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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

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 ISO 8871-4

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 4: Biological requirements and test methods (ISO 8871-4:2006); German version EN ISO 8871-4:2006
Edition 2006-09

Standards [CURRENT]

DIN EN ISO 11737-1

Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018 + Amd 1:2021); German version EN ISO 11737-1:2018 + A1:2021
Edition 2021-10

Standards [CURRENT]

DIN EN 16602-70-55

Space product assurance - Microbiological examination of flight hardware and cleanrooms; English version EN 16602-70-55:2015
Edition 2015-12

Standards [CURRENT]

CSA ISO 11737-1

Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018, IDT)
Edition 2019-06-01

Standards [CURRENT]

CAN/CSA-Z11135

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (Adopted ISO 11135:2014, second edition, 2014-07-15)
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

Technical rule [CURRENT]

AAMI TIR 106

Microbiological methods - Understanding and use of product bioburden data
Edition 2024

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