EN 60601-1-9-2008 en Medical electrical equipment - Part 1-9 General requirements for basic safety and essential performance - Collateral Standard Requirements for environmentally .pdf

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1、BRITISH STANDARD BS EN 60601-1-9:2008Medical electrical equipment Part 1-9: General requirements for basic safety and essential performance Collateral Standard: Requirements for environmentally conscious designICS 11.040.01; 13.020.99nullnull nullnullnullnullnullnullnull nullnullnullnullnullnullnull

2、 nullnullnull nullnullnullnullnullnullnullnullnullnull nullnullnullnullnullnull nullnull nullnullnullnullnullnullnullnullnull nullnull nullnullnullnullnullnullnullnullnull nullnullnull+A1:2013National forewordThis British Standard is the UK implementation of EN 60601-1-9:2008+A1:2013. It is identica

3、l to IEC 60601-1-9:2007, incorporating amendment 1:2013. It supersedes BS EN 60601-1-9:2008, which will be withdrawn on 31 December 2018.The start and finish of text introduced or altered by amendment is indicated in the text by tags. Tags indicating changes to IEC text carry the number of the IEC a

4、mendment. For example, text altered by IEC amendment 1 is indicated by !“.The UK participation in its preparation was entrusted by Technical Committee CH/62, Electrical Equipment in Medical Practice, to Subcommittee CH/62/1, Common aspects of Electrical Equipment used in Medical Practice.A list of o

5、rganizations represented on this subcommittee 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 ob

6、ligations.BS EN 60601-1-9:2008+A1:2013This British Standard waspublished under the authorityof the Standards Policy andStrategy Committeeon 31 July 2008 The British Standards Institution 2014. Published by BSI Standards Limited2014Amendments/corrigenda issued since publicationDate Comments 31 Januar

7、y 2014 Implementation of IEC amendment 1:2013 with CENELEC endorsement A1:2013. Annex ZA amendedISBN 978 0 580 80620 9EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORMCENELEC European Committee forElectrotechnicalStandardization Comit Europen de Normalisation ElectrotechniqueEuropisches Komitee fr E

8、lektrotechnische NormungCentral Secretariat:rue de Stassart35, B - 1050 Brussels 2008 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELECmembers.Ref. No. EN 60601-1-9:2008 EICS 11.040; 13.020 English versionMedical electricalequipment - Part 1-9: General

9、requirementsfor basic safety and essential performance - Collateral Standard:Requirements for environmentally conscious design (IEC 60601-1-9:2007)A ppareils lectromdicaux -Partie 1-9: Exigences gnrales pour la scurit de base et les performances essentielles -Norme collatrale: Exigencespour une conc

10、eption co-responsable(CEI 60601-1-9:2007)Medizinische elektrische Gerte -Teil 1-9: Allgemeine Festlegungen fr die Sicherheit einschlielich der wesentlichen Leistungsmerkmale -Ergnzungsnorm: Anforderungen zur Reduzierungvon Umweltauswirkungen (IEC 60601-1-9:2007)This European Standard was approved by

11、 CENELEC on 2008-04-16. CENELEC members are bound to complywith 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 sta

12、ndards may be obtained onapplication to the Central Secretariat or to any CENELEC member. This European Standard exists in three official versions (English, French, German). A version in any otherlanguage made by translation under the responsibility of a CENELEC member into its own language and noti

13、fiedto the Central Secretariat has the same status as the official versions.CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Cyprus, theCzech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,Lithuania, L

14、uxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom.EN 60601-1-9:2008+A1November 2013ForewordThe text of document 62A/571/FDIS, future edition 1 of IEC 60601-1-9, prepared by SC 62A, Commonaspects of electrical e

15、quipment 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 CENELECas 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 pu

16、blication of an identicalnational standard or by endorsement (dop) 2009-02-01 latest date by which the national standards conflictingwith the EN have to be withdrawn (dow) 2011-05-01This European Standard has been prepared under a mandate g iven to CENELEC by the EuropeanCommission and the European

17、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 asthe general standard.In the 60601 series of publications, collateral standards specify general require

18、ments for safetyapplicable to a subgroup of MEDICAL ELECTRICAL EQUIPMENT (e.g. radiological equipment); or a specific characteristic of all MEDICAL ELECTRICAL EQUIPMENT , not fullyaddressed in the generalstandard (e.g. alarm systems).In this collateral standard the following print types are used: re

