UL 60601-1-2003 UL Standard for Safety Medical Electrical Equipment Part 1 General Requirements for Safety (First Edition Reprint with Revisions Through and Including April 26 2006_1.pdf

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1、UL COPYRIGHTED MATERIAL NOT AUTHORIZED FOR FURTHER REPRODUCTION ORDISTRIBUTION WITHOUT PERMISSION FROM ULUL 60601-1ISBN 0-7629-0848-3Medical Electrical Equipment,Part 1: General Requirementsfor SafetyUL COPYRIGHTED MATERIAL NOT AUTHORIZED FOR FURTHER REPRODUCTION ORDISTRIBUTION WITHOUT PERMISSION FR

2、OM ULUL COPYRIGHTED MATERIAL NOT AUTHORIZED FOR FURTHER REPRODUCTION ORDISTRIBUTION WITHOUT PERMISSION FROM ULUnderwriters Laboratories Inc. (UL)333 Pfingsten RoadNorthbrook, IL 60062-2096UL Standard for Safety for Medical Electrical Equipment, Part 1: General Requirements for Safety, UL60601-1First

3、 Edition, Dated April 25, 2003Revisions: This Standard contains revisions through and including April 26, 2006.Summary of TopicsThese editorial revisions to UL 60601-1 replace all references to UL 1020, the Standard forThermal Cutoffs for Use in Electrical Appliances and Components, with reference t

4、o UL 60691,the Standard for Thermal-Links Requirements and Application Guide. UL 1020 was withdrawnand superseded by UL 60691.Announcement Bulletin(s): This Standard contains the announcement bulletin(s) dated July 16, 1997, May10, 1999 and June 16, 2000. The announcement bulletin is located at the

5、end of the Standard (after theadoption bulletin(s).UL Standards for Safety are developed and maintained in the Standard Generalized Markup Language(SGML). SGML - an international standard (ISO 8879-1986) - is a descriptive markup language thatdescribes a documents structure and purpose, rather than

6、its physical appearance on a page. Due toformatting differences resulting from the use of ULs new electronic publishing system, please note thatadditional pages (on which no requirements have been changed) may be included in revision pages dueto relocation of existing text and reformatting of the St

7、andard.Text that has been changed in any manner is marked with a vertical line in the margin. Changes inrequirements are marked with a vertical line in the margin and are followed by an effective date noteindicating the date of publication or the date on which the changed requirement becomes effecti

8、ve.The revisions dated April 26, 2006 include a reprinted title page (page1) for this Standard.The revisions dated April 26, 2006 editorially replace all references to UL 1020 with the reference to UL60691.The UL Foreword is no longer located within the UL Standard. For information concerning the us

9、e andapplication of the requirements contained in this Standard, the current version of the UL Foreword islocated on ULStandardsInfoNet at: http:/ master for this Standard at ULs Northbrook Office is the official document insofar as it relates to aUL service and the compliance of a product with resp

10、ect to the requirements for that product and service,or if there are questions regarding the accuracy of this Standard.ULs Standards for Safety are copyrighted by UL. Neither a printed copy of a Standard, nor the distributiondiskette for a Standard-on-Diskette and the file for the Standard on the di

11、stribution diskette should bealtered in any way. All of ULs Standards and all copyrights, ownerships, and rights regarding thoseStandards shall remain the sole and exclusive property of UL.APRIL 26, 2006 UL 60601-1 tr1UL COPYRIGHTED MATERIAL NOT AUTHORIZED FOR FURTHER REPRODUCTION ORDISTRIBUTION WIT

12、HOUT PERMISSION FROM ULAll rights reserved. No part of this publication may be reproduced, stored in a retrieval system, ortransmitted in any form by any means, electronic, mechanical photocopying, recording, or otherwisewithout prior permission of UL.Revisions of UL Standards for Safety are issued

