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.
Cross References:ISO 11138-5:2017
ISO 11737-2
ISO 11138-1
ISO 11140-1
ISO 11737-1
ISO 22442-3
ISO 22442-1
ISO 14161
ISO 13485
IEC 61010-2-040
ISO Guide 64
EN 556-1
ISO 15883 (all parts)
EN 867-5
ISO 17664
ISO 22442-2
ISO 11607 (all parts)
EN 868 (series)
ANSI/AAMI ST 67:2011
ISO 14937:2009
EN 14180:2014
ISO 11139:2018
ISO/IEC 90003:2014
All current amendments available at time of purchase are included with the purchase of this document. | File Size : | 1
file
, 2 MB |
| ISBN(s) : | 9780580936180 |
| Note : | This product is unavailable in Ukraine, Russia, Belarus |
| Number of Pages : | 66 |
| Product Code(s) : | 30338807, 30338807, 30338807 |
| Published : | 11/21/2019 |
| Same As : | BS EN ISO 25424:2019 |
