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Standards [CURRENT]

DIN EN ISO 11137-3
Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017); German version EN ISO 11137-3:2017

Title (German)

Sterilisation von Produkten für die Gesundheitsfürsorge - Strahlen - Teil 3: Anleitung zu dosimetrischen Aspekten der Entwicklung, Validierung und Lenkung der Anwendung (ISO 11137-3:2017); Deutsche Fassung EN ISO 11137-3:2017

Overview

An integral part of radiation sterilization is the ability to measure dose. Dose is measured during all stages of development, validation and routine monitoring of the sterilization process. Dosimetry requirements are specified in ISO 11137-1 and -2 and ISO/TS 13004. ISO 11137-3 provides guidance on the use of dose measurements (dosimetry) in the development, validation and control of use during all stages of the radiation sterilization process, including explanations and procedures that are considered appropriate means of meeting the requirements. This standard has been prepared by Technical Committee ISO/TC 198 "Sterilization of health care products" (secretariat: ANSI, USA) in collaboration with Technical Committee CEN/TC 204 "Sterilization of medical devices" (secretariat: BSI, United Kingdom) with the participation of German experts. The responsible committee for this standard is NA 063-04-07 AA at DIN Standards Committee Medicine (NAMed).

Document: references other documents

Document: referenced in other documents

Responsible national committee

NA 176-03-09 AA - Sterilization and processing of medical devices  

Responsible european committee

CEN/TC 204 - Sterilization of medical devices  

Edition 2017-11
Original language German
Translation English
Price from 135.10 €
Table of contents

Contact

Dipl.-Phys.

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