SIST EN ISO 80601-2-56:2013
(Main)Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2009)
Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2009)
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of a CLINICAL THERMOMETER in combination with its ACCESSORIES, hereafter referred to as ME EQUIPMENT. This standard specifies the general and technical requirements for electrical CLINICAL THERMOMETERS. This standard applies to all electrical CLINICAL THERMOMETERS that are used for measuring the body temperature of PATIENTS. CLINICAL THERMOMETERS can be equipped with interfaces to accommodate secondary indicators, printing equipment, and other auxiliary equipment to create ME SYSTEMS. This standard does not apply to auxiliary equipment. ME EQUIPMENT that measures a temperature not as a primary purpose, but as a secondary function, is outside the scope of this standard. EXAMPLE 1 Swan-Ganz thermodilution determination of cardiac output is not in the scope of this standard. EXAMPLE 2 A Foley catheter that includes a temperature PROBE is in the scope of this standard. EXAMPLE 3 PATIENT heating ME EQUIPMENT that includes a skin temperature measurement such as infant incubators, heating blankets, heating pads and heating mattresses are not in the scope of this standard, unless they indicate a temperature of a REFERENCE BODY SITE in which they are in the scope of this standard. Requirements for ME EQUIPMENT intended to be used for non-invasive human febrile temperature screening of groups of individuals under indoor environmental conditions are given in IEC 80601-2-59:2008 and such ME EQUIPMENT is not covered by this standard. 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 IEC 60601-1:2005, 7.2.13 and 8.4.1.
Medizinische elektrische Geräte - Teil 2-56: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von medizinischen Thermometern zum Messen der Körpertemperatur (ISO 80601-2-56:2009)
Diese Internationale Norm gilt für die BASISSICHERHEIT und die WESENTLICHEN LEISTUNGSMERKMALE eines
MEDIZINISCHEN THERMOMETERS in Kombination mit seinem Zubehör, nachstehend als ME-GERÄTE bezeichnet.
Diese Internationale Norm spezifiziert die allgemeinen und technischen Anforderungen für elektrische
MEDIZINISCHE THERMOMETER. Diese Norm gilt für alle MEDIZINISCHEN THERMOMETER die für die Messung der
Körpertemperatur von PATIENTEN verwendet werden.
MEDIZINISCHE THERMOMETER können mit Schnittstellen zum Einbinden von Sekundäranzeigen, Druckgeräten
und anderen Zusatzgeräten ausgestattet werden und somit ME-SYSTEME bilden. Diese Norm gilt nicht für
Zusatzgeräte.
ME-GERÄTE, die eine Temperatur nicht als Primäraufgabe, sondern als Sekundärfunktion messen, liegen
außerhalb des Anwendungsbereiches dieser Norm.
BEISPIEL 1 Swan-Ganz-Thermodilutionsbestimmung des Herzminutenvolumens ist nicht im Anwendungsbereich
dieser Norm.
BEISPIEL 2 Ein Foleykatheder, der eine TEMPERATURSONDE beinhaltet, ist im Anwendungsbereich dieser Norm.
BEISPIEL 3 ME-GERÄTE zur Erwärmung des PATIENTEN, die eine Messung der Hauttemperatur beinhalten, wie z. B.
Inkubatoren für Kleinkinder, Wärmedecken, Wärmekissen und Wärmematratzen sind nicht im Anwendungsbereich dieser
Norm, außer, sie zeigen eine Temperatur der REFERENZKÖRPERSTELLE an und sind dann im Anwendungsbereich dieser Norm.
Die Anforderungen an ME-GERÄTE, die für das nicht-invasive Fieber(temperatur)-Screening von Menschengruppen
oder Einzelpersonen unter Innenraum-Umgebungsbedingungen eingesetzt werden sollen, sind in
IEC 80601-2-59:2008 angegeben und so ein ME-GERÄT wird von dieser Norm nicht abgedeckt.
Ist ein Abschnitt oder Unterabschnitt nur speziell für die Anwendung auf ME-GERÄTE oder ME-SYSTEME
vorgesehen, ist dies aus Überschrift und Inhalt des Abschnittes oder Unterabschnittes ersichtlich. Ist das nicht
der Fall, trifft der Abschnitt oder Unterabschnitt, wo anwendbar, auf das ME-GERÄT und das ME-SYSTEM zu.
GEFÄHRDUNGEN, die sich aus der vorgesehenen physiologischen Wirkungsweise von ME-GERÄTEN oder
ME-SYSTEMEN im Anwendungsbereich dieser Norm ergeben, sind nicht durch besondere Anforderungen in
dieser Norm erfasst, ausgenommen in IEC 60601-1:2005, 7.2.13 und 8.4.1.
ANMERKUNG Zusätzlich Informationen sind in IEC 60601-1:2005, 4.2, angegeben.
Appareils électromédicaux - Partie 2-56: Exigences particulières relatives à la sécurité fondamentale et aux performances essentielles des thermomètres médicaux pour mesurer la température de corps (ISO 80601-2-56:2009)
L'ISO/CEI 80601-2-56:2009 s'applique à la sécurité de base et aux performances essentielles d'un thermomètre médical en combinaison avec ses accessoires, désigné ci-après appareil EM. L'ISO/CEI 80601‑2‑56:2009 spécifie les exigences générales et techniques relatives aux thermomètres médicaux électriques. L'ISO/CEI 80601‑2‑56:2009 s'applique à tous les thermomètres médicaux électriques qui sont utilisés pour mesurer la température du corps des patients.
