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2、afety and essential performance Collateral Standard: Requirements for environmentally conscious designICS 11.040.01; 13.020.99Medical electrical equipment Part 1-9: General requirements for basic BRITISH STANDARDBS EN 60601-1-9:2008BS EN 60601-1-9:2008Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STAN
3、DARDS, 12/09/2008 02:48, Uncontrolled Copy, (c) BSIThis British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 July 2008 BSI 2008ISBN 978 0 580 54461 3Amendments/corrigenda issued since publicationDate CommentsThis publication does not purport to incl
4、ude all the necessary provisions of a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunity from legal obligations.National forewordThis British Standard is the UK implementation of EN 60601-1-9:2008. It is identical to IEC 60601-1-9:20
5、07. The UK participation in its preparation was entrusted by Technical Committee CH/62, Electromedical equipment in medical practice, to Subcommittee CH/62/1, Common aspects of electrical equipment used in medical practice.A list of organizations represented on this committee can be obtained on requ
6、est to its secretary.EUROPEAN STANDARD EN 60601-1-9 NORME EUROPENNE EUROPISCHE NORM April 2008 CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B -
7、 1050 Brussels 2008 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 60601-1-9:2008 E ICS 11.040; 13.020 English version Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Col
8、lateral Standard: Requirements for environmentally conscious design (IEC 60601-1-9:2007) Appareils lectromdicaux - Partie 1-9: Exigences gnrales pour la scurit de base et les performances essentielles - Norme collatrale: Exigences pour une conception co-responsable (CEI 60601-1-9:2007) Medizinische
9、elektrische Gerte - Teil 1-9: Allgemeine Festlegungen fr die Sicherheit einschlielich der wesentlichen Leistungsmerkmale - Ergnzungsnorm: Anforderungen zur Reduzierung von Umweltauswirkungen (IEC 60601-1-9:2007) This European Standard was approved by CENELEC on 2008-04-16. CENELEC members are bound
10、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 references concerning such national standards may be obtained on application to the Cent
11、ral 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 CENELEC member into its own language and notified to the Central Secretariat has the same st
12、atus as the official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway,
13、Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 12/09/2008 02:48, Uncontrolled Copy, (c) BSIForeword The text of document 62A/571/FDIS, future edition 1 of IEC 60601-1-9, prepared by SC 62A, Comm
14、on aspects of electrical equipment used in medical practice, of IEC TC 62, Electrical equipment in medical practice, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 60601-1-9 on 2008-04-16. The following dates were fixed: latest date by which the EN has to be impleme
15、nted at national level by publication of an identical national standard or by endorsement (dop) 2009-02-01 latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 2011-05-01 This European Standard has been prepared under a mandate given to CENELEC by the Europe
16、an Commission and the European Free Trade Association and covers essential requirements of EC Directive 93/42/EEC. See Annex ZZ. This European Standard constitutes a collateral standard to EN 60601-1:2006, hereafter referred to as the general standard. In the 60601 series of publications, collateral
17、 standards specify general requirements for safety 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 t
18、he following print types are used: requirements 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 T
19、HE GENERAL STANDARD, IN THIS COLLATERAL STANDARD 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.); “su
20、bclause” means a numbered subdivision of a clause (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,
21、the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the conditions is true. BS EN 60601-1-9:2008 2 Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 12/09/2008 02:48, Uncontrolled Copy, (c) BSIThe verbal forms used in this standard conform to usage des
22、cribed 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 mandatory for compliance with this standard; “should” means that compliance with a requirement or a test is recommended but is not
23、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 definitions for which a rationale is provided in informative Annex A are marked with an asterisk (*). Annexes ZA and ZZ have been added b
24、y CENELEC. _ Endorsement notice The text of the International Standard IEC 60601-1-9:2007 was approved by CENELEC as a European Standard without any modification. _ BS EN 60601-1-9:2008 3 Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 12/09/2008 02:48, Uncontrolled Copy, (c) BSICONTENTS INTR
25、ODUCTION.5 1 Scope, object and related standards.6 1.1 * Scope .6 1.2 Object .6 1.3 Related standards .6 2 Normative references .6 3 Terms and definitions .7 4 Protection of the ENVIRONMENT9 4.1 * Identification of ENVIRONMENTAL ASPECTS.9 4.2 * Determination of significant ENVIRONMENTAL ASPECTS.9 4.