19、quirements and definitions: roman type; test specifications: italic type; informative material appearing outside of tables,such as notes, examples and references: in smaller type. Normative textof tables is also in a smaller type; TERMS DEFINED IN C LAUSE 3 OF THE GENERAL STANDARD, IN THIS COLLATERA

20、L 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 allsubdivisions (e.g. Clause 4 includes Subclauses 4.1, 4.2, etc.); “subclause” means a numbered subdivision o

21、f a clause (e.g. 4.1, 4.5 and 4.5.1 are all subclausesof 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 “inclu

22、sive or” so a statement is true if anycombination of the conditions is true. 2 BS EN 60601-1-9:2008+A1:2013 EN 60601-1-9:2008+A1:2013(E)The verbal forms used in this standard conform to usage described in Annex H of the ISO/IECDirectives, Part 2. For the purposes of this standard, the auxiliary verb

23、 “shall” means that compliance with a requirement or a test is mandatory for c ompliance 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 compli

24、ance with a requirement or test. Clauses, subclauses and definitions for wh ich a rationale is provided in informative Anne x A aremarked with an asterisk(*).Annexes ZA and ZZ have been added by CENELEC._Endorsement noticeThe text of the International Standard IEC 60601-1-9:2007 was approved by CENE

25、LEC as a European Standard without any modification._ 3 The text of document 62A/874/FDIS, future IEC 60601-1-9:2007/A1, 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 pa

26、rallel vote and approved by CENELEC as EN 60601-1-9:2008/A1:2013. The following dates are fixed: latest date by which the document has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2014-04-23 latest date by which the national standards c

27、onflicting with the document have to be withdrawn (dow) 2018-12-31 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CENELEC and/or CEN shall not be held responsible for identifying any or all such patent rights. Endorsement notice

28、The text of the International Standard IEC 60601-1-9:2007/A1:2013 was approved by CENELEC as a European Standard without any modification. Foreword to amendment A1BS EN 60601-1-9:2008+A1:2013 EN 60601-1-9:2008+A1:2013(E)CONTENTSINTRODUCTION.51 Scope, objectand related standards. 61.1* Scope .61.2Obj

29、ect.61.3Related standards .62Normative references.63Terms and definitions.74Protection of the ENVIRONMENT 94.1* Identification of ENVIRONMENTAL ASPECTS.94.2* Determination ofsignificant ENVIRONMENTAL ASPECTS .94.3* Information from the SUPPLY CHAIN 94.4* Reduction ofadverse ENVIRONMENTAL IMPACTS 1 0

30、4.5Environmental information.1 0AnnexA (informative) General guidance and rationale.1 2Annex B (informative) Guide to marking and labelling requirements for ME EQUIPMENT .2 7Bibliography2 8Indexof defined terms used in this collateral standard29Table A.1 Example product LIFE- CYCLE stages.1 3Table A

31、.2 Examples of ENVIRONMENTAL IMPACTS and their cause19Table A.3 E NVIRONMENTAL ASPECTS and typical ENVIRONMENTAL IMPACTS 2 2Table B.1 A CCOMPANYING DOCUMENTS , General2 7Table B.2 Other information.2 7 4 Annex Z A (normative) Normative references to international publications with theircorresponding

32、 European publications.30Annex ZZ (informative) Coverage of Essential Requirements of EC Directives 31BS EN 60601-1-9:2008+A1:2013 IEC 60601-1-9:2007+A1:2013INTRODUCTION The objective of this collateral standardis to improve the ENVIRONMENTAL IMPACT for the entirerange of MEDICAL ELECTRICAL EQUIPMEN

33、T , taking into account all stages of the product LIFECYCLE: 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 th

34、e generation of WASTE , as well asminimizing the adverse ENVIRONMENTAL IMPACTS associated with WASTE . The criteria needed toreach this goal must be integ rated intoall stages of the MEDICAL ELECTRICAL EQUIPMENTLIFECYCLE from the specification stage t o END OF LIFE management. The ENVIRONMENTAL IMPA

35、CTS of ME EQUIPMENT through all LIFE- CYCLE stages aredetermined from the MEDICAL ELECTRICAL EQUIPMENT S ENVIRONMENTAL ASPECTS defined during the identification ofneed, product planning, and design stages(see Table A.1). Consideration of ENVIRONMENTAL ASPECTS as early as possible in these stages can

