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OEVE/OENORM EN ISO 15223-1/A1
Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements - Amendment 1: Addition of defined term for authorized representative and Modified EC REP symbol to not be country or region specific (ISO 15223 1:2021/DAM 1:2024)
Edition
2024-06-15
OVE EN IEC 61326-2-6
Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment ((IEC 61326-2-6:2020) EN IEC 61326-2-6:2021) (german version)
Edition
2023-01-01
OVE EN IEC 61010-2-040
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials (( IEC 61010-2-040:2020) EN IEC 61010-2-040:2021) (german version)
Edition
2023-03-01
OENORM EN 17387
Chemical disinfectants and antiseptics - Quantitative test for the evaluation of bactericidal and yeasticidal and/or fungicidal activity of chemical disinfectants in the medical area on non-porous surfaces without mechanical action - Test method and requirements (phase 2, step 2)
Edition
2021-11-15
OENORM EN ISO 11137-1
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006 + Amd.1:2013 + Amd.2:2018) (consolidated version)
Edition
2020-04-01
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
2017-04-15
OEVE/OENORM EN 61557-16
Electrical safety in low voltage distribution systems up to 1000 V a.c. and 1500 V d.c. - Equipment for testing, measuring or monitoring of protective measures - Part 16: Equipment for testing the effectiveness of the protective measures of electrical equipment and/or medical electrical equipment (IEC 61557-16:2014) (german version)
Edition
2016-01-01
OENORM EN ISO 15883-6
Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment (ISO 15883-6:2011)
Edition
2016-03-15
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
OVE EN IEC 61223-3-5
Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests and and constancy tests - Imaging performance of computed tomography X-ray equipment (( IEC 61223-3-5:2019) EN IEC 61223-3-5:2019) (german version)
Edition
2022-12-01