26、3 * Information from the SUPPLY CHAIN 9 4.4 * Reduction of adverse ENVIRONMENTAL IMPACTS 10 4.5 Environmental information.10 Annex A (informative) General guidance and rationale.12 Annex B (informative) Guide to marking and labelling requirements for ME EQUIPMENT .27 Bibliography28 Index of defined
27、terms used in this collateral standard29 Table A.1 Example product LIFE-CYCLE stages .13 Table A.2 Examples of ENVIRONMENTAL IMPACTS and their cause 19 Table A.3 ENVIRONMENTAL ASPECTS and typical ENVIRONMENTAL IMPACTS 22 Table B.1 ACCOMPANYING DOCUMENTS, General 27 Table B.2 Other information .27 BS
28、 EN 60601-1-9:2008 4 Annex ZA (normative) Normative references to international publications with their corresponding European publications.30 Annex ZZ (informative) Coverage of Essential Requirements of EC Directives 31 Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 12/09/2008 02:48, Uncont
29、rolled Copy, (c) BSIINTRODUCTION 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, installati
30、on; use; 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
31、 goal 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
32、during 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 th
33、e product. 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 st
34、andard 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 acc
35、eptability 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 MEDICA
36、L ELECTRICAL 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,
37、 that a medical benefit outweighs the associated adverse ENVIRONMENTAL IMPACTS. BS EN 60601-1-9:2008 5 Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 12/09/2008 02:48, Uncontrolled Copy, (c) BSIMEDICAL ELECTRICAL EQUIPMENT Part 1-9: General requirements for basic safety and essential perform
38、ance Collateral Standard: Requirements for environmentally conscious design 1 Scope, object and related standards 1.1 * Scope This International Standard applies to the reduction of adverse ENVIRONMENTAL IMPACTS of MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT. MEDICAL ELECTRIC
39、AL SYSTEMS are excluded from the scope of this collateral standard. 1.2 Object The object of this collateral standard is to specify general requirements, in addition to those of the general standard, for the reduction of the adverse ENVIRONMENTAL IMPACT of ME EQUIPMENT, and to serve as the basis for
40、 particular standards. 1.3 Related standards 1.3.1 IEC 60601-1 For ME EQUIPMENT, this collateral standard complements IEC 60601-1. When referring to IEC 60601-1 or to this collateral standard, either individually or in combination, the following conventions are used: “the general standard“ designate
41、s IEC 60601-1 alone; “this collateral standard“ designates IEC 60601-1-9 alone; “this standard“ designates the combination of the general standard and this collateral standard. 1.3.2 Particular standards A requirement in a particular standard takes priority over the corresponding requirement in this
42、 collateral standard. 1.3.3 Environmental standards This standard takes into account the ISO 14000 series of environmental standards with particular emphasis on ISO 14062 81). 2 Normative references The following referenced documents are indispensable for the application of this document. For dated
43、references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. 1)Figures in square brackets refer to the Bibliography. BS EN 60601-1-9:2008 6 Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 12/09/2008 02:48
44、, Uncontrolled Copy, (c) BSIIEC 60601-1:2005, Medical electrical equipment Part 1: General requirements for basic safety and essential performance 3 Terms and definitions For the purposes of this document, the terms and definitions given in IEC 60601-1:2005 and the following definitions apply. NOTE
45、An index of defined terms is found beginning on page 30. 3.1 DESIGN AND DEVELOPMENT set of PROCESSES that transforms requirements into specified characteristics or into the specification of a product, PROCESS or system NOTE 1 The terms “design” and “development” are sometimes used synonymously and s
46、ometimes used to define different stages of the overall PROCESS of turning an idea into a product. NOTE 2 Product development is the PROCESS of taking a product idea from planning to market launch and post-market review of the product, in which business strategies, marketing considerations, research
47、 methods and design aspects are used to take a product to a point of practical use. It includes improvements or modifications to existing products or PROCESSES NOTE 3 The integration of ENVIRONMENTAL ASPECTS into product DESIGN AND DEVELOPMENT can also be termed design for the ENVIRONMENT (DFE), eco
48、-design, the environmental part of product stewardship, etc. ISO/TR 14062:2002, definition 3.3 3.2 END OF LIFE EOL state of a ME EQUIPMENT when it is finally removed from its INTENDED USE NOTE Adapted from IEC Guide 109:2003, Definition 3.1. 3.3 ENVIRONMENT surroundings in which an ORGANIZATION oper
49、ates, including air, water, land, natural resources, flora, fauna, humans and their interrelation NOTE Surroundings in this context extend from within an ORGANIZATION to the global system. ISO 14001:2004, definition 3.5 3.4 * ENVIRONMENTAL ASPECT element of an ORGANIZATIONS activities, products or services that can interact with the ENVIRONMENT NOTE A significant ENVIRONMENTAL ASPECT has or can have a significant ENVIRONMENTAL IMPACT. ISO 14001:2004, definition 3
