DIN EN ISO 25424/A1:2021 Edition
$19.50
Sterilization of health care products – Low temperature steam and formaldehyde – Requirements for development, validation and routine control of a sterilization process for medical devices – Amendment 1
| Published By | Publication Date | Number of Pages |
| DIN | 2021-03 | 24 |
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. 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.
