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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
SNG CEN ISO/TR 20416
Medical devices - Post-market surveillance for manufacturers (ISO/TR 20416:2020)
Edition
2020-09
SNG CEN ISO/TR 24971
Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)
Edition
2020-08
OENORM EN ISO 9241-394
Ergonomics of human-system interaction - Part 394: Ergonomic requirements for reducing undesirable biomedical effects of visually induced motion sickness during watching electronic images (ISO 9241-394:2020)
Edition
2022-09-15
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
Edition
2011-04
SN EN ISO 80601-2-56/A1
Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2017/Amd 1:2018); Amendment A1
Edition
2020-11
SN EN 60601-2-68
Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment
Edition
2015-05
