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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 5840-2

Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2021); German version EN ISO 5840-2:2021
Edition 2021-05

Standards [CURRENT]

DIN EN ISO 16671

Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2015 + Amd 1:2017); German version EN ISO 16671:2015 + A1:2017
Edition 2018-03

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 EN 61391-2

Ultrasonics - Pulse-echo scanners - Part 2: Measurement of maximum depth of penetration and local dynamic range (IEC 61391-2:2010); German version EN 61391-2:2010
Edition 2010-09

Draft standard

DIN EN ISO 7199

Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO/DIS 7199:2023); German and English version prEN ISO 7199:2023
Edition 2023-08

Standards [CURRENT]

DIN EN ISO 10993-17

Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023); German version EN ISO 10993-17:2023
Edition 2024-02

Standards [CURRENT]

DIN EN ISO 20166-1

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 1: Isolated RNA (ISO 20166-1:2018); German version EN ISO 20166-1:2018
Edition 2019-04

Standards [CURRENT]

DIN EN ISO 10993-6

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016); German version EN ISO 10993-6:2016
Edition 2017-09

Standards [CURRENT]

DIN EN ISO 25539-3

Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO 25539-3:2011); German version EN ISO 25539-3:2011
Edition 2012-03

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