ISO 13408-1-2008 医疗保健产品的无菌加工.第1部分:一般要求

标准号：ISO 13408-1-2008
中文标准名称：医疗保健产品的无菌加工.第1部分:一般要求
英文标准名称：Aseptic processing of health care products - Part 1: General requirements
标准类型：C50
发布日期：1999/12/31 12:00:00
实施日期：1999/12/31 12:00:00
中国标准分类号：C50
国际标准分类号：11.080.01
引用标准：ISO 9001;ISO 11135-1;ISO 11137-1;ISO 11137-2;ISO 13408-2;ISO 13408-3;ISO 13408-4;ISO 13408-5;ISO 13408-6;ISO 13485;ISO 14160;ISO 14644-1-1999;ISO 14644-2;ISO 14644-3;ISO 14644-4;ISO 14644-5;ISO 14644-7;ISO 14698-1;ISO 14698-2;ISO 14937;ISO 14971;ISO 17665
适用范围：1.1 This part of ISO 13408 specifies the general requirements for, and offers guidance on, processes,programmes and procedures for development, validation and routine control of the manufacturing process foraseptically-processed health care products.1.2 This part of ISO 13408 includes requirements and guidance relative to the overall topic of asepticprocessing. Specific requirements and guidance on various specialized processes and methods related tofiltration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems aregiven in other parts of ISO 13408.NOTE This part of ISO 13408 does not supersede or replace national regulatory requirements, such as GoodManufacturing Practices (GMPs) and/or pharmacopoeial requirements that pertain in particular national or regionaljurisdictions.