Les thermomètres médicaux peuvent être munis d'interfaces pour prendre en charge des indicateurs secondaires, un matériel d'impression et autres matériels auxiliaires pour créer des systèmes EM. L'ISO/CEI 80601-2-56:2009 ne s'applique pas au matériel auxiliaire.
L'appareil EM qui ne mesure pas une température en première intention, mais uniquement comme une fonction
Les exigences pour l'appareil EM destiné à être utilisé pour le dépistage non évasif de la température de fébrilité humaine parmi des groupes d'individus dans des conditions ambiantes à l'intérieur de locaux sont données dans la CEI 80601-2-59:2008 et un tel appareil EM n'est pas couvert par l'ISO/CEI 80601-2-56:2009.
Elektromedicinska oprema - 2-56. del: Posebne zahteve za osnovno varnost in bistvene lastnosti kliničnih termometrov za merjenje telesne temperature (ISO 80601-2-56:2009)
Ta mednarodni standard se uporablja za OSNOVNO VARNOST in BISTVENE LASTNOSTI KLINIČNIH TERMOMETROV v kombinaciji s PRIPOMOČKI, v nadaljevanju: ELEKTROMEDICINSKA OPREMA. Ta standard določa splošne in tehnične zahteve za električne KLINIIČNE TERMOMETRE. Ta standard velja za vse električne KLINIČNE TERMOMETRE, ki se uporabljajo pri merjenju telesne temperature PACIENTOV. KLINIČNI TERMOMETRI so lahko opremljeni z vmesniki, ki lahko imajo sekundarne pokazatelje, opremo za tiskanje in drugo zunanjo opremo ter tako sestavljajo ELEKTROMEDICINSKO OPREMO. Ta standard se ne uporablja za zunanjo opremo. Na področje uporabe tega standarda ne spada ELEKTROMEDICINSKA OPREMA, ki meri temperaturo, pri čemer je to njena sekundarna funkcija. PRIMER 1 Standard ne vsebuje termodilucijskega določanja minutnega volumna srca Swan-Ganz. PRIMER 2 Standard ne vsebuje Foleyevega katetra s tipalom temperature. PRIMER 3 ELEKTROMEDICINSKA OPREMA za ogrevanje PACIENTOV, ki vsebuje merjenje temperature kože, na primer inkubatorji za dojenčke, grelne odeje, grelne plošče in grelne žimnice, ne spadajo na področje uporabe tega standarda, razen če prikazujejo temperaturo REFERENČNEGA DELA TELESA. V tem primeru spadajo na področje uporabe tega standarda. Zahteve za ELEKTROMEDICINSKO OPREMO, ki je namenjena uporabi za nevsiljiv pregled vročine skupine posameznikov pod notranjimi okoljskimi pogoji, so podane v standardu IEC 80601-2-59:2008. Ta standard se ne uporablja za navedeno opremo. Če je poglavje ali podpoglavje namenjeno samo obravnavi ELEKTROMEDICINSKE OPREME ali samo ELEKTROMEDICINSKIH SISTEMOV, bo v naslovu in vsebini poglavja ali podpoglavja to zapisano. Če ni zapisano, poglavje ali podpoglavje obravnava ELEKTROMEDICINSKO OPREMO in ELEKTROMEDICINSKE SISTEME. Temeljnih TVEGANJ pri nameravani fiziološki funkciji ELEKTROMEDICINSKE OPREME in SISTEMOV, ki spadajo na področje tega standarda, posebne zahteve iz tega standarda ne obravnavajo, razen v delih IEC 60601-1:2005, 7.2.13 in 8.4.1.
General Information
Relations
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Medizinische elektrische Geräte - Teil 2-56: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von medizinischen Thermometern zum Messen der Körpertemperatur (ISO 80601-2-56:2009)Appareils électromédicaux - Partie 2-56: Exigences particulières relatives à la sécurité fondamentale et aux performances essentielles des thermomètres médicaux pour mesurer la température de corps (ISO 80601-2-56:2009)Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2009)11.040.55Diagnostic equipmentICS:Ta slovenski standard je istoveten z:EN ISO 80601-2-56:2012SIST EN ISO 80601-2-56:2013en01-januar-2013SIST EN ISO 80601-2-56:2013SLOVENSKI
STANDARDSIST EN 12470-5:2003SIST EN 12470-4:2001+A1:2009SIST EN 12470-3:2000+A1:20091DGRPHãþD
SIST EN ISO 80601-2-56:2013
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO 80601-2-56
October 2012 ICS 11.040.55 Supersedes EN 12470-3:2000+A1:2009, EN 12470-4:2000+A1:2009, EN 12470-5:2003English Version
Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2009)
Appareils électromédicaux - Partie 2-56: Exigences particulières relatives à la sécurité fondamentale et aux performances essentielles des thermomètres médicaux pour mesurer la température de corps (ISO 80601-2-56:2009)
Medizinische elektrische Geräte - Teil 2-56: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von medizinischen Thermometern zum Messen der Körpertemperatur (ISO 80601-2-56:2009) This European Standard was approved by CEN on 16 September 2012.
