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EU Autoclave Reg

EU Autoclave Reg

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Published by Chefi84
Autoclave Validation
Autoclave Validation

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Published by: Chefi84 on Oct 09, 2011
Copyright:Attribution Non-commercial


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Health Technical
Part 3 (Including Amendment 1): Validation andverification
London: HMSO
An Executive Agency of the Department of Health
© Crown copyright 1994. Published with permission of NHSEstates,an Executive Agency of the Department of Health,on behalf of the Controller of Her Majesty’s Stationery Office.Applications for reproduction should be made in writing toThe Copyright Unit, Her Majesty’s Stationery Office,St Clements House, 2–16 Colegate, Norwich NR3 1BQ.First published 1994Second impression 1995 (with amendments)Reprinted 1998ISBN 0-11-321746-3ii
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About thispublication
Health Technical Memoranda (HTMs)give comprehensive advice and guidance
on the design, installation and operationof specialised building and engineeringtechnology used in the delivery of
They are applicable to new and existing
sites, and are for use at various stages
during the inception, design,construction, refurbishment andmaintenance of a building.
Health Technical Memorandum 2010
HTM 2010 is being published in five
Part 1 -
Management policy
- is a
summary of the information requiredby non-technical personnelresponsible for the management of
sterilization services. It discusses the
various types of sterilizer, for both
clinical and laboratory use, and also
contains guidance on legal andpolicy matters, and on theappointment and responsibilities ofpersonnel. It should be read byanyone consulting this memorandum
for the first time;
Part 2 -
Design considerations
-contains information relevant to thespecification and installation of new
sterilizing equipment. It discusses the
requirements for each type ofsterilizer and outlines thespecifications to be included in anycontract. Practical considerations forthe installation of sterilizers arediscussed, including siting, heatemission, ventilation, noise andvibration, and mains services with an
emphasis on steam quality;
Part 3 -
Validation andverification
- covers all aspects ofvalidation and periodic testing of
sterilizers. It includes detailedschedules and procedures for tests
and checks to be carried out forcommissioning and performancequalification, and for subsequent
periodic testing;
Part 4 -
Operational management
covers all aspects of the routineoperation and maintenance of
sterilizers, stressing the need for a
planned maintenance programmealong with the type of records to bekept. Advice on the safe and efficient
operation of sterilizers is given, as

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