing bacteria, fungi, protozoa and viruses Note: 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: GB/T 19971-2015, definition 2.26] 3.22 operational qualification; OQ process of obtaining and documenting evidence that installed equipment operates within predetermined limits when used in accordance with its operational procedures [Source: GB/T 19971-2015, definition 2.27] 3.23 overkill approach 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 3.24 parametric release declaration that product is sterile, based on records demonstrating that the process parameters were delivered within specified tolerances Note: This method of process release does not include the use of biological indicators. [Source: GB/T 19971-2015, definition 2.29] 3.25 performance qualification; 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: GB/T 19971-2015, definition 2.30] 3.26 preconditioning treatment of product, prior to the sterilization cycle, in a room or chamber to attain specified conditions for temperature and relative humidity 3.27 process challenge device; PCD item designed to constitute a defined resistance to a sterilization process and used to assess performance of the process Note 1: For the purpose of this document, a PCD may be product, simulated product or other device that is inoculated directly or indirectly. See 7.1.6 and D.7.1.6. Note 2: In this document, 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 sterilization cycles. [Source: GB/T 19971-2015, definition 2.33] 3.28 process parameter specified value for a process variable Note: The specification for a sterilization process includes the process parameters and their tolerances. [Source: GB/T 19971-2015, definition 2.34] 3.29 process variable condition within a sterilization process, changes in which alter microbicidal effectiveness Example: Time, temperature, pressure, concentration, humidity, wavelength. [Source: GB/T 19971-2015, definition 2.35] 3.30 processing category collection of different product or product families that may be sterilized together Note: 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 category. 