UL 60601-1 (ND)-2003 National Differences For UL 60601-1 Medical Electrical Equipment Part 1 General Requirements for Safety (First Edition Reprint with revisions through and inclu.pdf

1、UL COPYRIGHTED MATERIAL NOT AUTHORIZED FOR FURTHER REPRODUCTION ORDISTRIBUTION WITHOUT PERMISSION FROM ULNational Differences ForUL 60601-1Medical Electrical Equipment, Part 1: General Requirements for SafetyUL COPYRIGHTED MATERIAL NOT AUTHORIZED FOR FURTHER REPRODUCTION ORDISTRIBUTION WITHOUT PERMI

2、SSION FROM ULNational Differences ForUL 60601-1Medical Electrical Equipment, Part 1: General Requirements for SafetyEdition: 1Edition Date: April 25, 2003Revision Date: April 26, 2006These editorial revisions to UL 60601-1 replace all references to UL 1020, the Standard forThermal Cutoffs for Use in

3、 Electrical Appliances and Components, with reference to UL 60691,the Standard for Thermal-Links Requirements and Application Guide. UL 1020 was withdrawnand superseded by UL 60691.This document provides a single listing of the National Differences included in the UL adoption ofthe corresponding IEC

4、 standard. Editorial differences appearing in the UL standard are notincluded in this technical compilation. The complete listing of National Differences is available inthe UL standard.The master for this standards document at ULs Northbrook Office is the official standards documentinsofar as it rel

5、ates to a UL service and the compliance of a product with respect to the requirements forthat product and service, or if there are questions regarding the accuracy of this document.ULs standards documents are copyrighted by UL. Neither a printed copy of a standards document, northe electronic file f

6、or a standards document should be altered in any way. All of ULs standards documentsand all copyrights, ownerships, and rights regarding those standards documents shall remain the sole andexclusive property of UL.All rights reserved. No part of this standards document may be reproduced, stored in a

7、retrieval system,or transmitted in any form by any means, electronic, mechanical photocopying, recording, or otherwisewithout prior permission of UL.UL provides this standards document as is without warranty of any kind, either expressed or implied,including but not limited to, the implied warrantie

8、s of merchantability or fitness for any purpose.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 standards document,

9、even if UL or an authorized UL representative has been advisedof the possibility of such damage. In no event shall ULs liability for any damage ever exceed the pricepaid for this standards document, regardless of the form of the claim.UL reserves the right to change the format, presentation, file ty

10、pes and formats, delivery methods andformats, and the like of both its printed and electronic Standards documents without prior notice.APRIL 26, 2006NATIONAL DIFFERENCES FOR UL UL 60601-12UL COPYRIGHTED MATERIAL NOT AUTHORIZED FOR FURTHER REPRODUCTION ORDISTRIBUTION WITHOUT PERMISSION FROM ULPurchas

11、ers of the electronic versions of ULs standards documents agree to defend, indemnify, and holdUL harmless from and against any loss, expense, liability, damage, claim, or judgement (includingreasonable attorneys fees) resulting from any error or deviation introduced while purchaser is storing anelec

12、tronic standards document on the purchasers computer system.If a single-user version electronic standards document was purchased, one copy of this standardsdocument may be stored on the hard disk of a single personal computer, or on a single LAN file-serveror the permanent storage device of a multip

13、le-user computer, or made available through the purchasersIntranet in such a manner that this standards document may only be accessed by one user at a time andfor which there is no possibility of multiple simultaneous, concurrent access.If a multiple-user version electronic standards document was pu

14、rchased, one copy of the standardsdocument may be stored on a single LAN file-server, or on the permanent storage device of amultiple-user computer, or made available through the purchasers Intranet. The number of simultaneous,concurrent users shall not exceed the number of users authorized.Electron

15、ic standards documents are intended for on-line use, such as for viewing the requirements of astandards document, conducting a word search, and the like. Only one copy of the standards documentmay be printed from each single-user version of an electronic standards document. Only one copy of thestand

16、ards document may be printed for each authorized user of a multiple-user version of an electronicstandards document. Because of differences in the computer/software/printer setup used by UL and thoseof electronic standards document purchasers, the printed copy obtained by a purchaser may not lookexa

17、ctly like the on-line screen view or the printed standards document.An employee of an organization purchasing a UL standards document can make a copy of the page orpages being viewed for their own fair and/or practical internal use.Copyright 2006 Underwriters Laboratories Inc.APRIL 26, 2006 NATIONAL

18、 DIFFERENCES FOR UL UL 60601-1 3UL COPYRIGHTED MATERIAL NOT AUTHORIZED FOR FURTHER REPRODUCTION ORDISTRIBUTION WITHOUT PERMISSION FROM ULPrefaceThis document provides a single listing of the technical National Differences included in the UL adoptionof the corresponding IEC standard. Editorial nation

19、al differences (those marked DE) are not included inthis technical compilation.In its IEC-based standards, UL uses the notations indicated below to identify national difference type, andthese types are additionally noted in this document. The standard may not use all types of thesedeviations.DR - Th