13、from time to time. A UL Standard for Safety is currentonly if it incorporates the most recently adopted revisions.UL provides this Standard as is without warranty of any kind, either expressed or implied, including butnot limited to, the implied warranties of merchantability or fitness for any purpo

14、se.In no event will UL be liable for any special, incidental, consequential, indirect or similar damages,including loss of profits, lost savings, loss of data, or any other damages arising out of the use of or theinability to use this Standard, even if UL or an authorized UL representative has been

15、advised of thepossibility of such damage. In no event shall ULs liability for any damage ever exceed the price paid forthis Standard, regardless of the form of the claim.UL will attempt to answer support requests concerning electronic versions of its Standards. However, thissupport service is offere

16、d on a reasonable efforts basis only, and UL may not be able to resolve everysupport request. UL supports the electronic versions of its Standards only if they are used under theconditions and operating systems for which it is intended. ULs support policies may change fromtime-to-time without notifi

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19、was purchased, one copy of this Standard may be stored onthe hard disk of a single personal computer, or on a single LAN file-server or the permanent storagedevice of a multiple-user computer in such a manner that this Standard may only be accessed by one userat a time and for which there is no poss

20、ibility of multiple concurrent access.If a multiple-user version electronic Standard was purchased, one copy of the Standard may be stored ona single LAN file-server, or on the permanent storage device of a multiple-user computer, or on an Intranetserver. The number of concurrent users shall not exc

21、eed the number of users authorized.Electronic Standards are intended for on-line use, such as for viewing the requirements of a Standard,conducting a word search, and the like. Only one copy of the Standard may be printed from eachsingle-user version of an electronic Standard. Only one copy of the S

22、tandard may be printed for eachauthorized user of a multiple-user version of an electronic Standard. Because of differences in thecomputer/software/printer setup used by UL and those of electronic Standards purchasers, the printedcopy obtained by a purchaser may not look exactly like the on-line scr

23、een view or the printed Standard.An employee of an organization purchasing a UL Standard can make a copy of the page or pages beingviewed for their own fair and/or practical internal use.The requirements in this Standard are now in effect, except for those paragraphs, sections, tables, figures,and/o

24、r other elements of the Standard having future effective dates as indicated in the preface. The priortext for requirements that have been revised and that have a future effective date are located after theStandard, and are preceded by a SUPERSEDED REQUIREMENTS notice.APRIL 26, 2006 UL 60601-1tr2UL C

25、OPYRIGHTED MATERIAL NOT AUTHORIZED FOR FURTHER REPRODUCTION ORDISTRIBUTION WITHOUT PERMISSION FROM ULNew product submittals made prior to a specified future effective date will be judged under all of therequirements in this Standard including those requirements with a specified future effective date

26、, unlessthe applicant specifically requests that the product be judged under the current requirements. However, ifthe applicant elects this option, it should be noted that compliance with all the requirements in thisStandard will be required as a condition of continued Listing, Recognition, Classifi

27、cation and Follow-UpServices after the effective date, and understanding of this should be signified in writing.Copyright 2006 Underwriters Laboratories Inc.APRIL 26, 2006 UL 60601-1 tr3UL COPYRIGHTED MATERIAL NOT AUTHORIZED FOR FURTHER REPRODUCTION ORDISTRIBUTION WITHOUT PERMISSION FROM ULThis Stan

28、dard consists of pages dated as shown in the following checklist:Page Date1-3April 26, 20064-8.June 30, 20039-11 April 25, 200312-13 .June 30, 200314April 26, 200615-16 .April 25, 200317June 30, 200318-19 .April 25, 200320-24BJune 30, 200325April 25, 200326-42BJune 30, 200343April 25, 200344June 30,

29、 200345April 25, 200346-59 .June 30, 200360April 25, 200361June 30, 200362-64 .April 25, 200365June 30, 200366April 25, 200367-70 .June 30, 200371-75 .April 25, 200376June 30, 200377April 25, 200378-79 .June 30, 200380April 25, 200381June 30, 200382April 25, 200383June 30, 200384April 25, 200385-86B

