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Standards [CURRENT]

OENORM EN ISO 13408-5

Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)
Edition 2011-09-15

Standards [CURRENT]

OENORM EN 556-1

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices (consolidated version)
Edition 2006-12-01

Standards [CURRENT]

OENORM EN ISO 11140-3

Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007, including Cor 1:2007)
Edition 2009-09-15

Standards [CURRENT]

OENORM EN ISO 11140-6

Sterilization of health care products - Chemical indicators - Part 6: Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers (ISO 11140-6:2022)
Edition 2023-04-15

Standards [CURRENT]

OENORM 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) (consolidated version)
Edition 2021-11-01

Standards [CURRENT]

OENORM EN ISO 11140-4

Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration (ISO 11140-4:2007)
Edition 2007-06-01

Indikatoren und Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte
Edition 2020-12

Niedertemperatur-Sterilisation - Anforderungen an Verfahren, Geräte und zugehörige Ausrüstung
Edition 2020-12

Technical rule [CURRENT]

ONR 112069-1

Guideline for the validation and routine control of sterilization processes with moist heat for medical device products - Part 1: General
Edition 2009-07-01

Technical rule [CURRENT]

ONR 112069-2

Guideline for the validation and routine control of steam sterilization processes for medical devices in/for in health care institutions - Part 2: Further specifications
Edition 2009-07-01

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