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Standards [CURRENT]

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

Pre-standard

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

Standards [CURRENT]

OENORM EN 1642

Dentistry - Medical devices for dentistry - Dental implants
Edition 2012-02-15

Standards [CURRENT]

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

Technical rule [CURRENT]

OVE-Richtlinie/ONR R 8

Guideline for procurement and operation of medical devices in IT-networks
Edition 2012-06-01

Standards [CURRENT]

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

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

Draft standard [New]

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

Draft standard [New]

OENORM EN ISO 14155

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO/DIS 14155:2024)
Edition 2024-07-15

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