EN ISO 80601-2-12-2011 en Medical electrical equipment - Part 2-12 Particular requirements for basic safety and essential performance of critical care ventilators《医用电气设备 第2-12部分 危重.pdf

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1、BSI Standards PublicationBS EN ISO 80601-2-12:2011Medical electrical equipmentPart 2-12: Particular requirements for basicsafety and essential performance of criticalcare ventilators (ISO 80601-2-12:2011)Incorporating corrigendum October 2011BS EN ISO 80601-2-12:2011National forewordThis British Sta

2、ndard is the UK implementation of EN ISO 80601-2-12:2011. It is identical to ISO 80601-2-12:2011, incorporating corrigendum October 2011. It supersedes BS EN 794-1:1997+A2:2009 and BS EN 60601-2-12:2006, which are withdrawn.The start and finish of text introduced or altered by corrigendum is indicat

3、ed in the text by tags. Text altered by ISO corrigendum October 2011 is indicated in the text by .The UK participation in its preparation was entrusted by Technical Committee CH/121, Anaesthetic and respiratory equipment to Subcommittee CH/121/5, Lung ventilators, tracheal tubes and related equipmen

4、t.A list of organizations represented on this subcommittee 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 application. The British Standards Institution 2013. Published by BSI

5、Standards Limited 2013ISBN 978 0 580 76391 5ICS 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 Committee on 30 September 2011.Amendments/corrigenda issued since pub

6、licationDate Text affected31 August 2013 Implementation of ISO corrigendum October 2011BRITISH STANDARDEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 80601-2-12 April 2011 ICS 11.040.10 Supersedes EN 794-1:1997+A2:2009English Version Medical electrical equipment - Part 2-12: Particular req

7、uirements for basic safety and essential performance of critical care ventilators (ISO/IEC 80601-2-12:2011) Appareils lectromdicaux - Partie 2-12: Exigences particulires relatives la scurit de base et aux performances essentielles des ventilateurs pulmonaires pour utilisation en soins intensifs (ISO

8、/IEC 80601-2-12:2011) Medizinische elektrische Gerte - Teil 2-12: Besondere Festlegungen fr die Sicherheit einschlielich der wesentlichen Leistungsmerkmale von Beatmungsgerten fr die Intensivpflege (ISO/IEC 80601-2-12:2011) This European Standard was approved by CEN on 5 February 2011. CEN members a

9、re bound to comply with the CEN/CENELEC Internal Regulations which stipulate 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

10、 the CEN-CENELEC Management Centre or to any CEN member. This European Standard 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 C

11、entre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, N

12、orway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2011 CEN All rights of exploitation in any fo

13、rm and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 80601-2-12:2011: EBS EN ISO 80601-2-12:2011EN ISO 80601-2-12:2011 (E) 3 Foreword This document (EN ISO 80601-2-12:2011) has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment“ in coll

14、aboration with Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” the secretariat of which is held by BSI. 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 October 2011, and con

15、flicting national standards shall be withdrawn at the latest by October 2011. 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 doc

16、ument supersedes EN 794-1:1997+A2:2009, EN 60601-2-12:2006. This first edition of ISO 80601-2-12 cancels and replaces the second edition of IEC 60601-2-12 (2001). This edition of ISO 80601-2-12 constitutes a major technical revision of IEC 60601-2-12:2001 and includes an alignment with third edition

17、 of IEC 60601-1. This document 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

18、 document. According to the CEN/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, France, Germany, Greece, Hungary, Icela

19、nd, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO/IEC 80601-2-12:2011 has been approved by CEN as a EN ISO 80601-2-12:2011 without any mod

20、ification. ISO 2013 All rights reservedBS EN ISO 80601-2-12:2011EN ISO 80601-2-12:2011 (E) 4 Annex ZA (informative) Relationship between this Document and the Essential Requirements of EU Directive 93/42/EEC This Document has been prepared under a mandate given to CEN by the European Commission and

21、the European Free Trade Association to provide a means to conforming to Essential Requirements of the New Approach Directive 93/42/EEC, Council Directive of 14 June 1993 on the approximation of the laws of the Member States concerning medical devices” (Medical Device Directive). Once this document i

22、s 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 clauses of this document given in Table ZA.1, within the limits of the scope of this document, a presumption of conformity with

23、 the corresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZA.1 Correspondence between this Document and Directive 93/42/EEC Clause/subclause of this Document Corresponding essential requirement of Directive 93/42/EEC Qualifying remarks/notes All 1, 2, 3201.4

24、1 201.7 5, 8.6, 8.7, 10.3, 11.4.1,12.7.4, 12.8.2, 12.9, 13.1, 13.2, 13.3, 13.4, 13.5, 13.6 201.7.2.3 13.1, 13.2 201.7.2.101 a) 13.3 i) 201.7.2.101 b) 13.3 j), 13.3 k) 201.7.2.101 c), 201.7.2.101 d) 13.1 201.7.2.101 e) 13.3 j), 13.3 k) 201.7.2.101 f) 13.3 e) 201.7.2.101 g) 13.3 k) 201.7.2.101 h) 13.3

