ANSI UL 61010-2-040-2016 UL Standard for Safety Requirements for Electrical Equipment for Measurement Control and Laboratory Use C Part 2-040 Particular Requirements for Sterilizer.pdf

1、UL COPYRIGHTED MATERIAL NOT AUTHORIZED FOR FURTHER REPRODUCTION OR DISTRIBUTION WITHOUT PERMISSION FROM UL UL 61010-2-040 (IEC 61010-2-040:2015) Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use Part 2-040: Particular Requirements for Sterilizers and Washer-Di

2、sinfectors Used To Treat Medical Materials STANDARD FOR SAFETYUL COPYRIGHTED MATERIAL NOT AUTHORIZED FOR FURTHER REPRODUCTION OR DISTRIBUTION WITHOUT PERMISSION FROM ULUL COPYRIGHTED MATERIAL NOT AUTHORIZED FOR FURTHER REPRODUCTION OR DISTRIBUTION WITHOUT PERMISSION FROM UL UL Standard for Safety fo

3、r Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use Part 2-040: Particular Requirements for Sterilizers and Washer-Disinfectors Used To Treat Medical Materials, UL 61010-2-040 (IEC 61010-2-040:2015) Second Edition, Dated January 15, 2016 Summary of Topics Adop

4、tion of IEC 61010-2-040, Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use Part 2-040: Particular Requirements for Sterilizers and Washer-Disinfectors Used To Treat Medical Materials (second edition issued July 2015) as a new IEC-based UL standard, UL 61010-2-

5、040 (IEC 61010-2-040:2015), with no National Differences. Although this is the rst-time publication of this Standard by UL, it is being published as the Second edition in order to align ULs edition number with that of the IEC Standard. As a result, one or more UL edition numbers have been skipped to

6、 match that of the IEC edition number. The new requirements are substantially in accordance with Proposal(s) on this subject dated November 13, 2015. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form by any means, electronic,

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9、ch damage. In no event shall ULs liability for any damage ever exceed the price paid for this Standard, regardless of the form of the claim. Users of the electronic versions of ULs Standards for Safety agree to defend, indemnify, and hold UL harmless from and against any loss, expense, liability, da

10、mage, claim, or judgment (including reasonable attorneys fees) resulting from any error or deviation introduced while purchaser is storing an electronic Standard on the purchasers computer system. JANUARY 15, 2016 UL 61010-2-040 (IEC 61010-2-040:2015) tr1UL COPYRIGHTED MATERIAL NOT AUTHORIZED FOR FU

11、RTHER REPRODUCTION OR DISTRIBUTION WITHOUT PERMISSION FROM UL JANUARY 15, 2016 UL 61010-2-040 (IEC 61010-2-040:2015) tr2 No Text on This PageUL COPYRIGHTED MATERIAL NOT AUTHORIZED FOR FURTHER REPRODUCTION OR DISTRIBUTION WITHOUT PERMISSION FROM UL JANUARY 15, 2016 1 UL 61010-2-040 (IEC 61010-2-040:2

12、015) Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use Part 2-040: Particular Requirements for Sterilizers and Washer-Disinfectors Used To Treat Medical Materials Second Edition January 15, 2016 This ANSI/UL Standard for Safety consists of the Second Edition.

13、The most recent designation of ANSI/UL 61010-2-040 (IEC 61010-2-040:2015) as an American National Standard (ANSI) occurred on January 15, 2016. ANSI approval for this IEC standard does not include the Cover Page, Transmittal Pages, Title Page, Preface or the IEC Foreword. Comments or proposals for r

14、evisions on any part of the Standard may be submitted to UL at any time. Proposals should be submitted via a Proposal Request in ULs On-Line Collaborative Standards Development System (CSDS) at http:/. ULs Standards for Safety are copyrighted by UL. Neither a printed nor electronic copy of a Standar

15、d should be altered in any way. All of ULs Standards and all copyrights, ownerships, and rights regarding those Standards shall remain the sole and exclusive property of UL. COPYRIGHT 2016 UNDERWRITERS LABORATORIES INC. ANSI/UL 61010-2-040-2016UL COPYRIGHTED MATERIAL NOT AUTHORIZED FOR FURTHER REPRO

