EN ISO 80601-2-55-2011 en Medical electrical equipment - Part 2-55 Particular requirements for the basic safety and essential performance of respiratory gas monitors《医用电气设备 第2-55部分.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationMedical electrical equipmentPart 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitorsBS EN ISO 80601-2-55:2011National forewor

2、dThis British Standard is the UK implementation of EN ISO 80601-2-55:2011. Itsupersedes BS EN ISO 21647:2009 which is withdrawn.The UK participation in its preparation was entrusted by Technical CommitteeCH/121, Anaesthetic and respiratory equipment, to Subcommittee CH/121/1,Breathing attachments an

3、d anaesthetic machines.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisions of acontract. Users are responsible for its correct application. The British Standards Institution 2012Pub

4、lished by BSI Standards Limited 2012ISBN 978 0 580 66582 0ICS 11.040.10Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of the StandardsPolicy and Strategy Committee on 31 July 2012.Amendments issued since publica

5、tionAmd. No. Date Text affectedBRITISH STANDARDBS EN ISO 80601-2-55:2011EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 80601-2-55 December 2011 ICS 11.040.10 Supersedes EN ISO 21647:2004English Version Medical electrical equipment - Part 2-55: Particular requirements for the basic safety a

6、nd essential performance of respiratory gas monitors (ISO 80601-2-55:2011) Appareils lectromdicaux - Partie 2-55: Exigences particulires relatives la scurit de base et aux performances essentielles des moniteurs de gaz respiratoires (ISO 80601-2-55:2011) Medizinische elektrische Gerte - Teil 2-55: B

7、esondere Festlegungen fr die Sicherheit einschlielich der wesentlichen Leistungsmerkmale von berwachungsgerten fr Atemgase (ISO 80601-2-55:2011) This European Standard was approved by CEN on 2 December 2011. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate th

8、e 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 Standard

9、 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 nationa

10、l 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, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerlan

11、d 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 form and by any means reserved worldwide for CEN national Members. Ref. No. EN IS

12、O 80601-2-55:2011: EBS EN ISO 80601-2-55:2011EN ISO 80601-2-55:2011 (E) 2 Contents Page Foreword 3Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC 4BS EN ISO 80601-2-55:2011EN ISO 80601-2-55:2011 (E) 3 Foreword This document

13、(EN ISO 80601-2-55:2011) has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment“ in collaboration 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

14、of a national standard, either by publication of an identical text or by endorsement, at the latest by June 2012, and conflicting national standards shall be withdrawn at the latest by December 2014. Attention is drawn to the possibility that some of the elements of this document may be the subject

15、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 21647:2004. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports

16、essential requirements of EU Directive. For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European St

17、andard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the Unit

18、ed Kingdom. Endorsement notice The text of ISO 80601-2-55:2011 has been approved by CEN as a EN ISO 80601-2-55:2011 without any modification. BS EN ISO 80601-2-55:2011EN ISO 80601-2-55:2011 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU

19、Directive 93/42/EEC This International Standard has been prepared under a mandate given to CEN by the European Commission and 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 t

20、he approximation of the laws of the Member States concerning medical devices” (Medical Device Directive). 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 c

21、lauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZA.1 Correspondence between this European Standard and Directive 93

22、/42/EEC Clause(s)/subclause(s) of this European Standard Essential requirements (ERs) of EU Directive 93/42/EEC Qualifying remarks/Notes 201.11.6.4 to 201.11.6.6 7.2 Only the parts of ER 7.2 relating to safety in use for the patient are addressed 201.11.6.4, 201.11.6.8 7.3 Only the part of the first

23、 sentence relating to design is addressed 201.11.6.4 7.5 201.11.6.5, 201.101 7.6 201.11.6.6, 201.11.6.7 , 201.105 8.1 The part of ER 8.1 relating to easy handling is not addressed 201.11.6.7 8.4 Validated processes for sterilization are required via the normative references to ISO 11134, ISO 11135,

24、ISO 11137 201.7.2.17.101 8.7 201.7.2.101, 201.7.2.4.101, 201.7.2.13.101, 201.7.2.17.101, 201.12.1.102, 201.102, 201.103, 208 9.1 201.9, 201.101, 202, 206 9.2 The 4thindent of ER 9.2 is not addressed BS EN ISO 80601-2-55:2011EN ISO 80601-2-55:2011 (E) 5 Table ZA.1 (continued) Clause(s)/subclause(s) o

25、f this European Standard Essential requirements (ERs) of EU Directive 93/42/EEC Qualifying remarks/Notes 201.11 9.3 201.12.1, 201.101 10.1 201.7, 201.12.1.103, 201.12.1.104, 206, 208 10.2 201.7.4.3 10.3 201.10 11.1.1 202 11.3.1201.14 12.1 201.14 12. a) 201.11.8.101, 208 12.2 201.11.8.101, 208 12.3 2

