AS ISO 9360.1—2 9360.1—2003 003 ISO 9360-1:2000
A S I S O 9 3 6 0 . 1
Australian Standard ™ . m o c . l a b o l g i a s . e r o t s o f n i / / : p t t h t a n o i s r e v l l u f e h t s s e c c A . e l p m a s e g a p 7 e e r f a s i s i h T
Anaesthetic and respiratory equipment—Heat equipment—Heat and moisture exchangers (HMEs) for humidifying respired gases in humans Part 1: HMEs for use with minimum tidal volumes of 250 ml
This Australian Standard was prepared by Committee HE-019, Anaesthetic and Breathing Equipment. It was approved on behalf of the Council of Standards Australia on 21 May 2003 and published on 30 June 2003.
The following are represented on Committee HE-019: Australasian Society of Anaesthesia Paramedical Officers Australian Chamber of Commerce and Industry Australian College of Operating Room Nurses Australian Industry Group . m o c . l a b o l g i a s . e r o t s o f n i / / : p t t h t a n o i s r e v l l u f e h t s s e c c A . e l p m a s e g a p 7 e e r f a s i s i h T
Australian and New Zealand College of Anaesthetists Australian and New Z ealand Intensive Care Society Australian Society of Anaesthetists College of Biomedical Engineering Institution of Engineers Australia Commonwealth Department of Health and Ageing Department of Human Services (South Australia) Health Department of Western Australia Medical Industry Association of Australia Inc NSW Heal th Depart Dep art men t
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This Standard was issued in draft form for comment as DR 03170.
AS ISO 9360.1—2003
Australian Standard™ . m o c . l a b o l g i a s . e r o t s o f n i / / : p t t h t a n o i s r e v l l u f e h t s s e c c A . e l p m a s e g a p 7 e e r f a s i s i h T
Anaesthetic and respiratory equipment—Heat and moisture exchangers (HMEs) for humidifying humidifying respired gases in humans Part 1: 1: HMEs for for use use with minimum minimum tidal volumes of 250 ml
First published as AS ISO 9360.1—2003.
COPYRIGHT © Standards A ustralia Inte rnational All rights are reserved. No part of this work may be reproduced or copied in any form or by any means, electronic or mechanical, including photocopying, without the written permission of the publisher. Published by Standards Australia International Ltd GPO Box 5420, Sydney, NSW 2001, Australia ISBN 0 7337 5348 5
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PREFACE This Standard was prepared by the Australian members of the Joint Standards Australia/ Standards New Zealand Committee HE-019, Anaesthetic and Breathing Equipment. After consultation with stakeholders in both countries, Standards Australia and Standards New Zealand decided to develop this Standard as an Australian, rather than an Australian/ New Zealand Standard. This Standard is identical with and has been reproduced from ISO 9360-1:2000, Anaest Ana esthet hetic ic and respiratory equipment—Heat and moisture exchangers (HMEs) for humidifying respired gases in humans—Part 1: HMEs for use with minimum tidal volumes of 250 ml.
. m o c . l a b o l g i a s . e r o t s o f n i / / : p t t h t a n o i s r e v l l u f e h t s s e c c A . e l p m a s e g a p 7 e e r f a s i s i h T
The objective of this Standard is to specify certain requirements for heat and moisture exchangers, including those incorporating breathing system filters, intended for the humidification of respired gases for use primarily with patients with a tidal volume equal to or greater than 250 ml, and incorporating at least one machine port, and describes test methods for their evaluation. The terms ‘normative’ and ‘informative’ are used to define the application of the annex to which they apply. A normative annex is an integral part of a standard, whereas an informative annex is only for information and guidance. As this Standard is reproduced from an international Standard, the following applies: (a)
Its number does not appear on each page of text and its identity is shown only on the cover and title page.
(b)
In the source text ‘this International Standard’ should read ‘this Australian Standard’.
(c)
A full point substitutes for a comma when when referring to a decimal marker.
References to International Standards should be replaced by references to Australian or Australian/New Zealand Standards as follows: Refere Ref erence nce to Interna Int ernati tional onal Standa Sta ndard rd
Austral Aus tral ian Standar Sta ndard d
IEC
AS/NZS
60601 60601-1
Medical electrical equipment Part 1: General requirements for safety
3200 3200.1
Medical electrical equipment Part 1.0: General requirements for safety—Parent Standard
iii ii i
CONTENTS
Introduction ................................................................................................ ................................................................................................................................................................. .................................................................i v
. m o c . l a b o l g i a s . e r o t s o f n i / / : p t t h t a n o i s r e v l l u f e h t s s e c c A . e l p m a s e g a p 7 e e r f a s i s i h T
1
Scope ...... ........... ........... ............ ............ ............ ........... ........... ........... ........... ............ ........... ........... ........... ........... ............ ........... ........... ........... ........... ............ ........... .......... ........... ............ ............ ............ ...........1 .....1
2
Normative Normative references references ..... ........... ........... ........... ............ ............ ............ ............ ............ ........... ........... ........... ........... ........... ........... ........... ........... ............ ............ ............ ........... ........... ........... .......1 ..1
3
Terms and definitions definitions ..... ........... ............ ............ ............ ........... ........... ............ ........... ........... ............ ............ ............ ........... ........... ............ ........... ........... ........... ........... ............ ............ ...........1 .....1
4
Symbols Symbols and abbreviated abbreviated terms ...... ........... ........... ............ ........... ........... ............ ........... ........... ............ ............ ............ ........... ........... ............ ........... ........... ........... ........... ........... ......2 .2
5 5.1 5.2 5.3
