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I.S. EN 455-2:2015

Current

Current

The latest, up-to-date edition.

MEDICAL GLOVES FOR SINGLE USE - PART 2: REQUIREMENTS AND TESTING FOR PHYSICAL PROPERTIES

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2015

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Dimensions
5 Strength
6 Test report
7 Labelling
Annex ZA (informative) - Relationship between this
         European Standard and the Essential
         Requirements of EU Directive 93/42/EEC
         concerning medical devices

Defines 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.

DocumentType
Standard
Pages
14
PublisherName
National Standards Authority of Ireland
Status
Current

Standards Relationship
NF EN 455-2 : 2010 + A2 2013 Identical
NBN EN 455-2 : 2015 Identical
NEN EN 455-2 : 2015 Identical
NS-EN 455-2:2015 Identical
SN EN 455-2:2015 Identical
UNI EN 455-2 : 2013 Identical
BS EN 455-2:2015 Identical
UNE-EN 455-2:2015 Identical
EN 455-2:2015 Identical
DIN EN 455-2:2015-07 Identical

ISO 23529:2016 Rubber General procedures for preparing and conditioning test pieces for physical test methods
EN 455-4:2009 Medical gloves for single use - Part 4: Requirements and testing for shelf life determination
ISO 188:2011 Rubber, vulcanized or thermoplastic — Accelerated ageing and heat resistance tests
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements

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