BS EN 60601-2-24-1998 Medical electrical equipment - Particular requirements for safety - Particular requirements for the safety of infusion pumps and controllers《医疗电气设备 详细安全性要求 输液.pdf

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1、BRITISH STANDARD BS EN 60601-2-24:1998 BS 5724-2-124: 1998 IEC 60601-2-24: 1998 Incorporating Corrigendum No. 1 Medical electrical equipment Part 2: Particular requirements for the safety of infusion pumps and controllers The European Standard EN60601-2-24:1998 has the status of a British Standard I

2、CS 11.040.20BSEN60601-2-24:1998 This British Standard, having been prepared under the directionof the Health and Environment Sector Board, waspublished under the authorityof the Standards Boardand comes into effect on 15 June 1998 BSI 05-1999 ISBN 0 580 29663 6 National foreword This British Standar

3、d is the English language version of EN 60601-2-24:1998. It is identical with IEC 60601-2-24:1998. The UK participation in its preparation was entrusted to Technical Committee CH/115, Infusion pumps and controllers, which has the responsibility to: aid enquirers to understand the text; present to th

4、e responsible European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. A list of organizations represented on this committee can be obtained on request t

5、o its secretary. From 1 January 1997, all IEC publications have the number 60000 added to the old number. For instance, IEC 27-1 has been renumbered as IEC60027-1. For a period of time during the change over from one numbering system to the other, publications may contain identifiers from both syste

6、ms. Cross-references Attention is drawn to the fact that CEN and CENELEC standards normally include an annex which lists normative references to international publications with their corresponding European publications. The British Standards which implement international or European publications ref

7、erred to in this document may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary provisions of a

8、 contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, the EN title page, pages 2

9、 to 54, an inside back cover and a back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover. Amendments issued since publication Amd. No. Date Comments 10114 Corr. No. 1 July 1998

10、 Indicated by a sideline in the marginBSEN60601-2-24:1998 BSI05-1999 i Contents Page National foreword Inside front cover Foreword 2 Text of EN 60601-2-24 5ii blankEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 60601-2-24 April 1998 ICS 11.040.20 Descriptors: Medical electrical equipment, infu

11、sion pump, infusion controller, safety requirements, protection against electric shock, protection against mechanical hazard, radiation protection, fire protection, environmental conditions English version Medical electrical equipment Part 2: Particular requirements for the safety of infusion pumps

12、and controllers (IEC 60601-2-24:1998) Appareils lectromdicaux Partie 2: Rgles particulires de scurit des pompes et rgulateurs de perfusion (CEI 60601-2-24:1998) Medizinische elektrische Gerte Teil 2: Besondere Festlegungen fr die Sicherheit von Infusionspumpen und Steuergerten (IEC 60601-2-24:1998)

13、This European Standard was approved by CENELEC on 1998-04-01. CENELEC 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

14、references concerning such national standards may be obtained on application 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 CENE

15、LEC member into its own language and notified to the Central Secretariat has 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, Net

16、herlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B-1050 Brussels 1998 CE

17、NELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 60601-2-24:1998 EEN60601-2-24:1998 BSI05-1999 2 Foreword The text of document 62D/250/FDIS, future edition1 of IEC60601-2-24, prepared by SC 62D, Electromedical equipment, of IECTC 62, E

18、lectrical equipment in medical practice, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN60601-2-24 on 1998-04-01. The following dates were fixed: CLC/TC62 notes to the text of IEC 60601-2-24: 1) Where the phrase “ISO class III water for medical use” is used it should

19、 be replaced by “water, Grade III, according to ISO 3696”. 2) InFigure 104b the syringe used in the test procedure needs to comply with ISO7886-2. Endorsement notice The text of the International Standard IEC60601-2-24:1998 was approved by CENELEC as a European Standard without any modification. Con

