EN ISO 80601-2-61-2011 en Medical electrical equipment - Part 2-61 Particular requirements for basic safety and essential performance of pulse oximeter equipment《医用电气设备 第2-61部分 脉氧仪.pdf

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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 80601-2-61:2011Medical electrical equipmentPart 2-61: Particular requirements for basicsafety and essential performance of pulseoximeter equipment (ISO 80601-2-61:2011)

2、BS EN ISO 80601-2-61:2011 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO80601-2-61:2011. It supersedes BS EN ISO 9919:2009 which iswithdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/121/5, Lung ventilators, tracheal tub

3、es and relatedequipment.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 responsible for its correctapplication. BSI 2011ISBN 978 0 580 63052 1ICSComplian

4、ce with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 August 2011.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN IS

5、O 80601-2-61 April 2011 ICS 11.040.10 Supersedes EN ISO 9919:2009English Version Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601-2-61:2011) Appareils lectromdicaux - Partie 2-61: Exigences particulire

6、s pour la scurit de base et les performances essentielles pour les oxymtres de pouls (ISO 80601-2-61:2011) Medizinische elektrische Gerte - Teil 2-61: Besondere Festlegungen fr die Sicherheit einschlielich der wesentlichen Leistungsmerkmale von Pulsoximetriegerten (ISO 80601-2-61:2011) This European

7、 Standard was approved by CEN on 17 March 2011. CEN members are 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 concern

8、ing such national standards may be obtained on application to 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

9、its own language and notified to the CEN-CENELEC Management Centre 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

10、, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, 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,

11、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 ISO 80601-2-61:2011: EBS EN ISO 80601-2-61:2011EN ISO 80601-2-61:2011 (E) 3 Foreword This document (EN ISO 80601-2-61:2011) has been prepared by Technical Committ

12、ee 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 of a national standard, either by publication of an identical t

13、ext or by endorsement, at the latest by October 2011, and conflicting 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 respon

14、sible for identifying any or all such patent rights. This document supersedes EN ISO 9919:2009. 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 wi

15、th 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 Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech

16、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 United Kingdom. Endorsement notice The text of ISO 80601-2-61:2

17、011 has been approved by CEN as a EN ISO 80601-2-61:2011 without any modification. BS EN ISO 80601-2-61:2011EN ISO 80601-2-61:2011 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC This European Standard has been prepare

18、d 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 the approximation of the laws of the Member States concerning med

19、ical 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 clauses of this standard given in Table ZA.1 confers, within the

20、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 93/42/EEC Clause(s)/sub-clause(s) of this European standard Essent

21、ial requirements (ERs) of EU Directive 93/42/EEC Qualifying remarks/Notes all 1, 2, 3 201.4 1, 2, 3, 6 201.4.3 1, 2201.4.101 2, 3201.4.102 3, 6 201.4.103 6, 9.1201.7 12.9, 13201.7.2.3 13.2, 13.3 j), 13.3 k) 201.7.2.9 2, 9.1, 13.1 201.7.2.13.101 13.3 k)201.7.2.17.101 8.3, 13.1, 13.2, 13.3 b), 13.3 d)

22、, 13.3 f), 13.5 201.7.2.101 9.1, 12.4, 13.2, 13.3 b), 13.3 d), 13.3 e), 13.3 f), 13.3 k), 13.5 201.7.2.4.101 13.3 e), 13.3 i) 201.7.4.3 10.3201.7.9.1 13.3.a)201.7.9.2.1.101 6, 13.6 201.7.9.2.1.101 a), 201.7.9.2.1.101 b) 13.4 201.7.9.2.1.101 c) 11.4.1, 13.6 j) 201.7.9.2.1.101 d) 13.6 b) 201.7.9.2.1.1

23、01 e) 13.6 b), 13.6 p) 201.7.9.2.1.101 f) 13.4 BS EN ISO 80601-2-61:2011EN ISO 80601-2-61:2011 (E) 5 Table ZA.1 (continued) Clause(s)/sub-clause(s) of this European standard Essential requirements (ERs) of EU Directive 93/42/EEC Qualifying remarks/Notes 201.7.9.2.1.101 g) 13.6 c) 201.7.9.2.1.101 h)

24、13.6 h) 201.7.9.2.1.101 i) 13.6 q) 201.7.9.2.2.101 13.6 c), 13.6 d) 201.7.9.2.8.101 13.6 i)201.7.9.2.9.101 b) 13.6 a) 201.7.9.2.9.101 c), d) “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subclauses of Clause 7). References to clauses within this standard are p

25、receded by the term “Clause” followed by the clause number. References to subclauses within this standard are by number only. In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the conditions is true. The verbal forms used in this standar

26、d conform to usage described in Annex H of the ISO/IEC Directives, Part 2. For the purposes of this standard, the auxiliary verb: BS EN ISO 80601-2-61:2011ISO 80601-2-61:2011(E) ISO 2011 All rights reserved vii “shall” means that compliance with a requirement or a test is mandatory for compliance wi

27、th this standard; “should” means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this standard; “may” is used to describe a permissible way to achieve compliance with a requirement or test. An asterisk (*) as the first character of a title or at t

28、he beginning of a paragraph or table title indicates that there is guidance or rationale related to that item in Annex AA. The attention of Member Bodies and National Committees is drawn to the fact that equipment manufacturers and testing organizations may need a transitional period following publi

