EN 60601-2-23-2000 en Medical Electrical Equipment Part 2 Particular Requirements for the Safety Including Essential Performance of Transcutaneous Partial Pressure Monitoring Equip.pdf

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1、BRITISH STANDARD Medical electrical BS EN 60601-2-23:2000 IEC 60601-2-23:1999 equipment - Part 2-23: Particular requirements for the safety, including essential performance, of transcutaneous partial pressure monitoring equipment The European Standard EN 60601-2-232000 has the status of a British St

2、andard ICs 11.040.55 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMIlTED BY COPYRIGHT LAW BS EN 60601-2-23:2000 National foreword This British Standard is the officai English language vemion of EN 60601-2-23:2OOO. It is identical with IEC 60601-2-23 1999. It supersedes BS EN 60601-2-23 1995 and BS

3、 EN 60601-3-1:1997 which are withdrawn. The UK participation in its preparation was entrusted to Technical Committee Cw96, Monitoring equipment, which has the responsibility to: - aid enquirers to understand the text; - present to the responsible intemationaVEuropean committee any enquiries on the i

4、nterpretation, or proposals for change, and keep the UK interests informed - monitor related inteniationa and European developments and promulgate them in the UK A list of organizations represented on this committee can be obtained on request to its secretary. From 1 January 1997, all IEC publicatio

5、ns have the number 6 added to the old number. For instance, IEC 27-1 has been renumbered as IEC 60027-1. For a period of time during the change over from one numbering system to the other, publications may contain identifiers from both systems. Cross-references Attention is drawn to the fact that CE

6、N and CENELEC Standards normally include an annex which lists normative references to internationai publications with their corresponding European publications. The British Standads which implement these international or European publications may be found in the BSI Standards Catalogue under the sec

7、tion entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Elecironic Catalogue. A British Sandard does not purport to include ai the necessary provisions of a contract. Users of British Standards are responsible for their correct application.

8、Compliance with a British Standard does not of itself confer immunity from legal obligations. This British Standard, having been prepared under the direction of the Health and Environment Sector Committee, was published under the authority of the Standards Committee and comes into effect on 15 June

9、ZOO0 Summary of pages This document comprises a front cover, an inside front cover, the EN title page, the EN foreword page, pages 3 to 35, the annex ZA and ZB pages and a back cover. The BSI copynght notice displayed in this document indicates when the docunient was last issued. Amendments issued s

10、ince publication IDae I ISBN O 580 34057 O STD-BSI BS EN bObO3-2-23-ENGL 2000 m 3b24bb7 0853832 587 m EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 6060 1 -2-23 March 2000 ICs 11.040.55 Supersedes EN 60601 -2-23: 1997 English version Medical electrical equipment Part 2-23: Particular requirem

11、ents for the safety, including essential performance, of transcutaneous partial pressure monitoring equipment (IEC 60601 -2-23: 1 999) Appareils lectromdicaux Medizinische elektrische Gerte Partie 2-23: Rgles particulires de Teil 2-23: Besondere Festlegungen scurit et performances essentielles fr di

12、e Sicherheit einschlielich des appareils de surveillance de wesentlicher Leistungsmerkmale la pression partielle transcutane von Gerten fr die transkutane (CE1 60601 -2-23:1999) Partialdruckberwachung (IEC 60601 -2-231999) This European Standard was approved by CENELEC on 2000-01-01. CENELEC members

13、 are bound to comply with the CENICENELEC 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

14、to the Central Secretariat or to any CENELEC 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 CENELEC member into its own language and notified to the Central Secretariat has

15、the same status as the official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CE

16、NELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue de Stassari 35, B - 1050 Brussels 2000 CENELEC - All rights of exploitation in any form and by any means reserved wo

17、rldwide for CENELEC members. Ref. No. EN 60601-2-23:2000 E EN 60601-2-23:ZOOO Fore word The text of document 62D/335/FDIS, future edition 2 of IEC 60601-2-23, prepared by SC 62D, Electromedical equipment, of IEC TC 62, Electrical equipment in medical practice, was submitted to the IEC-CENELEC parall

18、el vote and was approved by CENELEC as EN 60601 -2-23 on 2000-01 -01. This European Standard supersedes EN 60601 -2-23: 1 997. This European Standard also covers the scope of EN 60601 -3-1 :1996. The following dates were fixed: - latest date by which the EN has to be implemented at national level by

19、 publication of an identical national standard or by endorsement (dop) 2000- 1 0-01 - latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 2003-0 1 -0 1 Annexes designated “normative“ are part of the body of the standard. Annexes designated “informative“ are

