BS ISO 18190-2016 Anaesthetic and respiratory equipment General requirements for airways and related equipment《麻醉和呼吸器 气道和相关设备的通用要求》.pdf

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1、BS ISO 18190:2016Anaesthetic and respiratoryequipment Generalrequirements for airways andrelated equipmentBSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS ISO 18190:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of ISO 18190:20

2、16.The UK participation in its preparation was entrusted to TechnicalCommittee CH/121/5, Airways and related equipment.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 contra

3、ct. Users are responsible for its correctapplication. The British Standards Institution 2016.Published by BSI Standards Limited 2016ISBN 978 0 580 82535 4ICS 11.040.10Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authori

4、ty of theStandards Policy and Strategy Committee on 31 October 2016.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dBS ISO 18190:2016 ISO 2016Anaesthetic and respiratory equipment General requirements for airways and related equipmentMatriel danesthsie et de ranimation resp

5、iratoire Exigences gnrales pour canules et quipement connexe INTERNATIONAL STANDARDISO18190First edition2016-11-01Reference numberISO 18190:2016(E)BS ISO 18190:2016ISO 18190:2016(E)ii ISO 2016 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2016, Published in SwitzerlandAll rights reserved. Unle

6、ss otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, 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 a

7、ddress below or ISOs member body in the country of the requester.ISO copyright officeCh. de Blandonnet 8 CP 401CH-1214 Vernier, Geneva, SwitzerlandTel. +41 22 749 01 11Fax +41 22 749 09 47copyrightiso.orgwww.iso.orgBS ISO 18190:2016ISO 18190:2016(E)Foreword ivIntroduction v1 Scope . 12 Normative ref

8、erences 13 Terms and definitions . 24 General requirements for airways and related equipment 34.1 * Risk management 34.2 Usability 34.3 Clinical evaluation 44.4 Biophysical or modelling research 45 Materials . 45.1 Biological safety testing . 45.2 Intended use and environmental conditions 45.3 Leach

9、ing 45.4 Cleaning, disinfecting or sterilizing agents . 45.5 Phthalates 55.6 Natural rubber (latex) 55.7 Gas compatibility 55.8 * Durability of marking 65.9 Resistance to deterioration 65.10 Magnetic resonance imaging (MRI) compatibility . 66 Design requirements for airways and related equipment . 6

10、6.1 Mechanical safety 66.2 Medical electrical equipment safety . 76.3 Pneumatic safety . 76.4 Protection against inadvertent adjustments . 76.5 * Prevention of electrostatic charges . 76.6 Device lifetime . 77 Requirements for airways and related equipment supplied sterile 87.1 Sterility assurance 8

11、8 Packaging . 89 Information supplied by the manufacturer . 89.1 Marking . 89.1.1 General 89.1.2 Marking on controls and instruments 109.2 Instructions for use 10Annex A (informative) Rationale .13Annex B (informative) Hazard identification for risk assessment .16Bibliography .21 ISO 2016 All rights

12、 reserved iiiContents PageBS ISO 18190:2016ISO 18190:2016(E)ForewordISO (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 committ

13、ees. 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 organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the Int

14、ernational Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the di

15、fferent 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/directives).Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO sh

16、all 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 the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).Any trade name used in this document

17、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 related to conformity assessment, as well as information about ISOs adherence to the World Trade Organization (WTO) principles in the Techn

18、ical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.The committee responsible for this document is ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 2, Airways and related equipment.iv ISO 2016 All rights reservedBS ISO 18190:2016ISO 18190:2016(E)Introd

19、uctionThis International Standard provides the general requirements for basic safety and performance for the design, packaging, marking and labelling that are generally applicable to all airways and related equipment.This International Standard is intended to replace or supplement the often, repetit

20、ive general requirements that are common among the set of standards within the category of airways and related equipment. The aim of this International Standard is to serve as a central catalogue of these common requirements, allowing each device-specific standard to more concisely focus on the uniq

21、ue safety and essential requirements for the equipment.For certain types of airways and related equipment, these general requirements are either supplemented or modified by the specific requirements of a device-specific standard. Where device-specific standards exist, this International Standard sho

22、uld not be used alone.For the purposes of clarity, the following conventions have been used: defined terms appear in small caps type; clauses/subclauses for which a rationale is provided in Annex A is indicated by an asterisk (*); compliance checks are given in italics type. ISO 2016 All rights rese

23、rved vBS ISO 18190:2016BS ISO 18190:2016Anaesthetic and respiratory equipment General requirements for airways and related equipment1 ScopeThis International Standard specifies the general requirements common to airways and related equipment and applicable to those device-specific standards that ref

24、erence it.The requirements of a device-specific standard take priority over this International Standard.NOTE General requirements contained in this International Standard have historically been referenced in more than two other airways and related equipment standards.2 Normative referencesThe follow

25、ing documents, in whole or in part, are normatively 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.NOTE See Annex A f

26、or information on the use of dated and undated normative references.ISO 7396-1, Medical gas pipeline systems Part 1: Pipeline systems for compressed medical gases and vacuumISO 10524-1, Pressure regulators for use with medical gases Part 1: Pressure regulators and pressure regulators with flow-meter

27、ing devicesISO 10524-3, Pressure regulators for use with medical gases Part 3: Pressure regulators integrated with cylinder valvesISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management processISO 11135, Sterilization of health-care products Ethy

28、lene oxide Requirements for development, validation and routine control of a sterilization process for medical devicesISO 11137-1:2006/Amd.1:2013, Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medic