29、cation of a new, amended or revised ISO or IEC publication in which to make products in accordance with the new requirements and to equip themselves for conducting new or revised tests. It is the recommendation of the committee that the content of this publication be adopted for implementation natio

30、nally not earlier than 3 years from the date of publication for equipment newly designed and not earlier than 5 years from the date of publication for equipment already in production. BS EN ISO 80601-2-61:2011ISO 80601-2-61:2011(E) viii ISO 2011 All rights reservedIntroduction The approximation of a

31、rterial haemoglobin saturation and pulse rate using pulse oximetry is common practice in many areas of medicine. This standard covers BASIC SAFETY and ESSENTIAL PERFORMANCE requirements achievable within the limits of existing technology. Annex AA contains a rationale for some of the requirements. I

32、t is included to provide additional insight into the reasoning of the committee that led to a requirement and identifying the HAZARDS that the requirement addresses. Annex BB is a literature survey relevant to the determination of the maximum safe temperature of the interface between a PULSE OXIMETE

33、R PROBE and a PATIENTS tissue. Annex CC discusses both the formulae used to evaluate the SpO2ACCURACY of PULSE OXIMETER EQUIPMENT measurements, and the names that are assigned to those formulae. Annex DD presents guidance on when in vitro blood calibration of PULSE OXIMETER EQUIPMENT is needed. Anne

34、x EE presents a guideline for a CONTROLLED DESATURATION STUDY for the calibration of PULSE OXIMETER EQUIPMENT. Annex FF is a tutorial introduction to several kinds of testers used in pulse oximetry. Annex GG describes concepts of PULSE OXIMETER EQUIPMENT response time. BS EN ISO 80601-2-61:2011INTER

35、NATIONAL STANDARD ISO 80601-2-61:2011(E) ISO 2011 All rights reserved 1Medical electrical equipment Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment 201.1 Scope, object and related standards IEC 60601-1:2005, Clause 1 applies, except as follow

36、s: 201.1.1 * Scope Subclause 1.1 of The general standard is replaced by: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of PULSE OXIMETER EQUIPMENT intended for use on humans, hereafter referred to as ME EQUIPMENT. This includes any part necessary for NORMAL USE, i

37、ncluding the PULSE OXIMETER MONITOR, PULSE OXIMETER PROBE, and PROBE CABLE EXTENDER. These requirements also apply to PULSE OXIMETER EQUIPMENT, including PULSE OXIMETER MONITORS, PULSE OXIMETER PROBES and PROBE CABLE EXTENDERS, which have been REPROCESSED. The intended use of PULSE OXIMETER EQUIPMEN

38、T includes, but is not limited to, the estimation of arterial oxygen haemoglobin saturation and pulse rate of PATIENTS in professional healthcare institutions as well as PATIENTS in the HOME HEALTHCARE ENVIRONMENT. This International Standard is not applicable to PULSE OXIMETER EQUIPMENT intended fo

39、r use in laboratory research applications nor to oximeters that require a blood sample from the PATIENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the c

40、ase, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 201.11 and in 7.2.13 a

41、nd 8.4.1 of the general standard. NOTE See also 4.2 of the general standard. This standard can also be applied to PULSE OXIMETER EQUIPMENT and their ACCESSORIES used for compensation or alleviation of disease, injury or disability. This International Standard is not applicable to PULSE OXIMETER EQUI

42、PMENT intended solely for foetal use. This International Standard is not applicable to remote or slave (secondary) devices that display SpO2values that are located outside of the PATIENT ENVIRONMENT. 201.1.2 Object Subclause 1.2 of The general standard is replaced by: The object of this particular s

43、tandard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for PULSE OXIMETER EQUIPMENT as defined in 201.3.216 and its ACCESSORIES. BS EN ISO 80601-2-61:2011ISO 80601-2-61:2011(E) 2 ISO 2011 All rights reservedNOTE ACCESSORIES are included because the combination of the

44、PULSE OXIMETER MONITOR and the ACCESSORIES needs to be safe. ACCESSORIES can have a significant impact on the BASIC SAFETY and ESSENTIAL PERFORMANCE of PULSE OXIMETER EQUIPMENT. 201.1.3 Collateral standards IEC 60601-1:2005, subclause 1.3 applies with the following addition: This particular standard

45、 refers to those applicable collateral standards that are listed in Clause 2 of the general standard and Clause 201.2 of this particular standard. IEC 60601-1-3 does not apply. NOTE Additional requirements for ME EQUIPMENT and ME SYSTEMS intended for use in the HOME HEALTHCARE ENVIRONMENT are found

46、in IEC 60601-1-11. 201.1.4 Particular standards Subclause 1.4 of The general standard is replaced by: In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in the general standard as appropriate for the particular ME EQUIPMENT under consideration, and may

47、 add other BASIC SAFETY and ESSENTIAL PERFORMANCE requirements. A requirement of a particular standard takes priority over the general standard. For brevity, IEC 60601-1 is referred to in this particular standard as the general standard. Collateral standards are referred to by their document number.

48、 The numbering of sections, clauses and subclauses of this particular standard corresponds to that of the general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x” where x is

49、the final digit(s) of the collateral standard document number (202.4 in this particular standard addresses the content of Clause 4 of the 60601-1-2 collateral standard, 208.6 in this particular standard addresses the content of Clause 6 of the 60601-1-8 collateral standard, etc.). The changes to the text of the general standard are specified by the use of the following words: “Replacement“ means that the clause or subclause of the general standard or applicable collateral standard is replaced completely by the text of this particular standar