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Draft standard

DIN EN ISO 14644-5

Cleanrooms and associated controlled environments - Part 5: Operations (ISO/DIS 14644-5:2024); German and English version prEN ISO 14644-5:2024
Edition 2024-07

Standards [CURRENT]

DIN EN 16602-70-58

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

Draft standard

DIN EN ISO 18362

Manufacture of cell-based health care products - Control of microbial risks during processing (ISO 18362:2016); German and English version prEN ISO 18362:2018
Edition 2018-11

Standards [New]

DIN EN ISO 13408-1

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023); German version EN ISO 13408-1:2024
Edition 2024-09

Standards [CURRENT]

DIN EN ISO 14644-4

Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up (ISO 14644-4:2022); German version EN ISO 14644-4:2022
Edition 2023-04

Standards [CURRENT]

DIN EN 17141

Cleanrooms and associated controlled environments - Biocontamination control; German version EN 17141:2020
Edition 2021-02

Standards [CURRENT]

DIN EN ISO 14644-16

Cleanrooms and associated controlled environments - Part 16: Energy efficiency in cleanrooms and separative devices (ISO 14644-16:2019); German version EN ISO 14644-16:2019
Edition 2020-06

Standards [CURRENT]

DIN EN 13795-1

Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns; German version EN 13795-1:2019
Edition 2019-06

Draft standard

DIN EN 13795-1

Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns; German and English version prEN 13795-1:2023
Edition 2023-10

Standards [CURRENT]

DIN EN ISO 11607-1

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019 + Amd 1:2023); German version EN ISO 11607-1:2020 + A1:2023
Edition 2024-02

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