29、al devices/Amendment 1ISO 14155:2011/Cor.1:2011, Clinical investigation of medical devices for human subjects Good clinical practice/Technical Corrigendum 1ISO 15001:2010, Anaesthetic and respiratory equipment Compatibility with oxygenISO 80369-71), Small-bore connectors for liquids and gases in hea

30、lthcare applications Part 7: Connectors for intravascular or hypodermic applicationsIEC 60601-1:2005, Medical electrical equipment Part 1: General requirements for basic safety and essential performanceIEC 60601-1-2, Medical electrical equipment Part 1-2: General requirements for basic safety and es

31、sential performance Collateral standard: Electromagnetic compatibility Requirements and testsIEC 60601-1-8:2006, Medical electrical equipment Part 1-8: General requirements for basic safety and essential performance Collateral standard: General requirements, tests and guidance for alarm systems in m

32、edical electrical equipment and medical electrical systems1) To be published.INTERNATIONAL STANDARD ISO 18190:2016(E) ISO 2016 All rights reserved 1BS ISO 18190:2016ISO 18190:2016(E)EN 556-1:2001, Sterilization of medical devices Requirements for medical devices to be designated “STERILE” Part 1: Re

33、quirements for terminally sterilized medical devicesEN 1041, Information supplied by the manufacturer of medical devicesASTM F640, Standard test methods for determining radiopacity for medical useASTM F2052, Standard test method for measurement of magnetically induced displacement force on medical d

34、evices in the magnetic resonance environmentASTM F2213, Standard test method for measurement of magnetically induced torque on medical devices in the magnetic resonance environmentASTM F2503, Standard practice for marking medical devices and other items for safety in the magnetic resonance environme

35、nt3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.3.1airways and related equipmentdevices that provide an interface to the patients airways, either through direct contact, or as an intermediate component to other anaesthetic and respiratory equipme

36、nt3.2antistaticproperty of material or a procedure that disperses or inhibits the accumulation of electrostatic charges3.3riskcombination of the probability of occurrence of harm and the severity of that harmSOURCE: ISO 14971:2007, 2.163.4risk analysissystematic use of available information to ident

37、ify hazards and to estimate the risk (3.3)SOURCE: ISO 14971:2007, 2.17, modifiedNote 1 to entry: Risk analysis includes examination of different sequences of events that can produce hazardous situations and harm (see Annex B and ISO 14971:2007, Clause 4).3.5risk assessmentoverall process comprising

38、a risk analysis (3.4) and a risk evaluation (3.6)SOURCE: ISO 14971:2007, 2 .183.6risk evaluationprocess of comparing the estimated risk (3.3) against given risk criteria to determine the acceptability of the riskSOURCE: ISO 14971:2007, 2 . 212 ISO 2016 All rights reservedBS ISO 18190:2016ISO 18190:2

39、016(E)3.7risk managementsystematic application of management policies, procedures and practices to the tasks of analysing, evaluating, controlling and monitoring risk (3.3)SOURCE: ISO 14971:2007, 2.223.8risk management fileset of records and other documents that are produced by risk management (3.7)

40、SOURCE: ISO 14971:2007, 2 . 233.9single fault conditioncondition in which a single means for reducing a risk (3.3) is defective or a single abnormal condition is presentSOURCE: IEC 60601-1:2005, 3.1163.10validationconfirmation through the provision of objective evidence that the requirements for a s

41、pecific intended use or application have been fulfilledNote 1 to entry: The term “validated” is used to designate the corresponding status.Note 2 to entry: The use conditions for validation can be real or simulated.4 General requirements for airways and related equipment4.1 * Risk management4.1.1 Th

42、is International Standard specifies requirements that are generally applicable to risks associated with airways and related equipment. An established risk management process shall be applied to the design of airways and related equipment. The risk management process shall include the following eleme

43、nts: risk analysis; risk evaluation; risk control - production and post-production information.EXAMPLE ISO 14971.NOTE See Annex B for a list of hazards that can be used as guidance in the risk assessment.Check compliance by inspection of the risk management file.4.2 UsabilityThe manufacturer shall a

44、pply a usability engineering process to assess and mitigate any risks caused by usability problems associated with correct use (i.e. normal use) and use errors (see IEC 60601-1-6 and IEC 62366-1).Check compliance by inspection of the usability engineering file. ISO 2016 All rights reserved 3BS ISO 1

45、8190:2016ISO 18190:2016(E)4.3 Clinical evaluationWhere appropriate, clinical studies shall be performed under the conditions for which performance is claimed and documented in the risk management file. The clinical studies shall comply with the requirements of ISO 14155.NOTE Clinical data may be sou

46、rced from clinical investigation(s) of the device concerned, clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated, or published and/or unpublished reports on other clinical experience

47、 with either the device in question or a similar device for which equivalence to the device in question can be demonstrated.Check compliance by inspection of the risk management file.4.4 Biophysical or modelling researchWhere appropriate, validated biophysical or modelling research shall be performe

48、d under the conditions for which performance is claimed, and documented in the risk management file.NOTE Biophysical or modelling research is the application of validated physical methods and theories to biological problems. Examples include the use of a combination of models (i.e. mathematical, com

49、puter, physical, cell and tissue culture, and animal) in a complementary and interactive manner to simulate the performance of medical devices.29Check compliance by inspection of the technical file.5 Materials5.1 Biological safety testingAirways and related equipment, in their ready-to-use state after any preparation for use recommended by the manufacturer, shall satisfy appropriate biological safety testing (e.g. ISO 10993-1).Check compliance by inspection of the technical file.5.2