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Standards [CURRENT]

DIN EN ISO 10993-1

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10); German version EN ISO 10993-1:2020
Edition 2021-05

Draft standard

DIN EN ISO 18562-1

Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process (ISO/DIS 18562-1:2022); German and English version prEN ISO 18562-1:2022
Edition 2022-12

Draft standard [New]

DIN EN ISO 10993-1

Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process (ISO/DIS 10993-1:2024); German and English version prEN ISO 10993-1:2024
Edition 2024-07

Standards [CURRENT]

DIN EN ISO 10993-18

Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020 + Amd 1:2022); German version EN ISO 10993-18:2020 + A1:2023
Edition 2023-11

Standards [CURRENT]

FD S99-130

Guidelines for the implementation of a quality system within a health establishment
Edition 2002-11-01

Standards [CURRENT]

BS EN 61666+A1

Industrial systems, installations and equipment and industrial products. Identification of terminals within a system
Edition 2010-11-30

Standards [CURRENT]

BS EN ISO 10993-18+A1

Biological evaluation of medical devices. Chemical characterization of medical device materials within a risk management process
Edition 2020-06-01

Standards [CURRENT]

BS EN ISO 10993-1

Biological evaluation of medical devices. Evaluation and testing within a risk management process
Edition 2020-12-16

Biological evaluation of medical devices - Part 1 : evaluation and testing within a risk management system.

Industrial systems, installations and equipment and industrial products - Identification of terminals within a system
Edition 2021-08-06

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