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1、 Reference number ISO 8835-2:2007(E) ISO 2007 INTERNATIONAL STANDARD ISO 8835-2 Third edition 2007-08-15 Inhalational anaesthesia systems Part 2: Anaesthetic breathing systems Systmes danesthsie par inhalation Partie 2: Systmes respiratoires danesthsie Copyright International Organization for Standa
2、rdization Provided by IHS under license with ISO Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 09/03/2007 01:19:48 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 8835-2:2007(E) PDF disclaimer This PDF file may contain embedded typefaces. In accor
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5、ing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. COPYRIGHT PROTECTED DOCUMENT ISO 2007 All rights reserved. Unless otherwise
6、 specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISOs member body in the country of the requester. ISO copyright off
7、ice Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2007 All rights reserved Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=IHS Employees/1
8、111111001, User=Wing, Bernie Not for Resale, 09/03/2007 01:19:48 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 8835-2:2007(E) ISO 2007 All rights reserved iii Contents Page Foreword. v Introduction. vi * 1 Scope . 1 2 Normative references. 1 3 Terms and definitions. 2
9、 4 General. 3 4.1 Materials 3 4.2 Anaesthetic breathing system component packaging. 3 4.3 Electrical requirements 3 4.4 Alternative test methods 4 5 Connection ports 4 5.1 Patient connection port 4 5.2 Y-Piece. 4 5.3 Exhaust connection port 4 5.4 Interchangeable non-rebreathing exhaust valves. 4 * 5
10、.5 Reservoir bag connection port 4 5.6 Anaesthetic ventilator connection port 5 5.7 Connection ports of interchangeable anaesthetic breathing system components. 5 * 5.8 Inspiratory and expiratory connection ports of an interchangeable circle absorber assembly 5 5.9 Other connection ports 5 6 Reservo
11、ir bag/anaesthetic ventilator selector switch. 5 7 Complete anaesthetic breathing system either supplied assembled or assembled in accordance with the manufacturers instructions 5 * 7.1 Leakage 5 * 7.2 Inspiratory and expiratory pressure/flow characteristics 6 8 Interchangeable anaesthetic breathing
12、 system components Exhaust valves 6 8.1 Direction of movement of controls. 6 8.2 Pressure/flow characteristics 6 8.3 Opening pressure. 6 8.4 Leakage 6 9 Circle absorber assemblies. 6 9.1 Construction 6 9.2 Absorbent bypass mechanism 7 9.3 Pressure/flow characteristics 7 9.4 Inspiratory and expirator
13、y valves . 7 10 Pressure monitoring and limitation 8 10.1 Pressure monitoring. 8 10.2 Pressure-limiting device 8 * 11 Location of components in an anaesthetic breathing system containing a circle absorber assembly (as defined in 3.3) 8 11.1 Exhaust valve 8 11.2 Reservoir bag connection port 8 11.3 F
14、resh gas inlet. 8 11.4 Inspiratory and expiratory valves . 8 12 Marking 9 Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 09/03/2007 01:19:48 MDTNo reproduction or networking permitte
15、d without license from IHS -,-,- ISO 8835-2:2007(E) iv ISO 2007 All rights reserved 12.1 Marking of complete anaesthetic breathing systems and anaesthetic breathing system components.9 12.2 Marking of packages.10 13 Information to be provided by the manufacturer or supplier.10 13.1 General.10 13.2 F
16、or anaesthetic breathing systems supplied complete10 13.3 For anaesthetic breathing system components11 Annex A (normative) Typical test arrangements and methods.13 Annex B (informative) Rationale .18 Annex C (informative) Environmental aspects20 Annex D (normative) Antistatic requirements.21 Biblio
17、graphy .22 Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 09/03/2007 01:19:48 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 8835-2:2007(E) ISO 2007 Al
18、l rights reserved v Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a s
19、ubject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission
20、(IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical comm
21、ittees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not
22、be held responsible for identifying any or all such patent rights. ISO 8835-2 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 1, Breathing attachments and anaesthetic machines. This third edition cancels and replaces the second edition (ISO 8835
23、-2:1999), which has been technically revised. ISO 8835 consists of the following parts, under the general title Inhalational anaesthesia systems: Part 2: Anaesthetic breathing systems Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems Part 4: Anaesthetic vapour deliv
24、ery devices Part 5: Anaesthetic ventilators Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 09/03/2007 01:19:48 MDTNo reproduction or networking permitted without license from IHS -,-
25、,- ISO 8835-2:2007(E) vi ISO 2007 All rights reserved Introduction An anaesthetic breathing system comprises an assembly of tubes and connectors and may include valves, a reservoir bag and a circle absorber assembly. Other items of equipment (e.g. humidifiers, filters, spirometers, thermometers, gas
26、 analysers) may be incorporated into an anaesthetic breathing system. Its function is to convey mixtures of gases to and from the patient. Annex A gives typical test arrangements and methods. Annex B gives the rationale for some of the requirements found within this part of ISO 8835. Annex B contain
27、s rationale statements for some of the requirements of this part of ISO 8835. The clauses and subclauses marked with an asterix (*) before their number have corresponding rationale contained in Annex B, included to provide additional insight into the reasoning that led to the requirements and recomm
