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Standards [CURRENT]

DIN EN ISO 29701

Nanotechnologies - Endotoxin test on nanomaterial samples for in vitro systems - Limulus amebocyte lysate (LAL) test (ISO 29701:2010); German version EN ISO 29701:2010
Edition 2011-01

Standards [CURRENT]

DIN ISO 13022

Medical products containing viable human cells - Application of risk management and requirements for processing practices (ISO 13022:2012)
Edition 2014-06

Standards [CURRENT]

DIN EN ISO 20186-1

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA (ISO 20186-1:2019); German version EN ISO 20186-1:2019
Edition 2019-08

Draft standard [New]

DIN EN ISO 10993-23/A1

Biological evaluation of medical devices - Part 23: Tests for irritation - Amendment 1: Additional in vitro reconstructed human epidermis models (ISO 10993-23:2021/DAM 1:2024); German and English version EN ISO 10993-23:2021/prA1:2024
Edition 2024-10

Standards [CURRENT]

DIN EN ISO 10993-23

Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021); German version EN ISO 10993-23:2021
Edition 2021-10

Standards [CURRENT]

DIN EN ISO 11238

Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on substances (ISO 11238:2018); German version EN ISO 11238:2018
Edition 2018-11

Standards [New]

DIN EN ISO 23500-3

Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies (ISO 23500-3:2024); German version EN ISO 23500-3:2024
Edition 2024-09

Standards [CURRENT]

DIN EN ISO 10993-10

Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021); German version EN ISO 10993-10:2023
Edition 2023-04

Standards [CURRENT]

DIN EN ISO 10993-11

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017); German version EN ISO 10993-11:2018
Edition 2018-09

Standards [CURRENT]

DIN EN ISO 23500-1

Preparation and quality management of fluids for haemodialysis and related therapies - Part 1: General requirements (ISO 23500-1:2019); German version EN ISO 23500-1:2019
Edition 2019-11

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