30、June 30, 200387-90 .April 25, 200391-94 .June 30, 200395-98 .April 25, 200399-107 June 30, 2003108-109 .April 25, 2003110.June 30, 2003111-113 .April 25, 2003114-120B .June 30, 2003121.April 25, 2003122-126B .June 30, 2003127.April 25, 2003128-130.June 30, 2003131.April 25, 2003132-132B .June 30, 20

31、03133-134 .April 25, 2003135-141.June 30, 2003142.April 25, 2003143-147.June 30, 2003APRIL 26, 2006 UL 60601-1tr4UL COPYRIGHTED MATERIAL NOT AUTHORIZED FOR FURTHER REPRODUCTION ORDISTRIBUTION WITHOUT PERMISSION FROM UL148-149 .April 25, 2003150-152B .June 30, 2003153.April 25, 2003154-158B .June 30,

32、 2003159-206 .April 25, 2003207.June 30, 2003208-266 .April 25, 2003267.June 30, 2003268-269 .April 25, 2003270.April 26, 2006271-282 .April 25, 2003APRIL 26, 2006 UL 60601-1 tr5UL COPYRIGHTED MATERIAL NOT AUTHORIZED FOR FURTHER REPRODUCTION ORDISTRIBUTION WITHOUT PERMISSION FROM ULAPRIL 26, 2006 UL

33、 60601-1tr6No Text on This PageUL COPYRIGHTED MATERIAL NOT AUTHORIZED FOR FURTHER REPRODUCTION ORDISTRIBUTION WITHOUT PERMISSION FROM ULAPRIL 25, 2003(Title Page Reprinted: April 26, 2006)1UL 60601-1Medical Electrical Equipment, Part 1: General Requirements for SafetyPrior to the first edition of UL

34、 60601-1, the requirements for the products coveredby this Standard were included in UL 2601-1. This Standard replaces UL 2601-1.First EditionApril 25, 2003An effective date included as a note immediately following certain requirementsis one established by Underwriters Laboratories Inc.Revisions of

35、this Standard will be made by issuing revised or additional pagesbearing their date of issue. A UL Standard is current only if it incorporates themost recently adopted revisions, all of which are itemized on the transmittal noticethat accompanies the latest set of revised requirements.ISBN 0-7629-08

36、48-3COPYRIGHT 1994, 2006 UNDERWRITERS LABORATORIES INC.UL COPYRIGHTED MATERIAL NOT AUTHORIZED FOR FURTHER REPRODUCTION ORDISTRIBUTION WITHOUT PERMISSION FROM ULAPRIL 26, 2006UL 60601-12No Text on This PageUL COPYRIGHTED MATERIAL NOT AUTHORIZED FOR FURTHER REPRODUCTION ORDISTRIBUTION WITHOUT PERMISSI

37、ON FROM ULCONTENTSUL INTRODUCTION 11Preface (UL) .12NATIONAL DIFFERENCES 15FOREWORD .16INTRODUCTION .18SECTION ONE GENERAL1 *Scope and object .201.1 Scope 201.2 Object .201.3 *Particular Standards 211.4 Environmental conditions .211.5 Collateral Standards .212 Terminology and definitions+212.1 EQUIP

38、MENT parts, auxiliaries and ACCESSORIES 212.2 EQUIPMENT types (classification) 242.3 Insulation .262.4 Voltages .262.5 Currents 272.6 Earth terminals and conductors .272.7 Electrical connection (devices) 282.8 Transformers 28A2.9 Controls and limiting devices 28A2.10 Operation of EQUIPMENT .28B2.11

39、Mechanical safety 292.12 Miscellaneous .303 General requirements 313.10DV.1 Components 323.10DV.2 Primary circuit components .334 *General requirements for tests 334.1 *Tests 334.2 Repetition of tests .334.3 *Number of samples .334.4 Components 344.5 Ambient temperature, humidity, atmospheric PRESSU

