IEC 60601-1-9-2007 Medical electrical equipment - Part 1-9 General requirements for basic safety and essential performance - Collateral Standard Requirements fo.pdf

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1、 INTERNATIONAL STANDARD IECCEINORME INTERNATIONALE60601-1-9First editionPremire dition2007-07Medical electrical equipment Part 1-9: General requirements for basic safety and essential performance Collateral Standard: Requirements for environmentally conscious design Appareils lectromdicaux Partie 1-

2、9: Exigences gnrales pour la scurit de base et les performances essentielles Norme collatrale: Exigences pour une conception co-responsable Reference number Numro de rfrence IEC/CEI 60601-1-9:2007 THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2007 IEC, Geneva, Switzerland All rights reserved. Un

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15、TERNATIONALE60601-1-9First editionPremire dition2007-07Medical electrical equipment Part 1-9: General requirements for basic safety and essential performance Collateral Standard: Requirements for environmentally conscious design Appareils lectromdicaux Partie 1-9: Exigences gnrales pour la scurit de

16、 base et les performances essentielles Norme collatrale: Exigences pour une conception co-responsable U Commission Electrotechnique InternationaleInternational Electrotechnical Commission PRICE CODE CODE PRIX For price, see current cataloguePour prix, voir catalogue en vigueur 2 60601-1-9 IEC:2007 C

17、ONTENTS FOREWORD.3 INTRODUCTION.6 1 Scope, object and related standards.7 1.1 * Scope .7 1.2 Object .7 1.3 Related standards .7 2 Normative references .7 3 Terms and definitions .8 4 Protection of the ENVIRONMENT10 4.1 * Identification of ENVIRONMENTAL ASPECTS.10 4.2 * Determination of significant E

18、NVIRONMENTAL ASPECTS.10 4.3 * Information from the SUPPLY CHAIN 10 4.4 * Reduction of adverse ENVIRONMENTAL IMPACTS 11 4.5 Environmental information.11 Annex A (informative) General guidance and rationale.13 Annex B (informative) Guide to marking and labelling requirements for ME EQUIPMENT .28 Bibli

19、ography29 Index of defined terms used in this collateral standard30 Table A.1 Example product LIFE-CYCLE stages .14 Table A.2 Examples of ENVIRONMENTAL IMPACTS and their cause 20 Table A.3 ENVIRONMENTAL ASPECTS and typical ENVIRONMENTAL IMPACTS 23 Table B.1 ACCOMPANYING DOCUMENTS, General 28 Table B

20、.2 Other information .28 60601-1-9 IEC:2007 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 1-9: General requirements for basic safety and essential performance Collateral Standard: Requirements for environmentally conscious design FOREWORD 1) The International Electr

21、otechnical Commission (IEC) 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 fields. T

22、o this end and in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their preparation is entrusted to technical committees; any IEC Nati

23、onal Committee interested in the 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 (I

24、SO) in accordance with conditions 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

25、from all interested IEC National 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

26、 held responsible for the way in 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. An

27、y divergence between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter. 5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any equipment declared to be in conformity with an IEC Public

28、ation. 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 technical committees and IEC National Committees for any personal injury, prope

29、rty 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 Publications. 8) Attention is drawn to the Normative references cited in t

30、his 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 of patent rights. IEC shall not be held responsible for identifying any

31、or all such patent rights. International standard IEC 60601-1-9 has been prepared by IEC subcommittee 62A: Common aspects of electrical equipment used in medical practice, of IEC technical committee 62: Electrical equipment in medical practice. This first edition constitutes a collateral standard to

32、 IEC 60601-1: Medical electrical equipment Part 1: General requirements for safety and essential performance hereafter referred to as the general standard. 4 60601-1-9 IEC:2007 The text of this standard is based on the following documents: FDIS Report on voting 62A/571/FDIS 62A/575/RVDFull informati

33、on 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. In the 60601 series of publications, collateral standards specify general requirements for safety

34、 applicable to: a subgroup of MEDICAL ELECTRICAL EQUIPMENT (e.g. radiological equipment); or a specific characteristic of all MEDICAL ELECTRICAL EQUIPMENT, not fully addressed in the general standard (e.g. alarm systems). In this collateral standard, the following print types are used: Requirements

