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Standards [New]

DIN EN ISO 16571

Systems for evacuation of plume generated by medical devices (ISO 16571:2024); German version EN ISO 16571:2024
Edition 2024-09

Standards [CURRENT]

DIN EN ISO 13485

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016 + AC:2018 + A11:2021
Edition 2021-12

Standards [CURRENT]

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]

OEVE/OENORM EN ISO 13485

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Edition 2022-02-01

Standards [CURRENT]

SN EN ISO 13485/A11

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); Amendment A11
Edition 2021-11

Standards [CURRENT]

SN EN ISO 13485

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Edition 2016-03

Standards [CURRENT]

SN EN ISO 13485/AC

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); Corrigendum AC
Edition 2020-04

Standards [New]

OENORM EN ISO 16571

Systems for evacuation of plume generated by medical devices (ISO 16571:2024)
Edition 2024-09-15

Standards [CURRENT]

SN EN ISO 16571

Systems for evacuation of plume generated by medical devices (ISO 16571:2024)
Edition 2024-04

Standards [CURRENT]

DIN EN ISO 11073-20701

Health informatics - Device interoperability - Part 20701: Point-of-care medical device communication - Service-oriented medical device exchange architecture and protocol binding (ISO/IEEE 11073-20701:2020); English version EN ISO 11073-20701:2020
Edition 2020-07

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