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DIN EN 455-3

Medical gloves for single use - Part 3: Requirements and testing for biological evaluation

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Organization: DIN
Publication Date: 1 July 2015
Status: active
Page Count: 36
ICS Code (Hospital equipment): 11.140
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.

Document History

DIN EN 455-3/A1
November 1, 2016
Medical gloves for single use - Part 3: Requirements and testing for biological evaluation; German and English version EN 455-3:2015/prA1:2016
A description is not available for this item.
DIN EN 455-3
July 1, 2015
Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
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...
DIN EN 455-3
March 1, 2007
Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
A description is not available for this item.
DIN EN 455-3
February 1, 2000
Medical gloves for single use - Part 3: Requirements and testing for biological evaluation; English version of DIN EN 455-3
A description is not available for this item.

References

This document references:
DIN EN 1041 - Information supplied by the manufacturer of medical devices; German version EN 1041:2008+A1:2013
Published by DIN on December 1, 2013
Die vorliegende Europäische Norm legt Anforderungen an Informationen fest, die von einem Hersteller für Medizinprodukte nach der EU-Richtlinie 90/385/EWG zu aktiven implantierbaren medizinischen...
This document references:
DIN EN ISO 10993-1 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system (ISO 10993-1:2009); German version EN ISO 10993-1:2009
Published by DIN on April 1, 2010
A description is not available for this item.
This document references:
DIN EN ISO 10993-10 - Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
Published by DIN on October 1, 2014
This part of ISO 10993 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization. This...
This document references:
DIN EN ISO 10993-5 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009); German version EN ISO 10993-5:2009
Published by DIN on October 1, 2009
A description is not available for this item.
This document references:
DIN EN ISO 14971 - Medical devices - Application of risk management to medical devices (ISO 14971:2019)
Published by DIN on July 1, 2020
A description is not available for this item.
This document is referenced by:
DIN EN 16844 - Aesthetic medicine services - Non-surgical medical treatments (includes Amendment :2019)
Published by DIN on October 1, 2019
A description is not available for this item.
This document is referenced by:
DIN EN 16844 - Aesthetic medicine services - Non-surgical medical treatments; German version EN 16844:2017+A2:2019
Published by DIN on October 1, 2019
A description is not available for this item.
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