11.080.99 - Other standards related to sterilization and disinfection
Other standards related to sterilization and disinfection
Weitere Sterilisations- und Desinfektionsaspekte
Autres normes de sterilisation et de desinfection
Drugi standardi v zvezi s sterilizacijo in dezinfekcijo
General Information
20191119 - Negative assessment addressed through BT decision C168/2019 (SV)
2019-03-07-JO- under HAS assessment at PUB stage. E&Y Report was due on 03 March 2019- Awaiting for the assessment report E&Y Report
- Amendment19 pagesEnglish language
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- Amendment4 pagesEnglish language
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ISO 11137-3:2017 gives guidance on meeting the requirements in ISO 11137-1 and ISO 11137-2 and in ISO/TS 13004 relating to dosimetry and its use in development, validation and routine control of a radiation sterilization process.
- Standard50 pagesEnglish language
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This Standard describes a test protocol to determine the compatibility of materials, components, parts, and assemblies with sterilization processes. It is dedicated to test on non-flight hardware only. Any additional requirements that can be imposed by the potential use of
test samples as flight hardware are not covered in this document (e.g. handling requirements). This Standard covers the following:
• Identification of critical test parameters to establish functional integrity of the hardware....view more
- Standard53 pagesEnglish language
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