CEN 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 CEN-CENELEC Management Centre or to any CEN 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 CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2012 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 80601-2-56:2012: ESIST EN ISO 80601-2-56:2013
EN ISO 80601-2-56:2012 (E) 2 Contents Page Foreword .3Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices .4 SIST EN ISO 80601-2-56:2013
EN ISO 80601-2-56:2012 (E) 3 Foreword The text of ISO 80601-2-56:2009 has been jointly prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” of the International Organization for Standardization (ISO) and Sub-Committee IEC/SC 62D “Electromedical equipment” of the International Electrotechnical Commission (IEC) and has been taken over as EN ISO 80601-2-56:2012 by Technical Committee CEN/TC 205 “Non-active medical devices” the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by April 2013, and conflicting national standards shall be withdrawn at the latest by October 2015. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights. This document supersedes EN 12470-4:2000+A1:2009, EN 12470-5:2003, EN 12470-3:2000+A1:2009. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive. For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document. According to the CEN/CENELEC Internal Regulations, the national standards organisations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 80601-2-56:2009 has been approved by CEN as a EN ISO 80601-2-56:2012 without any modification.
SIST EN ISO 80601-2-56:2013
EN ISO 80601-2-56:2012 (E) 4 Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC on medical devices.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC on medical devices Clause(s)/sub-clause(s) of this International standard Essential requirements (ERs) of EU Directive 93/42/EEC Qualifying remarks/Notes 201.11 7.2 Only the parts of ER 7.2 relating to safety in use for the patient are addressed. 201.11 7.3 Only the part of the first sentence relating to design is addressed. 201.7.9.2.14.101 7.5 Only the third paragraph of ER 7.5 is addressed. 201.11, 201.103 7.6
201.11 8.1 The part of ER 8.1 relating to easy handling is not addressed. 201.11 8.4 Validated processes for sterilization are required via the normative references to ISO 11134, ISO 11135, ISO 11137. 201.7.2.1.101 8.7
201.4, 201.4.2.101, 201.7, 201.7.9.2.101 e), 201.16, 201.101.1, 201.102.1, 201.103, 201.103.2 9.1
201.9, 201.12.1.101, 201.12.2, 201.15, 202 9.2 The 4th indent of ER 9.2 is not addressed. 201.11, 201.13 9.3
201.7.9.2.101 d), 201.12, 201.101, 201.102, 201.103 10.1
201.12.2 10.2
201.7 10.3
SIST EN ISO 80601-2-56:2013
EN ISO 80601-2-56:2012 (E) 5 Table ZA.1 (continued) Clause(s)/sub-clause(s) of this International standard Essential requirements (ERs) of EU Directive 93/42/EEC Qualifying remarks/Notes 202 11.3.1
201.14 12.1
201.14 12.1 a)
201.12 12.4
202 12.5
201.8 12.6
201.9 12.7.1
201.9 12.7.2
201.9 12.7.3
201.8, 201.11, 201.15 12.7.4
201.11, 201.15 12.7.5
201.7, 201.12.2, 201.15, 206 12.9
201.7, 201.7.2.1, 201.7.2.1.101, 201.7.2.2, 201.7.9 13.1 The requirement for information on the sales packaging is not addressed. 201.7, 201.7.2.1, 201.8, 201.9 13.2
201.7, 201.7.9.1 13.3 a)
201.7, 201.7.2.1.101 b) 13.3 b)
201.7.2.1.101 c) 13.3 c)
201.7 13.3 d) This ER is only covered if the batch number is preceded by the word LOT. 201.7.2.1.101 d) 13.3 e)
201.7.2.1.101, 201.7.2.1.101 e) 13.3 f)
201.7, 201.7.2.1.101 f) 13.3 i)
201.7 13.3 j)
201.7 13.3 k)
201.7.2.1.101 c) 13.3 m) Presumption of conformity is only provided if symbols 4 to 7 are utilized. 201.7, 201.7.9.1, 201.16 13.6 a)
201.7.9.2.101 c), 201.7.9.2.101 d) 13.6 b)
201.7, 201.7.9.2.101 e), 201.16 13.6 c)
201.7, 201.7.9.2.101 g), 201.16 13.6 d)
201.7, 201.16 13.6 f)
201.7, 201.7.2.9.2.101 j), 201.11, 201.16 13.6 h) The requirement for information on the packaging is not addressed. SIST EN ISO 80601-2-56:2013
EN ISO 80601-2-56:2012 (E) 6 Table ZA.1 (continued) Clause(s)/sub-clause(s) of this International standard Essential requirements (ERs) of EU Directive 93/42/EEC Qualifying remarks/Notes 201.7 13.6 i)
201.7.2.9.2.101 i) 13.6 n)
201.7.2.9.2.101 d) 13.6 p)
201.7.2.9.2.101 k) 13.6 q)
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. SIST EN ISO 80601-2-56:2013
Reference numberISO 80601-2-56:2009(E)© ISO 2009
INTERNATIONAL STANDARD ISO80601-2-56First edition2009-10-01Medical electrical equipment — Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement Appareils électromédicaux — Partie 2-56: Exigences particulières relatives à la sécurité fondamentale et aux perfomances essentielles des thermomètres médicaux pour mesurer la température de corps SIST EN ISO 80601-2-56:2013
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SIST EN ISO 80601-2-56:2013
