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SFS-EN 455-3:en Withdrawn

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

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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.

The standards writing body responsible for this document in Finland is General Industry Federation.
Product group(s)
11.140 Hospital equipment »
Relationships
Normative references
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
EN ISO 10993-10:2013 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
EN ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)
Technical committee
CEN/TC 205 Non-active medical devices »
Directive
93/42/EEC Medical devices

http://ec.europa.eu »
Date of implementation
27.04.2015
Withdrawn
08.12.2023
Edition
3
Pages
35
Language(s)
English

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