26、08 12.4 202 12.5 201.8 12.6 201.9 12.7.1 201.9 12.7.2201.9 12.7.3 201.8, 201.15, 201.103 12.7.4 201.11 12.7.5201.104 12.8.2 Only the first sentence of ER 12.8.2 is covered 201.7, 201.12.1, 206 12.9 201.7, 201.7.2.4.101, 201.7.2.13.101, 201.7.2.17.101, 201.7.2.101 13.1 201.7, 201.7.2.3, 201.7.2.13.10

27、1, 201.7.2.17.101, 201.7.2.101 13.2 201.7.9.1 13.3 a) 201.7, 201.7.2.17.101, 201.7.2.101 13.3 b) 201.7, 201.7.2.17.101 13.3 c) 201.7.2.17.101, 201.7.2.101 13.3 d) Is only covered if the batch number is preceded by the word LOT 201.7.2.101 13.3 e) 201.7.2.4.101, 201.7.2.17.101 b) 13.3 f) Distinction

28、between “single use“ and “single-patient use” taken into account 201.7.2.101 a) 13.3 i) 201.7, 201.7.2 13.3 j) BS EN ISO 80601-2-55:2011EN ISO 80601-2-55:2011 (E) 6 Table ZA.1 (continued) Clause(s)/subclause(s) of this European Standard Essential requirements (ERs) of EU Directive 93/42/EEC Qualifyi

29、ng remarks/Notes 201.7, 201.7.9.2.2.101 13.3 k) 201.7, 201.7.2.17 a) 13.3 m) Presumption of conformity is only provided if symbols 5.21 to 5.24 are utilized 201.7.9.2.1.101 a), 201.7.2.17.101, 201.7.2.101 13.4 201.7.2.17.101 a), 201.7.2.101 b) 13.5 Is only covered if the batch number is preceded by

30、the word LOT 201.7, 201.7.9.1, 201.7.9.2.1.101, 201.7.9.2.2.101 13.6 a) 201.7, 201.7.9.2.1.101, 201.7.9.2.2.101, 201.7.9.2.9.101 c), 201.7.9.2.9.101 d) 13.6 b) 201.7, 201.7.9.2.2.101, 201.7.9.2.5.101, 201.7.9.2.9.101 e) 13.6 c) 201.7, 201.7.9.2.13.101 13.6 d) 201.7, 201.7.9.2.9.101 g), , 201.7.9.2.9

31、.101 k) 13.6 f) 201.7.9.2.14.101 b) 13.6 g) 201.7, 201.7.9.2.9.101 l) , 201.7.9.2.14.101 b) 13.6 h) 201.7 13.6 i) 201.7.9.2.1.101 c) 13.6 j) 201.7 13. k)201.7 13.6 l)201.7, 201.7.9.2.14.101 c), 201.7.9.2.15.101 13.6 n) 201.12.1.101.1 13.6 p) 201.7.9.2.9.101 m) 13.6 q) BS EN ISO 80601-2-55:2011EN ISO

32、 80601-2-55:2011 (E) 7 For devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC on Machinery, in accordance with Article 3 of Directive 93/42/EEC, the following Table ZA.2 details the relevant essential health and safety requirements of Directive 2006/42/EC on

33、Machinery to the extent to which they are more specific than essential requirements of Directive 93/42/EEC along with the corresponding clauses of this International Standard. Table ZA.2, however, does not imply any citation in the OJEU under the machinery directive and thus does not provide presump

34、tion of conformity for the machinery directive. Table ZA.2 Relevant Essential Requirements from Directive 2006/42/EC on machinery that are addressed by this European Standard (according to article 3 of amended Directive 93/42/EEC) Clause(s)/subclause(s) of this European Standard Essential health and

35、 safety requirements (ERs) of EU Directive 2006/42/EC Qualifying remarks/Notes 201.7, 201.12.1 1.1.4 Only the first sentence of EHSR 1.1.4 is addressed 201.12.1, 201.12.1.104, 206, 208.6.5.1, 208.6.6.2.101 1.2.2 Only the parts of EHST 1.2.2 relevant to the RGM are addressed 201.7.2.101 d), 201.7.2.1

36、01 e), 201.7.2.101 f), 201.7.2.101 g) 201.7.2.101 h), 201.103, 201.105 1.5.4 201.7 1.6.2 201.8 1.6.3201.7, 201.7.2.101 i) 3.6.2 WARNING: Other requirements and other EU Directives may be applicable to the products falling within the scope of this standard. BS EN ISO 80601-2-55:2011ISO 80601-2-55:201

