Need help?

EN 455-1:2020+A2:2024 Standard

wave
Save  

  Keywords:

#order #testing #requirements #part #medical

  Directive

Medical devices Regulation ((EU) 2017/745)

  Last Official Journal reference

Thursday 11th of June 2026

  Description:

Medical gloves for single use - Part 1: Requirements and testing for freedom of holes

  Purpose

This document specifies requirements and gives the test method for medical gloves for single use in order to determine freedom from holes.

  Publication

Tuesday 8th of April 2025

  Amendment

This standard is an amendment for "EN 455-1:2020"

  Related Standards

EN ISO 10993-4:2017

Medical devices Regulation ((EU) 2017/745)

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)

EN ISO 13485:2016

Medical devices Regulation ((EU) 2017/745)

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

EN ISO 18562-4:2024

Medical devices Regulation ((EU) 2017/745)

Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate (ISO...

EN ISO 21535:2024

Medical devices Regulation ((EU) 2017/745)

Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:20...

EN ISO 21536:2024

Medical devices Regulation ((EU) 2017/745)

Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 21536:2...

EN ISO 80369-2:2024

Medical devices Regulation ((EU) 2017/745)

Small-bore connectors for liquids and gases in healthcare applications - Part 2: Connectors for respiratory applications (ISO 8036...

  Stay up to date

  ACCESS

Search for a standard
GO

Register

Already a member?
Login

  OTHER APPLICATIONS

If you are interested in DO160 tests, you can give a try to our other free of charge software:
CE-Marking assistant, Version: 1.3.0