3.31 product result of a process Note: For the purposes of sterilization standards, product is tangible and may be raw material(s), component(s), intermediate(s) and health care products. [Source: GB/T 19971-2015, definition 2.36] 3.32 product family group of product possessing characteristics that allow them to be sterilized using defined process conditions 3.33 product load volume defined space within the usable chamber volume occupied by product 3.34 recognized culture collection depository authority under the Budapest Treaty on “The International Recognition of the Deposit of Microorganisms for the Purposes of Patent and Regulation” [Source: GB/T 19971-2015, definition 2.38] 医疗保健产品灭菌 环氧乙烷 医疗器械 灭菌过程的开发、确认和常规控制要求 1 范围 1.1 适用 本文件规定了医疗器械产品在制造过程中环氧乙烷灭菌过程的开发、确认和常规控制要求,适用于采用环氧乙烷灭菌的医疗器械。 注1:产品制造过程和医疗保健机构中的灭菌过程开发、确认和常规控制有共性和差异,医疗保健机构中的环氧乙烷灭菌过程可参考本文件。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;主要的区别涉及医疗保健机构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。 注2:医疗保健机构在灭菌区域的硬件设计、所使用的设备以及具备足够培训和经验的人员方面与医疗器械制造商不同。医疗保健机构的主要功能是为病人提供医疗保健服务,医疗器械的再处理仅是支持这一功能的无数活动之一。 注3:就医疗器械的初始条件而言,医疗器械制造商通常是对从原始材料开始、批量生产类似的医疗器械进行灭菌。另一方面,医疗保健机构应同时处理和加工新的,以及重复使用的有着不同生物负载水平的医疗器械,因此面临着灭菌前清洗、评估、准备和包装医疗器械的额外挑战。本文件推荐了针对医疗保健机构的灭菌过程开发、确认和控制的替代方法和指南。 注4:环氧乙烷气体及其混合物是有效的灭菌剂,主要用于对热和/或水汽敏感而不能进行湿热灭菌的医疗器械。 注5:尽管本文件限于医疗器械,但标准规定的要求和提供的指南同样可以适用于其他医疗保健产品。 1.2 不适用 1.2.1 本文件不适用于海绵状脑病(如骚痒病、牛海绵状脑病和克-雅病)的致病因子灭活过程的开发、确认和常规控制。 注:见YY/T 0771.1、YY/T 0771.2和YY/T 0771.3。 1.2.2 本文件未规定标明为无菌的医疗器械的特定要求。 1.2.3 本文件未规定对控制医疗器械生产所有阶段的质量管理体系。 注:医疗器械灭菌过程的开发、确认和常规控制,需要有效实施规定的和形成文件的程序。这些程序通常作为质量管理体系的要素。本文件不要求在制造或再加工过程中有完整的质量管理体系。必要的要素在本文件的适当位置进行了规范性引用(第4章)。需要注意控制医疗器械生产或再加工所有阶段的质量管理体系标准(见YY/T 0287—2017)。 1.2.4 本文件未规定与环氧乙烷灭菌设施的设计和操作相关的职业安全要求。 注:环氧乙烷有毒,易燃、易爆,有关安全性的更多信息,请参阅参考文献。 1.2.5 本文件未包含直接注入环氧乙烷或其混合气体到产品包装或柔性柜室中的灭菌。 1.2.6 本文件未包含确定环氧乙烷和/或其反应产物残留水平的分析方法。 注:详细信息见GB/T 16886.7—2015。 2 规范性引用文件 下列文件中的内容通过文中的规范性引用而构成本文件必不可少的条款。其中,注日期的引用文件,仅该日期对应的版本适用于本文件;不注日期的引用文件,其最新版本(包括所有的修改单)适用于本文件。 GB 18281.1—2015 医疗保健产品灭菌 生物指示物 第1部分:通则(ISO 11138-1:2006,IDT) GB 18281.2—2015 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 11138-2:2006,IDT) GB 18282.1 医疗保健产品灭菌 化学指示物 第1部分:通则(GB 18282.1—2015,ISO 11140-1:2005,IDT) 3 术语和定义 下列术语和定义适用于本文件。 3.1 解析 aeration 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。 