EN 1060-2:1995+A1:2009
(Main)Non-invasive sphygmomanometers - Part 2: Supplementary requirements for mechanical sphygmomanometers
Non-invasive sphygmomanometers - Part 2: Supplementary requirements for mechanical sphygmomanometers
This part of EN 1060, in conjunction with EN 1060-1:1995, specifies performance, efficiency and mechanical and electrical safety requirements, including test methods, for non-invasive mechanical sphygmomanometers and their accessories which, by means of an inflatable cuff, are used for the non-invasive measurement of arterial blood pressure.
Nichtinvasive Blutdruckmessgeräte - Teil 2: Ergänzende Anforderungen für mechanische Blutdruckmessgeräte
Dieser Teil der EN 1060 legt in Verbindung mit EN 1060-1:1995 Anforderungen hinsichtlich der Gebrauchstauglichkeit,
Messsicherheit, mechanischen und elektrischen Sicherheit von nichtinvasiven mechanischen Blutdruckmessgeräten
und deren Zubehör fest, die zur nichtinvasiven Messung des arteriellen Blutdrucks mit Hilfe
einer aufblasbaren Manschette verwendet werden und beinhaltet Prüfverfahren.
Tensiomètres non invasifs - Partie 2: Exigences complémentaires concernant les tensiomètres mécaniques
Cette partie de l’EN 1060, avec l’EN 1060-1:1995, spécifie les caractéristiques de performances, d'efficacité et les
exigences mécaniques et électriques de sécurité, ainsi que les méthodes d'essai des tensiomètres mécaniques non
invasifs et de leurs accessoires qui, au moyen d'un brassard gonflable, sont utilisés pour la mesure non invasive de
la pression artérielle.
Neinvazivni sfigmomanometri - 2. del: Dodatne zahteve za neavtomatizirane sfigmomanometre
Ta del EN 1060 v povezavi z EN 1060-1:1995 določa zahteve za zmogljivost, učinkovitost ter mehansko in električno varnost, vključno s preskusnimi metodami, za neinvazivne mehanske sfigmomanometre in njihove dodatke, ki se s pomočjo napihljive manšete uporabljajo za neinvazivno merjenje arterijskega krvnega tlaka.
General Information
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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Neinvazivni sfigmomanometri - 2. del: Dodatne zahteve za neavtomatizirane sfigmomanometreNichtinvasive Blutdruckmessgeräte - Teil 2: Ergänzende Anforderungen für mechanische BlutdruckmessgeräteTensiomètres non invasifs - Partie 2: Exigences complémentaires concernant les tensiomètres mécaniquesNon-invasive sphygmomanometers - Part 2: Supplementary requirements for mechanical sphygmomanometers11.040.55Diagnostic equipmentICS:Ta slovenski standard je istoveten z:EN 1060-2:1995+A1:2009SIST EN 1060-2:2000+A1:2010en,fr,de01-marec-2010SIST EN 1060-2:2000+A1:2010SLOVENSKI
STANDARD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 1060-2:1995+A1
November 2009 ICS 11.040.55 Supersedes EN 1060-2:1995English Version
Non-invasive sphygmomanometers - Part 2: Supplementary requirements for mechanical sphygmomanometers
Tensiomètres non invasifs - Partie 2: Exigences complémentaires concernant les tensiomètres mécaniques Nichtinvasive Blutdruckmessgeräte - Teil 2: Ergänzende Anforderungen für mechanische Blutdruckmessgeräte This European Standard was approved by CEN on 30 July 1995 and includes Corrigendum 1 issued by CEN on 24 July 2002 and Amendment 1 approved by CEN on 17 October 2009.
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 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 Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, 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 and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 1060-2:1995+A1:2009: ESIST EN 1060-2:2000+A1:2010
A-deviations . 14Annex B (informative)
Advice to be included in the instructions accompanying a sphygmomanometer using a mercury manometer . 15Annex ZA (informative)
!!!!Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices"""" . 17!!!!Bibliography"""" . 22 SIST EN 1060-2:2000+A1:2010
These normative references are cited at the appropriate places in the text and the publications are listed hereafter.
For dated references subsequent amendments to, or revisions of, any of these publications apply to this European Standard only when incorporated in it by amendment or revision.
For undated references the latest edition of the publication referred to applies. !EN 980:2008, Symbols for use in the labelling of medical devices" EN 1060-1:1995, Non-invasive sphygmomanometers – Part 1: General requirements 3 Definitions For the purposes of this Part of EN 1060, the definitions in EN 1060-1:1995 together with the following apply, 3.1 mechanical sphygmomanometer sphygmomanometer which uses either a mercury or an aneroid manometer or other mechanical measuring device for the non-invasive measurement of the arterial blood pressure by means of an inflatable cuff NOTE Components of these devices are manometer, cuff, valve for deflation (often in combination with rapid exhaust valve), hand pump or electro-mechanical pump and connection hoses. These devices may also contain electro-mechanical components for pressure control. 3.2 self-linearizing deflation valve valve for controlled linearizing exhaust of the pneumatic system during measurement 3.3 rapid exhaust valve valve for rapidly exhausting the pneumatic system 3.4 tamper proofing means of preventing the user gaining easy access to the measuring mechanism of the device 4 Cuff Clause 4 of EN 1060-1:1995 shall apply. 5 Display Clause 5 of EN 1060-1:1995 shall apply. SIST EN 1060-2:2000+A1:2010
200220240260280300mmHg180160140120100806040200 Figure 1 — Example of an aneroid manometer scale (division in mmHg without a tolerance zone at zero) 7.1.4.2.4 Scale spacing and thickness of the scale marks The distance between adjacent scale marks shall be not less than 0,7 mm. The thickness of the scale marks shall not exceed 20 % of the smallest scale spacing. All scale marks shall be of equal thickness. SIST EN 1060-2:2000+A1:2010
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