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CEN - EN 14180

Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing

active, Most Current
Organization: CEN
Publication Date: 1 May 2014
Status: active
Page Count: 66
ICS Code (Sterilizing equipment): 11.080.10

Document History

PREN 14180
April 1, 2023
Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
This document specifies requirements and tests for LTSF sterilizers, which use a mixture of low temperature steam and formaldehyde as sterilizing agent, and which are working below ambient pressure...
EN 14180
May 1, 2014
Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
A description is not available for this item.
EN 14180
July 22, 2003
Sterilizers for medical purposes Low temperature steam and formaldehyde sterilizers Requirements and testing
A description is not available for this item.
EN 14180
July 22, 2003
Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
A description is not available for this item.

References

This document references:
IEC 61010-2-101 - Safety requirements for electrical equipment for measurement, control and laboratory use – Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
Published by IEC on October 1, 2018
Equipment included in scope This part of IEC 61010 applies to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes. IVD medical equipment,...
This document references:
IEC 61010-2-010 - Safety requirements for electrical equipment for measurement, control and laboratory use – Part 2-010: Particular requirements for laboratory equipment for the heating of materials
Published by IEC on February 1, 2019
Equipment included in scope This group safety publication is primarily intended to be used as a product safety standard for the products mentioned in the scope, but shall also be used by technical...
This document references:
IEC 61010-2-030 - Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 2-030: Particular requirements for equipment having testing or measuring circuits
Published by IEC on January 1, 2017
This clause of Part 1 is applicable except as follows: Equipment included in scope Replacement: Replace the text with the following: This group safety publication is primarily intended to be used as...
This document references:
IEC 61010-2-081 - Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 2-081: Particular requirements for automatic and semi-automatic laboratory equipment for analysis and other purposes
Published by IEC on February 1, 2019
This clause of Part 1 is applicable except as follows: Equipment included in scope Replacement: Replace the text, except the first paragraph, by the following new text: This part of IEC 61010 applies...
This document is referenced by:
BS EN ISO 25424 - Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices
Published by BSI on November 30, 2019
A description is not available for this item.
This document is referenced by:
EN ISO 11607-1 - Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
Published by CEN on January 1, 2020
This document specifies requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of...
This document is referenced by:
BS EN ISO 11607-1 + A1 - Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
Published by BSI on January 31, 2020
A description is not available for this item.
This document is referenced by:
ISO 11140-1 - Sterilization of health care products - Chemical indicators - Part 1: General requirements
Published by ISO on November 1, 2014
This part of ISO 11140 specifies general requirements and test methods for indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances, and...
This document is referenced by:
AAMI 11607-1 - Packaging for terminally sterilized medical devices— Part 1: Requirements for materials, sterile barrier systems, and packaging
Published by AAMI on January 1, 2019
This document specifies requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of...
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