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EN 556-2:2015 Standard

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  Keywords:

#medical #devices #aseptic #specified #iso

  Directive

Active implantable medical devices Directive (90/385/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 11137-1:2015/A2:2019

Active implantable medical devices Directive (90/385/EEC)

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a ster...

EN ISO 17665-1:2006

Active implantable medical devices Directive (90/385/EEC)

Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a...

EN ISO 13408-6:2011

Active implantable medical devices Directive (90/385/EEC)

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)

EN ISO 13408-7:2015

Active implantable medical devices Directive (90/385/EEC)

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

EN ISO 13485:2016

Active implantable medical devices Directive (90/385/EEC)

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

EN ISO 14155:2011

Active implantable medical devices Directive (90/385/EEC)

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)

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