EN ISO 81060-1:2012

Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007)

ISO 81060-1:2007 specifies requirements for non-automated sphygmomanometers and their accessories, which, by means of inflatable cuffs, are used for the non-invasive blood pressure measurement by operator observation.
ISO 81060-1:2007 specifies requirements for the safety and essential performance, including effectiveness and labelling, for non-automated sphygmomanometers and their accessories, including test methods to determine the accuracy of non-invasive blood pressure measurement.
ISO 81060-1:2007 covers non-invasive blood pressure measurement devices with a pressure-sensing element and display used in conjunction with means of detecting blood flow.

Nicht invasive Blutdruckmessgeräte - Teil 1: Anforderungen und Prüfverfahren der nicht-automatisierten Bauart (ISO 81060-1:2007)

Dieser Teil der ISO 81060 legt Anforderungen für nicht-automatisierte nicht invasive Blutdruckmessgeräte mit
aufblasbaren Manschetten, wie in 3.11 definiert, und deren Zubehör, welche durch eigene Beobachtungen
des Bedieners zur nicht invasiven Blutdruckmessung verwendet werden, fest.
Dieser Teil der ISO 81060 legt Anforderungen für die Sicherheit und die wesentlichen Leistungsmerkmale,
einschließlich der Wirksamkeit und der Kennzeichnung der nicht-automatisierten nicht invasiven
Blutdruckmessgeräte und deren Zubehör, einschließlich der Prüfverfahren zur Bestimmung der Genauigkeit
der nicht invasiven Blutdruckmessung, fest.
Dieser Teil der ISO 81060 berücksichtigt nicht invasive Blutdruckmessgeräte mit einem druckmessenden
Bauelement und einer Druckanzeige, die in Verbindung mit einem Hilfsmittel zur Feststellung des Blutflusses
verwendet werden.
BEISPIEL 1 Ein Stethoskop zur Erfassung der Korotkoff-Geräusche, Doppler-Ultraschall oder andere manuelle
Methoden.
Anforderungen an nicht invasive Blutdruckmessgeräte mit elektrisch beschriebenen druckmessenden
Bauelementen und/oder Druckanzeigen, die in Verbindung mit automatischen Verfahren zur Bestimmung des
Blutdrucks verwendet werden, sind im Dokument IEC 60601-2-30[7] festgelegt.
Anforderungen an invasive Blutdruckmessgeräte, die den Blutdruck direkt messen, sind im Dokument
IEC 60601-2-34[8] festgelegt.
BEISPIEL 2 Messeinrichtung, einschließlich angeschlossenen Druckaufnehmern, die zur invasiven Druckmessung
des Kreislaufs verwendet wird.

Sphygmomanomètres non invasifs - Partie 1: Exigences et méthodes d'essai pour type à mesurage non automatique (ISO 81060-1:2007)

L'ISO 81060-1:2007 spécifie les exigences relatives aux sphygmomanomètres non automatiques tels que définis en 3.11 et à leurs accessoires qui, à l'aide d'un brassard gonflable, sont utilisés pour le mesurage non invasif de la pression artérielle par le biais de l'observation d'un opérateur.
L'ISO 81060-1:2007 spécifie les exigences relatives à la sécurité, aux performances essentielles, à l'efficacité et au marquage des sphygmomanomètres non automatiques et de leurs accessoires, y compris les méthodes d'essai destinées à déterminer l'exactitude de mesure non invasive de la pression artérielle.
L'ISO 81060-1:2007 traite des dispositifs de mesure non invasive de la pression artérielle équipés d'un élément détecteur de pression et d'un affichage utilisés conjointement dans le but de déterminer le flux sanguin.