20、tents Page Foreword 2 Introduction 5 Section 1. General 1 Scope and object 6 2 Terminology and definitions 7 3 General requirements 9 5 Classification 10 6 Identification, marking and documents 10 Section 2. Environmental Conditions 10 Environmental conditions 12 Section 3. Protection against electr

21、ic shock hazards 14 Requirements related to classification 12 17 Separation 12 19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS 12 Section 4. Protection against mechanical hazards 21 Mechanical strength 14 Section 5. Protection against hazards from unwanted or excessive radiation 36 Ele

22、ctromagnetic compatibility 14 Section 6. Protection against hazards of ignition of flammable anaesthetic mixtures Section 7. Protection against excessive temperatures and other safety hazards 44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization, disinfection and comp

23、atibility 16 47 Electrostatic charges 17 49 Interruption of the power supply 17 Section 8. Accuracy of operating data and protection against hazardous output 50 Accuracy of operating data 17 51 Protection against hazardous output 34 Section 9. Abnormal operation and fault conditions: environmental t

24、ests Section 10. constructional requirements 54 General 37 56 Components and general assembly 38 Annex L References Publications mentioned in this standard 39 Annex AA (informative) General guidance and rationale 40 latest date by which the EN has to be implemented at national level by publication o

25、f an identical national standard or by endorsement (dop) 1999-01-01 latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 2001-01-01EN60601-2-24:1998 BSI05-1999 3 Page Annex ZA (noramative) Normative references to international publications with their corresp

26、onding European publications 54 Annex ZB (informative) Other international publications mentioned in this standard with the references of the relevant European publications Inside back cover Figure 101 PATIENT LEAKAGE CURRENT external power supply 13 Figure 102 PATIENT LEAKAGE CURRENT INTERNAL ELECT

27、RICAL POWER SOURCE 13 Figure 103 Analysis periods 21 Figure 104a Test apparatus for VOLUMETRIC INFUSION PUMPS and VOLUMETRIC INFUSION CONTROLLERS 22 Figure 104b Test apparatus for SYRINGE PUMPS 22 Figure 105 Start-up graph plotted from data gathered during the first 2h of the test period 23 Figure 1

28、06 Trumpet curve plotted from data gathered during the second hour of the test period 23 Figure 107 Trumpet curve plotted from data gathered during the last hour of the ADMINISTRATION SET CHANGE INTERVAL 23 Figure 108 Test apparatus for DRIP-RATE INFUSION PUMPS and DRIP-RATE INFUSION CONTROLLERS 25

29、Figure 109 Start-up graph plotted from data gathered during the first 2h of the test period 25 Figure 110 Start-up graph over the stabilization period 28 Figure 111 Trumpet curve plotted from data at the end of the stabilization period 28 Figure 112 Start-up curve over the stabilization period for q

30、uasi-continuous output pumps 29 Figure 113 Trumpet curve plotted from data at the end of the stabilization period for quasi-continuous pumps 29 Figure 114 Test apparatus to determine the OCCLUSION ALARM THRESHOLD (PRESSURE) and BOLUS volumes 36 Figure AA.3.1 Start-up graph 46 Figure AA.3.2 Trumpet c

31、urve 46 Figure AA.3.3 Calculation for E p (max.) and E p (min.) 49 Page Figure AA.4.1 Sampling protocol 50 Figure AA.4.2 Observation windows 51 Figure AA.4.3 Distribution of parent variate X 51 Figure AA.4.4 Distribution of observation windows 52 Figure AA.4.5 The statistical trumpet graph 52 Table

32、101 Vibration value 14 Table 102 Set rates, BOLUS volumes and test apparatus for the accuracy tests of 50.102 to 50.108 344 blankEN60601-2-24:1998 BSI05-1999 5 Introduction This Particular Standard deals with the safety of INFUSION PUMPS and CONTROLLERS. The relationship between this Particular Stan

33、dard, IEC60601-1 (including amendments 1 and 2), and the Collateral Standards is explained in 1.3. The safe use of infusion pumps and controllers is primarily the responsibility of the OPERATOR. It is also recognized that OPERATORS should be trained in the operation of MEDICAL ELECTRICAL EQUIPMENT a