25、 k) 201.7.2.4.101 13.1, 13.3 e), 13.3 i), 13.3 j), 13.3 k) 201.7.2.13.101 13.1, 13.2, 13.3 k) 201.7.2.17.101 a) 13.2, 13.3 b), 13.3 c), 13.3 d), 13.3 f), 13.5 201.7.2.17.101 b) 13.2, 13.3 b), 13.3 d), 13.5 201.7.9.1 13.3 a) 201.7.9.2.8.101 13.6 d) 201.7.9.2.9.101 13. b) 201.7.9.2.1 a) 13.6 h), 13.6

26、i) 201.7.9.2.1 b) 13.6 q) 201.7.9.2.2.101 13.1, 13.6 a) ISO 2013 All rights reservedBS EN ISO 80601-2-12:2011EN ISO 80601-2-12:2011 (E) 5 Table ZA.1 (continued) Clause/subclause of this Document Corresponding essential requirement of Directive 93/42/EEC Qualifying remarks/notes 201.7.9.2.9.101 13.6

27、a), 13.6 b), 13.6 c), 13.6 d) 201.7.9.2.12 13.6 h), 13.6 i) 201.7.9.2.14.101 13.6 c)201.8 9.1, 9.2, 9.3, 12.6, 12.7.4 201.9 7.1, 9.1, 9.2, 12.7.1, 12.7.2, 12.7.3 201.10 11.1.1, 11.3201.11 7.1, 7.2, 7.3, 7.5, 7.6, 8.1, 8.5, 9.1, 9.3, 12.7.5 201.11.6.4 7.5 201.11.8 12.2, 12.3 201.12 9.2, 10.1, 10.2, 1

28、1.1.1, 11.3, 12.3, 12.4, 12.8.1, 12.8.2, 12.9 201.12.1 3, 4201.12.4 3, 4, 12.4, 12.8 201.13 1, 2, 4, 7.5, 7.6, 9.3 And via IEC 60601-1-6 201.14 9.1, 12.1, 12.1 a) 201.15 4, 9.1, 9.2, 9.3, 12.6, 12.7.1, 12.7.4, 12.7.5 201.16 9.1, 12.6, 12.7, 13.1 201.17 11.1.1, 12.5201.101 9.1, 9.2, 12.7.4, 12.8.1 20

29、1.102 3, 4, 9.1, 13.6 c) 201.103 2, 6201.104 12.9 201.105 2, 3, 4 201.106 1, 2, 9.1, 9.2 And via IEC 60601-1-6 201.107 1, 12.9 And via IEC 60601-1-6 201.108 1, 3, 9.1, 9.2 And via IEC 60601-1-6 202 9.2, 11.1.1, 12.5 206 1, 9.2, 12.9 And via IEC 60601-1-6 208 12.4 WARNING: Other requirements and othe

30、r EU Directives may be applicable to the products falling within the scope of this International Standard. ISO 2013 All rights reservedBS EN ISO 80601-2-12:2011EN ISO 80601-2-12:2011 (E) 6 For devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC on Machinery, i

31、n accordance with Article 3 of Directive 93/42/EEC the following table ZA.2 details the relevant essential requirements of Directive 2006/42/EC on Machinery to the extent to which they are more specific than those of Directive 93/42/EEC along with the corresponding clauses of this European Standard.

32、 Table ZA.2, however, does not imply any citation in the OJEU under the machinery directive and thus does not provide presumption of conformity for the machinery directive. Table ZA.2 Relevant Essential Requirements from Directive 2006/42/EC on machinery that are addressed by this Document (accordin

33、g to article 3 of amended Directive 93/42/EEC) Clause(s)/sub-clause(s) of this EN EHSR of 2006/42/EC Qualifying remarks/Notes 201.12.1 1.1.4 And via IEC 60601-1 1.1.8201.12.1, 201.12.101 1.2.2 And via IEC 60601-1 and IEC 60601-1-6 201.7.2.101 c), 201.7.2.101 d), 201.101.2, 201.101.3, 201.101.4 1.5.4

34、 1.6.1 Via IEC 60601-1 1.6.2 Via IEC 60601-1 1.6.3 Via IEC 60601-1 3.4.5 Via IEC 60601-1 201.7.2.101 i) 3.6.2 And via IEC 60601-1 ISO 2013 All rights reservedBS EN ISO 80601-2-12:2011ISO 80601-2-12:2011(E) iiiContents Page Foreword vi Introduction viii 201.1 Scope, object and related standards . 1 2

35、01.1. 1 Scope . 1 201.1. 2 Object 2 201.1. 3 Collateral standards . 2 201.1. 4 Particular standards . 2 201.2 Normative references 3 201.3 Terms and definitions . 6 201.4 General requirements . 9 201.4. 3 ESSENTIAL PERFORMANCE . 9 201.4. 3.101 Additional requirements for ESSENTIAL PERFORMANCE 9 201.

