DS/EN 455-4:2009

Medical gloves for single use - Part 4: Requirements and testing for shelf life determination


Status:
Current
Type:
Standard
Language:
EN
Subject:
Price from:
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Legislation:

Legislation

Harmonized under:
  • Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

Harmonized standards:
Links

Scope

for labelling and the disclosure of information relevant to the test methods used. This European Standard applies to existing, new and significantly changed designs. Existing designs that do not currently have ageing data available should generate that data within a reasonable period of time. 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.

Number of pages: 24

Published: 2009-10-06

Date of approval: 2009-10-01

International relationships: EN 455-4:2009 IDT

ICS: 11.140 - Hospital equipment

Item number: M219118



Committees

Committee

  • CEN/TC 205/WG 3

Danish committee

DS/S-447