20、ese are deviations based on the National Electrical Code (NEC) and other U.S. RegulatoryRequirements.D1 - These are deviations which are based on basic safety principles and requirements, elimination ofwhich would compromise safety for U.S. consumers and users of products.D2 - These are deviations b

21、ased on safety practices. These are deviations for IEC requirements that maybe acceptable, but adopting the IEC requirements would require considerable retesting or redesign on themanufacturers part.DC - These are deviations based on the component standards and will not be deleted until a particular

22、component standard is harmonized with the IEC component standard.DE - These are deviations based on editorial comments or correctionsAPRIL 26, 2006NATIONAL DIFFERENCES FOR UL UL 60601-14UL COPYRIGHTED MATERIAL NOT AUTHORIZED FOR FURTHER REPRODUCTION ORDISTRIBUTION WITHOUT PERMISSION FROM ULNational

23、Differences1.1DV D2 Replacement of the third paragraph of 1.1 with the following:SAFETY HAZARDS resulting from intended physiological function of EQUIPMENT covered by thisStandard are not considered. These requirements do not contemplate the investigation ofprotection against ionizing radiation or r

24、adioactive isotopes. Such EQUIPMENT is subject toFederal radiation Standards (21CFR Part 1020) promulgated under the Radiation Controlfor Health and Safety Act of 1968.2.10.12DV DR Addition:X-RAY INSTALLATIONS (LONG-TIME RATING): A rating based on an operating interval of 5 minutes orlonger.2.10.13D

25、V DR Addition:X-RAY INSTALLATIONS (MOMENTARY RATING): A rating based on an operating interval that does notexceed 5 seconds.2.12.19DV D2 Addition:PATIENT CARE EQUIPMENT: EQUIPMENT intended for use in or likely to be used in the PATIENT VICINITY.2.12.20DV D2 Addition:PATIENT VICINITY: In areas in whi

26、ch PATIENTS are normally cared for, the PATIENT VICINITY is thespace with surfaces likely to be contacted by the PATIENT or an attendant who can touchthe PATIENT. This encloses a space within the room 1,83 m (6 feet) beyond the perimeter ofthe bed (examination table, dental chair, treatment booth, a

27、nd the like) in its intendedlocation, and extending vertically 2,29 m (7-1/2 feet) above the floor.2.12.21DV D2 Addition:INTERNATIONALLY HARMONIZED COMPONENT STANDARD: A standard satisfying U.S. national andinternational safety concerns and may include national differences (exceptions) whichmodify t

28、he requirements of the relevant internationally recognized safety standard, (suchas an IEC/ISO standard). When necessary, due to national safety concerns, the nationaldifferences may include the unique U.S. national safety, regulatory, and legalrequirements taken from the relevant nationally recogni

29、zed safety standard (such as anANSI/UL standard).3.10DV D2 Addition of 3.10DV.1 3.10DV.3:3.10DV.1 Components3.10DV.1.1 In addition to compliance with this standard, the following components shallmeet nationally recognized standards (such as ANSI/UL standards) or INTERNATIONALLYHARMONIZED COMPONENT S

30、TANDARDS:APRIL 26, 2006 NATIONAL DIFFERENCES FOR UL UL 60601-1 5UL COPYRIGHTED MATERIAL NOT AUTHORIZED FOR FURTHER REPRODUCTION ORDISTRIBUTION WITHOUT PERMISSION FROM ULa) Printed wiring boardsb) Lithium batteriesc) Optical isolatorsd) Wiring and tubinge) CRTs 5 inchesItems a), c), and d) are exempt

31、 from this requirement if they are connected totally in an SELVcircuit limited to 15 W, or less, maximum available power and whose failure will not resultin a SAFETY HAZARD.3.10DV.2 Primary circuit components3.10DV.2.1 In addition to compliance with this basic standard, components in the primarycirc

32、uit up to the isolation transformer shall meet nationally recognized standards (such asANSI/UL standards) or INTERNATIONALLY HARMONIZED COMPONENT STANDARDS.3.10DV.3 Annex DVA tabulates UL component Standards covering components asspecified in subclauses 3.10DV.1 and 3.10DV.2.6DV D2 Modification of 6

33、 by adding 6DV.1 6DV.4:6DV.1 The text of the marking prefaced with an upper case signal word CAUTION,WARNING,orDANGER, shall consist of upper and lower case letters, in English, thatcomply with the following:a) All words comprising the text of the marking, excluding the signal word, shallbe in lette

34、rs not less than 1,6 mm (1/16 inch) high, based upon upper case,b) The signal word shall be in letters at least 2,8 mm (7/64 inch),c) The letters shall be in contrast color to the background. Letters that are raisedor indented and do not have a contrasting color to the background are notacceptable.6

35、DV.2 EQUIPMENT capable of emitting ionizing radiation shall bear a warning statementconcerning the risk of injury to persons from X-radiation. The control panel containing themain power switch shall bear the warning statement, legible and accessible to view:WARNING: This X-ray unit may be dangerous