36、4. 6 ME EQUIPMENT or ME SYSTEM parts that contact the PATIENT 9 201.4. 11.101 Additional requirements for pressurized gas input 9 201.4. 11.101.1 Overpressure requirement 9 201.4. 11.101.2 Compatibility requirement . 10 201.5 General requirements for testing of ME EQUIPMENT . 10 201.5. 101 Additiona

37、l requirements for general requirements for testing of ME EQUIPMENT . 10 201.5. 101.1 VENTILATOR test conditions . 10 201.5. 101.2 Gas flowrate and leakage specifications 11 201.5. 101.3 VENTILATOR testing errors . 11 201.6 Classification of ME EQUIPMENT and ME SYSTEMS 11 201.7 ME EQUIPMENT identifi

38、cation, marking and documents . 11 201.7. 2.3 Consult ACCOMPANYING DOCUMENTS 11 201.7. 2 .101 Additional requirements for marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts 11 201.7. 2.4.101 Additional requirements for ACCESSORIES 12 201.7. 2.13.101 Additional requirements for physiologica

39、l effects . 12 201.7. 2.17.101 Additional requirements for protective packaging . 13 201.7. 4.3 Unit of measure . 13 201.7. 9.1 Additional general requirements . 13 201.7. 9.2.1.101 Additional general requirements . 14 201.7. 9.2.2.101 Additional requirements for warnings and safety notices . 14 201

40、.7. 9.2.8.101 Additional requirements for start-up procedure 15 201.7. 9.2.9.101 Additional requirements for operating instructions . 15 201.7. 9.2.12 Cleaning, disinfection, and sterilization 16 201.7. 9.2.14.101 Additional requirements for ACCESSORIES , supplementary equipment , used material . 16

41、 201.7. 9.2.16.101 Additional requirements for reference to the technical description . 16 201.7. 9.3.1.101 Additional general requirements . 16 201.7. 9.3.101 Additional requirements for the technical description 17 201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 17 201.9 Protection

42、 against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS 17 201.9. 6.2.1.101 Additional requirements for audible acoustic energy . 17 201.9. 101 Additional requirements for suction procedures . 18 201.10 Protection against unwanted and excessive radiation HAZARDS 20 ISO 2013 All rights reservedBS

43、EN ISO 80601-2-12:2011ISO 80601-2-12:2011(E) iv 201.11 Protection against excessive temperatures and other HAZARDS .20 201.11. 6.4 Leakage .20 201.11. 6.5.101 Additional requirements for ingress of water or particulate matter into ME EQUIPMENT or ME SYSTEM 21 201.11. 6.6 Cleaning and disinfection of

44、 ME EQUIPMENT or ME SYSTEM 21 201.11. 6.7 Sterilization of ME EQUIPMENT or ME SYSTEM 21 201.11. 8 .101 Additional requirements for interruption of the power supply/SUPPLY MAINS to ME EQUIPMENT 22 201.11. 8.101.1 TECHNICAL ALARM CONDITION for power supply failure 22 201.11. 8.101.2 INTERNAL ELECTRICA

45、L POWER SOURCE or external reserve electrical power source 22 201.12 Accuracy of controls and instruments and protection against hazardous outputs .23 201.12. 1 Accuracy of controls and instruments 23 201.12. 1.101 Volume-controlled breath type .23 201.12. 1.102 Pressure-controlled breath type 26 20

46、1.12. 1.103 DELIVERED VOLUME MONITORING .29 201.12. 1.104 Response of the VENTILATOR to an increase in O2concentration 29 201.12. 4 Protection against hazardous output .31 201.12. 4.101 Oxygen monitor .31 201.12. 4.102 Measurement of AIRWAY PRESSURE .31 201.12. 4.103 Measurement of expired volume an

47、d low-volume ALARM CONDITIONS 32 201.12. 4.103.1 VENTILATORS intended to provide a DELIVERED VOLUME 50 ml .32 201.12. 4.103.2 VENTILATORS intended to provide a DELIVERED VOLUME 50 ml .32 201.12. 4.104 MAXIMUM LIMITED PRESSURE PROTECTION DEVICE .33 201.12. 4.105 High-pressure ALARM CONDITION and PROT

48、ECTION DEVICE .33 201.12. 4.106 PEEP ALARM CONDITIONS.33 201.12. 4.107 Obstruction ALARM CONDITION33 201.12. 4.108 Partial-occlusion ALARM CONDITION .34 201.12. 101 Protection against accidental adjustments .34 201.13 HAZARDOUS SITUATIONS and fault conditions 34 201.13. 2.101 Additional specific SIN

49、GLE FAULT CONDITIONS .34 201.13. 102 Failure of one gas supply to a VENTILATOR .35 201.13. 103 Independence of ventilation control function and related RISK CONTROL measures 35 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) 35 201.14. 101 Software life cycle 35 201.15 Construction of ME EQUIPMENT .35 201.15. 3.5.101 Additional requirements for rough handling .35 201.15. 3.5.101.1 Shock and vibration 35 201.15. 3.5.101.2 Shock and vibration for a MOBILE VENTILATOR .36 201.15. 101 Mode of operation .37 20