Product adoption and process equivalency for ethylene oxide sterilization
环氧乙烷灭菌产品分类及过程等效
1 Scope 范围
This TIR address medical devices that are procesd by ethylene oxide sterilization using conventional or parametric product relea. The document applies to the following situations for the sterilization of medical devices:
此技术信息报告应用于传统或参数放行的医疗器械环氧乙烷灭菌过程，适用于以下条件下的医疗器械灭菌：
⎜ a new product is being added to the previously validated process;
在已经确认过的环氧乙烷灭菌过程中增加新产品；
⎜ changes to validated products are being evaluated;
中考自主招生评估已确认产品的变化；
⎜ a previously validated process is being moved to a different facility and/or equipment; and
已确认过的过程被转移到不同的场地和/或设备；
⎜ equivalency of a sterilization process is being evaluated.
评估灭菌过程的等效性。
Although the information prented was developed for application to medical devices, the content of this guideline may also be applied to other relevant products or materials. This document does not address the equivalency of two or more sterilization process run in the same or different sterilization process equipment.
尽管此信息报告应用与医疗器械方面，但报告中的内容也适用于其他相关的产品和材料。此信息报告不能用于评价两个或更多的使用相同或不同灭菌设备的灭菌过程。
2 References and bibliography 参考文献
ANSI/AAMI/ISO 10993-7:1995, Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals, 2ed.
ANSI/AAMI/ISO 11135:1994, Medical devices—Validation and routine control of ethylene oxide sterilization, 3ed.
ANSI/AAMI/ISO 11737-1:1995, Sterilization of medical devices—Microbiological methods—Part 1: Estimation of population of microorganisms on products, 1ed. AAMI ST67:200X,2 Sterilization of medical devices—Requirements for products labeled ‘STERILE.’ (In preparation.)
AAMI TIR14:1997, Contract sterilization for ethylene oxide, 1ed.
AAMI TIR15:1997, Ethylene oxide sterilization equipment, process considerations, and pertinent calculations, 1ed.
AAMI TIR16:2000, Process development for ethylene oxide sterilization—Microbiological aspects, 1ed.
AAMI TIR19:1998, Guidance for ANSI/AAMI/ISO 10993-7:1995, Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals, 1ed.
EN550:1994, Sterilization of medical devices—Validation and routine control of ethylene oxide
sterilization. Burgess DJ and Reich RR. Industrial Ethylene Oxide Sterilization. In Morrisy RF and Phillips GB, eds. Sterilization technology: A practical guide for manufacturers and urs of health care products. New York, NY: Van Nostrand Reinhold, 1993.
Gillis J and Schmidt WC. Scanning electron microscopy of spores on inoculated product surfaces. Medical Device and Diagnostic Industry. June 1983, vol. 5, no. 6, pp. 46–49.
Lowery A and DeRisio R. Adopting a device into a validated sterilization system. Text of prentation at HIMA conference, April 1982, by A. Lowery.
West KL. Ethylene oxide sterilization: A study of resistance relationships. In Gaughran E and Kereluk K, eds. Sterilization of medical products. New Brunswick, NJ: Johnson & Johnson,1977.
3 Terms and definitions 术语和定义
For the purpos of this AAMI TIR, the following terms and definitions apply.
以下术语和定义被应用于此AAMI技术信息报告：
pls
3.1 candidate equipment: New or modified piece of equipment propod for delivering the existing validated sterilization process.
3.1 候补设备：用于已确认的灭菌过程的新的或有变化的设备。
3.2 candidate product: New or modified product, including the packaging system, propod for inclusion into the existing validated sterilization process.
3.2 候补产品：用于已确认的灭菌过程的新的或有变化的产品。
3.3 installation qualification (IQ): Obtaining and documenting evidence that equipment has been provided and installed in accordance with its specifications.
3.3 安装鉴定：获得并编制文件证明设备已经按规范要求被提供和安装的过程.
