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Licensed copy: University of Auckland Library, University of Auckland Library, Version correct as of 21/05/2012 10:33, (c) The British Standards Institution 2012

BRITISH STANDARD

Medical gloves for single
use Ð
Part 1: Requirements and testing for
freedom from holes

The European Standard EN 455-1:2000 has the status of a
British Standard

ICS 11.140

NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW

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BS EN
455-1:2000


Licensed copy: University of Auckland Library, University of Auckland Library, Version correct as of 21/05/2012 10:33, (c) The British Standards Institution 2012


BS EN 455-1:2000

National foreword
This British Standard is the official English language version of EN 455-1:2000.
It supersedes BS EN 455-1:1994 which is withdrawn.
The UK participation in its preparation was entrusted to Technical Committee CH/6,
Rubber products for hospital use, which has the responsibility to:
Ð aid enquirers to understand the text;
Ð present to the responsible European committee any enquiries on the
interpretation, or proposals for change, and keep the UK interests informed;
Ð monitor related international and European developments and promulgate
them in the UK.
A list of organizations represented on this committee can be obtained on request to
its secretary.
Cross-references
The British Standards which implement international or European publications
referred to in this document may be found in the BSI Standards Catalogue under the
section entitled ªInternational Standards Correspondence Indexº, or by using the
ªFindº facility of the BSI Standards Electronic Catalogue.
A British Standard does not purport to include all the necessary provisions of a
contract. Users of British Standards are responsible for their correct application.
Compliance with a British Standard does not of itself confer immunity
from legal obligations.

Summary of pages
This document comprises a front cover, an inside front cover, the EN title page,
pages 2 to 5 and a back cover.
The BSI copyright notice displayed in this document indicates when the document
was last issued.


This British Standard, having
been prepared under the
direction of the Health and
Environment Sector Committee,
was published under the
authority of the Standards
Committee and comes into effect
on 15 December 2000
 BSI 12-2000

ISBN 0 580 36697 9

Amendments issued since publication
Amd. No.

Date

Comments


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Licensed copy: University of Auckland Library, University of Auckland Library, Version correct as of 21/05/2012 10:33, (c) The British Standards Institution 2012

BS EN
455-1:2000

BSI

389 Chiswick High Road
London
W4 4AL

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