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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

Wednesday 5th of January 2022

  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 supersedes the "EN 556-2:2003"

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

  Related Standards

EN ISO 10651-4:2009

Medical devices Directive (93/42/EEC)

Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002)

EN ISO 10993-4:2009

Medical devices Directive (93/42/EEC)

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd...

EN ISO 10555-1:2009

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Sterile, single-use intravascular catheters - Part 1: General requirements (ISO 10555-1:1995, including Amd 1:1999 and Amd 2:2004)

EN ISO 10651-2:2009

Medical devices Directive (93/42/EEC)

Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilat...

EN 60601-1-8:2007/A11:2017

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: Ge...

EN ISO 10651-6:2009

Medical devices Directive (93/42/EEC)

Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6: Home-care ventilat...

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