3.5 operational qualification (OQ): Obtaining and documenting evidence that installed equipment operates within predetermined limits when ud in accordance with operational procedures.
3.5 运行鉴定：获得并编制文件证明已安装的设备按操作程序使用时，设备在规定范围内运行的过程.
3.6 packaging system: Entire packaging for a product that consists of the sterile barrier (primary package), the carton or shelf pack (condary packaging), and the
shipping container (tertiary packaging). Secondary and tertiary packaging might not be ud in the packaging of all products.
3.6 包装系统：包装系统包括无菌屏障系统，外包装和运输包装。并非所有产品都有二级和三级包装。
3.7 performance qualification (PQ): Obtaining and documenting evidence that the equipment, as installed and perated in accordance with operational procedures, consistently performs in accordance with predetermined criteria and thereby yields a product that meets specifications.
3.7 性能鉴定：获得并编制文件证明，设备安装和运行按操作规范进行操作时，能始终如一的生产出合格产品的过程.
3.8 process challenge device (PCD): Object that simulates the worst ca of conditions as they are given for the sterilizing agent(s) in terms of the goods to be sterilized.
Note 1—The design of the process challenge device depends on the kind of goods to be sterilized and the sterilization procedure. The device should be so constituted that a biological indicator can be arranged in the place most difficult for the sterilant to reach. The biological indicator should not interfere with the function of the process challenge device.
特兰斯特勒默Note 2—In some process challenge devices, an inoculated carrier may be ud in place of a biological indicator.
3.8过程挑战装置: 对灭菌过程有指定抵抗力的装置，用于评定灭菌过程性能.
3.9 process equivalency: Documented evaluation that the same sterilization process can be delivered by two or more pieces of sterilization process equipment. 3.9 过程等效性：评价相同的灭菌过程能适用于其他灭菌设备。
3.10 processing group: Collection of products or product families that can be sterilized in the same EO sterilization process. All products within the group have been determined to prent an equal or lesr challenge to the sterilization process.
3.10 过程组：不同产品和产品族可以使用同一种灭菌过程参数，所有的产品已经证明不大于过程的灭菌能力。
3.11 product adoption: Process of formally including a candidate product into an existing validated sterilization process.
3.11 产品引入：将候补产品引入到当前的灭菌过程中。
3.12 product family: Collection of products that are determined to be similar or equivalent for validation purpos.
3.12 产品族：用于确认目的的相似产品集合。
男生的英文名字3.13 sterility assurance level (SAL): Probability of a viable microorganism being prent on a product unit after sterilization.
youthNOTE—SAL is normally expresd as 10–n.
3.13 无菌保证水平：灭菌后的产品上出现单个存活微生物的概率。
3.14 sterilization process equipment: Preconditioning area (if ud),
chamber/sterilizer and aeration area, and their respective ancillary equipment.
3.14 灭菌过程设备：预处理区（若适用），灭菌柜/器和解析区，还包括辅助设备。3.15 sterilization specialist: Person who is knowledgeable, by training and experience, of the science of sterilization.
3.15 灭菌专家：通过灭菌培训，拥有灭菌经验的人。
4 Product adoption 产品引入
4.1 Introduction
Product adoption is the process of determining whether a candidate product can be included in an existing validated sterilization process by performing a documented evaluation. The determination involves comparing the relative resistance to the sterilization process of the candidate product versus the existing PCD. A sterilization specialist performs this determination. If the candidate product cannot be adopted into the existing validated process, refer to ANSI/AAMI/ISO 11135:1994.
4.1 介绍
产品归类是通过文件化的评价证明待确认产品是否可以纳入已确认过的灭菌过程. 此证明包括对比待确认产品和已存在的过程挑战器械之间相对于灭菌过程的抗性. 由灭菌专家进行此证明. 如果待确认产品不能归类于已存在的灭菌过程, 待确认产品的确认参照ANSI/AAMI/ISO 11135:1994. （Note: 新的版本ISO11135:2007 将于2010年正式生效）
4.2 Families
kapValidating every individual product for placement within a product family is not feasible in many ca
s. Therefore, products are traditionally grouped together into product families and processing groups on the basis of similarities in configuration, materials, density, packaging, or difficulty of sterilization compared against a worst-ca reprentative. Often, products within a family can consist of various combinations of similar items. For example, kits may contain various combinations of sponges, bowls, instruments, towels, drapes, and other items. The only difference between kits in a chon family may be the types, quantities, and sizes of items included within the kits.
