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DIN EN 13060

Small steam sterilizers (includes Amendment :2018)

active, Most Current
Organization: DIN
Publication Date: 1 February 2019
Status: active
Page Count: 86
ICS Code (Sterilizing equipment): 11.080.10
scope:

This European Standard specifies the performance requirements and test methods for small steam sterilizers and sterilization cycles which are used for medical purposes or for materials that are likely to come into contact with blood or body fluids.

This European Standard applies to automatically controlled small steam sterilizers that generate steam using electrical heaters or use steam that is generated by a system external to the sterilizer.

This European Standard applies to small steam sterilizers used primarily for the sterilization of medical devices with a chamber volume of less than 60 l and unable to accommodate a sterilization module (300 mm × 300 mm × 600 mm). The requirements concerning the quality management and risk management are addressed by other standards (e.g. EN ISO 13485, EN ISO 14971).

This European Standard does not apply to small steam sterilizers that are used to sterilize liquids or pharmaceutical products.

This European Standard does not specify safety requirements related to risks associated with the zone in which the sterilizer is used (e.g. flammable gases).

This European Standard does not specify requirements for the validation and routine control of sterilization by moist heat.

NOTE Requirements for the validation and routine control of sterilization by moist heat are given in EN ISO 17665-1.

This European Standard does not specify requirements for other sterilization processes that also employ moist heat as part of the process (i.e. formaldehyde, ethylene oxide).

Document History

DIN EN 13060
February 1, 2019
Small steam sterilizers (includes Amendment :2018)
This European Standard specifies the performance requirements and test methods for small steam sterilizers and sterilization cycles which are used for medical purposes or for materials that are...
November 1, 2017
Small steam sterilizers; German and English version EN 13060:2014/prA1:2017
A description is not available for this item.
March 1, 2015
Small steam sterilizers
This European Standard specifies the performance requirements and test methods for small steam sterilizers and sterilization cycles which are used for medical purposes or for materials that are...
June 1, 2010
Small steam sterilizers (includes Amendment A2:2010)
A description is not available for this item.
October 1, 2009
Small steam sterilizers (includes Amendment A1:2009)
A description is not available for this item.
February 1, 2009
Small steam sterilizers; English version EN 13060:2004/prA1:2008
A description is not available for this item.
September 1, 2004
Small steam sterilizers
A description is not available for this item.

References

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