20、 given for information only. In this standard, annex ZA is normative and annexes AA and ZB are informative. Annexes ZA and ZB have been added by CENELEC. Endorsement notice The text of the International Standard IEC 60601 -2-23:1999 was approved by CENELEC as a European Standard without any modifica

21、tion. STD-BSI BS EN bbl-2-23-ENGL 2000 E Lb24bb 065Lb39 351 E Page 3 EN 60601-2-23:2000 CONTENTS Page SECTION ONE - GENERAL 1 Scope and object . 4 2 Terminology and definitions . 5 3 General requirements 8 4 General requirements for tests . 8 5 Classification . 8 6 Identification, marking and docume

22、nts . 9 SECTION TWO - ENVIRONMENTAL CONDITIONS SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS 14 20 Dielectric strength . 1 O Requirements related to classification 1 O 17 Separation 10 SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS 21 Mechanical strength 10 SECTION FIVE - PROTECTIO

23、N AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION *36 Electromagnetic compatibility 11 SECTION SIX - PROTECTION AGAINST THE HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES ANDOTHERSAFETYHAZARDS 42 Excessive temperatures . 14 44 Ove

24、rflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization, disinfection and compatibility . 15 49 Interruption of the power supply . 15 SECTION EIGHT -ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT 51 Protection against hazardous output 17 SECTION NINE - ABN

25、ORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS 52 Abnormal operation and fault conditions . 23 I SECTION TEN - CONSTRUCTIONAL REQUIREMENTS 56 57 MAINS PARTS, components and layout . 24 Components and general assembly . 23 O BSI 06-2000 Page 4 EN 60601-2-23:2000 Figure 101 - TRANSDUCER cab

26、le strain relief test . 24 Figure 102 - Foam block test . 25 Figure 103a - Linearity and hysteresis test Set-up - Gas mix chamber, assembled 26 Figure 103b - Linearity and hysteresis test Set-up - Gas mix chamber, manufacturing dimensions. . ._. . . . . . . . . . ._ . _. . . . ._. . . . . . . . . .

27、. . . . . . . . . . 27 Figure 103c - Linearity and hysteresis test set-up - Gas mix chamber, dimensions of hose connector 28 Figure 104 - EMC test Set-up for conducted and radiated emission, and radiated immunity test . 29 Appendix L (normative) References - Publications mentioned in this standard 3

28、0 Annex AA (informative) General guidance and rationale . . 31 Annex ZA (normative) Normative references to international publications with their corresponding European publicatins . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

29、 . . . . . . . . .32 Annex ZB (informative) Other international publications mentioned in this standard with the references of the relevant European publications . . . . . . . . . . . . . . . . . . . 33 O BSI 06-2000 Page 6 EN 60601-2-23:2000 MEDICAL ELECTRICAL EQUIPMENT - Part 2-23: Particular requ

30、irements for the safety, including essential performance, of transcutaneous partial pressure monitoring equipment SECTION ONE - GENERAL The clauses and subclauses of the General Standard apply except as follows: 1 Scope and object This clause of the General Standard applies except as follows: *1.1 S

31、cope Addition This Particular Standard specifies requirements for the safety, including essential in 2.101 and hereinafter referred to as EQUIPMENT, whether this EQUIPMENT is stand alone or part of a system. performance, Of TRANSCUTANEOUS PARTIAL PRESSURE MONITORING EQUIPMENT, as defined It applies

32、to transcutaneous monitors used with adults, children and neonates, and it includes the use of these devices in foetal monitoring during birth. It does not apply to haemoglobin saturation oximeters or to devices applied to surfaces of the body other than the skin (for example conjunctiva, mucosa). 1

33、.2 Object Replacement: The object of this Particular Standard is to establish particular requirements for the safety, including essential performance, Of TRANSCUTANEOUS PARTIAL PRESSURE MONITORING EQUIPMENT as defined in 2.101. 1.3 Particular standards Addition: This Particular Standard amends and s

34、upplements a set of IEC publications consisting of: IEC 60601-1 :1988, Medical electrical equipment - Part I: General requirements for safety, amendment 1, amendment 2, IEC 60601-1-2:1993, Medical electrical equipment - Part 7: General requirements for safety - 2. Collateral Standard: Electromagneti