ISO 80601-2-56:2009(E) © ISO 2009 – All rights reserved iii Contents Page Foreword.v Introduction.vi 201.1 * Scope, object and related standards.1 201.1. 1 Scope.1 201.1. 2 Object.2 201.1. 3 Collateral standards.2 201.1. 4 Particular standards.2 201.2 Normative references.3 201.3 Terminology and definitions.3 201.4 General requirements.6 201.4. 2 RISK MANAGEMENT PROCESS for ME EQUIPMENT or ME SYSTEMS.6 201.4. 2.101 Additional requirements for RISK MANAGEMENT PROCESS for ME EQUIPMENT or ME SYSTEMS.7 201.4. 3 ESSENTIAL PERFORMANCE.7 201.4. 3.101 * Additional requirements for ESSENTIAL PERFORMANCE.7 201.4. 101 Environmental conditions of use.7 201.5 General requirements for testing of ME EQUIPMENT.7 201.6 Classification of ME EQUIPMENT and ME SYSTEMS.7 201.7 ME EQUIPMENT identification, marking and documents.7 201.7. 2.1 Minimum requirements for marking on ME EQUIPMENT and interchangeable parts.8 201.7. 2.1.101 Additional requirements for minimum requirements for marking on ME EQUIPMENT and interchangeable parts, marking of the packaging.8 201.7. 2.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts.8 201.7. 2.101 Additional requirements for marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts.8 201.7. 4.3 Unit of measure.8 201.7. 4.3.101 Additional requirements for unit of measure.8 201.7. 9 ACCOMPANYING DOCUMENT.9 201.7. 9.1 Additional general requirements.9 201.7. 9.2 Additional requirements for instructions for use.9 201.7. 9.2.14.101 Additional requirements for ACCESSORIES, supplementary equipment, used material.9 201.7. 9.2.101 Instructions for use.9 201.7. 9.101 Additional requirements for ACCOMPANYING DOCUMENT.10 201.8 Protection against electrical HAZARDS from ME 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.10 201.12 Accuracy of controls and instruments and protection against hazardous outputs.10 201.12. 1 Accuracy of controls and instruments.10 201.12. 1.101 Additional requirements for accuracy of controls and instruments.10 201.12. 2 USABILITY.11 201.12. 2.101 * Additional requirements for USABILITY.11 201.13 HAZARDOUS SITUATIONS and fault conditions.11 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS).11 SIST EN ISO 80601-2-56:2013
ISO 80601-2-56:2009(E) iv © ISO 2009 – All rights reserved 201.15 Construction of ME EQUIPMENT.11 201.16 ME SYSTEMS.11 201.17 * Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS.11 201.101 Laboratory performance requirements.11 201.101. 1 * General test requirements.11 201.101. 2 * Laboratory accuracy.12 201.101. 3 * Time response for a continuous clinical thermometer.13 201.102 * Clinical accuracy validation.13 201.102. 1 Method.13 201.102. 2 * Human subject population requirements.14 201.102. 3 * Clinical bias calculation.15 201.102. 4 * Limits of agreement calculation.15 201.102. 5 * Clinical repeatability calculation.16 201.103 * Probes, probe cable extenders and probe covers.16 201.103. 1 General.16 201.103. 2 Labeling.17 202 Medical electrical equipment — Part 1-2: General requirements for basic safety and essential performance — Collateral standard: Electromagnetic compatibility — Requirements and tests.17 202.6.2.1.10 Compliance criteria.17 Annexes Annex C (informative)
Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS.19 Annex D (informative)
Symbols on Marking.22 Annex AA (informative)
Particular Guidance and rationale.24 Annex BB (informative)
REFERENCE TEMPERATURE SOURCE.37 Annex CC (informative)
Environmental aspects.39 Annex DD (informative)
Reference to the essential principles of safety and performance of medical devices in accordance with ISO/TR 16142.40 Bibliography.42 Alphabetized index of defined terms used in this particular standard.45
SIST EN ISO 80601-2-56:2013
ISO 80601-2-56:2009(E) © ISO 2009 – All rights reserved v Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 80601-2-56 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 3, Lung ventilators and related equipment, in cooperation with Subcommittee 62D, Electrical equipment, of Technical Committee IEC/TC 62: Electrical equipment in medical practice. ISO 80601 consists of the following parts, under the general title Medical electrical equipment: ⎯ Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators ⎯ Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation ⎯ Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors ⎯ Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement ⎯ Part 2-61: Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use IEC 80601-2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers, IEC 80601-2-35: Particular requirements for basic safety and essential performance of blankets, pads and mattresses intended for heating in medical use, IEC 80601-2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery, IEC 80601-2-59: Particular requirements for basic safety and essential performance of screening thermographs for human febrile temperature screening and IEC 80601-2-60: Particular requirements for basic safety and essential performance of dental equipment are published by IEC. SIST EN ISO 80601-2-56:2013
ISO 80601-2-56:2009(E) vi © ISO 2009 – All rights reserved Introduction In this International 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 International Standard, the term ⎯ “clause” means one of the 20 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 International Standard are preceded by the term “Clause” followed by the clause number. References to subclauses within this International Standard are by number only. In this International 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 International Standard conform to usage described in Annex H of the ISO/IEC Directives, Part 2. For the purposes of this International 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. This international standard deals with electrical CLINICAL THERMOMETERS, either already available or that will come available in the future. The purpose of a CLINICAL THERMOMETER is to assess the true temperature of a REFERENCE BODY SITE. The temperature of the PATIENT'S body is an important vital sign in assessing overall health, typically in combination with blood pressure and pulse rate. Determining whether a PATIENT is afebrile or febrile is an important purpose of a CLINICAL THERMOMETER, since being febrile suggests that the PATIENT is ill. SIST EN ISO 80601-2-56:2013
