文档介绍：BRITISH STANDARD BS EN
1422:1998
Incorporating
Corrigendum No. 1
Sterilizers for medical
purposes — Ethylene
oxide sterilizers —
Requirements and test
methods
The European Standard EN 1422:1997 has the status of a
British Standard
ICS
Licensed Copy: Wang Wenwen, TUV Rheinland (Shanghai), Tue Sep 26 08:18:27 BST 2006, Uncontrolled Copy, (c) BSI
BS EN 1422:1998
National foreword
This British Standard is the English language version of EN 1422:1997,
including Corrigendum July 2002, published by the mittee for
Standardization (CEN). It partially supersedes the current provisions of
BS 3970-1:1990, which is subject to amendment.
The UK participation in its preparation was entrusted by mittee
LBI/35, Sterilizers, autoclaves and disinfectors, to mittee LBI/35/6,
Ethylene oxide sterilizers, which has the responsibility to:
— aid enquirers to understand the text;
— present to the responsible mittee any enquiries on the
interpretation, or proposals for change, and keep the UK interests
informed;
— monitor related international and European developments and
promulgate them in the UK.
A list anizations represented on mittee can be obtained on
request to its secretary.
Ethylene oxide sterilizers falling within the scope of this standard are
considered to be medical devices under Directive 93/42/EEC pliance
with the requirements of the standard is a means of ensuring that particular
essential requirements of the Directive are met (see Annex ZA of this
standard).
Attention is drawn to United Kingdom statutory requirements pertaining to
sterilizers and their use. Attention is also drawn to the guidance contained
within Health Technical Memorandum (HTM) 2010, published by the
Department of Health.
Cross-references
The British Standards which implement international or European
publications referred to