General General requirements requirements and recommendati recommendations ons ...... ............ ............ ............ ........... ........... ............ ........... ........... ............ ............ ........... ........... ............ ........... .......... ......2 .2 HME patient patient port connecto connector...... r........... ........... ............ ........... ........... ............ ........... ........... ............ ........... ........... ............ ........... ........... ............ ............ ............ ........... ........... ........... ........2 ...2 Additional ports ................................................................................... .............................................................................................................................................2 ..........................................................2 Packaging Packaging of sterile sterile HME......... HME............... ........... ........... ........... ........... ........... ........... ............ ............ ............ ........... ........... ........... ........... ........... ........... ............ ........... ........... ............ ..........3 ....3
6 6.1 6.2 6.3 6.4 6.5
Test methods.... methods.......... ........... ........... ............ ............ ............ ........... ........... ........... ........... ............ ........... ........... ........... ........... ............ ........... ........... ........... ........... ............ ............ ............ ............ ...........3 .....3 General ................................................................. ........................................................................................................................................... ...........................................................................................3 .................3 Measurement Measurement of of moisture moisture loss........ loss.............. ........... ........... ............ ............ ............ ........... ........... ............ ........... ........... ............ ............ ............ ........... ........... ............ ............ ...........3 .....3 Measurement Measurement of pressure pressure drop..... drop ........... ........... ........... ............ ........... ........... ............ ........... ........... ............ ............ ............ ........... ........... ............ ........... .......... ........... ........... .......13 ..13 Test for gas leakage leakage ...... ............ ............ ............ ............ ........... ........... ........... ........... ........... ........... ........... ........... ............ ........... ........... ........... ........... ........... ........... ........... ........... ........... ........13 ...13 Test for complia compliance.......... nce................ ............ ............ ............ ........... ........... ........... ........... ............ ........... ........... ........... ........... ............ ........... ........... ........... ........... ........... ........... ........... ..........13 .....13
7
Marking Marking ...... ............ ............ ............ ........... ........... ........... ........... ........... ........... ........... ........... ............ ........... ........... ........... ........... ........... ........... ........... ........... ............ ........... ........... ........... ........... ........... .......15 ..15
Annex A (informative) Lists of parts and specification specifications s in Figures 1 and 2 ...... ........... ........... ............ ............ ............ ............ ............ ........... ........17 ...17 Annex B (informative) Rationale ........................................................................ ..............................................................................................................................18 ......................................................18
iv INTRODUCTION
The gases gases general generally ly availab available le for medical medical use lack lack suffici sufficient ent moisture moisture to be physiol physiologi ogicall cally y accepta acceptable ble to the respiratory tract of patients. Heat and moisture exchangers are used to raise the water content and the temperature of the gas delivered to the respiratory tract. They are primarily intended for use independently or as part of a breathing system.
. m o c . l a b o l g i a s . e r o t s o f n i / / : p t t h t a n o i s r e v l l u f e h t s s e c c A . e l p m a s e g a p 7 e e r f a s i s i h T
1
AUSTRALIAN STANDARD
Anaesthetic and respiratory equipment—Heat and moisture exchangers (HMEs) for humidifying respired gases in humans h umans Part 1: HMEs for use with minimum tidal volumes of 250 ml
. m o c . l a b o l g i a s . e r o t s o f n i / / : p t t h t a n o i s r e v l l u f e h t s s e c c A . e l p m a s e g a p 7 e e r f a s i s i h T
1
Scope
This part of ISO 9360 specifies certain requirements for heat and moisture exchangers (HMEs), including those incorp incorporat orating ing breathi breathing ng system system filter filters, s, intende intended d for the humidif humidifica icatio tion n of respir respired ed gases gases for use primari primarily ly with with patients with a tidal volume equal to or greater than 250 ml, and incorporating at least one machine port, and describes test methods for their evaluation.
2
Normat Normativ ive e refere reference nces s
The following normative documents documents contain contain provisions provisions which, through reference in this text, constitute constitute provisions of this part of ISO 9360. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this part of ISO 9360 are encouraged to investigate the possi possibi bili lity ty of apply applying ing the the most most recen recentt edit edition ions s of the the norma normati tive ve docu documen ments ts indic indicat ated ed below below.. For For undat undated ed references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards. ISO 4135: 1995, Anaesthesiology — Vocabulary. ISO 5356-1:1996, Anaesthetic Anaesthetic and respiratory equipment equipment — Conical connectors connectors — Part 1: Cones and sockets. ISO 5356-2:1987, Anaesthetic Anaesthetic and respiratory respiratory equipment — Conical Conical connectors connectors — Part 2: Screw-threaded Screw-threaded weight- bearing connectors. ISO 7000:1989, Graphical Graphical symbols for use on equipment equipment — Index and synopsis. ISO 11607, Packaging for terminally sterilized medical devices. IEC 60601-1:1988, Medical Medical electrical electrical equipment — Part 1: General requirements requirements for safety.
3
Terms Terms and defin definiti itions ons
For the purposes of this part of ISO 9360, the terms and definitions given in ISO 4135 and the following apply. 3.1 heat and moisture moisture exchanger HME device intended to retain a portion of the patient's expired moisture and heat, and return it to the respiratory tract during inspiration
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. m o c . l a b o l g i a s . e r o t s o f n i / / : p t t h t a n o i s r e v l l u f e h t s s e c c A . e l p m a s e g a p 7 e e r f a s i s i h T
AS ISO 9360.1-2003, Anaesthetic and respiratory respiratory equipment - Heat and mositure exchangers (HMEs) for humidifying respired gases in humans HMEs for use with minimum tidal volumes of 250 ml
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