36、to PATIENT and OPERATOR unless safe exposurefactors and operating instructions are observed.6DV.3 When a manufacturer produces or assembles EQUIPMENT at more than one factory, theEQUIPMENT shall have a distinctive marking which may be in code by means of which itmay be identified as the product of a

37、 particular factory.APRIL 26, 2006NATIONAL DIFFERENCES FOR UL UL 60601-16UL COPYRIGHTED MATERIAL NOT AUTHORIZED FOR FURTHER REPRODUCTION ORDISTRIBUTION WITHOUT PERMISSION FROM UL6DV.4 Multiple-voltage EQUIPMENT intended for permanent connection to the branch circuitshall be marked to indicate the pa

38、rticular voltage for which it is connected when shippedfrom the factory. The marking may be in the form of a paper tag or any other nonpermanentmaterial.6.2DV D2 Modification of item l) in 6.2:Replace 75C by 60C.6.6DV DR Modification of 6.6 by replacing item (a) with the following:a) Identification

39、of the content of gas cylinders used in medical practice as partof electrical EQUIPMENT, if accomplished through color coding, shall be inaccordance with the color coding requirements of the Standard for Health CareFacilities, ANSI/NFPA 99. See also sub-clause 56.3(a).6.8DV D2 Modification of 6.8 by

40、 adding the following:Cord-connected EQUIPMENT shall be provided with instructions to indicate the type ofattachment plug that should be used for connection to the alternate voltage.10.2.2DV DR Modification of item a) in 10.2.2:Replace 500 V with 600 V in both locations in the text associated with t

41、he first dash. Inthe text of the last dash of this sub-clause, add and the National Electrical Code,ANSI/NFPA 70 after the reference to IEC Publication 364.14DV DR Modification of 14 by adding the following:All FIXED EQUIPMENT and PERMANENTLY INSTALLED EQUIPMENT shall be CLASS I EQUIPMENT.18DV D2 Mo

42、dification of 18 by adding the following items:m) All parts of X-ray EQUIPMENT operating at over 600 V ac, 850 V dc, or 850 V peakshall be enclosed within PROTECTIVELY EARTHED (grounded) ENCLOSURES. Theconnections from the high-voltage EQUIPMENT to X-ray tubes and other high-voltagecomponents shall

43、be made with high-voltage shielded cables intended foroperation at over 600 V ac, 850 V dc, or 850 V peak.n) All accessible non-current carrying conductive parts, likely to becomeenergized, of X-ray and associated EQUIPMENT (controls, tables, transformer tanks,shields of shielded cables, tube heads

44、and supports, etc.) shall be PROTECTIVELYEARTHED (grounded) in accordance with Clause 18.19.5DV DR Addition of 19.5DV.1 and 19.5DV.2:19.5DV.1 In addition to the requirements in 19.1 19.4, the following requirements apply,except for X-ray EQUIPMENT and EQUIPMENT covered by note 3) on Table IV.APRIL 2

45、6, 2006 NATIONAL DIFFERENCES FOR UL UL 60601-1 7UL COPYRIGHTED MATERIAL NOT AUTHORIZED FOR FURTHER REPRODUCTION ORDISTRIBUTION WITHOUT PERMISSION FROM UL19.5DV.2 The LEAKAGE CURRENTS specified in Tables 19.5DV.1 and 19.5DV.2 are not to beexceeded when the EQUIPMENT is tested in accordance with Claus

46、e 19 except:a) When the EQUIPMENT is to be connected to the highest RATED MAINS VOLTAGE1);b) When the notes in Tables 19.5DV.1 and 19.5DV.2 apply.1)Minimum 120 VAC and 240 VAC for EQUIPMENT and marked voltage ranges of 105 120 VAC and 210 240 VAC respectively.Table 19.5DV.1 DR Addition:Table 19.5DV.

47、1 PATIENT CARE EQUIPMENTa)maximum LEAKAGE CURRENT (microamperes)Earth and ENCLOSUREb)CLASS I EQUIPMENTc)CLASS II EQUIPMENTd)AC or DC AC or DCRMS RMS300 150(500)e)(250)e)a)See 2.12.19DV.b)Metal ENCLOSURE or metal foil over insulating material as per 19.4 (g)(5).c)Measured with and without the loss of

48、 PROTECTIVE EARTH with the supply conductors normal or reversed.d)Measured with supply conductors normal and reversed. When measured with either BASIC or SUPPLEMENTARY INSULATIONeffectively bypassed, the allowable LEAKAGE CURRENT is twice that shown.e)EQUIPMENT with all surfaces, likely to be contac

49、ted by someone in the PATIENT VICINITY (2.12.20DV), constructed ofnonconductive materials may comply with the bottom number (in parentheses) instead of the top one.When the EQUIPMENT is marked or identified in the installation instructions for use on a center-tapped, 240 V, single phasecircuit, the LEAKAGE CURRENT may be measured from a center-tapped circuit.Table 19.5DV.2 DR Addition:Table 19.5DV.2 Nonpatient EQUIPMENT maximum LEAKAGE CURRENT (microamperes)Earth and ENCLOSUREa)CLASS I EQUIPMENTb)CLASS II EQUIPMENTc)AC or DC AC or DC