35、c compatibility - Requirements and tests and IEC 60601-1-4:1996, Medical electrical equipment - Part I: General requirements for safety - 4. Collateral Standard: Programmable electrical medical systems. O BSI 06-2000 STD=BSI BS EN bObO3-2-23-ENGL 2000 II Lb24bb7 0853837 ObO Page 6 EN 60601-2-23:2000

36、 For brevity, IEC 60601-1 is referred to, in this Particular Standard, either as the “General Standard“ or as the “General Requirement(s)“. The term “this Standard“ covers the Particular Standard used together with the General Standard and any Collateral Standards. The numbering of sections, clauses

37、 and subclauses of this Particular Standard corresponds with that of the General Standard. 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 is replaced completely by the text of t

38、his Particular Standard. “Addition“ means that the text of this Particular Standard is additional to the requirements of the General Standard. “Amendment“ means that the clause or subclause of the General Standard is amended as indicated by the text of this Particular Standard. Subclauses or figures

39、 which are additional to those of the General Standard are numbered starting from 101, additional annexes are lettered AA, BE, etc., and any additional items aa), bb), etc. Clauses and subclauses for which there is a rationale are marked with an asterisk*. These rationales can be found in an informa

40、tive annex AA. Annex AA should be used in determining the relevance of the requirements addressed, but should never be used to establish additional test requirements. Where there is no corresponding section, clause or subclause in this Particular Standard, the section, clause or subclause of the Gen

41、eral Standard or Collateral Standard applies without modification. Where it is intended that any part of the General Standard or Collateral Standard, although possibly relevant, is not to be applied, a statement to that effect is given in this Particular Standard. A requirement of this Particular St

42、andard replacing or modifying requirements of the General Standard or Collateral Standard takes precedence over the corresponding General Requirement(s). 2 Terminology and definitions This clause of the General Standard applies except as follows: 2.1.5 APPLIED PART Replacement: TRANSDUCER and its co

43、nnecting lead. Additional definitions: O BSI 06-2000 STD.BS1 BS EN bObO3-2-23-ENGL 2000 Lb2LibbS 0853838 TT7 = Page 7 EN 60601-2-23:2000 2.101 device and associated TRANSDUCERS for the monitoring of partial pressures of oxygen and/or carbon dioxide at the skin surface TRANSCUTANEOUS PARTIAL PRESSURE

44、 MONITORING EQUIPMENT (EQUIPMENT) O BSI 06-2000 STDaBSI BS EN bOb01-2-23-ENGL 2000 Lb2qbb7 0851837 733 Page 8 EN 60601-2-232000 2.102 TRANSDUCER device for converting the partial pressure of a gas into a signal for monitoring or recording 2.103 TEMPERATURE LIMITER means Of limiting the temperature o

45、f the APPLIED PART INTERFACE 2.104 SET TEMPERATURE desired applied part interface temperature 2.105 WARNING SIGNAL means of signalling a predetermined state of a physiological parameter or EQUIPMENT 2.106 that portion of the APPLIED PART intended to come into contact with the PATIENTS skin APPLIED P

46、ART INTERFACE 2.2.102 MULTIFUNCTION PATIENT MONITORING EQUIPMENT stationary or mobile EQUIPMENT powered by an electrical power source and including one or more physiological monitoring units designed to collect information from a PATIENT, process it and generate ALARMS 2.12.101 ALARM signai which in

47、dicates abnormal events occurring to the PATIENT or EQUIPMENT 2.12.1 02 PHYSIOLOGICAL ALARM signal which either indicates that a monitored physiological parameter is out of the specified limits or indicates an abnormal PATIENT condition 2.1 2.1 03 TECHNICAL ALARM signal which indicates that an EQUIP

48、MENT is not capable of accurately monitoring or no longer monitors the PATIENTS condition 2.12.104 SILENCING stopping an auditory ALARM manifestation by manual action 2.12.105 SILENCINGIRESET stopping a visual and/or auditory ALARM manifestation and re-enabling the equipment response to an abnormal

49、PATIENT condition 2.1 2.1 06 INHIBITION disabling, or SILENCING and disabling, an ALARM until intentionally revoked O BSI 06-2000 STD-BSI BS EN bObOl-2-23-ENGL 2000 Lb24bb 0853840 b55 Page 9 EN 60601-2-23:2000 2.12.107 SUSPENSION disabling, or SILENCING and disabling, an ALARM temporarily 2.12.108 LATCHEDALARM an ALARM, the visual and auditory manifestation of which does not stop when the parameter returns to a value which no longer exceeds the ALARM limit or when the abnormal PATIENT condition does not exist any longer 2.12.109