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Draft standard

DIN EN ISO 11135

Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135.2:2024); German and English version prEN ISO 11135:2024
Edition 2024-04

Spezielle Regeln für die Akkreditierung im Bereich Medizinprodukte "Sterile Medizinprodukte"
Edition 2013-10-16

Standards [CURRENT]

SN EN ISO 17664-1

Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)
Edition 2021-10

Standards [CURRENT]

SN EN ISO 10993-13

Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)
Edition 2010-09

Draft standard

DIN EN ISO 15883-7

Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-critical thermolabile medical devices and health care equipment (ISO/DIS 15883-7:2024); German and English version prEN ISO 15883-7:2024
Edition 2024-03

Allgemeine Regeln für die Akkreditierung im Bereich Medizinprodukte
Edition 2013-10-16

Regeln für die Akkreditierung von Laboratorien im Bereich Medizinprodukte
Edition 2014-12-16

Standards [CURRENT]

SN EN ISO 20417

Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021)
Edition 2021-07

Standards [CURRENT]

SN EN 1642

Dentistry - Medical devices for dentistry - Dental implants
Edition 2012-01

Standards [CURRENT]

ISO 10993-14

Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics
Edition 2001-11

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