16、DUCTION OR DISTRIBUTION WITHOUT PERMISSION FROM UL JANUARY 15, 2016 UL 61010-2-040 (IEC 61010-2-040:2015) 2 No Text on This PageUL COPYRIGHTED MATERIAL NOT AUTHORIZED FOR FURTHER REPRODUCTION OR DISTRIBUTION WITHOUT PERMISSION FROM UL CONTENTS Preface (UL) 6 FOREWORD 7 1 Scope and object .10 2 Norma

17、tive references .12 3 Terms and denitions 12 4 Tests .13 5 Marking and documentation .15 5.2 Warning markings .15 6 Protection against electric shock .23 7 Protection against mechanical HAZARDS 24 8 Mechanical resistance to shock and impact .29 9 Protection against the spread of re 30 9.1 General 30

18、 10 Equipment temperature limits and resistance to heat 30 10.1 Surface temperature limits for protection against burns .30 10.3 Other temperature measurements 31 11 Protection against HAZARDS from uids .31 11.1 General .31 11.101 Discharge to atmosphere .34 11.102 Instruments and indicating devices

19、 .34 11.103 Protection of hot and cold water services .35 11.104 Equipment with inatable or pressure-activated seals .35 12 Protection against radiation, including laser sources, and against sonic and ultrasonic pressure .36 12.3 Optical radiation 36 12.5 Sonic and ultrasonic pressure 37 13 Protecti

20、on against liberated gases, substances, explosion and implosion 38 13.1 Poisonous and injurious gases and substances 38 13.2 Explosion and implosion 42 13.101 Other HAZARDS arising from the use of toxic sterilants 43 13.102 Chemical dosing systems .45 14 Components .45 14.101 PRESSURE VESSELS and sh

21、ell boilers 45 14.102 Access ports 45 14.103 Control systems 46 14.104 Microprocessors .47 14.105 Asbestos 47 15 Protection by interlocks 47 16 HAZARDS resulting from application .47 17 RISK assessment 47 JANUARY 15, 2016 UL 61010-2-040 (IEC 61010-2-040:2015) 3UL COPYRIGHTED MATERIAL NOT AUTHORIZED

22、FOR FURTHER REPRODUCTION OR DISTRIBUTION WITHOUT PERMISSION FROM UL Annexes Annex G (informative) Leakage and rupture from uids under pressure Annex L (informative) Index of dened terms Bibliography JANUARY 15, 2016 UL 61010-2-040 (IEC 61010-2-040:2015) 4UL COPYRIGHTED MATERIAL NOT AUTHORIZED FOR FU

23、RTHER REPRODUCTION OR DISTRIBUTION WITHOUT PERMISSION FROM UL JANUARY 15, 2016 UL 61010-2-040 (IEC 61010-2-040:2015) 5 No Text on This PageUL COPYRIGHTED MATERIAL NOT AUTHORIZED FOR FURTHER REPRODUCTION OR DISTRIBUTION WITHOUT PERMISSION FROM UL Preface (UL) This UL Standard is based on IEC Publicat

24、ion 61010-2-040: second edition Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use Part 2-040: Particular Requirements for Sterilizers and Washer-Disinfectors Used To Treat Medical Materials. IEC publication 61010-2-040 is copyrighted by the IEC. Efforts have b

25、een made to synchronize the UL edition number with that of the corresponding IEC standard with which this standard is harmonized. As a result, one or more UL edition numbers have been skipped to match that of the IEC edition number. This UL Standard 61010-2-040 Standard for Safety for Safety Require

26、ments for Electrical Equipment for Measurement, Control, and Laboratory Use Part 2-040: Particular Requirements for Sterilizers and Washer-Disinfectors Used To Treat Medical Materials, is to be used in conjunction with the third edition of UL 61010-1. The requirements for laboratory equipment for th

27、e heating of materials are contained in this Part 2 Standard and UL 61010-2-040. Requirements of this Part 2 Standard, where stated, amend the requirements of UL 61010-1. Where a particular subclause of UL 61010-1 is not mentioned in UL 61010-2-040, the UL 61010-1 subclause applies. The text, gures

28、and tables of IEC Publication Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use Part 2-040: Particular Requirements for Sterilizers and Washer-Disinfectors Used To Treat Medical Materials, IEC 61010-2-040, copyright July, 2015 are used in this Standard with th

