British Standards Institution

Source:: CEN
Committee:: CH/198 - Sterilization and Associated Equipment and Processes
Categories:: Information management | Standardization. General rules | Healthcare | Medical equipment | Sterilization and disinfection | Sterilizing equipment

Scope

This European Standard specifies the requirements for a terminally-sterilized medical device to be designated “STERILE”. Part 2 of this European Standard specifies the requirements for an aseptically processed medical device to be designated “STERILE”.

Purpose

EN 556-1: 2001:AC 2006 “Sterilization of medical devices. Requirements for medical devices to be designated "STERILE" - Requirements for terminally sterilized medical devices” is the standard that specifies the requirements for a terminally sterilized medical device to be designated “STERILE”. The current version of the standard is harmonised under three European Directives pertaining to active implantable medical devices, medical devices and in vitro diagnostic medical devices. These Directives have been replaced by two regulations covering medical devices (MDR (EU) 2017/745) and in vitro diagnostic medical devices (IVDR (EU) 2017/746). The standardization request for the MDR and IVDR ( M/575 of 14.4.2021) has been accepted by CEN. The deadline for adoption of the new or amended standards in the standardization request is 27 May 2024. EN 556-1 does not require technical change but needs new Annex Zs to show the relationship between the standard and the requirements of the European regulations. In addition, there are some editorial updates that have been identified in systematic review that can be implemented.

Therefore, CEN TC204 needs to add this standard to its work programme.

Comment on proposal

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Please email further comments to: debbie.stead@bsigroup.com

Standard timeline

1. Proposal

Proposal start date:

21/03/2022

Proposal end date:

27/04/2022

2. Draft

3. Public Comments

4. Comment Resolution

5. Approval

6. Publication

Learn more about the standards development process

Standards Development

CEN/TC 204 N 764, BS EN 556-1;2001 Sterilization of medical devices. Requirements for medical devices to be designated “STERILE". Requirements for terminally sterilized medical devices

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