BS-EN-60601-1-9-2008.pdf

BRITISH STANDARD BS EN 60601-1-9:2008 Medical electrical equipment Part 1-9: General requirements for basic safety and essential performance Collateral Standard: Requirements for environmentally conscious design ICS 11.040.01; 13.020.99 ? Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2008 21:13:03 MDTNo reproduction or networking permitted without license from IHS -,-,- BS EN 60601-1-9:2008 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 July 2008 © BSI 2008 ISBN 978 0 580 54461 3 National foreword This British Standard is the UK implementation of EN 60601-1-9:2008. It is identical to IEC 60601-1-9:2007. 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 request to its secretary. This publication does not purport to include 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. Amendments/corrigenda issued since publication DateComments Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2008 21:13:03 MDTNo reproduction or networking permitted without license from IHS -,-,- EUROPEAN STANDARD EN 60601-1-9 NORME EUROPÉENNE EUROPÄISCHE NORM April 2008 CENELEC European Committee for Electrotechnical Standardization Comité Européen de Normalisation Electrotechnique Europäisches Komitee für Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B - 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 - Collateral Standard: Requirements for environmentally conscious design (IEC 60601-1-9:2007) Appareils électromédicaux - Partie 1-9: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Exigences pour une conception éco-responsable (CEI 60601-1-9:2007) Medizinische elektrische Geräte - Teil 1-9: Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: 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 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 Central 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 status 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, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2008 21:13:03 MDTNo reproduction or networking permitted without license from IHS -,-,- Foreword The text of document 62A/571/FDIS, future edition 1 of IEC 60601-1-9, prepared by SC 62A, Common 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 implemented 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 European 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 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 the 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 THE 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.); “subclause” 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, 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 Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2008 21:13:03 MDTNo reproduction or networking permitted without license from IHS -,-,- 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 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 definitions for which a rationale is provided in informative Annex A are marked with an asterisk (*). Annexes ZA and ZZ have been added by 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 Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2008 21:13:03 MDTNo reproduction or networking permitted without license from IHS -,-,- CONTENTS INTRODUCTION.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 4.3 * Information from the SUPPLY CHAIN9 4.4 * Reduction of adverse ENVIRONMENTAL IMPACTS10 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 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 IMPACTS22 Table B.1 ACCOMPANYING DOCUMENTS, General 27 Table B.2 Other information .27 BS 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 Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2008 21:13:03 MDTNo reproduction or networking permitted without license from IHS -,-,- 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; 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 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 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 the 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 standard 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 acceptability of MEDICAL ELECTRICAL EQUIPMENT'S 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 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, that a medical benefit outweighs the associated adverse ENVIRONMENTAL IMPACTS. BS EN 60601-1-9:2008 5 Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2008 21:13:03 MDTNo reproduction or networking permitted without license from IHS -,-,- MEDICAL ELECTRICAL EQUIPMENT Part 1-9: General requirements for basic safety and essential performance 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 ELECTRICAL 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 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“ designates 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 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 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 Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2008 21:13:03 MDTNo reproduction or networking permitted without license from IHS -,-,- IEC 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 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 us