29、e consent of the IEC and the American National Standards Institute (ANSI). The IEC copyrighted material has been reproduced with permission from ANSI. ANSI should be contacted regarding the reproduction of any portion of the IEC material. The IEC Foreword and Introduction are not a part of the requi

30、rements of this Standard but are included for information purposes only. Copies of IEC Publication 61010-2-040 may be purchased from ANSI, 11 West 42nd Street, New York, New York, 10036, (212) 642-4900. Note Although the intended primary application of this Standard is stated in its Scope, it is imp

31、ortant to note that it remains the responsibility of the users of the Standard to judge its suitability for their particular purpose. JANUARY 15, 2016 UL 61010-2-040 (IEC 61010-2-040:2015) 6UL COPYRIGHTED MATERIAL NOT AUTHORIZED FOR FURTHER REPRODUCTION OR DISTRIBUTION WITHOUT PERMISSION FROM UL INT

32、ERNATIONAL ELECTROTECHNICAL COMMISSION SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials FOREWORD 1) The International Electrotechnical Commission (IEC)

33、 is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international co-operation on all questions concerning standardization in the electrical and electronic elds. To this end and in addition to

34、 other activities, IEC publishes International Standards, Technical Specications, Technical Reports, Publicly Available Specications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested in the

35、subject dealt with may participate in this preparatory work. International, governmental and non-governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for Standardization (ISO) in accordance with conditions

36、 determined by agreement between the two organizations. 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international consensus of opinion on the relevant subjects since each technical committee has representation from all interested IEC National

37、Committees. 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC Publications is accurate, IEC cannot be held responsible for the way in

38、which they are used or for any misinterpretation by any end user. 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications transparently to the maximum extent possible in their national and regional publications. Any divergence between any IEC Publ

39、ication and the corresponding national or regional publication shall be clearly indicated in the latter. 5) IEC itself does not provide any attestation of conformity. Independent certication bodies provide conformity assessment services and, in some areas, access to IEC marks of conformity. IEC is n

40、ot responsible for any services carried out by independent certication bodies. 6) All users should ensure that they have the latest edition of this publication. 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and members of its technic

41、al committees and IEC National Committees for any personal injury, property damage or other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC Pu

42、blications. 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is indispensable for the correct application of this publication. 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject

43、of patent rights. IEC shall not be held responsible for identifying any or all such patent rights. International Standard IEC 61010-2-040 has been prepared by IEC technical committee 66: Safety of measuring, control and laboratory equipment. It has the status of a group safety publication, as specie

44、d in IEC Guide 104. JANUARY 15, 2016 UL 61010-2-040 (IEC 61010-2-040:2015) 7UL COPYRIGHTED MATERIAL NOT AUTHORIZED FOR FURTHER REPRODUCTION OR DISTRIBUTION WITHOUT PERMISSION FROM UL This second edition cancels and replaces the rst edition published in 2005. This edition constitutes a technical revi

45、sion. This edition includes the following signicant technical changes with respect to the previous edition: a) A new clause (4.3.2.101) has been added for non-electrical supplies and services. b) Additional requirements for marking and documentation (Clause 5) have been added. c) Additional requirem

46、ents for protection against mechanical hazards (Clause 7) have been included. d) Additional requirements for protection against radiation, including laser sources, and against sonic and ultrasonic pressure (Clause 12) have been included. The text of this standard is based on the following documents:

47、 FDIS Report on voting 66/570/FDIS 66/576/RVD Full information on the voting for the approval of this standard can be found in the report on voting indicated in the above table. This publication has been drafted in accordance with the ISO/IEC Directives, Part 2. A list of all parts in the IEC 61010

48、series, published under the general title Safety requirements for electrical equipment for measurement, control, and laboratory use, can be found on the IEC website. This Part 2-040 is intended to be used in conjunction with IEC 61010-1. It was established on the basis of the third edition (2010). C

49、onsideration may be given to future editions of, or amendments to, IEC 61010-1. Where a particular subclause of Part 1 is not mentioned in this Part 2-040, that subclause applies as far as is reasonable. Where this part states “addition”, “modication”, “replacement”, or “deletion”, the relevant requirement, test specication or note in Part 1 should be adapted accordingly. In this standard: 1) the following print types are used: requirements: in roman type; NOTES: in small roman type; conformity and