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BS EN 455-2:2015

Current
Current

The latest, up-to-date edition.

Medical gloves for single use Requirements and testing for physical properties
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

04-30-2015

Publisher

British Standards Institution

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.

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.

Committee
CH/205/3
DevelopmentNote
Together with BS EN 455-1 & BS EN 455-3 supersedes BS 4005(1996). Supersedes 99/566715 DC. (09/2005) Supersedes 08/30176484 DC. (11/2009) Supersedes 13/30281501 DC. (05/2015)
DocumentType
Standard
Pages
16
PublisherName
British Standards Institution
Status
Current
Supersedes

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

11/30234645 DC : 0 BS 8599-1 - WORKPLACE FIRST AID KITS - PART 1: SPECIFICATION FOR THE CONTENTS OF WORK PLACE FIRST AID KITS
BS 4005:1996 Specification for single use, sterilized surgical rubber gloves
BS 8599-2:2014 First aid kits Specification for the contents of motor vehicle first aid kits
BS 8599-1:2011 Workplace first aid kits Specification for the contents of workplace first aid kits
13/30284622 DC : 0 BS 8599-2 - MOTOR VEHICLE FIRST AID KITS - PART 2: SPECIFICATION FOR THE CONTENTS OF MOTOR VEHICLE FIRST AID KITS

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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