BS ISO 18835-2015 Inhalational anaesthesia systems Draw-over anaesthetic systems《吸入式麻醉剂系统 气流抽吸型麻醉系统》.pdf

1、BSI Standards PublicationBS ISO 18835:2015Inhalational anaesthesiasystems Draw-overanaesthetic systemsBS ISO 18835:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of ISO 18835:2015. Itsupersedes DD ISO/TS 18835:2004 which is withdrawn.The UK participation in its

2、preparation was entrusted to TechnicalCommittee CH/121/1, Breathing attachments and anaestheticmachines.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are r

3、esponsible for its correctapplication. The British Standards Institution 2015. Published by BSI StandardsLimited 2015ISBN 978 0 580 80893 7ICS 11.040.10Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStanda

4、rds Policy and Strategy Committee on 30 April 2015.Amendments issued since publicationDate Text affectedBS ISO 18835:2015 ISO 2015Inhalational anaesthesia systems Draw-over anaesthetic systemsSystmes danesthsie par inhalation Alimentation en vapeur et quipements annexesINTERNATIONAL STANDARDISO18835

5、First edition2015-04-01Reference numberISO 18835:2015(E)BS ISO 18835:2015ISO 18835:2015(E)ii ISO 2015 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2015All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any mea

6、ns, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below or ISOs member body in the country of the requester.ISO copyright officeCase postale 56 CH-1211 Geneva 2

7、0Tel. + 41 22 749 01 11Fax + 41 22 749 09 47E-mail copyrightiso.orgWeb www.iso.orgPublished in SwitzerlandBS ISO 18835:2015ISO 18835:2015(E)Foreword ivIntroduction v1 * Scope . 12 Normative references 13 Terms and definitions . 14 General requirements . 24.1 Risk management . 24.2 Construction 34.3

8、Performance 44.4 * Components for use with flammable anaesthetic agents 44.5 Materials . 44.6 Mechanical hazards . 44.7 Particulate matter. 44.8 Environmental requirements . 45 Draw-over vaporizer 55.1 Construction 55.2 Performance 55.3 * Ports and connectors . 66 Breathing system 66.1 Construction

9、66.2 Performance 76.3 Ports and connectors . 77 Reservoir 77.1 Construction 77.2 Performance 77.3 Ports and connectors . 88 Bellows-type manual ventilator . 88.1 * Construction 88.2 Performance 88.3 Ports and connectors . 99 Marking of operator-assembled components 99.1 General . 99.2 Marking of the

10、 draw-over vaporizer . 99.3 Marking of breathing-system attachments . 109.4 Marking of reservoir 109.5 Marking of bellows-type manual ventilator . 109.6 Marking of packages 1110 Information supplied by the manufacturer 11Annex A (informative) Rationale .13Annex B (normative) Test methods 15Annex C (

11、informative) Environmental aspects .17Annex D (informative) Reference to the essential principles 18Bibliography .22 ISO 2015 All rights reserved iiiContents PageBS ISO 18835:2015ISO 18835:2015(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national s

12、tandards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International

13、organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.The procedures used to develop this document and those intended for

14、its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/

15、directives).Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in

16、 the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions rel

17、ated to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT), see the following URL: Foreword Supplementary information .This International Standard cancels and replaces ISO/TS 18835:2004, which has been technically revised

18、.iv ISO 2015 All rights reservedBS ISO 18835:2015ISO 18835:2015(E)IntroductionThe continuous-flow anaesthetic workstations described in ISO 80601-2-13 rely upon an uninterrupted supply of compressed medical gases and electricity. These in turn depend upon a highly developed infrastructure of transpo

19、rt, power generation, and technical services.The World Health Organization (WHO) and the World Federation of Societies of Anaesthesiologists (WFSA) have requested ISO ensure that the needs for safe anaesthesia for people in populous and low to middle income countries of the world are also addressed

20、in ISO standards for anaesthetic equipment.In accordance with this request, ISO/TC 121/SC 1 has developed a standard for anaesthetic systems (ISO 8835-7) that can give a safe inhalation anaesthetic without relying on electricity or compressed gas.To achieve this, it is recognized that the draw-over

