Standard [CURRENT]
DIN EN ISO 17665:2024-09
Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665:2024); German version EN ISO 17665:2024
- German title
- Sterilisation von Produkten für die Gesundheitsfürsorge - Feuchte Hitze - Anforderungen an die Entwicklung, Validierung und Lenkung der Anwendung eines Sterilisationsverfahrens für Medizinprodukte (ISO 17665:2024); Deutsche Fassung EN ISO 17665:2024
- Publication date
- 2024-09
- Original language
- German
- Pages
- 195
- Publication date
- 2024-09
- Original language
- German
- Pages
- 195
- DOI
- https://dx.doi.org/10.31030/3541461
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Overview
This document provides requirements for the development, validation and routine control of moist heat sterilization processes for medical devices. It also contains guidance which is intended to explain the requirements set forth in the normative sections. The guidance given is intended to promote good practice related to moist heat sterilization processes according to this document. The application within industrial and health care settings is considered. The responsible national 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
DOI
This document replaces DIN EN ISO 17665-1:2006-11 , DIN ISO/TS 17665-2:2009-07 .