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EN 556-2:2015 Standard

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  Keywords:

#medical #devices #requirements #device #requirements

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  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 455-1:2000

Medical devices Directive (93/42/EEC)

Medical gloves for single use - Part 1: Requirements and testing for freedom from holes

EN 455-3:2006

Medical devices Directive (93/42/EEC)

Medical gloves for single use - Part 3: Requirements and testing for biological evaluation

EN 455-4:2009

Medical devices Directive (93/42/EEC)

Medical gloves for single use - Part 4: Requirements and testing for shelf life determination

EN 556-1:2001

Medical devices Directive (93/42/EEC)

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminal...

EN 556-1:2001/AC:2006

Medical devices Directive (93/42/EEC)

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminal...

EN 1041:2008

Medical devices Directive (93/42/EEC)

Information supplied by the manufacturer of medical devices

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