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Standards [CURRENT]

OENORM EN 16442

Controlled environment storage cabinet for processed thermolabile endoscopes
Edition 2015-05-01

Standards [CURRENT]

OEVE/OENORM EN 60731

Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy (IEC 60731:2011) (german version)
Edition 2015-05-01

Standards [CURRENT]

OEVE/OENORM EN 60601-2-27

Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment (IEC 60601-2-27:2011) (german version)
Edition 2015-05-01

Standards [CURRENT]

OENORM EN ISO 15883-1

Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006 + Amd 1:2014) (consolidated version)
Edition 2014-11-01

Standards [CURRENT]

OENORM EN 16438

Chemical disinfectants and antiseptics - Quantitative surface test for the evaluation of fungicidal or yeasticidal activity of chemical disinfectants and antiseptics used in the veterinary area on non-porous surfaces without mechanical action - Test method and requirements (phase 2, step 2)
Edition 2014-12-01

Standards [CURRENT]

OENORM K 1960

Process reference model in health care services
Edition 2014-12-01

Standards [CURRENT]

OENORM EN ISO 15378

Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017)
Edition 2018-04-01

Standards [CURRENT]

OENORM EN ISO 11138-2

Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2017)
Edition 2017-07-15

Standards [CURRENT]

OENORM EN ISO 11138-3

Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2017)
Edition 2017-07-15

Standards [CURRENT]

SN EN 80601-2-35+A11+AC+A1

Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use
Edition 2017-12

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