GSO ISO 13408-5:2014

Aseptic processing of health care products -- part 5 : sterilization in place

GSO ISO 13408-5:2014 发布历史

GSO ISO 13408-5:2014由GSO 发布于 2014-12-25。

GSO ISO 13408-5:2014在国际标准分类中归属于: 11.080.01 消毒和灭菌综合。

GSO ISO 13408-5:2014 的最新版本是哪一版？

最新版本是 GSO ISO 13408-5:2014 。

GSO ISO 13408-5:2014的历代版本如下：

• 2014年 GSO ISO 13408-5:2014

1.1 This part of ISO 13408 specifies the general requirements for sterilization in place (SIP) applied to product contact surfaces of the equipment used in the manufacture of sterile health care products by aseptic processing and offers guidance on qualification, validation, operation and control. NOTE SIP can be achieved by using steam or other gaseous or liquid sterilizing agents. Specific guidance on steam sterilization in place, which is the most common method used, is given in . 1.2 This part of ISO 13408 applies to processes where sterilizing agents are delivered to the internal surfaces of equipment that can come in contact with the product. 1.3 This part of ISO 13408 does not apply to processes where equipment is dismantled and delivered to a sterilizer. 1.4 This part of ISO 13408 does not supersede or replace national regulatory requirements, such as Good Manufacturing Practices (GMPs) and/or compendial requirements that pertain in particular national or regional jurisdictions. 1.5 This part of ISO 13408 does not specify requirements for 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. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents. NOTE See also ISO 22442-1, ISO 22442-2 and ISO 22442-3.

标准号

GSO ISO 13408-5:2014

发布

2014年

发布单位

GSO

当前最新

GSO ISO 13408-5:2014

 

 

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