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Standards [CURRENT]

DIN EN ISO 21535

Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2007 + Amd 1:2016); German version EN ISO 21535:2009 + A1:2016
Edition 2017-04

Standards [CURRENT]

DIN EN ISO 21536

Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 21536:2007 + Amd.1:2014); German version EN ISO 21536:2009 + A1:2014
Edition 2014-07

Draft standard

DIN EN ISO 5840-2/A1

Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes - Amendment 1 (ISO 5840-2:2021/DAM 1:2024); German and English version EN ISO 5840-2:2021/prA1:2024
Edition 2024-03

Draft standard

DIN EN ISO 5840-3/A1

Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques - Amendment 1 (ISO 5840-3:2021/DAM 1:2024); German and English version EN ISO 5840-3:2021/prA1:2024
Edition 2024-03

Standards [CURRENT]

DIN ISO 11418-4

Containers and accessories for pharmaceutical preparations - Part 4: Tablet glass bottles (ISO 11418-4:2005); text in German and English
Edition 2005-08

Technical Specification

DIN CEN ISO/TS 20342-10 ; VDE V 0750-2-52-10:2022-10

Assistive products for tissue integrity when lying down - Part 10: Guide to cleaning, disinfecting, and care of polyurethane APTI covers (ISO/TS 20342-10:2022); German version CEN ISO/TS 20342-10:2022
Edition 2022-10

Standards [CURRENT]

DIN EN ISO 80601-2-85

Medical electrical equipment - Part 2-85: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment (ISO 80601-2-85:2021); German version EN ISO 80601-2-85:2021
Edition 2022-01

Standards [CURRENT]

DIN EN 62304 ; VDE 0750-101:2016-10

Medical device software - Software life-cycle processes (IEC 62304:2006 + A1:2015); German version EN 62304:2006 + Cor.:2008 + A1:2015
Edition 2016-10

Standards [CURRENT]

DIN EN ISO 80601-2-84

Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment (ISO 80601-2-84:2023); German version EN ISO 80601-2-84:2023
Edition 2024-04

Standards [CURRENT]

DIN EN 60601-2-64 ; VDE 0750-2-64:2018-01

Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment (IEC 60601-2-64:2014); German version EN 60601-2-64:2015
Edition 2018-01

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