ISO 80601-2-56:2009(E) © ISO 2009 – All rights reserved vii There are different temperatures at each REFERENCE BODY SITE according to the balance between the production, transfer, and loss of heat.[38] CLINICAL ACCURACY of a CLINICAL THERMOMETER is VERIFIED by comparing its OUTPUT TEMPERATURE with that of a REFERENCE THERMOMETER, which has a specified uncertainty for measuring true temperature. For an equilibrium CLINICAL THERMOMETER, the CLINICAL ACCURACY can be sufficiently determined under laboratory conditions that create an equilibrium state between the two thermometers. For a CLINICAL THERMOMETER that operates in the ADJUSTED MODE, laboratory VERIFICATION alone is not sufficient because the adjustment algorithm for deriving the OUTPUT TEMPERATURE includes the characteristics of the PATIENT and the environment.[3] Therefore the CLINICAL ACCURACY of a CLINICAL THERMOMETER that operates in the ADJUSTED MODE has to be VALIDATED clinically, using statistical methods of comparing its OUTPUT TEMPERATURE with that of a REFERENCE CLINICAL THERMOMETER which has a specified CLINICAL ACCURACY in representing a particular REFERENCE BODY SITE temperature. For a CLINICAL THERMOMETER that operates in the ADJUSTED MODE, the LABORATORY ACCURACY is VERIFIED in a DIRECT MODE and the CLINICAL ACCURACY is VALIDATED in the ADJUSTED MODE (OPERATING MODE) with a sufficiently large group of human subjects. The intention of this International Standard is to specify the requirements and the test procedures for the VERIFICATION of the LABORATORY ACCURACY for all types of electrical CLINICAL THERMOMETERS as well as for the VALIDATION of the CLINICAL ACCURACY of a CLINICAL THERMOMETER that operates in the ADJUSTED MODE.
SIST EN ISO 80601-2-56:2013
SIST EN ISO 80601-2-56:2013
INTERNATIONAL STANDARD ISO 80601-2-56:2009(E) © ISO 2009 – All rights reserved 1 Medical electrical equipment — Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement 201.1 * Scope, object and related standards IEC 60601-1:2005, Clause 1 applies, except as follows: 201.1.1 Scope Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of a CLINICAL THERMOMETER in combination with its ACCESSORIES, hereafter referred to as ME EQUIPMENT. This standard specifies the general and technical requirements for electrical CLINICAL THERMOMETERS. This standard applies to all electrical CLINICAL THERMOMETERS that are used for measuring the body temperature of PATIENTS. CLINICAL THERMOMETERS can be equipped with interfaces to accommodate secondary indicators, printing equipment, and other auxiliary equipment to create ME SYSTEMS. This standard does not apply to auxiliary equipment. ME EQUIPMENT that measures a temperature not as a primary purpose, but as a secondary function, is outside the scope of this standard. EXAMPLE 1 Swan-Ganz thermodilution determination of cardiac output is not in the scope of this standard. EXAMPLE 2 A Foley catheter that includes a temperature PROBE is in the scope of this standard. EXAMPLE 3 PATIENT heating ME EQUIPMENT that includes a skin temperature measurement such as infant incubators, heating blankets, heating pads and heating mattresses are not in the scope of this standard, unless they indicate a temperature of
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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Medizinische elektrische Geräte - Teil 2-56: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von medizinischen Thermometern zum Messen der Körpertemperatur (ISO 80601-2-56:2009)Appareils électromédicaux - Partie 2-56: Exigences particulières relatives à la sécurité fondamentale et aux performances essentielles des thermomètres médicaux pour mesurer la température de corps (ISO 80601-2-56:2009)Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2009)11.040.55Diagnostic equipmentICS:Ta slovenski standard je istoveten z:FprEN ISO 80601-2-56kSIST FprEN ISO 80601-2-56:2012en01-maj-2012kSIST FprEN ISO 80601-2-56:2012SLOVENSKI
STANDARD
kSIST FprEN ISO 80601-2-56:2012
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
FINAL DRAFT
FprEN ISO 80601-2-56
March 2012 ICS 11.040.55 Will supersede EN 12470-3:2000+A1:2009, EN 12470-4:2000+A1:2009, EN 12470-5:2003English Version
Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2009)
Appareils électromédicaux - Partie 2-56: Exigences particulières relatives à la sécurité fondamentale et aux performances essentielles des thermomètres médicaux pour mesurer la température de corps (ISO 80601-2-56:2009)
Medizinische elektrische Geräte - Teil 2-56: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von medizinischen Thermometern zum Messen der Körpertemperatur (ISO 80601-2-56:2009) This draft European Standard is submitted to CEN members for unique acceptance procedure. It has been drawn up by the Technical Committee CEN/TC 205.
