Dear Customer
Our Customer Service will be available again as of 2 January 2025.
Please note that new registrations and requests to be processed manually will only be processed from this point onwards.
You can of course place orders and receive downloads online at any time.
We wish you happy holidays, a peaceful time and a healthy New Year!
Your DIN Media
Standard [CURRENT]
Product information on this site:
Quick delivery via download or delivery service
All transactions are encrypted
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).