36、 produce numerous benefitsthat might include lower costs, stimulation of innovation and creativity, and increasedknowledge about the product. It can also provide newbusiness opportunities, and improvedproduct qualityas well asreduction ofadverse ENVIRONMENTAL IMPACTS. The assessment ofthe ENVIRONMEN

37、TAL ASPECTS and IMPACTS of MEDICAL ELECTRICAL EQUIPMENT is a developingscience and itis anticipated that this collateral standard will require periodic updating asthescience develops.Therequirements given inthiscollateralstandard do not replace national orinternational lawsand regulations.Environmen

38、tal protection is one element of the overall RISK MANAGEMENT PROCESS as required by the general standard. The acceptability of MEDICAL ELECTRICAL EQUIPMENT SENVIRONMENTAL IMPACTS are balanced against other factors, such as the productsintended function, performance, safety, cost,marketability, quali

39、ty, legal and regulatory requirements. Thisbalance can differ depending onthe intended function ofthe MEDICAL ELECTRICAL EQUIPMENT. For example, a solution appropriate for life-saving or life-supporting MEDICAL ELECTRICAL EQUIPMENT might not beappropriate fora device intended to correct a minor ailm

40、ent. A MANUFACTURER of MEDICALELECTRICAL EQUIPMENT might have to justify, as a result of RISK MANAGEMENT, that a medical benefit outweighs the associated adverse ENVIRONMENTAL IMPACTS . 5 BS EN 60601-1-9:2008+A1:2013 IEC 60601-1-9:2007+A1:2013MEDICAL ELECTRICAL EQUIPMENT Part 1-9: General requiremen

41、ts for basic safetyand essential performance Collateral Standard:Requirements for environmentally conscious design 1 Scope, object and related standards 1.1 * Scope This InternationalStandardapplies to the reduction of adverse ENVIRONMENTAL IMPACTS ofMEDICAL ELECTRICAL EQUIPMENT ,hereafter referred

42、to as ME EQUIPMENT . M EDICAL ELECTRICAL SYSTEMS areexcluded from the scope ofthis collateral standard. 1.2 ObjectThe object of this collateral standard is to specifygeneral requirements, in addition to those ofthe general standard, for the reduction of theadverse ENVIRONMENTAL IMPACT ofME EQUIPMENT

43、, and toserve as the basis for particular standards.1.3 Related standards 1.3.1 IEC60601-1For ME EQUIPMENT , this collateral standard complements IEC 60601-1.When referring to IEC60601-1 or to this collateral standar d, eitherindividually orin combination, the following conventions areused: “this st

44、andard“ designates the combination of the general st andardand this collateralstandard. 1.3.2 Particular standards Arequirement in a particular standard takes priority over the corresponding requirement inthis collateral standard.1.3.3 Environmentalstandards This standard takes into account the ISO

45、14000 series of environmental standardswith particularemphasis on ISO14062 8 1). 2 Normative references 1) Figures in square brackets refer to the Bibliography. 6 !“the general standard“ designates IEC 60601-1 alone (IEC 60601-1:2005+A1:2012);“!“this collateral standard“ designates IEC 60601-1-9 alo

46、ne (IEC 60601-1-9:2007+A1:2013);“!The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application.“ For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (includi

47、ng any amendments) applies.BS EN 60601-1-9:2008+A1:2013 IEC 60601-1-9:2007+A1:20133 Terms and definitionsNOTE An index of defined terms is found beginning on page 30.3.1DESIGN ANDDEVELOPMENTset of PROCESSES that transforms requirements into specified characteristics or into thespecification of a pro

48、duct, PROCESS orsystemNOTE 1 The terms “design” and “development” are sometimes used synonymously and sometimes used to definedifferent 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 an

49、d post-market review of the product, in which business strategies, marketing considerations, research methods and design aspects are used to take a product to a point ofpractical use. It includes improvements or modifications to existingproducts or PROCESSESNOTE 3 The integration of ENVIRONMENTAL ASPECTS into product DESIGN AND DEVELOPMENT can also be termeddesign for the ENVIRONMENT (DFE), eco-design, the environmental part of product stewardship, etc.ISO/TR 14062:2002, definiti