If this draft becomes a European Standard, CEN 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.
This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to provide supporting documentation.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2012 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. FprEN ISO 80601-2-56:2012: EkSIST FprEN ISO 80601-2-56:2012
FprEN ISO 80601-2-56:2012 (E) 2 Contents Page Foreword .3Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices .4 kSIST FprEN ISO 80601-2-56:2012
FprEN ISO 80601-2-56:2012 (E) 3 Foreword The text of ISO 80601-2-56:2009 has been jointly prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” of the International Organization for Standardization (ISO) and Sub-Committee IEC/SC 62D “Electromedical equipment” of the International Electrotechnical Commission (IEC) and has been taken over as FprEN ISO 80601-2-56:2012 by Technical Committee CEN/TC 205 “Non-active medical devices” the secretariat of which is held by DIN. This document is currently submitted to the Unique Acceptance Procedure. This document will supersede EN 12470-3:2000+A1:2009, EN 12470-4:2000+A1:2009, EN 12470-5:2003,. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. Endorsement notice The text of ISO 80601-2-56:2009 has been approved by CEN as a FprEN ISO 80601-2-56:2012 without any modification.
kSIST FprEN ISO 80601-2-56:2012
FprEN ISO 80601-2-56:2012 (E) 4 Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC on medical devices.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC on medical devices Clause(s)/sub-clause(s) of this International standard Essential requirements (ERs) of EU Directive 93/42/EEC Qualifying remarks/Notes 201.11 7.2 Only the parts of ER 7.2 relating to safety in use for the patient are addressed. 201.11 7.3 Only the part of the first sentence relating to design is addressed. 201.7.9.2.14.101 7.5 Only the third paragraph of ER 7.5 is addressed. 201.11, 201.103 7.6
201.11 8.1 The part of ER 8.1 relating to easy handling is not addressed. 201.11 8.4 Validated processes for sterilization are required via the normative references to ISO 11134, ISO 11135, ISO 11137. 201.7.2.1.101 8.7
201.4, 201.4.2.101, 201.7, 201.7.9.2.101 e), 201.16, 201.101.1, 201.102.1, 201.103, 201.103.2 9.1
201.9, 201.12.1.101, 201.12.2, 201.15, 202 9.2 The 4th indent of ER 9.2 is not addressed. 201.11, 201.13 9.3
201.7.9.2.101 d), 201.12, 201.101, 201.102, 201.103 10.1
201.12.2 10.2
201.7 10.3
kSIST FprEN ISO 80601-2-56:2012
FprEN ISO 80601-2-56:2012 (E) 5 Table ZA.1 (continued) Clause(s)/sub-clause(s) of this International standard Essential requirements (ERs) of EU Directive 93/42/EEC Qualifying remarks/Notes 202 11.3.1
201.14 12.1
201.14 12.1 a)
201.12 12.4
202 12.5
201.8 12.6
201.9 12.7.1
201.9 12.7.2
201.9 12.7.3
201.8, 201.11, 201.15 12.7.4
201.11, 201.15 12.7.5
201.7, 201.12.2, 201.15, 206 12.9
201.7, 201.7.2.1, 201.7.2.1.101, 201.7.2.2, 201.7.9 13.1 The requirement for information on the sales packaging is not addressed. 201.7, 201.7.2.1, 201.8, 201.9 13.2
201.7, 201.7.9.1 13.3 a)
201.7, 201.7.2.1.101 b) 13.3 b)
201.7.2.1.101 c) 13.3 c)
201.7 13.3 d) This ER is only covered if the batch number is preceded by the word LOT. 201.7.2.1.101 d) 13.3 e)
201.7.2.1.101, 201.7.2.1.101 e) 13.3 f)
201.7, 201.7.2.1.101 f) 13.3 i)
201.7 13.3 j)
201.7 13.3 k)
201.7.2.1.101 c) 13.3 m) Presumption of conformity is only provided if symbols 4 to 7 are utilized. 201.7, 201.7.9.1, 201.16 13.6 a)
201.7.9.2.101 c), 201.7.9.2.101 d) 13.6 b)
201.7, 201.7.9.2.101 e), 201.16 13.6 c)
201.7, 201.7.9.2.101 g), 201.16 13.6 d)
201.7, 201.16 13.6 f)
201.7, 201.7.2.9.2.101 j), 201.11, 201.16 13.6 h) The requirement for information on the packaging is not addressed. kSIST FprEN ISO 80601-2-56:2012
FprEN ISO 80601-2-56:2012 (E) 6 Table ZA.1 (continued) Clause(s)/sub-clause(s) of this International standard Essential requirements (ERs) of EU Directive 93/42/EEC Qualifying remarks/Notes 201.7 13.6 i)
201.7.2.9.2.101 i) 13.6 n)
201.7.2.9.2.101 d) 13.6 p)
201.7.2.9.2.101 k) 13.6 q)
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. kSIST FprEN ISO 80601-2-56:2012
Reference numberISO 80601-2-56:2009(E)© ISO 2009
INTERNATIONAL STANDARD ISO80601-2-56First edition2009-10-01Medical electrical equipment — Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement Appareils électromédicaux — Partie 2-56: Exigences particulières relatives à la sécurité fondamentale et aux perfomances essentielles des thermomètres médicaux pour mesurer la température de corps kSIST FprEN ISO 80601-2-56:2012
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kSIST FprEN ISO 80601-2-56:2012