34、nd that safe use of the EQUIPMENT can only be achieved if it is operated in accordance with the manufacturers instructions for use. The minimum specified, safety requirements are considered to provide a practical degree of safety in operation. It is the responsibility of the manufacturer to ensure t

35、hat the requirements of this Particular Standard are reliably implemented. This Particular Standard has been developed in accordance with these principles. Safe use can be ensured only if the associated disposable parts, especially lines and syringes are consistent with the system. ISO 7886-2:1996,

36、Sterile hypodermic syringes for single use Part 2: Syringes for use with power-driven syringe pumps should be taken into account.EN60601-2-24:1998 6 BSI05-1999 Section 1. General The clauses and subclauses of this section of the General Standard and of this section of the Collateral Standard IEC 606

37、01-1-2 apply, except as follows: 1 Scope and object This clause of the General Standard and this clause of the Collateral Standard IEC60601-1-2 apply, except as follows: 1.1 Scope* Addition: This Particular Standard specifies the requirement for INFUSION PUMPS, INFUSION CONTROLLERS, SYRINGE PUMPS an

38、d PUMPS FOR AMBULATORY USE, as defined in 2.101 to 2.110. These devices are intended for use by medical staff and home PATIENTS as prescribed and medically indicated. These particular requirements do not apply to devices: 1) specifically intended for diagnostic or similar use (e.g. angiography or ot

39、her pumps permanently controlled or supervised by the OPERATOR), 2) enteral infusion, 3) extracorporeal circulation of blood, 4) implantable or disposable devices, 5) EQUIPMENT specifically intended for diagnostic use within urodynamics (measurement of pressure-volume relationship of the urinary bla

40、dder when filled through a catheter with water); 6) EQUIPMENT specifically intended for diagnostic use within male impotence testing (measurement of amount of liquid infused, necessary to maintain a preset pressure level for maintaining penile erection: cavernosometry, cavernosography). 1.3 Particul

41、ar standards Addition: This Particular Standard refers to IEC60601-1:1988, Medical electrical equipment Part 1: General requirements for safety as amended by its amendment 1 (1991) and amendment 2 (1995) and to the Collateral Standard IEC 60601-1-2:1993, Medical electrical equipment Part 1: General

42、requirements for safety 2. Collateral Standard: Electromagnetic compatibility Requirements and tests. For brevity, Part 1 is referred to in this Particular Standard either as the General Standard or as the General Requirement(s) and IEC60601-1-2 as the Collateral Standard. The numbering of sections,

43、 clauses and subclauses of this Particular Standard corresponds to 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 tex

44、t of this 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 f

45、igures which are additional to those of the General Standard are numbered starting from101, additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc. The term “this Standard” is used to make reference to the General Standard, the Collateral Standard and this Particular Standa

46、rd taken together. Where there is no corresponding section, clause or subclause in this Particular Standard, the section, clause or subclause of the General Standard, although possibly not relevant, applies without modification; where it is intended that any part of the General Standard, although po

47、ssibly relevant, is not to be applied, a statement to that effect is given in this Particular Standard. The requirements of this Particular Standard take priority over those of the General Standard. The requirements are followed by specifications for the relevant tests.EN60601-2-24:1998 BSI05-1999 7

48、 Following the decision taken by subcommittee 62D at the meeting in Washington in 1979, a “General guidance and rationale” section giving some explanatory notes, where appropriate, about the more important requirements is included in Annex AA. Clauses or subclauses for which there are explanatory no

49、tes in Annex AA are marked with an asterisk (*). It is considered that a knowledge of the reasons for these requirements will not only facilitate the proper application of the standard but will, in due course, expedite any revision necessitated by changes in clinical practice or as a result of developments in technology. However, this annex does not form part of the requirements of this Standard. 1.5 Collateral Standards Addition: This Particular Standard also refers to IEC60601-1-2,