1.1本文件规定了医疗器械辐射灭菌工艺的开发、验证和常规控制的要求。 注:虽然范围仅限于医疗器械，但本文件可适用于其他产品和设备。 本文件涵盖了使用辐照器的辐射过程，所述辐照器使用: a)放射性核素60Co或137Cs； b)来自电子发生器的束；或者 c)来自X射线发生器的射束。 1.2本文件不适用于灭活病毒或海绵状脑病（如羊瘙痒病、牛海绵状脑病和克雅氏病）病原体的工艺。 注有关此类工艺的信息，请参见ISO 22442-1、ISO 22442-2、ISO 22442-3、ISO 13022和ICH Q5A。1.2.1本文件未规定指定医疗器械为无菌的要求。 注:地区和国家要求可将医疗器械指定为无菌。参见例如EN 556-1或ANSI/AAMI ST67。 1.2.2本文件未规定医疗器械生产各阶段控制的质量管理体系。 注:本文件并不要求在生产过程中建立完整的质量管理体系，但在正文的适当位置对控制灭菌过程所必需的最低质量管理体系要素进行了规范性引用（特别参见第4条）。提请注意控制医疗器械生产所有阶段（包括灭菌过程）的质量管理体系标准（参见ISO 13485）。提供医疗器械的地区和国家法规可能要求实施完整的质量管理体系，并由第三方对该体系进行评估。 1.2.3本文件不要求生物指示剂用于辐射灭菌的验证或监测，也不要求产品放行时进行无菌药典试验。 1.2.4本文件没有规定与辐照设施的设计和操作相关的职业安全要求。 注:某些国家可能存在与辐射相关的职业安全的安全要求法规。 1.2.5本文件未规定使用或再加工器械的灭菌要求。

1.1       This document specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices.

NOTE         Although the scope is limited to medical devices, this document can be applicable to other products and equipment.

This document covers radiation processes employing irradiators using:

a)      the radionuclide ⁶⁰Co or ¹³⁷Cs;

b)      a beam from an electron generator; or

c)       a beam from an X-ray generator.

1.2       This document is not applicable to processes for inactivating viruses or the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease.

NOTE         For information on such processes, see ISO 22442-1, ISO 22442-2, ISO 22442-3, ISO 13022 and ICH Q5A.

1.2.1       This document does not specify requirements for designating a medical device as sterile.

NOTE         Regional and national requirements can designate medical devices as sterile. See, for example, EN 556-1 or ANSI/AAMI ST67.

1.2.2       This document does not specify a quality management system for the control of all stages of production of medical devices.

NOTE         It is not a requirement of this document to have a complete quality management system during manufacture, but the elements of a quality management system that are the minimum necessary to control the sterilization process 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 of medical devices, including the sterilization process. Regional and national regulations for the provision of medical devices can require implementation of a complete quality management system and the assessment of that system by a third party.

1.2.3       This document does not require that biological indicators be used for validation or monitoring of radiation sterilization, nor does it require that a pharmacopoeial test for sterility be carried out for product release.

1.2.4       This document does not specify requirements for occupational safety associated with the design and operation of irradiation facilities.

NOTE         Regulations on safety requirements for occupational safety related to radiation can exist in some countries.

1.2.5       This document does not specify requirements for the sterilization of used or reprocessed devices.