SIST EN 60601-2-39:2008
(Main)Medical electrical equipment -- Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
Medical electrical equipment -- Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of PERITONEAL DIALYSIS ME EQUIPMENT as defined in 201.3.208, hereafter referred to as PD EQUIPMENT. It applies to PD EQUIPMENT intended for use either by medical staff or under the supervision of medical experts, including PD EQUIPMENT operated by the PATIENT, regardless of whether the PD EQUIPMENT is used in a hospital or domestic environment. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard.
Medizinische elektrische Geräte - Teil 2-39: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Peritoneal-Dialyse-Geräten
Appareils électromédicaux -- Partie 2-39: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de dialyse péritonéale
S'applique à la sécurité de base et aux performances essentielles des appareils électromédicaux de dialyse péritonéale. Elle s'applique aux appareils de dialyse péritonéale destinés à être utilisés soit par le personnel médical soit sous la supervision d'experts médicaux, y compris les appareils de dialyse péritonéalemis en fonctionnement par le patient, que l'appareil de dialyse péritonéale soit utilisé dans un hôpital ou dans un environnement domestique. Cette seconde édition annule et remplace la première édition de la CEI 60601-2-39 dont elle constitue une révision technique. Les changements principaux depuis la dernière édition incluent un résumé des exigences de performances essentielles.
Medicinska električna oprema - 2-39. del: Posebne zahteve za osnovno varnost in bistvene lastnosti opreme za trebušno dializo (IEC 60601-2-39:2007)
Ta mednarodni standard velja za OSNOVNO VARNOST in BISTVENE LASTNOSTI ME OPREME ZA TREBUŠNO DIALIZO, kot je določeno v 201.3.208, v nadaljevanju PD OPREMA. Velja za PD OPREMO, ki jo uporablja medicinsko osebje ali je pod nadzorom medicinskih strokovnjakov, vključno s PD OPREMO, ki jo upravlja BOLNIK, ne glede na to, ali je PD OPREMA uporabljena v bolniškem ali domačem okolju. Če bo točka ali podtočka izrecno namenjena samo uporabi za ME OPREMO ali samo za ME SISTEME, bosta naslov in vsebina te točke ali podtočke to tudi navedla. Sicer točka in podtočka veljata za ustrezno ME OPREMO in ME SISTEME. NEVARNOSTI, ki so del fiziološkega delovanja ME OPREME ali ME SISTEMOV v okviru uporabe tega standarda, niso zajete s posebnimi zahtevami tega standarda, razen v točkah 7.2.13 in 8.4.1 splošnega standarda.
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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment (IEC 60601-2-39:2007)Appareils électromédicaux - Partie 2-39: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de dialyse péritonéale
(CEI 60601-2-39:2007)Medizinische elektrische Geräte - Teil 2-39: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Peritoneal-Dialyse-Geräten
(IEC 60601-2-39:2007)11.040.99Druga medicinska opremaOther medical equipmentICS:SIST EN 60601-2-39:2008enTa slovenski standard je istoveten z:EN 60601-2-39:200801-julij-2008SIST EN 60601-2-39:2008SLOVENSKI
STANDARDSIST EN 60601-2-39:20021DGRPHãþD
EUROPEAN STANDARD EN 60601-2-39 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 60601-2-39:2008 E
ICS 11.040.99 Supersedes EN 60601-2-39:1999
English version
Medical electrical equipment -
Part 2-39: Particular requirements for basic safety
and essential performance of peritoneal dialysis equipment
(IEC 60601-2-39:2007)
Appareils électromédicaux -
Partie 2-39: Exigences particulières
pour la sécurité de base
et les performances essentielles
des appareils de dialyse péritonéale (CEI 60601-2-39:2007)
Medizinische elektrische Geräte -
Teil 2-39: Besondere Festlegungen
für die Sicherheit einschließlich
der wesentlichen Leistungsmerkmale
von Peritoneal-Dialyse-Geräten (IEC 60601-2-39:2007)
This European Standard was approved by CENELEC on 2008-03-01. 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.
EN 60601-2-39:2008
- 2 - Foreword The text of document 62D/555/CDV, future edition 2 of IEC 60601-2-39, prepared by SC 62D, Electromedical equipment, of IEC TC 62, Electrical equipment in medical practice, was submitted to the IEC-CENELEC Parallel Unique Acceptance Procedure and was approved by CENELEC as
EN 60601-2-39 on 2008-03-01. This European Standard supersedes EN 60601-2-39:1999 + corrigendum December 1999. Major changes since EN 60601-2-39:1999 include a summary of additional essential performance requirements. 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) 2008-12-01 – latest date by which the national standards conflicting
with the EN have to be withdrawn
(dow) 2011-03-01 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. In this standard, the following print types are used: − requirements and definitions: in roman type; − test specifications: in 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 PARTICULAR STANDARD OR AS NOTED: IN SMALL CAPITALS. In referring to the structure of this standard, the term – “clause” means one of the seventeen numbered divisions within the table of contents, inclusive of all subdivisions (e.g. Clause 7 includes Subclauses 7.1, 7.2, etc.); –
“subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subclauses of Clause 7). 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. 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. An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that there is guidance or rationale related to that item in Annex AA.
