ISO 11737-1:2018
Sterilization of health care products — Microbiological methods
Determination of the population of micro-organisms on product
- Category
- Harmonised standards
- Market
- European Union
- Applicable classes
- Class IIa medical device, Class IIb medical device, Class III medical device
In practice
Bioburden testing on samples before sterilization. A validated test method belongs in the technical documentation.
Official sources
https://www.iso.org/standard/70981.htmlSee where this text lands in your roadmap
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