BAS EN ISO 13408-1:2016
Aseptic processing of health care products - Part 1: General requirements
General Information
Status: Published
No. of pages: 19
Language: English
Edition: 2.
Adoption method: Endorsment
Publication date: 18.05.2016
Technical committee:
Directive:
90/385/EEC, Active implantable medical devices
93/42/EEC, Medical devices;
98/79/EC, In vitro diagnostic medical devices;
93/42/EEC, Medical devices;
98/79/EC, In vitro diagnostic medical devices;
...
Abstract
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 13408-1:2008 includes requirements and guidance relative to the overall topic of aseptic processing. Specific requirements and guidance on various specialized processes and methods related to filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in other parts of ISO 13408.
Lifecycle
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Original document and degree of correspondence
- EN ISO 13408-1:2015, identical
- ISO 13408-1:2008, identical
- ISO 13408-1:2008/Amd 1:2013, identical