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SFS-EN 455-2:en

Medical gloves for single use. Part 2: Requirements and testing for physical properties

Publication can be downloaded immediately Publication will be delivered the day after the order is submitted Delivery time 3 - 5 working days
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Scope
This European Standard specifies requirements and gives test methods for physical properties of single-use medical gloves (i.e. surgical gloves and examination/procedure gloves) in order to ensure that they provide and maintain in use an adequate level of protection from cross contamination for both patient and user. 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.

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 455-4:2009 Medical gloves for single use - Part 4: Requirements and testing for shelf life determination
EN ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2012)
Technical committee
CEN/TC 205 Non-active medical devices »
Directive
93/42/EEC Medical devices

http://ec.europa.eu »
Date of implementation
15.06.2015
Published
03.07.2015
Edition
5
Pages
12
Language(s)
English

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