注:可在灭菌器中进行,也可在独立的柜室或房间内进行。 3.2 解析区 aeration area 进行解析的柜室或房间。 3.3 生物负载 bioburden 产品和(或)无菌屏障系统表面或内部存活微生物的总数。 [来源:GB/T 19971—2015,2.2] 3.4 生物指示物 biological indicator 对规定的灭菌过程有特定的抗力,含有活微生物的测试系统。 [来源:GB/T 19971—2015,2.3] 3.5 校准 calibration 在规定条件下的系列操作,用于确定测量仪器或测量系统的示值,或由实物量具或参考物质所代表的值,与由标准得出的相对应值之间的关系。 [来源:GB/T 19971—2015,2.4] 3.6 化学指示物 chemical indicator 根据暴露于某一灭菌过程所产生的化学或物理变化,显现一个或多个预定过程变量变化的测试系统。 [来源:GB/T 19971—2015,2.6] 3.7 处理 conditioning 在注入环氧乙烷之前,对灭菌周期内的产品进行调节的阶段,以达到预定的温度和相对湿度。 注1:该阶段可在常压或真空下进行。 注2:见3.26“预处理”。 3.8 D值 D value D10值 D10 value 在规定的条件下,灭活试验微生物总数的90%所需的时间或剂量。 注:本文件中的D值是指灭活90%试验微生物所需的暴露时间。 [来源:GB/T 19971—2015,2.11] 3.9 开发 development 详细制定规范的活动。 [来源:GB/T 19971—2015,2.13] 3.10 露点 dew point 空气中水蒸气分压等于饱和蒸气压时的温度。 注:把空气冷却到露点以下的温度会产生冷凝水。 3.11 建立 establish 通过理论评估确定,并经试验证实。 [来源:GB/T 19971—2015,2.17] 3.12 环氧乙烷注入时间 ethylene oxide injection time 环氧乙烷气体或环氧乙烷混合气体从开始注入灭菌室至结束注入期间所需的时间。 3.13 暴露时间 exposure time 过程参数保持在规定允差范围内的阶段。 注:为了计算周期杀灭率,本文件中指环氧乙烷注入时间结東至环氧乙烷去除开始之间的阶段。 [来源:GB/T 19971—2015,2.18] 3.14 故障 fault 一个或多个过程参数超出了规定允差范围。 [来源:GB/T 19971—2015,2.19] 3.15 换气 flushing 通过以下方法之一去除装载或灭菌室环氧乙烷的过程: a)多次交替将经过滤的空气、惰性气体或水蒸气注入灭菌室,然后再抽空灭菌室内气体,或 b)不断将经过滤的空气或惰性气体通过装载和灭菌室。 3.16 部分周期 fractional cycle 与灭菌过程规定的暴露时间相比,将暴露时间减少的灭菌周期。 3.17 半周期 half cycle 与灭菌过程规定的暴露时间相比,暴露时间减少50%的灭菌周期。 3.18 医疗保健机构 health care facility;HCF 致力于推动、维持健康、预防和治疗疾病/损伤的政府和私立组织以及机构。 示例:一个医疗保健机构可以是医院、疗养院、长期保健机构、独立的手术中心、诊所、医务室或牙科诊所。 3.19 医疗保健产品 health care product 医疗器械(包括体外诊断医疗器械)或医药产品(包括生物制药产品)。 [来源:GB/T 19971—2015,2.20] 3.20 安装鉴定 installation qualification;IQ 证明设备已按规范要求提供和安装,获得并形成文件化证据的过程。 [来源:GB/T 19971—2015,2.22] 3.21 微生物 microorganism 在显微镜下才能看到的微小实体,包括细菌、真菌、原生动物和病毒。 注:在灭菌过程的确认和(或)常规控制中,特定的标准可能不需要灭活上述定义中所有微生物来证明灭菌过程的效果。 [来源:GB/T 19971—2015,2.26] 3.22 运行鉴定 operational qualification;OQ 证明已安装的设备按运行程序使用时能在预定限值内运行,获得并形成文件化证据的过程。 [来源:GB/T 19971—2015,2.27] 3.23 过度杀灭法 overkill approach 使用能让与产品生物负载相等或更大抗力的生物指示物芽孢对数下降值(SLR)至少为12的灭菌过程的方法。 3.24 参数放行 parametric release 根据能证明过程参数在规定公差范围内的记录,声明该产品无菌。 注:本过程放行方法不涉及使用生物指示物。 [来源:GB/T 19971—2015,2.29] 3.25 性能鉴定 performance qualification;PQ 证明已按操作程序安装和运行的设备,可持续地按预定规范生产出符合规格的产品,获得并形成文件化证据的过程。 [来源:GB/T 19971—2015,2.30] 3.26 预处理 preconditioning 灭菌周期开始前,在一房间或柜室内先对产品进行处理,以达到预定温度和相对湿度。 3.27 过程挑战装置 process challenge device;PCD 对某一灭菌过程构成特定抗力的装置,用于评价该灭菌过程的性能。 注1:本文件中过程挑战装置可以是产品、模拟产品或直接/间接接种的其他装置。见7.1.6和D.7.1.6。 注2:本文件区分了内部过程挑战装置和外部过程挑战装置。内部过程挑战装置用于证明要求的产品无菌保证水平已达到。放置于产品内部或销售包装内的过程挑战装置是一个内部的过程挑战装置,而放置于产品销售包装之间或装载的外表面上的过程挑战装置是外部过程挑战装置。外部过程挑战装置用于常规灭菌周期的微生物监视。 [来源:GB/T 19971—2015,2.33] 3.28 过程参数 process parameter 过程变量的规定值。 注:灭菌过程的规范包括过程参数及其允差。 [来源:GB/T 19971—2015,2.34] 3.29 过程变量 process variable 灭菌过程的条件,其变化可影响杀灭微生物效果。 示例:时间、温度、压力、浓度、湿度和波长。 [来源:GB/T 19971—2015,2.35] 3.30 加工组 processing category 可在同一灭菌过程中灭菌的不同产品或产品族的集合。 注:已确定该组内的所有产品对灭菌过程产生的挑战等于或小于用于该组的过程挑战装置。 3.31 产品 product 过程的结果。 注:灭菌标准中,产品为实物,可以是原料、组件、半成品和医疗保健产品。 [来源:GB/T 19971—2015,2.36] 3.32 产品族 product family 具有某些特性,允许使用同一已定义的过程条件灭菌的产品系列。 3.33 产品装载体积 product load volume 产品占用柜室可用容积的规定空间。 3.34 公认的菌种保存库 recognized culture collection 根据“国际公认微生物菌种保存专利与法规”布达佩斯(Budapest)公约建立的国际菌种保存机构。 [来源:GB/T 19971—2015,2.38] 3.35 参考微生物 reference microorganism 从公认的菌种保存库获得的菌株。 [来源:GB/T 19971—2015,2.39] 3.36 再鉴定 requalification 为证实某一规定过程持续合格而重新进行的部分确认活动。 [来源:GB/T 19971—2015,2.40] 3.37 可重复使用医疗器械 reusable medical device 制造商规定或预期适合于再处理和重复使用的医疗器械。 注:不是指制造商规定或预期仅用于一次性使用的医疗器械。 3.38 供给服务 services 设备运行所必需的各种外源供给。 示例:电力、水、压缩空气、排水系统。 [来源:GB/T 19971—2015,2.41] 3.39 一次性使用医疗器械 single use medical device 制造商规定或预期仅用于一次性使用的医疗器械。 3.40 规定 specify 在批准的文件内详细阐明。 [来源:GB/T 19971—2015,2.42] 3.41 芽孢对数下降值 spore-log-reduction;SLR 初始芽孢数N0的对数减去最终芽孢数Nu的对数。 注:暴露在规定条件下,生物指示物或接种后的物品上芽孢的对数下降值,公式如下: SLR=lgN0-lgNu 式中: N0——初始芽孢数; Nu——最终芽孢数。 对于部分阴性情况下: SLR=lgN0-lg[ln(q/n)] 式中: N0——初始芽孢数; q——测试样品数量; n——阴性样品数量。 若没有存活微生物,则无法计算实际SLR。若一个微生物呈阳性或存活,则SLR表述为“大于”lgN0。 3.42 无菌的 sterile 无存活微生物的。 [来源:GB/T 19971—2015,2.43] 3.43 无菌屏障系统 sterile barrier system 为了产品在使用时保持无菌,防止微生物进入的最低限度的包装。 [来源:GB/T 19971—2015,2.44] 3.44 无菌 sterility 无微生物存活的状态。 注1:实际上,绝对无微生物存活的状态是无法被证实的。 注2:见3.46“灭菌”。 [来源:GB/T 19971—2015,2.45] 3.45 无菌保证水平 sterility assurance level;SAL 灭菌后产品上存在单个活微生物的概率。 注:术语SAL为一定数量值,通常为10-6或10-3。当采用这个数据来确定无菌时,10-6虽然为低数值,但比10-3具有更高的无菌保证。 [来源:GB/T 19971—2015,2.46] 3.46 灭菌 sterilization 经确认的使产品无存活微生物的过程。 注1:灭菌过程中,微生物的灭活特性用指数函数表示,因此,任何单件产品上活微生物的存在可用概率表示。概率可以减少到很低,但不可能降到零。 注2:见3.45“无菌保证水平”。 [来源:GB/T 19971—2015,2.47] 3.47 灭菌周期 sterilization cycle 在一密闭的柜室内,包括进行去除空气、处理(若采用)、环氧乙烷.惰性气体(若采用)注入、环氧乙烷暴露、环氧乙烷去除和换气(若采用),以及注入空气/惰性气体的一系列处理步骤。 3.48 灭菌装载 sterilization load 采用给定灭菌过程,同放在一起待灭菌或已灭菌的物品。 [来源:GB/T 19971—2015,2.48,有修改] 3.49 灭菌过程 sterilization process 达到无菌规定要求所需的一系列动作和操作。 注:这一系列动作或操作包括预处理(若需要)、在规定条件下的环氧乙烷暴露和环氧乙烷及其产物去除所需的后处理。但不包括灭菌过程之前的任何清洗、消毒或包装操作。 [来源:GB/T 19971—2015,2.49] 3.50 灭菌专家 sterilization specialist 具有灭菌技术专业知识并了解灭菌对材料与微生物性能影响的人。 3.51 灭菌因子 sterilizing agent 在规定的条件下,具有充分的杀灭活力以达到无菌的物理或化学物质,或其组合。 [来源:GB/T 19971—2015,2.50] 3.52 存活曲线 survivor curve 显示在规定条件下随暴露于灭活因子的递增而变化的微生物总数的灭活情况的图表。 [来源:GB/T 19971—2015,2.51] 3.53 无菌检查 test for sterility 产品经过灭菌处理后,按药典上的规定对产品进行技术操作。 3.54 无菌试验 test of sterility 为确定单元产品或其部分上有或没有活微生物而进行的技术操作,是开发、确认或再鉴定的一部分。 3.55 可用柜室体积 usable chamber volume 灭菌器柜室内不受固定或可移动部件限制的,可容纳灭菌装载的空间。 注:柜室内装载周围用于气体循环的空间不计算在可用空间内。 3.56 确认 validation 为确定某一过程可持续生产出符合预定规格产品所需结果的获取、记录和解释的文件化程序。 [来源:GB/T 19971—2015,2.55] 3.57 原始材料 virgin material 以前未被使用过,除原始生产外未经加工过的材料。 4 质量管理体系 4.1 文件 4.1.1 应规定灭菌开发、确认、常规控制和产品放行程序。 4.1.2 本文件所要求的文件和记录应由指定人员进行评审和批准(见4.2.1)。 注:文件和记录见YY/T 0287—2017的适用条款。 4.2 管理职责 4.2.1 应规定实施和满足本文件要求的职责和权限,可按YY/T 0287—2017适用的条款将职责分配给胜任的人员。 4.2.2 若本文件的要求由具有独立质量管理体系的多个组织承担,则各方的职责和权限应加以规定。 4.3 产品实现 4.3.1 应规定采购程序。 注:程序见YY/T 0287—2017的适用条款。 4.3.2 应规定产品标识和可追溯性程序。 注:这些程序见YY/T 0287—2017的适用条款。 4.3.3 应规定用于满足本文件要求的所有设备(包括测试仪器)的校准程序。 注:程序见YY/T 0287—2017或GB/T 19022—2003的适用条款。 4.4 测量、分析和改进——不合格品控制 应规定不合格品控制以及纠正、纠正措施和预防措施的程序。 注:这些程序见YY/T 0287—2017的适用条款。 5 灭菌因子特征 5.1 通则 本章的目的是定义灭菌因子,指明它的灭菌效果,识别影响灭菌效果的因素,评估灭菌剂对材料的影响,识别人员安全和环境保护的要求。这些活动可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。本文件所指的灭菌因子是环氧乙烷。 5.2 灭菌剂 若适用,灭菌剂规范应包括在其有效期内,所需要的环氧乙烷储存条件。 5.3 杀灭微生物的有效性 若使用的环氧乙烷超出公认的成分范围或使用新的稀释剂,应开发杀灭微生物有效性的数据。 注:环氧乙烷对微生物的灭活性能已在文献中有全面记载,该文献提供了过程变量影响微生物灭活的知识。本文件不要求参考此类微生物灭活的综合性研究。 5.4 材料影响 环氧乙烷对制造医疗器械的大多数材料的影响已有全面记载,这些文件对使用环氧乙烷灭菌的医疗器械设计和开发是有价值的。本文件不要求进行环氧乙烷对材料影响的特定研究,但要求进行环氧乙烷对产品影响的研究(见第7章)。 5.5 安全和环境 5.5.1 环氧乙烷及其稀释剂(如有)应提供化学品安全技术说明书(MSDS)或类似的安全信息。应识别保护人员安全和健康的必要措施。 5.5.2 应评估灭菌过程对环境的潜在影响,并识别保护环境的措施。应将包括潜在影响和控制措施的评估形成文件。 5.5.3 应注意环氧乙烷及其稀释剂以及任何副产物的排放和处理。 6 过程和设备特征 6.1 通则 6.1.1 本章的目的是定义所必需的整个灭菌过程,与能使灭菌过程安全运行且能再现的设备。
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