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SN 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
2021-09
SN 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
SN 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
2016-06
SN 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
2016-02
SN EN 16615
Chemical disinfectants and antiseptics - Quantitative test method for the evaluation of bactericidal and yeasticidal activity on non-porous surfaces with mechanical action employing wipes in the medical area (4-field test) - Test method and requirements (phase 2, step 2)
Edition
2015-05
SN 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
Edition
2015-01
SN EN ISO 11135/A1
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018); Amendment A1
Edition
2020-06
SN EN ISO 11137-1/A2
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Revision to 4.3.4 and 1 (ISO 11137-1:2006/Amd 2:2018); Amendement A2
Edition
2020-04
OENORM EN ISO 10993-17/A1
Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents - Amendment 1 (ISO 10993-17:2023/DAmd 1:2024)
Edition
2024-08-15
SNG CEN ISO/TR 20416
Medical devices - Post-market surveillance for manufacturers (ISO/TR 20416:2020)
Edition
2020-09