EN ISO 11197-2016 en Medical supply units《医疗供应设备(ISO 11197 2016)》.pdf

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1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Medical supply unitsBS EN ISO 11197:2016National forewordThis British Standard is the UK implementation of EN ISO 11197:2016. It supersedes BS ISO 11197:2016, which is withdrawn.The UK participation in its preparation w

2、as entrusted to Technical Committee CH/121/6, Medical gas supply systems.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct ap

3、plication. The British Standards Institution 2018 Published by BSI Standards Limited 2018ISBN 978 0 539 00889 0ICS 11.040.10Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Co

4、mmittee on 31 May 2018.Amendments/corrigenda issued since publicationDate Text affected31 May 2018 This corrigendum renumbers BS ISO 11197:2016 as BS EN ISO 11197:2016BRITISH STANDARDBS EN ISO 11197:2016EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 11197March 2016ICS 11.040.10 Supersedes EN

5、ISO 11197:2009EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGCEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2016 CEN Ref. No. EN ISO 11197:2016: EAll rights of exploitation in any form and by any means reserved worldwide for CEN na

6、tional MembersMedical supply units (ISO 11197:2016)Gaines techniques usage mdical (ISO 11197:2016) Medizinische Versorgungseinheiten (ISO 11197:2016)This European Standard was approved by CEN on 25 December 2015.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulat

7、e the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.This European Stand

8、ard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions.CEN members are the natio

9、nal standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slov

10、akia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.English VersionEN ISO 11197:2016 (E)European forewordThis document (EN ISO 11197:2016) has been prepared by Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment”, the secretariat of which is held by BSI, in collab

11、oration with Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment”.This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by September 2016, and conflicting national standards shall be with

12、drawn at the latest by March 2019.Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights.This document supersedes EN ISO 11197:2009.This docum

13、ent has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s).For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document.According to the C

14、EN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hung

15、ary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.Endorsement noticeThe text of ISO 11197:2016 has been approved by CEN as EN ISO 11197:2016 without any mod

16、ification.2BS EN ISO 11197:2016EN ISO 11197:2016 (E)Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EECThis European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade

17、Association to provide a means of conforming to Essential Requirements of Directive 93/42/EEC.Once this standard is cited in the Official Journal of the European Union under that Directive and has been implemented as a national standard in at least one Member State, compliance with the normative cla

18、uses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the relevant Essential Requirements of that Directive.NOTE When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this Europ

19、ean Standard.Table ZA.1 Correspondence between this European Standard and Directive 93/42/EECClause(s)/subclause(s) of this ENEssential Re-quirements (ERs) of Directive 93/42/EECQualifying remarks/Notes201.4201.5201.6201.8201.9201.11.7201.12201.13201.157.1 (first and sec-ond indents)201.13201.15.4.1

20、01201.15.4.102201.15.4.103201.117.3 (up to semico-lon)201.7.2.1201.8201.9.1201.16201.159.1 (first sentence)3BS EN ISO 11197:2016EN ISO 11197:2016 (E)Clause(s)/subclause(s) of this ENEssential Re-quirements (ERs) of Directive 93/42/EECQualifying remarks/Notes201.5.9.2.3201.6201.8201.9201.10201.172029

21、.2 (first and sec-ond indents)Adds specific requirementsMandates 60601-2201.8201.11201.11.2201.12201.13201.15201.16201.15.1019.3201.10 11201.14 12.1201.14 12.1 a)201.1720212.5201.6.2201.8201.13201.1612.6201.9201.1512.7.1201.9.6201.9.812.7.2201.9.6 12.7.3201.7201.7.2.8201.15.4.10112.7.4 Only covered

22、for gas connectors201.4201.11.112.7.5201.7 12.9201.7 13.1201.7.2 13.3 a)201.7.9.2 13.6 a) Covers item in 13.3 a) only201.7.9.2 13.6 d)201.7.9.2.16 13.6 i)4BS EN ISO 11197:2016EN ISO 11197:2016 (E)Clause(s)/subclause(s) of this ENEssential Re-quirements (ERs) of Directive 93/42/EECQualifying remarks/

23、Notes201.7.9.2.1 13.6 q)NOTE Where a reference from a clause of this standard to the risk management process is made, the risk management process needs to be in compliance with the Medical Devices Directive 93/42/EEC. This means that risks have to be reduced as far as possible, to a minimum, to the

24、lowest possible level, minimized or removed, according to the wording of the corresponding essential requirement.WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard.5BS EN ISO 11197:2016ISO 11197:2016Foreword viiiIntroducti

25、on ix201.1 Scope, object and related standards 1201.1.1 Scope . 1201.1.2 Object 1201.1.3 Related standards 1201.1.3.1 Collateral standards 1201.1.3.2 Particular standards . 1201.2 Normative references 2201.3 Terms and definitions . 3201.4 General requirements 4201.5 General requirements for testing

26、me equipment . 4201.5.101 Medical supply unit test results 4201.6 Classification of me equipment and me systems . 5201.6.1 Protection against electric shock 5201.7 Me equipment identification, marking and documents 5201.7.2.1 Minimum requirements for marking on me equipment and on interchangeable pa

27、rts . 5201.7.2.6 Connection to the supply mains 5201.7.2.8 Output connectors . 6201.7.2.19 Functional earth terminals . 6201.7.3 Marking on the outside of me equipment or me equipment parts 6201.7.9 Accompanying documents . 6201.7.9.1 General . 6201.7.9.2 Instructions for use and maintenance 6201.7.

