EN IEC 80601-2-71:2018
(Main)Medical electrical equipment - Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment
Medical electrical equipment - Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment
IEC 80601-2-71:2015(E) applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of FUNCTIONAL NIRS EQUIPMENT intended to be used by themselves, or as a part of an ME SYSTEM, for the production of FUNCTIONAL NIRS EQUIPMENT output for adjunctive diagnostic purposes, hereinafter referred to as ME EQUIPMENT.
Medizinische elektrische Geräte - Teil 2-71: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von funktionalen Oximetriegeräten
Appareils électromédicaux - Partie 2-71: Exigences particulières pour la sécurité de base et les performances essentielles des appareils d’imagerie spectroscopique proche infrarouge (NIRS)
IEC 80601-2-71:2015 s'applique à la sécurité de base et aux performances essentielles des appareils NIRS fonctionnelle destinés à être utilisés seuls, ou en tant que partie d'un système EM, pour produire des caractéristiques de sortie d'appareils NIRS fonctionnelle, à des fins de diagnostic d'appoint. Ces appareils sont désignés ci-après appareils EM.
Medicinska električna oprema - 2-71. del: Posebne zahteve za osnovno varnost in bistvene lastnosti funkcionalne opreme spektrometra v bližnjem infrardečem spektru (IEC 80601-2-71:2015)
Standard EN-IEC 80601-2-71 se uporablja za OSNOVNO VARNOST in BISTVENE LASTNOSTI FUNKCIONALNE OPREME SPEKTOMETRA V BLIŽNJEM INFRARDEČEM SPEKTRU (NIRS), namenjene za samostojno uporabo ali kot del SISTEMA ME, za proizvodnjo izpisa FUNKCIONALNE OPREME NIRS za dodatne diagnostične namene, v nadaljevanju imenovane OPREMA ME. Področje uporabe tega zadevnega standarda ne vključuje: a) dela OPREME ME, ki meri nasičenost hemoglobina s kisikom v mikro-žilah (kapilarah, arteriolah in venulah), če je prisotna; b) opreme tkivnega oksimetra v bližnjem infrardečem spektru (NIRS), ki ni namenjena za pridobivanje izpisa FUNKCIONALNE OPREME NIRS; c) opreme pulznega oksimetra, ki ni namenjena za pridobivanje izpisa FUNKCIONALNE OPREME NIRS. Zahteve za opremo pulznega oksimetra so določene v standardu ISO 80601-2-61; d) frekvenčne in časovne opreme za funkcionalno spektroskopijo v bližnjem infrardečem spektru, ki lahko zahtevajo drugačne preskusne postopke, kot so opredeljeni tukaj; e) FUNKCIONALNE OPREME SPEKTOMETRA V BLIŽNJEM INFRARDEČEM SPEKTRU, ki meri spremembe v koncentraciji drugih kromoforov, ki niso oksi- in deoksihemoglobin, ki lahko zahtevajo drugačne preskusne postopke, kot so opredeljeni tukaj.
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Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN IEC 80601-2-71:2018
01-september-2018
0HGLFLQVNDHOHNWULþQDRSUHPDGHO 3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLIXQNFLRQDOQHRSUHPHVSHNWURPHWUDYEOLåQMHPLQIUDUGHþHP
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Medical electrical equipment - Part 2-71: Particular requirements for the basic safety and
essential performance of functional Near-Infrared Spectroscopy (NIRS) equipment (IEC
80601-2-71:2015)
Ta slovenski standard je istoveten z: EN IEC 80601-2-71:2018
ICS:
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
SIST EN IEC 80601-2-71:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN IEC 80601-2-71:2018
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SIST EN IEC 80601-2-71:2018
EUROPEAN STANDARD EN IEC 80601-2-71
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2018
ICS 11.040.55
English Version
Medical electrical equipment -
Part 2-71: Particular requirements for the basic safety
and essential performance of functional near-infrared
spectroscopy (NIRS) equipment
(IEC 80601-2-71:2015)
Appareils électromédicaux - Medizinische elektrische Geräte -
Partie 2-71: Exigences particulières pour la sécurité de Teil 2-71: Besondere Festlegungen für die Sicherheit
base et les performances essentielles des appareils einschließlich der wesentlichen Leistungsmerkmale von
d'imagerie spectroscopique proche infrarouge (NIRS) funktionalen Oximetriegeräten
(IEC 80601-2-71:2015) (IEC 80601-2-71:2015)
This European Standard was approved by CENELEC on 2018-02-28. 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 CEN-CENELEC
Management Centre 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 CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden,
Switzerland, Turkey and the United Kingdom.
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2018 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 80601-2-71:2018 E
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SIST EN IEC 80601-2-71:2018
EN IEC 80601-2-71:2018
European foreword
The text of document 62D/1238/FDIS, future edition 1 of IEC 80601-2-71, prepared by
SC 62D "Electromedical equipment" of IEC/TC 62 "Electrical equipment in medical practice", and SC 3
“Lung ventilators and related equipment” of ISO/TC 121 “Anaesthetic and respiratory equipment” was
submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
EN IEC 80601-2-71:2018.
The following dates are fixed:
(dop) 2018-12-22
• latest date by which the document has to be
implemented at national level by
publication of an identical national
standard or by endorsement
(dow) 2021-06-22
• latest date by which the national
standards conflicting with the
document have to be withdrawn
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
Endorsement notice
The text of the International Standard IEC 80601-2-71:2015 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards indicated:
IEC 60601-1-10 NOTE Harmonized as EN 60601-1-10.
1)
IEC 60601-1-11:2010 NOTE Harmonized as EN 60601-1-11:2010 (not modified).
1)
Superseded by IEC 60601-1-11:2015.
2
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SIST EN IEC 80601-2-71:2018
EN IEC 80601-2-71:2018
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents are referred to in the t
...
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