DIN Standards Committee Quality Management, Statistics and Certification
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
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