21、anaesthetic system is an essential part of this system. A technical specification for draw-over vaporizers and associated equipment, ISO/TS 18835 has been in publication since 2004 and forms the basis of this International Standard.Throughout this International Standard, text for which a rationale i

22、s provided in Annex A is indicated by an asterisk (*).In this International Standard, the following print types are used: requirements, compliance with which can be verified, and definitions: roman type; notes and examples: smaller roman type; test methods: italic type; terms defined in this documen

23、t: small caps. ISO 2015 All rights reserved vBS ISO 18835:2015BS ISO 18835:2015Inhalational anaesthesia systems Draw-over anaesthetic systems1 * ScopeThis International Standard specifies basic safety and essential performance requirements for anaesthetic systems utilizing the draw-over method to pr

24、ovide inhalational anaesthesia.Requirements are included to allow the use of these systems with both non-flammable and flammable anaesthetic agents.This International Standard also includes requirements for a bellows-type manual ventilator.NOTE 1 Requirements for automatic anaesthetic ventilators ar

25、e covered by ISO 80601-2-13.NOTE 2 Requirements for operator-powered self-inflating bags are covered by ISO 10651-4.This International Standard does not specify requirements for monitoring of the equipment or the patient.2 Normative referencesThe following documents, in whole or in part, are normati

26、vely referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 4135:2001, Anaesthetic and respiratory equipment VocabularyIS

27、O 5356-1, Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and socketsISO 5356-2, Anaesthetic and respiratory equipment Conical connectors Part 2: Screw-threaded weight-bearing connectorsISO 5360, Anaesthetic vaporizers Agent-specific filling systemsISO 5367, Anaesthetic and re

28、spiratory equipment Breathing sets and connectorsISO 14971, Medical devices Application of risk management to medical devicesISO 23328-1, Breathing system filters for anaesthetic and respiratory use Part 1: Salt test method to assess filtration performanceISO 23328-2, Breathing system filters for an

29、aesthetic and respiratory use Part 2: Non-filtration aspectsISO 80369-71), Small bore connectors for liquids and gases in healthcare applications Part 7: Connectors with 6% (Luer) taper for intravascular or hypodermic applicationsIEC 60601-1:2005+A1:2012, Medical electrical equipment Part 1: General

30、 requirements for basic safety and essential performanceEN 13544-2:2002+A1:2009, Respiratory therapy equipment Part 2: Tubing and connectors3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 4135:2001 and the following apply.1) This reference will be rep

31、laced by ISO 80369-2 once this International Standard has been published.INTERNATIONAL STANDARD ISO 18835:2015(E) ISO 2015 All rights reserved 1BS ISO 18835:2015ISO 18835:2015(E)3.1carrier gasrespirable gas that carries the anaesthetic agent to the patientNote 1 to entry: A common example of a carri

32、er gas is entrained ambient air supplemented with oxygen.3.2draw-over anaesthetic systemlow-resistance system for administering inhalational anaesthesia that can be used in the absence of compressed gas or electricity3.3draw-over valve systema valve, or combination of valves, that controls unidirect

33、ional flow to the patient during inspiration and unidirectional flow from the patient during exhalation under both spontaneous ventilation and intermittent positive pressure ventilation (IPPV)3.4draw-over vaporizervaporizer from which a sufficient flow of gas vapour mixture is produced by lowering t

34、he pressure at the outlet of the vaporizer below that at its inlet by a patients inspiratory effort or by a ventilatorSOURCE: ISO 4135:2001, 4.1.8, modified the breathing system and the vaporizer are treated as separate devices in this International Standard, and thus, the phrase “either in the brea

35、thing system and the vaporizer,” as used in ISO 4135, is inappropriate in this International Standard3.5exhaust portport through which the patient exhales to the atmosphere or into the inlet port of an anaesthetic gas scavenging transfer systemSOURCE: ISO 4135:2001, 4.2.1.6, modified in order to be

