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EN 13060:2014 Standard

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  Keywords:

#standard #european #sterilization #requirements #small

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Small steam sterilizers

  Purpose

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).

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN 13060:2004 +A2:2010"

Anyway is still possible use the "EN 13060:2004 +A2:2010" until November 17th, 2017

  Related Standards

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EN 60627:2001/AC:2002

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EN 60627:2001

Medical devices Directive (93/42/EEC)

Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter gridsIEC 60627:2001

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