28、endations that have been incorporated in this International Standard. Annex C lists the clauses of this part of ISO 8835 that address the environmental aspects of the device. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=IHS Employees/111111
29、1001, User=Wing, Bernie Not for Resale, 09/03/2007 01:19:48 MDTNo reproduction or networking permitted without license from IHS -,-,- INTERNATIONAL STANDARD ISO 8835-2:2007(E) ISO 2007 All rights reserved 1 Inhalational anaesthesia systems Part 2: Anaesthetic breathing systems * 1 Scope This part of
30、 ISO 8835 specifies requirements for anaesthetic breathing systems that are supplied either assembled by the manufacturer or for assembly by the user in accordance with the manufacturers instructions. It also covers circle absorber assemblies, exhaust valves, inspiratory and expiratory valves and, i
31、n some designs, those parts of an anaesthetic breathing system that are incorporated within an inhalation anaesthetic system, including the expiratory gas pathway of an anaesthetic ventilator. This part of ISO 8835 does not cover the performance of anaesthetic breathing systems regarding the elimina
32、tion of expired carbon dioxide since this is complex and depends on the interaction of the patient, the fresh gas flow, the carbon dioxide absorbent and the anaesthetic breathing system itself. This part of ISO 8835 does not apply to anaesthetic breathing systems intended for use with flammable anae
33、sthetic agents/gases as determined by Annex DD of IEC 60601-2-13:2003. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced
34、document (including any amendments) applies. ISO 594-2, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings ISO 2878:2005, Rubber Antistatic and conductive products Determination of electrical resistance ISO 4135, Anaesthetic and r
35、espiratory equipment Vocabulary ISO 5356-1, Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets ISO 5356-2, Anaesthetic and respiratory equipment Conical connectors Part 2: Screw-threaded weight- bearing connectors ISO 5362, Anaesthetic reservoir bags ISO 5367, Breathi
36、ng tubes intended for use with anaesthetic apparatus and ventilators ISO 7000:2004, Graphical symbols for use on equipment Index and synopsis IEC 60601-1, Medical electrical equipment Part 1: General requirements for basic safety and essential performance Copyright International Organization for Sta
37、ndardization Provided by IHS under license with ISO Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 09/03/2007 01:19:48 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 8835-2:2007(E) 2 ISO 2007 All rights reserved IEC 60601-1-2, Medical electrical e
38、quipment Part 1-2: General requirements for safety Collateral standard: Electromagnetic compatibility Requirements and tests IEC 60601-2-13:2003, Medical electrical equipment Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems 3 Terms and definitions Fo
39、r the purposes of this document, the terms and definitions given in ISO 4135 and IEC 60601-2-13 and the following apply. 3.1 anaesthetic breathing system ABS those inspiratory and expiratory pathways through which gas flows at respiratory pressure between the fresh gas inlet (3.6), the patient conne
40、ction port (3.9) and the exhaust valve (3.5) or exhaust port (3.4) 3.2 circle absorber assembly that part of a circle breathing system (3.3) which comprises one or more carbon-dioxide-absorbent containers, inspiratory and expiratory valves or other means of ensuring unidirectional gas flow, two port
41、s for connection to breathing tubes, a fresh gas inlet (3.6), a reservoir bag port and/or an anaesthetic ventilator port 3.3 circle breathing system anaesthetic breathing system (3.1) in which the direction of gas flow through inspiratory and expiratory pathways is unidirectional and in which the tw
42、o pathways form a circle 3.4 exhaust port that port through which waste gas(es) are discharged to the atmosphere or to an anaesthetic gas scavenging system (AGSS) 3.5 exhaust valve valve through which waste gas(es) are discharged to the atmosphere or to an AGSS NOTE Such a valve can or might not be
43、an adjustable pressure-limiting (APL) valve. 3.6 fresh gas inlet that port through which fresh gas is supplied to the anaesthetic breathing system (3.1) 3.7 interchangeable component operator-detachable anaesthetic breathing system component designed to be used with specified equipment from differen
44、t manufacturers 3.8 non-rebreathing exhaust valve exhaust valve (3.5) with three ports, namely an inlet port for connection to a breathing tube or ABS component, a patient connection port (3.9) and an exhaust port (3.4), the function of the valve being to prevent exhaled gas from re-entering the ana
45、esthetic breathing system (3.1) Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 09/03/2007 01:19:48 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 8835-
46、2:2007(E) ISO 2007 All rights reserved 3 3.9 patient connection port that port at the patient end of an anaesthetic breathing system (3.1) intended for connection to devices such as a tracheal or tracheostomy tube connector, or the connector to a face mask or supraglottic device 3.10 Y-piece three-w
47、ay connector with a patient connection port (3.9) and two ports for connection to breathing tubes 4 General 4.1 Materials All components of an anaesthetic breathing system shall be designed and manufactured in such a way as to reduce to a minimum the risks posed by substances leaching from them. Whe
48、n selecting materials for components of anaesthetic breathing systems, manufacturers should take particular care to ensure compatibility of the materials with the gases and anaesthetic agents with which they are intended to come into contact. 4.2 Anaesthetic breathing system component packaging Anaesthetic breathing system components shall be packaged in such a way as to minimize the risk of incomplete removal of the packaging before use. NOTE 1 This is to prevent