36、more specific as the exhaust port is an integral part of the draw-over valve system3.6operator-detachabledetachable without the use of a tool3.7patient connection portopening at the patient end of a breathing system intended for connection of an airway deviceSOURCE: ISO 4135:2001, 4.2.1.2, modified

37、the examples that were not considered necessary for this International Standard have been deleted3.8reservoircontainer where the carrier gas mixes with supplementary oxygen4 General requirements4.1 Risk managementThe manufacturer of a draw-over anaesthetic system or parts intended for use in a draw-

38、over anaesthetic system shall follow a risk management process in accordance with ISO 14971. Any unacceptable risk shall be mitigated by in this order:a) design features which prevent the hazard;b) inclusion of a means of protection;2 ISO 2015 All rights reservedBS ISO 18835:2015ISO 18835:2015(E)c)

39、inclusion of a monitoring and/or an alarm system;d) safety and handling advice by marking or labelling.If the inclusion of such risk mitigation measures is not feasible, the instructions for use shall contain a statement recommending that such risk mitigation measures be added prior to the use of th

40、e draw-over anaesthetic system, sufficient specification of such risk mitigation measures, and a description of any residual risk to the patient or user/bystander.Check compliance by inspection of the risk management file and, if applicable, the instructions for use.4.2 ConstructionA draw-over anaes

41、thetic system shall comprise a draw-over vaporizer and a breathing system. It can also include a ventilator and a reservoir if oxygen is to be added to the carrier gas.NOTE An example of a draw-over anaesthetic system is shown in Figure 1.Key1 ambient air inlet 8 ventilator2 means of particle protec

42、tion 9 part of draw-over valve system3 supplementary oxygen inlet 10 flow to and from patient4 reservoir 11 exhaust port5 draw-over vaporizer 12 direction of flow6 breathing system tubing 13 pressure relief valve7 part of draw-over valve systemFigure 1 Schematic representation of the components of a

43、 draw-over anaesthetic system ISO 2015 All rights reserved 3BS ISO 18835:2015ISO 18835:2015(E)4.3 PerformanceThe resistance to inspiration for the draw-over anaesthetic system shall not exceed 0,6 kPa and the resistance to expiration shall not exceed 0,2 kPa under the following conditions:a) a tidal

44、 volume of (600 60) ml;b) a frequency of 12 cycles per minute;c) using a sinusoidal wave form or at an I:E ratio of 1:1.Check compliance by the test given in B.3.4.4 * Components for use with flammable anaesthetic agentsAll components intended to be used with flammable anaesthetic agents shall compl

45、y with the applicable requirements of IEC 60601-1:2005+A1:2012, 11.4.Check compliance by inspection of the technical file.4.5 MaterialsThe materials from which all components are made shall be selected to take into account the chemical and physical properties of any substances with which the manufac

46、turer declares that they may come into contact with during use.The selection procedures used for materials shall be documented and retained by the manufacturer.NOTE draw-over anaesthetic systems have been used in areas where “normal” cleaning materials are not available and many corrosive and abrasi

47、ve materials have been substituted as cleaners. Water has also been used to flush out draw-over vaporizers after use.Check compliance by inspection of the technical file.4.6 Mechanical hazardsDraw-over anaesthetic systems shall comply with IEC 60601-1:2005+A1:2012, Clause 9, where applicable.Check c

48、ompliance by inspection of the technical file and the tests given in IEC 60601-1:2005+A1:2012.4.7 Particulate matterMeans shall be provided to reduce the risk of particulate matter from entering the draw-over anaesthetic system and being inhaled by the patient.NOTE Particulate matter can be taken to

49、 mean any foreign bodies including small creatures.If a breathing system filter is used, it shall comply with ISO 23328-1 and ISO 23328-2.Check compliance by visual inspection.4.8 Environmental requirementsDraw over anaesthetic systems and components thereof shall not be adversely affected when transported and stored under the following environmental conditions:a) ambient temperatures between 20 C and +70C;b) relative humidity between 30 % and 100 %;c) atmospheric pressures between 500 hPa and 10