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Draft standard

OENORM EN 868-3

Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods
Edition 2024-05-01

Anforderungen an die Hygiene bei der Aufbereitung von Medizinprodukten
Edition 2012-10

Standards [CURRENT]

OENORM EN ISO 15883-7

Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment (ISO 15883-7:2016)
Edition 2016-09-01

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11137-1:2023)
Edition 2023-05-15

Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for critical and semi-critical medical devices (ISO/DIS 15883-2:2023)
Edition 2023-06-01

Standards [CURRENT]

OENORM EN 868-5

Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods
Edition 2019-02-01

Standards [CURRENT]

OENORM 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) (consolidated version)
Edition 2022-12-01

Standards [CURRENT]

OENORM EN ISO 11607-2

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019) (consolidated version)
Edition 2022-12-01

Standards [CURRENT]

OENORM EN ISO 11607-1/A1

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019/Amd 1:2023) (Amendment)
Edition 2024-03-15

Standards [CURRENT]

OENORM EN ISO 11607-2/A1

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019/Amd 1:2023) (Amendment)
Edition 2024-03-15

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