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Technical rule [CURRENT]

ISO/TR 19024

Evaluation of CPB devices relative to their capabilities of reducing the transmission of gaseous microemboli (GME) to a patient during cardiopulmonary bypass
Edition 2016-09

Standards [CURRENT]

DIN EN ISO 20608

Dentistry - Powder jet handpieces and powders (ISO 20608:2018); German version EN ISO 20608:2018
Edition 2018-08

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 5840-3

Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2021); German version EN ISO 5840-3:2021
Edition 2021-05

Standards [available pre-publication]

DIN EN ISO 12417-1

Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2024); German version EN ISO 12417-1:2024
Edition 2024-08

Standards [CURRENT]

DIN EN ISO 22442-2

Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020); German version EN ISO 22442-2:2020
Edition 2021-04

Standards [CURRENT]

DIN EN ISO 12417-1

Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2015); German version EN ISO 12417-1:2015
Edition 2016-02

Standards [CURRENT]

DIN EN ISO 25539-1

Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2017); German version EN ISO 25539-1:2017
Edition 2018-05

Standards [CURRENT]

DIN EN ISO 10993-4

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017); German version EN ISO 10993-4:2017
Edition 2017-12

Standards [CURRENT]

DIN EN ISO 10555-4

Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters (ISO 10555-4:2023); German version EN ISO 10555-4:2023
Edition 2024-03

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