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Sterilization of medical devices - Microbiological methods - Part 3 : guidance on evaluation and interpretation of bioburden data.

Standards [CURRENT]

UNE-EN 16602-70-58

Space product assurance - Bioburden control of cleanrooms (Endorsed by AENOR in November of 2015.)
Edition 2015-11-01

Standards [CURRENT]

PD ISO/TS 22456

Sterilization of healthcare products. Microbiological methods. Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products
Edition 2021-03-22

Standards [CURRENT]

UNE-EN 16602-70-56

Space product assurance - Vapour Phase Bioburden Reduction for Flight Hardware (Endorsed by AENOR in November of 2015.)
Edition 2015-11-01

Standards [CURRENT]

UNE-EN 16602-70-57

Space product assurance - Dry Heat Bioburden Reduction for Flight Hardware (Endorsed by AENOR in November of 2015.)
Edition 2015-11-01

Pre-standard

ISO/TS 22456

Sterilization of healthcare products - Microbiological methods - Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products
Edition 2021-03

Standards [CURRENT]

ASTM D 8243

Standard Test Method for Determination of APS Reductase to Estimate Sulfate Reducing Bacterial Bioburdens in Water - Enzyme-Linked Immunosorbent Assay Method
Edition 2019

Standards [CURRENT]

DIN EN 16602-70-58

Space product assurance - Bioburden control of cleanrooms; English version EN 16602-70-58:2015
Edition 2015-12

Standards [CURRENT]

DIN EN 16602-70-56

Space product assurance - Vapour Phase Bioburden Reduction for Flight Hardware; English version EN 16602-70-56:2015
Edition 2015-12

Standards [CURRENT]

DIN EN 16602-70-57

Space product assurance - Dry Heat Bioburden Reduction for Flight Hardware; English version EN 16602-70-57:2015
Edition 2015-12

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