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CEN - EN 455-3

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

active, Most Current
Organization: CEN
Publication Date: 1 November 2023
Status: active
Page Count: 48
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

EN 455-3
November 1, 2023
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...
EN 455-3
April 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...
EN 455-3
December 1, 2006
Medical Gloves for Single Use - Part 3: Requirements and Testing for Biological Evaluation
A description is not available for this item.
EN 455-3
December 1, 1999
Medical Gloves for Single Use - Part 3: Requirements and Testing for Biological Evaluation
A description is not available for this item.

References

This document references:
EN ISO 10993-1 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Published by CEN on December 1, 2020
This document specifies: — the general principles governing the biological evaluation of medical devices within a risk management process; — the general categorization of medical devices based on the...
This document references:
EN ISO 15223-1 - Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
Published by CEN on September 1, 2021
This document specifies symbols used to express information supplied for a medical device. This document is applicable to symbols used in a broad spectrum of medical devices, that are available...
This document references:
EN ISO 21171 - Medical gloves Determination of removable surface powder
Published by CEN on May 1, 2006
A description is not available for this item.
This document is referenced by:
BS EN 13976-2 - Rescue systems - Transportation of incubators Part 2: System requirements
Published by BSI on July 31, 2018
A description is not available for this item.
This document is referenced by:
BS EN 13976-2 - TC - Tracked Changes (Redline) - Rescue systems - Transportation of incubators Part 2: System requirements
Published by BSI on February 25, 2020
A description is not available for this item.
This document is referenced by:
BS EN 16844 + A2 - TC - Tracked Changes (Redline) - Aesthetic medicine services - Non‑surgical medical treatments
Published by BSI on November 12, 2020
A description is not available for this item.
This document is referenced by:
BS EN 16844 - Aesthetic medicine services - Non-surgical medical treatments
Published by BSI on July 31, 2017
A description is not available for this item.
This document is referenced by:
14644-18 - Cleanrooms and associated controlled environments — Part 18: Assessment of suitability of consumables
Published by ISO on October 1, 2023
This document gives guidance for assessing personal and non-personal consumables for their appropriate use in cleanrooms, clean zones or controlled zones, based on product and process requirements,...
This document is referenced by:
BS EN ISO 14644-18 - Cleanrooms and associated controlled environments Part 18: Assessment of suitability of consumables
Published by BSI on November 30, 2023
A description is not available for this item.
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