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

Standard [CURRENT]

DIN EN 556-1:2024-09

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

German title
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
Publication date
2024-09
Original language
German
Pages
16

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Publication date
2024-09
Original language
German
Pages
16
DOI
https://dx.doi.org/10.31030/3550202
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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).

Content

ICS

11.080.01

DOI

https://dx.doi.org/10.31030/3550202
Replacement amendments

This document replaces DIN EN 556-1 Berichtigung 1:2006-12 , DIN EN 556-1:2002-03 .

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