ISO 13408-6, Aseptic processing of health care products — Part 6: Isolator systems ISO 14644-1:2015, Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness by particle concentration

ISO 13408-1:2008 specifies the general requirements for, and offers guidance on, processes, programmes and procedures for development, validation and routine control of the manufacturing process for aseptically-processed health care products.

ISO在制定ISO 13408—1：1998的过程中，发现对于诸如：过滤、．冻干和在线蒸汽灭菌等基本要求需 要补充信息，但在附录中给出则内容过多。 ISO 13408的本部分包含了用过滤的方式制造无菌医疗产 品的要求和指南。 由于ISO 13408的本部分替代了ISO 13408—1：1998第20章的内容，ISO将在ISO 13408—2发布后 对ISO ...

Agreement). replaces the second edition (ISO 13408-1:2008) which has been — a complete restructuring as follows: — inclusion of a diagram to explain of the document; — revision of the normative references; the relationship between the ISO 13408 series and ISO 18362; — — alignment positioning of of definitions the document 11139:2018 ...

ISO 13408-1:2023保健品无菌加工第1部分:一般要求本文件规定了医疗保健产品无菌加工开发、验证和常规控制的工艺、计划和程序的一般要求，并提供了指导。 本文件包括与无菌处理总体主题相关的要求和指导。

4 天之前 · ISO 13408-1:2023的标准全文信息,本文件规定了医疗保健产品无菌加工的开发、验证和常规控制的流程、程序和程序的一般要求，并提供了相关指导。

BS EN ISO 13408-1:2015 specifies the general requirements for, and offers guidance on, processes, programmes and procedures for development, validation and routine control of the manufacturing process for aseptically-processed health care products.This part of ISO 13408 includes requirements and guidance relative to the overall topic of a ...

Foreword The text of ISO 13408-1 :2008 has been prepared by Technical Committee ISO/TC 198 "Sterilization of health care products" of the International Organization for Standardization (ISO) and has been taken over as EN ISO 13408-1 :2011 by Technical Committee CENITC 204 "Sterilization of medical devices" the secretariat of which is held by BS!.

标准号 ISO 13408-1:2023 版本 3 标准来源 ISO 标准发布组织 ISO 国际组织机构 ISO/TC 198 标准语言 EN 发布日期 2023-08-15