DIN EN 556-1
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German version EN 556-1:2024
Sterilisation von Medizinprodukten - Anforderungen an Medizinprodukte, die als "STERIL" gekennzeichnet werden - Teil 1: Anforderungen an Medizinprodukte, die in der Endpackung sterilisiert wurden; Deutsche Fassung EN 556-1:2024
Overview
This document specifies the requirements for a terminally sterilized medical device to be designated "STERILE". Part 2 of the EN 556 series of standards specifies the requirements for an aseptically processed medical device to be designated "STERILE". The responsible German standardization committee is Working Committee NA 176-03-09 AA "Sterilisation und Aufbereitung von Medizinprodukten" "Sterilization and processing of medical devices" at DIN Standards Committee Health Technologies (NAGesuTech).
Document: references other documents
Responsible national committee
NA 176-03-09 AA - Sterilization and processing of medical devices
Responsible european committee
CEN/TC 204/WG 6 - Microbiological quality of processed medical devices
