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EN 556-2:2015 Standard

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  Keywords:

#medical #devices #aseptic #specified #iso

  This standard is no longer addressed in the last official Journal publication of the "2022-01-05 ". This standard is addressed for the last time in the official journal publication of the "2022-01-05"

  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 13408-7:2015

Medical devices Directive (93/42/EEC)

Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408...

EN ISO 18777:2009

Medical devices Directive (93/42/EEC)

Transportable liquid oxygen systems for medical use - Particular requirements (ISO 18777:2005)

EN ISO 15883-1:2009

Medical devices Directive (93/42/EEC)

Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006)

EN ISO 15883-2:2009

Medical devices Directive (93/42/EEC)

Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instrumen...

EN ISO 15883-3:2009

Medical devices Directive (93/42/EEC)

Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste contai...

EN 15986:2011

Medical devices Directive (93/42/EEC)

Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates

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