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

Tuesday 8th of April 2025

  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 11135:2014/A1:2019

Medical devices Regulation ((EU) 2017/745)

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a ste...

EN ISO 11737-1:2018

Medical devices Regulation ((EU) 2017/745)

Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on produ...

EN ISO 10993-10:2023

Medical devices Regulation ((EU) 2017/745)

Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)

EN 285:2015+A1:2021

Medical devices Regulation ((EU) 2017/745)

Sterilization - Steam sterilizers - Large sterilizers

EN ISO 10993-9:2021

Medical devices Regulation ((EU) 2017/745)

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation produc...

EN ISO 10993-12:2021

Medical devices Regulation ((EU) 2017/745)

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)

  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