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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 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 ISO 14602:2011

Medical devices Directive (93/42/EEC)

Non-active surgical implants - Implants for osteosynthesis - Particular requirements (ISO 14602:2010)

EN ISO 11137-2:2015

Medical devices Directive (93/42/EEC)

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

EN ISO 12870:2009

Medical devices Directive (93/42/EEC)

Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO 12870:2004)

EN ISO 11990-2:2014

Medical devices Directive (93/42/EEC)

Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 2: Tracheal tube cuffs (ISO 11990-...

EN ISO 11990-1:2014

Medical devices Directive (93/42/EEC)

Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 1: Tracheal tube shaft (ISO 11990-...

EN ISO 11979-8:2009

Medical devices Directive (93/42/EEC)

Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2006)

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