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OEVE/OENORM EN ISO 14971
Medical devices - Application of risk management to medical devices (ISO 14971:2019) (consolidated version)
Edition
2022-05-15
Praxisleitfaden zur DIN EN ISO 13485 und den neuen EU-Verordnungen
Edition
2019-04
SN ENV 13004
Nomenclature system for medical devices for the purposes of regulatory data exchange - Recommendations for an interim system and rules for a future system
Edition
1999-10
OENORM EN 1642
Dentistry - Medical devices for dentistry - Dental implants
Edition
2012-02-15
OENORM 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
2010-10-01
OVE-Richtlinie/ONR R 8
Guideline for procurement and operation of medical devices in IT-networks
Edition
2012-06-01
OENORM 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
2021-12-01
OENORM EN ISO 10993-4/A1
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment 1 (ISO 10993-4:2017/DAmd 1:2024)
Edition
2024-04-15
OENORM EN ISO 10993-12/A1
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials - Amendment 1 (ISO 10993 12:2021/DAM 1:2024)
Edition
2024-07-15
OENORM EN ISO 14155
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO/DIS 14155:2024)
Edition
2024-07-15