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Standards [New]

DIN EN ISO 21535

Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2023); German version EN ISO 21535:2024
Edition 2024-10

Standards [New]

DIN EN ISO 21536

Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 21536:2023); German version EN ISO 21536:2024
Edition 2024-10

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 [New]

DIN EN ISO 13408-1

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023); German version EN ISO 13408-1:2024
Edition 2024-09

Publication

Risikomanagement und Biologische Sicherheit von Medizinprodukten

Am Beispiel der biologischen Bewertung und unter Einbeziehung der DIN EN ISO 10993-1 und DIN EN ISO 14971
Edition 2022-01

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