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Draft standard

DIN EN ISO 11135

Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135.2:2024); German and English version prEN ISO 11135:2024
Edition 2024-04

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 58946-7

Sterilization - Steam sterilizers - Part 7: Edificial preconditions, requirements for the services and the operation of steam sterilizers used in health care facilities
Edition 2014-01

Standards [CURRENT]

DIN EN 868-6

Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods; German version EN 868-6:2017
Edition 2017-05

Standards [CURRENT]

DIN EN 868-7

Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods; German version EN 868-7:2017
Edition 2017-05

Standards [CURRENT]

DIN 58953-8

Sterilization - Sterile supply - Part 8: Logistics of sterile medical devices
Edition 2019-03

Standards [CURRENT]

DIN EN ISO 10993-7

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008 + Cor 1:2009 + Amd 1:2019); German version EN ISO 10993-7:2008 + AC:2009 + A1:2022
Edition 2022-09

Draft standard [New]

DIN EN 868-6

Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods; German and English version prEN 868-6:2024
Edition 2024-05

Draft standard

DIN 58953-9

Sterilization - Sterile supply - Part 9: Use of re-usable sterilization containers
Edition 2024-03

Draft standard [New]

DIN EN ISO 10993-7

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO/DIS 10993-7:2024); German and English version prEN ISO 10993-7:2024
Edition 2024-08

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