- 3 - EN 60601-2-39:2008
Annexes ZA and ZZ have been added by CENELEC. __________ Endorsement notice The text of the International Standard IEC 60601-2-39:2007 was approved by CENELEC as a European Standard without any modification. __________
EN 60601-2-39:2008
- 4 -
Annex ZA
(normative)
Normative references to international publications with their corresponding European publications
Addition to Annex ZA of EN 60601-1:2006: Publication Year Title EN/HD Year IEC 60601-1-9 2007 Medical electrical equipment -
Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design EN 60601-1-9 2008
IEC 60601-1-10 2007 Medical electrical equipment -
Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers EN 60601-1-10 2008
- 5 - EN 60601-2-39:2008
Annex ZZ (informative) Coverage of Essential Requirements of EC Directives
This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association and within its scope the standard covers all relevant essential requirements as given in Annex I of the EC Directive 93/42/EEC. Compliance with this standard provides one means of conformity with the specified essential requirements of the Directive concerned. WARNING: Other requirements and other EC Directives may be applicable to the products falling within the scope of this standard.
IEC 60601-2-39Edition 2.0 2007-11INTERNATIONAL STANDARD NORME INTERNATIONALEMedical electrical equipment –
Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
Appareils électromédicaux –
Partie 2-39: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de dialyse péritonéale
INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE QICS 11.040.99 PRICE CODECODE PRIXISBN 2-8318-9464-6
– 2 – 60601-2-39 © IEC:2007 CONTENTS FOREWORD.3
201.1 Scope, object and related standards.5 201.2 Normative references.6 201.3 Terms and definitions.7 201.4 General requirements.8 201.5 General requirements for testing of PD EQUIPMENT.8 201.6 Classification of ME EQUIPMENT and ME SYSTEMS.8 201.7 PD EQUIPMENT identification, marking and documents.8 201.8 Protection against electrical HAZARDS from PD EQUIPMENT.10 201.9 Protection against mechanical hazards of ME EQUIPMENT and ME SYSTEMS.10 201.10 Protection against unwanted and excessive radiation HAZARDS.10 201.11 Protection against excessive temperatures and other HAZARDS.11 201.12 Accuracy of controls and instruments and protection against hazardous outputs.11 201.13 HAZARDOUS SITUATIONS and fault conditions.13 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS).13 201.15 Construction of ME EQUIPMENT.13 201.16 ME SYSTEMS.13 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS.13 202 Electromagnetic compatibility – Requirements and tests.13 203 General requirements for radiation protection in diagnostic X-ray equipment.14 206 Usability.14 208 * General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems.14 209 Requirements for the reduction of environmental impacts.14 210 Process requirements for the development of physiologic closed-loop controllers.14
Annexes.15 Annex G (normative)
Protection against HAZARDS of ignition
of flammable anaesthetic mixtures.15 Annex AA (informative)
Particular guidance and rationale.16
Index of defined terms used in this particular standard.17
60601-2-39 © IEC:2007 – 3 – INTERNATIONAL ELECTROTECHNICAL COMMISSION ____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
FOREWORD 1) The International Electrotechnical 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. To 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 National 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 (ISO) 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 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 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. Any 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 Publication. 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, 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 Publications.
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 of patent rights. IEC shall not be held responsible for identifying any or all such patent rights. International standard IEC 60601-2-39 has been prepared by IEC subcommittee 62D: Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical practice. This second edition cancels and replaces the first edition of IEC 60601-2-39. It constitutes a technical revision. Major changes since the last edition include a summary of additional essential performance requirements. The text of this particular standard is based on the following documents: Enquiry draft Report on voting 62D/555/CDV 62D/638/RVC
Full information on the voting for the approval of this particular standard can be found in the report on voting indicated in the above table.
– 4 – 60601-2-39 © IEC:2007 This publication has been drafted in accordance with the ISO/IEC Directives, Part 2. In this 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 PARTICULAR STANDARD OR AS NOTED: SMALL CAPITALS. In referring to the structure of this standard, the term – “clause” means one of the seventeen numbered divisions within the table of contents, inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.); – “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subclauses of Clause 7). References to clauses within this standard are preceded by the term “Clause” followed by the clause number. References to subclauses within this collateral 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. 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. An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that there is guidance or rationale related to that item in Annex AA. 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. The committee has decided that the contents of this collateral standard 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.
60601-2-39 © IEC:2007 – 5 – MEDICAL ELECTRICAL EQUIPMENT –
Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
201.1 Scope, object and related standards Clause 1 of the general standard applies, except as follows: 201.1.1 Scope Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of PERITONEAL DIALYSIS ME EQUIPMENT as defined in 201.3.208, hereafter referred to as PD EQUIPMENT. It applies to PD EQUIPMENT intended for use either by medical staff or under the supervision of medical experts, including PD EQUIPMENT operated by the PATIENT, regardless of whether the PD EQUIPMENT is used in a hospital or domestic environment. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard. NOTE See also 4.2 of the general standard. This standard can also be applied to PD EQUIPMENT used for compensation or alleviation of disease, injury or disability. These particular requirements do not apply to the DIALYSING SOLUTION, or the DIALYSING SOLUTION CIRCUIT. 201.1.2 Object Replacement: The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for PD EQUIPMENT as defined in 201.3.208. 201.1.3 Collateral standards Addition: This particular standard refers to those applicable collateral standards that are listed in Clause 2 of the general standard and Clause 2 of this particular standard. The requirements of IEC 60601-1-3 and IEC 60601-1-8 do not apply to this standard.
– 6 – 60601-2-39 © IEC:2007 201.1.4 Particular standards Replacement: In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in the general standard as appropriate for the particular ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL PERFORMANCE requirements. A requirement of a particular standard takes priority over the general standard. For brevity, IEC 60601-1 is referred to in this particular standard as the general standard. Collateral standards are referred to by their document number. The numbering of sections, clauses and subclauses of this particular standard corresponds to that of the general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x” where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this particular standard addresses the content of Clause 4 of the 60601-1-2 collateral st
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