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EN 556-2:2015 Standard

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  Keywords:

#medical #devices #aseptic #specified #iso

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Friday 17th of November 2017

  Description:

Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices

  Purpose

This European Standard specifies the requirements for an aseptically processed medical device to be designated 'STERILE'. NOTE For the purpose of the EU Directive(s) for medical devices (see Bibliography), designating that a medical device is 'STERILE' is permissible when a validated manufacturing and sterilization process has been applied. Requirements for validation and routine control of aseptic processes are specified in EN ISO 13408 1. Specific requirements for the aseptic processing of solid medical devices and combination products are specified in ISO 13408 7.

  Publication

Friday 17th of November 2017

  Reference

This standard superseed the "EN 556-2:2003".

Anyway is still possible use the "EN 556-2:2003" until June 30th, 2016

  Related Standards

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EN ISO 11737-2:2009

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Lasers and laser-related equipment - Test method and classification for the laser resistance of surgical drapes and/or patient pro...

EN ISO 11810-2:2009

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Lasers and laser-related equipment - Test method and classification for the laser-resistance of surgical drapes and/or patient-pro...

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