The are product families and should not be confud with processing groups. A processing group is a collection of product families that may be dissimilar in details of construction or packaging. Each of the product families will have been qualified in a common sterilization process. For example, various IV ts may constitute a product family, and may be placed in a processing group that includes a product family of blood collection ts. The following list provides guidance to the elements that may be considered when placing products into families:
⎜ product design;
⎜ product function (end u);
⎜ manufacturing method;
⎜ manufacturing environment/area;
⎜ material of construction;
⎜ packaging materials;
⎜ primary and/or condary packaging configuration;
⎜ density;
platform
⎜ size and/or surface area; and
⎜ bioburden.
4.2产品族
多数确认过程不能确认产品族中所有的个体产品, 因此, 使用同一过程参数的产品族建立在相似的产品结构，产品原材料, 密度，包装和灭菌的难易程度上.但是有时产品族准中
的个体产品会有很大的差异，例如：一个包类产品中可能含有绷带，纱布球，手术器械，纱布片或其他产品, 被列入同一产品族内的包类产品之间的唯一的区别在于包类产品中器械的种类、数量和规格。
产品族不应该与过程组混淆，一个过程组是一些不相似的结构或包装的产品族的汇集。其中每一个产品族都可以适用于同一个灭菌过程。例如，不同种类的静脉输液器械可以被列入一个产品族，并且可以和采血器同时适用于同一个灭菌过程组，产品被列入一个产品族中需考虑下列因素：
* 产品设计；
4年级上册英语书
* 产品性能（最终用途）；
* 制造方法；
* 生产环境/区域；
* 组成材料；
* 包装材料；
* 无菌屏障系统的结构；
* 密度；
*尺寸/表面积；
* 生物负载。
4.3 Determination of adver effects
Before determining whether a product or packaging system can be adopted into a validated EO process, it should be determined whether the product and packaging system will remain functional and effective. A system to evaluate the aspects should be addresd by the design and/or change control process. Consideration should be given to functionality, integrity, stability, biocompatibility, and residuals, with special consideration given to determining the effect the sterilization process might have on drugs that could be included in devices/components. For products (e.g., kits) that may contain presterilized components (e.g., drugs), the manufacturer should consider regulatory requirements with regard to safety and efficacy of the components.
漂亮的英文网名
NOTE—The candidate product and its packaging should be evaluated for EO residuals, and any changes to either should be evaluated for the impact on product relea. ANSI/AAMI/ISO 10993-7 and AAMI TIR19 should be ud as guidance for making this evaluation.
4.3评价不良影响
在确定产品或包装系统是否适用于同一个确认过的EtO灭菌过程之前，必须先证明产品或包装系统的功能性和有效性。通过设计/变更控制流程系统的评估这些方面，需要考虑其功能性，一致性，稳定性，生物兼容性及环氧乙烷的残留量，还需特别考虑环氧乙烷灭菌过程不会影响器械/组件中含有的药物成分。如果器械/组件中含有的预灭菌过的药物成分，制造商需考虑这些药物成分不会被影响其功效。
备注：候选产品和它的包装需进行EtO残留量的评价，并在产品发行时评价任何变化带来的影响.ANSI//AAMI/10993-7和AAMI TIR19作为评价EtO残留量的指导标准.
idler4.4 Determination of sterilization challenge
Within each family or processing group, a worst-ca or reprentative member is lected for validation studies. The worst-ca or reprentative member should be lected on the basis of characteristics described in annex A, as applicable. This list is not all-inclusive; there may be other factors that should be considered. Converly,
