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BS EN ISO 25424:2019

Sterilization of health care products. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices

standard by British Standard / European Standard / International Organization for Standardization , 11/21/2019

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Full Description

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.
 

Product Details

Published:
11/21/2019
ISBN(s):
9780580936180
Number of Pages:
66
File Size:
1 file , 2 MB
Same As:
ISO 25424:2018
Product Code(s):
30338807, 30338807, 30338807
Note:
This product is unavailable in Ukraine, Russia, Belarus
 

Document History

  1. BS EN ISO 25424:2019+A1:2022


    Sterilization of health care products. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices

    • Most Recent

  2. BS EN ISO 25424:2019

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    Sterilization of health care products. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices

    • Historical Version

  3. BS EN ISO 25424:2011


    Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices

    • Historical Version

  4. BS EN 15424:2007


    Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices

    • Historical Version