ISO 13408-1:2023
Aseptic processing of health care products
General requirements for aseptic processing
- Category
- Harmonised standards
- Market
- European Union
- Applicable classes
- Class IIb medical device, Class III medical device
In practice
For sterile devices manufactured aseptically. Covers cleanrooms, filtration, validation and environmental control.
Official sources
https://www.iso.org/standard/83157.htmlSee where this text lands in your roadmap
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