ISO 80601-2-56:2009(E) © ISO 2009 – All rights reserved iii Contents Page Foreword.v Introduction.vi 201.1 * Scope, object and related standards.1 201.1. 1 Scope.1 201.1. 2 Object.2 201.1. 3 Collateral standards.2 201.1. 4 Particular standards.2 201.2 Normative references.3 201.3 Terminology and definitions.3 201.4 General requirements.6 201.4. 2 RISK MANAGEMENT PROCESS for ME EQUIPMENT or ME SYSTEMS.6 201.4. 2.101 Additional requirements for RISK MANAGEMENT PROCESS for ME EQUIPMENT or ME SYSTEMS.7 201.4. 3 ESSENTIAL PERFORMANCE.7 201.4. 3.101 * Additional requirements for ESSENTIAL PERFORMANCE.7 201.4. 101 Environmental conditions of use.7 201.5 General requirements for testing of ME EQUIPMENT.7 201.6 Classification of ME EQUIPMENT and ME SYSTEMS.7 201.7 ME EQUIPMENT identification, marking and documents.7 201.7. 2.1 Minimum requirements for marking on ME EQUIPMENT and interchangeable parts.8 201.7. 2.1.101 Additional requirements for minimum requirements for marking on ME EQUIPMENT and interchangeable parts, marking of the packaging.8 201.7. 2.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts.8 201.7. 2.101 Additional requirements for marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts.8 201.7. 4.3 Unit of measure.8 201.7. 4.3.101 Additional requirements for unit of measure.8 201.7. 9 ACCOMPANYING DOCUMENT.9 201.7. 9.1 Additional general requirements.9 201.7. 9.2 Additional requirements for instructions for use.9 201.7. 9.2.14.101 Additional requirements for ACCESSORIES, supplementary equipment, used material.9 201.7. 9.2.101 Instructions for use.9 201.7. 9.101 Additional requirements for ACCOMPANYING DOCUMENT.10 201.8 Protection against electrical HAZARDS from ME 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.10 201.12 Accuracy of controls and instruments and protection against hazardous outputs.10 201.12. 1 Accuracy of controls and instruments.10 201.12. 1.101 Additional requirements for accuracy of controls and instruments.10 201.12. 2 USABILITY.11 201.12. 2.101 * Additional requirements for USABILITY.11 201.13 HAZARDOUS SITUATIONS and fault conditions.11 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS).11 kSIST FprEN ISO 80601-2-56:2012
ISO 80601-2-56:2009(E) iv © ISO 2009 – All rights reserved 201.15 Construction of ME EQUIPMENT.11 201.16 ME SYSTEMS.11 201.17 * Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS.11 201.101 Laboratory performance requirements.11 201.101. 1 * General test requirements.11 201.101. 2 * Laboratory accuracy.12 201.101. 3 * Time response for a continuous clinical thermometer.13 201.102 * Clinical accuracy validation.13 201.102. 1 Method.13 201.102. 2 * Human subject population requirements.14 201.102. 3 * Clinical bias calculation.15 201.102. 4 * Limits of agreement calculation.15 201.102. 5 * Clinical repeatability calculation.16 201.103 * Probes, probe cable extenders and probe covers.16 201.103. 1 General.16 201.103. 2 Labeling.17 202 Medical electrical equipment — Part 1-2: General requirements for basic safety and essential performance — Collateral standard: Electromagnetic compatibility — Requirements and tests.17 202.6.2.1.10 Compliance criteria.17 Annexes Annex C (informative)
Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS.19 Annex D (informative)
Symbols on Marking.22 Annex AA (informative)
Particular Guidance and rationale.24 Annex BB (informative)
REFERENCE TEMPERATURE SOURCE.37 Annex CC (informative)
Environmental aspects.39 Annex DD (informative)
Reference to the essential principles of safety and performance of medical devices in accordance with ISO/TR 16142.40 Bibliography.42 Alphabetized index of defined terms used in this particular standard.45
kSIST FprEN ISO 80601-2-56:2012
ISO 80601-2-56:2009(E) © ISO 2009 – All rights reserved v Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 80601-2-56 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 3, Lung ventilators and related equipment, in cooperation with Subcommittee 62D, Electrical equipment, of Technical Committee IEC/TC 62: Electrical equipment in medical practice. ISO 80601 consists of the following parts, under the general title Medical electrical equipment: ⎯ Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators ⎯ Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation ⎯ Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors ⎯ Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement ⎯ Part 2-61: Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use IEC 80601-2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers, IEC 80601-2-35: Particular requirements for basic safety and essential performance of blankets, pads and mattresses intended for heating in medical use, IEC 80601-2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery, IEC 80601-2-59: Particular requirements for basic safety and essential performance of screening thermographs for human febrile temperature screening and IEC 80601-2-60: Particular requirements for basic safety and essential performance of dental equipment are published by IEC. kSIST FprEN ISO 80601-2-56:2012