40、RE 344.6 Other conditions .354.7 Supply and test voltages, type of current, nature of supply, frequency .354.8 *Preconditioning .374.9 Repairs and modifications 374.10 *Humidity preconditioning treatment 374.11 Sequence .385 *Classification .386 Identification, marking and documents 39APRIL 26, 2006

41、 UL 60601-1 3UL COPYRIGHTED MATERIAL NOT AUTHORIZED FOR FURTHER REPRODUCTION ORDISTRIBUTION WITHOUT PERMISSION FROM UL6.1 Marking on the outside of EQUIPMENT or EQUIPMENT parts .406.2 Marking on the inside of EQUIPMENT or EQUIPMENT parts .456.3 Marking of controls and instruments .466.4 *Symbols .46

42、B6.5 Colours of the insulation of conductors .46B6.6 Identification of medical gas cylinders and connections 476.7 *Indicator lights and push-buttons .476.8 ACCOMPANYING DOCUMENTS .487 Power input .51SECTION TWO ENVIRONMENTAL CONDITIONS8 *Basic safety categories 529 Removable protective means 5210 E

43、nvironmental conditions 5210.1 Transport and storage 5210.2 Operation .5211 Not used. 5312 Not used. 53SECTION THREE PROTECTION AGAINST ELECTRIC SHOCK HAZARDS13 General 5414 Requirements related to classification .5414.1 CLASS I EQUIPMENT 5414.2 CLASS II EQUIPMENT 5414.4 CLASS I and CLASS II EQUIPME

44、NT 5514.5 INTERNALLY POWERED EQUIPMENT 5514.6 *TYPES B, BF and CF APPLIED PARTS 5515 Limitation of voltage and/or energy 5616 *ENCLOSURES and PROTECTIVE COVERS .5617 *Separation 6118 Protective earthing, functional earthing and potential equalization .6519 Continuous LEAKAGE CURRENTS and PATIENT AUX

45、ILIARY CURRENTS .6719.1 General requirements .6719.2 SINGLE FAULT CONDITIONS .6819.3 *Allowable values 6919.4 Tests .7120 Dielectric strength .7820.1 General requirements for all types of EQUIPMENT .7820.2 Requirements for EQUIPMENT with an APPLIED PART 8020.3 *Values of test voltages .8120.4 Tests

46、.82SECTION FOUR PROTECTION AGAINST MECHANICAL HAZARDS21 Mechanical strength .8322 *Moving parts 8623 Surfaces, corners and edges .8924 Stability in NORMAL USE 8925 Expelled parts 9126 *Vibration and noise .9127 Pneumatic and hydraulic power 91JUNE 30, 2003UL 60601-14UL COPYRIGHTED MATERIAL NOT AUTHO

47、RIZED FOR FURTHER REPRODUCTION ORDISTRIBUTION WITHOUT PERMISSION FROM UL28 Suspended masses .9128.1 General .9128.3 Suspension system with SAFETY DEVICES 9128.4 Suspension systems of metal without SAFETY DEVICES 9228.5 *Dynamic loads 93SECTION FIVE PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSI

48、VERADIATION29 X-Radiation 9330 Alpha, beta, gamma, neutron radiation and other particle radiation 9431 Microwave radiation .9432 Light radiation (including lasers) 9433 Infra-red radiation .9434 Ultraviolet radiation .9435 Acoustical energy (including ultra-sonics) 9436 *Electromagnetic compatibilit

49、y 94SECTION SIX PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETICMIXTURES37 Locations and basic requirements 9538 Marking, ACCOMPANYING DOCUMENTS 9539 Common requirements for CATEGORY AP and CATEGORY APG EQUIPMENT 9639.1 Electrical connections .9639.2 Construction details .9739.3 Prevention of electrostatic charges .9739.4 Corona 9840 Requirements and tests for CATEGORY AP EQUIPMENT, parts and components thereof .9840.1 General .9840.2 Temperature limits 9840.3 *Low-energy cir