Neinvazivni sfigmomanometri - 1. del: Zahteve in preskusne metode za neavtomatizirane vrste merjenja (ISO 81060-1:2007)

Ta del standarda ISO 81060 določa zahteve glede neavtomatiziranih sfigmomanometrov, kot so opredeljeni v točki 3.11, in njihovih dodatkov, ki se s pomočjo napihljive manšete uporabljajo za neinvazivno merjenje krvnega tlaka, ki ga izvajalec merjenja odčita. Ta del standarda ISO 81060 določa zahteve glede varnosti in osnovnega delovanja, vključno z učinkovitostjo in označevanjem, za neavtomatizirane sfigmomanometre in njihove dodatke, vključno s preskusnimi metodami za določitev natančnosti neinvazivnega merjenja krvnega tlaka. Ta del standarda ISO 81060 zajema neinvazivne naprave za merjenje krvnega tlaka z elementom za zaznavanje tlaka in prikazovalnikom, ki se uporabljajo skupaj s sredstvom zaznavanja pretoka krvi. Zahteve glede neinvazivne opreme za merjenje krvnega tlaka z električnimi elementi za zaznavanje tlaka in/ali prikazovalniki, ki se uporabljajo skupaj z drugimi avtomatskimi metodami za določanje krvnega tlaka, so navedene v IEC 60601-2-30. Zahteve glede invazivne opreme za merjenje krvnega tlaka, ki neposredno meri krvni tlak, so navedene v dokumentu IEC 60601-2-34.

General Information

• Status: Published
• Publication Date: 22-May-2012
• Withdrawal Date: 30-May-2015
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• ICS: 11.040.55 - Diagnostic equipment
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205 - Non-active medical devices
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 23-May-2012
• Due Date: 06-Jun-2013
• Completion Date: 23-May-2012
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 81060-1:2012 - Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007)

Relations

• Replaces: EN 1060-2:1995+A1:2009 - Non-invasive sphygmomanometers - Part 2: Supplementary requirements for mechanical sphygmomanometers
• Effective Date: 08-Jun-2022
• Replaces: EN 1060-1:1995+A2:2009 - Non-invasive sphygmomanometers - Part 1: General requirements
• Effective Date: 30-May-2012

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 81060-1:2012
01-september-2012
1DGRPHãþD
SIST EN 1060-1:2000+A2:2010
SIST EN 1060-2:2000+A1:2010
Neinvazivni sfigmomanometri - 1. del: Zahteve in preskusne metode za
neavtomatizirane vrste merjenja (ISO 81060-1:2007)
Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-
automated measurement type (ISO 81060-1:2007)
Nicht invasive Blutdruckmessgeräte - Teil 1: Anforderungen und Prüfverfahren der nicht-
automatisierten Bauart (ISO 81060-1:2007)
Sphygmomanomètres non invasifs - Partie 1: Exigences et méthodes d'essai pour type à
mesurage non automatique (ISO 81060-1:2007)
Ta slovenski standard je istoveten z: EN ISO 81060-1:2012
ICS:
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
SIST EN ISO 81060-1:2012 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 81060-1:2012

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SIST EN ISO 81060-1:2012


EUROPEAN STANDARD
EN ISO 81060-1

NORME EUROPÉENNE

EUROPÄISCHE NORM
May 2012
ICS 11.040.10 Supersedes EN 1060-1:1995+A2:2009, EN 1060-
2:1995+A1:2009
English Version
Non-invasive sphygmomanometers - Part 1: Requirements and
test methods for non-automated measurement type (ISO 81060-
1:2007)
Sphygmomanomètres non invasifs - Partie 1: Exigences et Nicht invasive Blutdruckmessgeräte - Teil 1: Anforderungen
méthodes d'essai pour type à mesurage non automatique und Prüfverfahren der nicht-automatisierten Bauart (ISO
(ISO 81060-1:2007) 81060-1:2007)
This European Standard was approved by CEN on 28 April 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, 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 Ref. No. EN ISO 81060-1:2012: E
worldwide for CEN national Members.

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SIST EN ISO 81060-1:2012
EN ISO 81060-1:2012 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices .4

2

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SIST EN ISO 81060-1:2012
EN ISO 81060-1:2012 (E)
Foreword
The text of ISO 81060-1:2007 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 81060-1:2012 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 November 2012, and conflicting national standards shall be withdrawn
at the latest by May 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 1060-1:1995+A2:2009, EN 1060-2:1995+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(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document.
EN ISO 81060 consis
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