ISO 80601-2-56:2009(E) vi © ISO 2009 – All rights reserved Introduction In this International 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 International Standard, the term ⎯ “clause” means one of the 20 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 International Standard are preceded by the term “Clause” followed by the clause number. References to subclauses within this International Standard are by number only. In this International 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 International Standard conform to usage described in Annex H of the ISO/IEC Directives, Part 2. For the purposes of this International 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. This international standard deals with electrical CLINICAL THERMOMETERS, either already available or that will come available in the future. The purpose of a CLINICAL THERMOMETER is to assess the true temperature of a REFERENCE BODY SITE. The temperature of the PATIENT'S body is an important vital sign in assessing overall health, typically in combination with blood pressure and pulse rate. Determining whether a PATIENT is afebrile or febrile is an important purpose of a CLINICAL THERMOMETER, since being febrile suggests that the PATIENT is ill. kSIST FprEN ISO 80601-2-56:2012
ISO 80601-2-56:2009(E) © ISO 2009 – All rights reserved vii There are different temperatures at each REFERENCE BODY SITE according to the balance between the production, transfer, and loss of heat.[38] CLINICAL ACCURACY of a CLINICAL THERMOMETER is VERIFIED by comparing its OUTPUT TEMPERATURE with that of a REFERENCE THERMOMETER, which has a specified uncertainty for measuring true temperature. For an equilibrium CLINICAL THERMOMETER, the CLINICAL ACCURACY can be sufficiently determined under laboratory conditions that create an equilibrium state between the two thermometers. For a CLINICAL THERMOMETER that operates in the ADJUSTED MODE, laboratory VERIFICATION alone is not sufficient because the adjustment algorithm for deriving the OUTPUT TEMPERATURE includes the characteristics of the PATIENT and the environment.[3] Therefore the CLINICAL ACCURACY of a CLINICAL THERMOMETER that operates in the ADJUSTED MODE has to be VALIDATED clinically, using statistical methods of comparing its OUTPUT TEMPERATURE with that of a REFERENCE CLINICAL THERMOMETER which has a specified CLINICAL ACCURACY in representing a particular REFERENCE BODY SITE temperature. For a CLINICAL THERMOMETER that operates in the ADJUSTED MODE, the LABORATORY ACCURACY is VERIFIED in a DIRECT MODE and the CLINICAL ACCURACY is VALIDATED in the ADJUSTED MODE (OPERATING MODE) with a sufficiently large group of human subjects. The intention of this International Standard is to specify the requirements and the test procedures for the VERIFICATION of the LABORATORY ACCURACY for all types of electrical CLINICAL THERMOMETERS as well as for the VALIDATION of the CLINICAL ACCURACY of a CLINICAL THERMOMETER that operates in the ADJUSTED MODE.
kSIST FprEN ISO 80601-2-56:2012
kSIST FprEN ISO 80601-2-56:2012
INTERNATIONAL STANDARD ISO 80601-2-56:2009(E) © ISO 2009 – All rights reserved 1 Medical electrical equipment — Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement 201.1 * Scope, object and related standards IEC 60601-1:2005, Clause 1 applies, except as follows: 201.1.1 Scope Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of a CLINICAL THERMOMETER in combination with its ACCESSORIES, hereafter referred to as ME EQUIPMENT. This standard specifies the general and technical requirements for electrical CLINICAL THERMOMETERS. This standard applies to all electrical CLINICAL THERMOMETERS that are used for measuring the body temperature of PATIENTS. CLINICAL THERMOMETERS can be equipped with interfaces to accommodate secondary indicators, printing equipment, and other auxiliary equipment to create ME SYSTEMS. This standard does not apply to auxiliary equipment. ME EQUIPMENT that measures a temperature not as a primary purpose, but as a secondary function, is outside the scope of this standard. EXAMPLE 1 Swan-Ganz thermodilution determination of cardiac output is not in the scope of this standard. EXAMPLE 2 A Foley catheter that includes a temperature PROBE is in the scope of this standard. EXAMPLE 3 PATIENT heating ME EQUIPMENT that includes a skin temperature measurement such as infant incubators, heating blankets, heating pads and heating mattresses are not in the scope of this standard, unless they indicate a temperature of a REFERENCE BODY SITE in which they are in the scope of this standard. Requirements for ME EQUIPMENT intended to be used for non-invasive human febrile temperature screening of groups of individuals under indoor environmental conditions are given in IEC 80601-2-59:2008 and such ME EQUIPMENT is not covered by this standard. 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 EQUI
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