British Standards Institution

Source:: CEN
Committee:: CH/205 - Non-active medical devices
Categories:: Information management | Standardization. General rules | Measurement and Science | Metrology and measurement | Testing | Healthcare | Medical equipment | Medical equipment. General | Medical equipment. Other

Scope

This part of EN 455 specifies requirements for the evaluation of biological safety for medical gloves for single use. It gives requirements for labelling and the disclosure of information relevant to the test methods used.

Purpose

EN 455-3 has been published in 2015. In October 2016 a Draft Amendment (prA1) has been balloted to modify the Scope and the Labelling clause. The ballot was positive. However, due to not providing an updated Annex ZA the publication was blocked by CEN. It was therefore agreed in WG 3 "Medical gloves" to initiate a revision of EN 455-3 to include the modifications of the originally foreseen Amendment. To avoid further issues with the Annex ZA and the currently suspended harmonization process the project will be registered with no linkage to the MDD (running out in March 2020) or MDR (no standardization request available).

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

Standard timeline

1. Proposal

Proposal start date:

16/10/2019

Proposal end date:

25/11/2019

2. Draft

3. Public Comments

4. Comment Resolution

5. Approval

6. Publication

Learn more about the standards development process

Standards Development

Draft Decision 16-2019 - Revision of EN 455-3:2015 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation

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