PREN 455-2 : DRAFT 2013

Name: PREN 455-2 : DRAFT 2013
Brand: CEN

Superseded

View Superseded by

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

Superseded date

01-04-2015

Published date

19-06-2013

Publisher

Comite Europeen de Normalisation

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	TC 205
DocumentType	Draft
PublisherName	Comite Europeen de Normalisation
Status	Superseded
SupersededBy	EN 455-2:2015

Standards	Relationship
13/30281501 DC : 0	Identical
08/30176484 DC : DRAFT APR 2008	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