28、9.3 Technical description 7201.8 Protection against electrical hazards from me equipment 8201.8.1 Fundamental rule of protection against electric shock . 8201.8.6 Protection earthing, functional earthing and potential equalization of me equipment . 8201.8.6.2 Protective earth terminal . 8201.8.6.101

29、 Conductors . 9201.8.6.102 Bus bar . 9201.8.10 Components and wiring 10201.8.10.7 Insulation of internal wiring 10201.8.11 Main parts, components and layout . 13201.8.11.1 Isolation from the supply mains 13201.9 Protection against mechanical hazards of me equipment and me systems .14201.9.1.101 Dyna

30、mic forces . 14201.9.1.102 Impact resistance test 14201.9.1.103 Static forces . 14201.9.1.104 Static load test 14201.9.1.105 Mechanical damage 14201.9.6 Acoustic energy (including infra- and ultrasound) and vibration .15201.9.8 Mechanical hazards associated with support systems .16201.10 Protection

31、against unwanted and excessive radiation hazards 16201.11 Protection against excessive temperatures and other hazards 16201.11.1 Excessive temperatures in me equipment .16201.11.2 Fire prevention 16201.12 Accuracy of controls and instruments and protection against hazardous outputs .16201.13 Hazardo

32、us situations and fault conditions 16vi ISO 2016 All rights reservedContents PageBS EN ISO 11197:2016ISO 11197:2016201.13.2 Single fault conditions 16201.14 Programmable electrical medical systems (pems)17201.15 Construction of me equipment . 17201.15.1 Arrangements of controls and indicators of me

33、equipment 17201.15.4 me equipment components and general assembly17201.15.101 Venting 21201.16 Me systems 21201.17 Electromagnetic compatibility of me equipment and me systems .21202 Medical electrical equipment - part 1-2 General requirements for basic safety and essential performance Collateral st

34、andard: Electromagnetic disturbances Requirements and tests .21206 Medical electrical equipment - part 1-6 General requirements for basic safety and essential performance Collateral standard: Usability 21Annex AA (informative) Rationale .22Bibliography .23 ISO 2016 All rights reserved viiBS EN ISO 1

35、1197:2016ISO 11197:2016ForewordISO (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

36、 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 International Electrotechnical Commissio

37、n (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 different types of ISO documents shoul

38、d be Noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2. www.iso.org/directivesAttention 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 identifyin

39、g 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. www.iso.org/patentsAny trade name used in this document is information given for the convenience of user

40、s 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 WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementar

41、y informationThe committee responsible for this document is ISO/TC 121.ISO 11197 was prepared by the European Committee for Standardization (CEN) Technical Committee CEN/TC 215, Respiratory and anaesthetic equipment, in collaboration with ISO Technical Committee TC 121, Anaesthetic and respiratory e

42、quipment, Subcommittee SC 6, Medical gas systems, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement). This third edition cancels and replaces the second edition (ISO 11197:2004), which has been technically revised.viii ISO 2016 All rights reservedBS EN I

43、SO 11197:2016ISO 11197:2016IntroductionMany healthcare facilities use surface-mounted or recessed containment systems and enclosures for accommodating and displaying essential patient care services. These are known as medical supply units.This International Standard specifies requirements for medica

44、l supply units manufactured in factories or assembled from components on site.It is intended for use by those persons involved in the design, construction, inspection, testing, maintenance and operation of healthcare facilities as well as those manufacturing, assembling and installing medical supply

45、 units.Persons involved in the design, manufacture, installation, maintenance and testing of equipment intended to be connected to medical gas, vacuum, anaesthetic gas scavenging and/or plume extraction systems should be aware of the contents of this document.This International Standard is a particu

46、lar standard, based on IEC 60601-1:2005+A1:2012. IEC 60601-1:2005+A1:2012 is the basic standard for the safety of all medical electrical equipment used by or under the supervision of qualified personnel in the general medical and patient environment; it also contains certain requirements for reliabl

47、e operation to ensure safety.IEC 60601-1:2005+A1:2012 has associated collateral standards and particular standards. The collateral standards include requirements for specific technologies and/or hazards and apply to all applicable equipment, such as medical systems, EMC, radiation protection in diag

48、nostic X-ray equipment, software, etc. The particular standards apply to specific equipment types, such as medical electron accelerators, high frequency surgical equipment, hospital beds, etcNOTE Definitions of collateral standard and particular standard can be found in IEC 60601:2005+A1:2012.For an

49、 explanation of the special numbering in this document and more on the terms “collateral”, “particular” and “general” standards, see 201.1.3, 201.1.4, and 201.1.5.Annex AA contains rationale statements for some of the requirements of this International Standard. It is included to provide additional insight into the reasoning that led to the requirements and recommendations that have been incorporated in this International Standard. The clauses and subclauses marked with (*) after their number have a corresponding rationale contained in Annex AA.