RO
SR EN ISO 25424:2020
Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018)
1.1 Inclusions 1.1.1 This document specifies requirements for the development, validation and routine control of a low temperature steam and formaldehyde (LTSF) sterilization process for medical devices using a mixture of low temperature steam and formaldehyde as sterilizing agent and which operates below ambient pressure. NOTE Although the scope of this document is limited to medical devices, it specifies requirements and provides guidance that can be applicable to other products and equipment. 1.1.2 This document is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized and the organizations with responsibility for sterilizing medical devices (see ISO 14937:2009, Table E.1). 1.2 Exclusions 1.2.1 This document does not specify requirements for the development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced
Status :
Valid
Approval date : 3/31/2020
Number of pages : 60
ICS : 11.080.01 Sterilization and desinfectation
Technical Committee : 377 - Medical devices
- Replaces SR EN ISO 25424:2011
- Normative reference SR EN ISO 11138-1:2017
- Normative reference SR EN ISO 11737-1:2018
- Normative reference SR EN ISO 11138-5:2017
- Normative reference SR EN ISO 11737-1:2018/A1:2021
- Normative reference SR EN ISO 11140-1:2015
- Normative reference SR EN ISO 11737-2:2010
- Amended by SR EN ISO 25424:2020/A1:2022