BS EN 455-2:2015
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Medical gloves for single use Requirements and testing for physical properties
Hardcopy , PDF
08-05-2024
English
30-04-2015
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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.
| 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 |
Superseded
|
| SupersededBy | |
| Supersedes |
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.
| 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 |
| ONORM EN 455-2 : 2015 | 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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