EN 455-2:2009/FprA1

Medical gloves for single use - Part 2: Requirements and testing for physical properties EN 455-2:2009/FprA1

General information

50.60 Close of voting. Proof returned by secretariat   Dec 2, 2010

CEN

CEN/TC 205 Non-active medical devices

European Norm

11.140   Hospital equipment

Scope

This Amendment provides an updated Table 3 "The median values of force at break" to minimize the possible interpretation and misunderstandings regarding the values given in the appropriate table of EN 455-2:2009.

Scope of the mother text:
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 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.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Life cycle

PREVIOUSLY

WITHDRAWN
EN 455-2:2009

NOW

IN_DEVELOPMENT
EN 455-2:2009/FprA1
50.60 Close of voting. Proof returned by secretariat
Dec 2, 2010