37、1(E) ISO 2011 All rights reserved iiiContents Page Introduction . vii 1 Scope 1 201.1 Scope, object and related standards 1 201.1. 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 4 201.4 General

38、requirements 6 201.4. 3 ESSENTIAL PERFORMANCE . 6 201.4. 3.101 * Additional requirements for ESSENTIAL PERFORMANCE . 6 201.4. 3.102 Additional requirements for acceptance criteria 6 201.4. 6 * ME EQUIPMENT or ME SYSTEM parts that contact the PATIENT . 6 201.4.10.2.101 * Additional requirements for S

39、UPPLY MAINS for ME EQUIPMENT and ME SYSTEMS 6 201.5 General requirements for testing ME EQUIPMENT 7 201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 7 201.7 ME EQUIPMENT identification, marking and documents . 7 201.7. 2.3 * Consult ACCOMPANYING DOCUMENTS . 7 201.7. 2.101 * Additional requireme

40、nts for marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts 7 201.7. 2.4.101 Additional requirements for ACCESSORIES . 8 201.7. 2.13.101 * Additional requirements for physiological effects (safety signs and warning statements) 8 201.7. 2.17.101 Additional requirements for protective packagi

41、ng 8 201.7. 4.3 Unit of measure 8 201.7. 9.1 General requirements 9 201.7. 9.2.1.101 * Additional general requirements 9 201.7. 9.2.2.101 * Additional requirements for warnings and safety notices 9 201.7. 9.2.5.101 Additional requirements for ME EQUIPMENT description 10 201.7. 9.2.8.101 * Additional

42、 requirements for start-up procedure . 10 201.7. 9.2.9.101* Additional requirements for operating instructions 10 201.7. 9.2.13.101 * Additional requirements for maintenance . 11 201.7. 9.2.14.101 * Additional requirements for ACCESSORIES, supplementary equipment, used material 11 201.7. 9.2.15.101*

43、 Additional requirements for environmental protection . 11 201.7. 9.3.101 * Additional requirements for technical description 12 201.8 Protection against electrical HAZARDS from ME EQUIPMENT 12 201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS . 12 201.10 Protection against

44、unwanted and excessive radiation HAZARDS . 12 201.11 Protection against excessive temperatures and other HAZARDS . 12 201.11. 6.4 Leakage . 12 201.11. 6.5 * Ingress of water or particulate matter into ME EQUIPMENT or ME SYSTEMS . 13 201.11. 6.6 * Cleaning and disinfection of ME EQUIPMENT or ME SYSTE

45、MS 13 201.11. 6.7 Sterilization of ME EQUIPMENT or ME SYSTEMS 13 BS EN ISO 80601-2-55:2011ISO 80601-2-55:2011(E) iv ISO 2011 All rights reserved201.11. 6.8 Compatibility with substances used with ME EQUIPMENT .13 201.11. 8.101 Additional requirements for interruption of the power supply/SUPPLY MAINS

46、 to ME EQUIPMENT .14 201.11. 8.101.1 * Supply failure TECHNICAL ALARM CONDITION .14 201.11. 8.101.2 * Settings and data storage following short interruptions or automatic switchover 14 201.11. 8.101.3 * Operation following long interruptions .14 201.11. 8.101.4 * RESERVE ELECTRICAL POWER SOURCE 14 2

47、01.11. 8.101.5 * RESERVE ELECTRICAL POWER SOURCE for transport outside a healthcare facility .15 201.12 Accuracy of controls and instruments and protection against hazardous outputs 15 201.12. 1 Accuracy of controls and instruments 15 201.12. 1.101 * Measurement accuracy 15 201.12. 1.101.1 General .

48、15 201.12. 1.101.2 * DRIFT of MEASUREMENT ACCURACY 16 201.12. 1.101.3 * MEASUREMENT ACCURACY of GAS READINGS for gas mixtures .17 201.12. 1.102 * TOTAL SYSTEM RESPONSE TIME and rise time .17 201.12. 1.103 * Indication of units of measure for GAS READINGS .18 201.12. 1.104 * Indication of operating m

49、ode 19 201.13 HAZARDOUS SITUATIONS and fault conditions .19 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .19 201.15 Construction of ME EQUIPMENT19 201.15. 3.5.101 * Additional requirements for rough handling 19 201.15. 3.5.101.1 * Shock and vibration .19 201.15. 3.5.101.2 * Shock and vibration for professional transportation .20 201.15. 101 * Mode of operation 21 201.16 ME SYSTEMS 21 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS .21 201.101 * Interfering gas and vapour effects .22 201.102 * Gas leakage.2