Overview

This International Standard specifies requirements for the development, validation and routine control of a dry heat sterilization process for medical devices. It also describes requirements that, if met, will provide a dry heat depyrogenation process through an appropriate denaturation activity. The development, validation and routine control of a sterilization process and/or a depyrogenation process comprise a number of discrete but interrelated activities, for example calibration, maintenance, product definition, process definition, installation qualification, operational qualification and performance qualification. The informative Annexes provide explanations and also methods permitted as suitable means for meeting these requirements. This International Standard does not apply to processes that use infrared or microwaves as the heating technique. The International Standard has been prepared by ISO/TC 198 "Sterilization of health care products". On the European level, it has been adopted under the Unique Acceptance Procedure (UAP) by CEN/TC 204 "Sterilization of medical devices". The responsible German committee is Working Committee NA 063-01-07 AA "Sterilisation von Medizinprodukten" ("Sterilization of medical devices") at the Medical Standards Committee (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  

Responsible international committee

ISO/TC 198 - Sterilization of health care products