35、and definitions: roman type. Test specifications: italic type. Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of tables is also in a smaller type. TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS COLLATERAL STANDARD

36、 OR AS NOTED: SMALL CAPITALS. In referring to the structure of this standard, the term “clause” means one of the four numbered divisions within the table of contents, inclusive of all subdivisions (e.g. Clause 4 includes subclauses 4.1, 4.2, etc.); “subclause” means a numbered subdivision of a claus

37、e (e.g. 4.1, 4.5 and 4.5.1 are all subclauses of Clause 4). References to clauses within this standard are preceded by the term “Clause” followed by the clause number. References to subclauses within this standard are by number only. In this standard, the conjunctive “or” is used as an “inclusive or

38、” so a statement is true if any combination of the conditions is true. The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives, Part 2. For the purposes of this standard, the auxiliary verb: “shall” means that compliance with a requirement or a test is

39、mandatory for compliance with this standard; “should” means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this standard; “may” is used to describe a permissible way to achieve compliance with a requirement or test. Clauses, subclauses and defini

40、tions for which a rationale is provided in informative Annex A are marked with an asterisk (*). A list of all parts of the IEC 60601 series, published under the general title Medical electrical equipment, can be found on the IEC website. 60601-1-9 IEC:2007 5 The committee has decided that the conten

41、ts of this publication will remain unchanged until the maintenance result date indicated on the IEC web site under “http:/webstore.iec.ch“ in the data related to the specific publication. At this date, the publication will be reconfirmed; withdrawn; replaced by a revised edition, or amended. 6 60601

42、-1-9 IEC:2007 INTRODUCTION The objective of this collateral standard is to improve the ENVIRONMENTAL IMPACT for the entire range of MEDICAL ELECTRICAL EQUIPMENT, taking into account all stages of the product LIFE CYCLE: product specification; design; manufacturing; sales, logistics, installation; us

43、e; END OF LIFE management. This means protecting the ENVIRONMENT and human health from HAZARDOUS SUBSTANCES, conserving raw materials and energy, minimizing the generation of WASTE, as well as minimizing the adverse ENVIRONMENTAL IMPACTS associated with WASTE. The criteria needed to reach this goal

44、must be integrated into all stages of the MEDICAL ELECTRICAL EQUIPMENT LIFE CYCLE from the specification stage to END OF LIFE management. The ENVIRONMENTAL IMPACTS of ME EQUIPMENT through all LIFE-CYCLE stages are determined from the MEDICAL ELECTRICAL EQUIPMENTS ENVIRONMENTAL ASPECTS defined during

45、 the identification of need, product planning, and design stages (see Table A.1). Consideration of ENVIRONMENTAL ASPECTS as early as possible in these stages can produce numerous benefits that might include lower costs, stimulation of innovation and creativity, and increased knowledge about the prod

46、uct. It can also provide new business opportunities, and improved product quality as well as reduction of adverse ENVIRONMENTAL IMPACTS. The assessment of the ENVIRONMENTAL ASPECTS and IMPACTS of MEDICAL ELECTRICAL EQUIPMENT is a developing science and it is anticipated that this collateral standard

47、 will require periodic updating as the science develops. The requirements given in this collateral standard do not replace national or international laws and regulations. Environmental protection is one element of the overall RISK MANAGEMENT PROCESS as required by the general standard. The acceptabi

48、lity of MEDICAL ELECTRICAL EQUIPMENTS ENVIRONMENTAL IMPACTS are balanced against other factors, such as the products intended function, performance, safety, cost, marketability, quality, legal and regulatory requirements. This balance can differ depending on the intended function of the MEDICAL ELEC

49、TRICAL EQUIPMENT. For example, a solution appropriate for life-saving or life-supporting MEDICAL ELECTRICAL EQUIPMENT might not be appropriate for a device intended to correct a minor ailment. A MANUFACTURER of MEDICAL ELECTRICAL EQUIPMENT might have to justify, as a result of RISK MANAGEMENT, that a medical benefit outweighs the associat