Need help?

EN 455-4:2009 Standard

wave
Save  

  Keywords:

#requirements #lot #designs #standard #european

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 5th of January 2022

  Description:

Medical gloves for single use - Part 4: Requirements and testing for shelf life determination

  Purpose

This part of EN 455 specifies requirements for shelf life for medical gloves for single use. It also specifies the requirements for labelling and the disclosure of information relevant to the test methods used. This European Standard applies to existing, new and significantly changed designs. Existing designs that do not currently have ageing data available should generate that data within a reasonable period of time. This European Standard does not specify the size of a lot. Attention is drawn to the difficulties that can be associated with the distribution and control of very large lots. The recommended maximum individual lot size for production is 500 000.

  Publication

Friday 17th of November 2017

  Related Standards

EN ISO 3826-4:2015

Medical devices Directive (93/42/EEC)

Plastics collapsible containers for human blood and blood components - Part 4: Aphaeresis blood bag systems with integrated featur...

EN 60522:1999

Medical devices Directive (93/42/EEC)

Determination of the permanent filtration of X-ray tube assembliesIEC 60522:1999

EN 60601-1-8:2007/AC:2010

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: Ge...

EN 60601-1-8:2007

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: Ge...

EN 60601-1-6:2010

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Us...

EN 60601-1-4:1996/A1:1999

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical sy...

  Stay up to date

CELAB is Notified Body No.2037 for the EMC Directive and Italian office of a Notified Body for the RED Directive.

CELAB performs voluntary inspection activities on technical construction files to check their contents.

CELAB can accomplish all the required tests in order to affix the CE-marking related to EMC, LVD, RED, MDD, machines and many others.

CLICK HERE TO GET TESTS AND INFO ON THE EN 455-4:2009 STANDARD

  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