SIST EN 1060-2:2000+A1:2010
(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
Relations
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
SIST EN 1060-2:2000+A1:2010
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
EN 1060-2:1995+A1:2009 (E) 2 Contents Page Foreword .31Scope .42Normative references .43Definitions .44Cuff .45Display .46Units .57Requirements .58Test methods .99Information to be supplied by the manufacturer . 13Annex A (informative)
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
EN 1060-2:1995+A1:2009 (E) 3 Foreword This document (EN 1060-2:1995+A1:2009) has been prepared by Technical Committee 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 May 2010, and conflicting national standards shall be withdrawn at the latest by May 2010. 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 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. This document supersedes EN 1060-2:1995. The start and finish of text introduced or altered by amendment is indicated in the text by tags !". The modifications of the related CEN Corrigendum have been implemented at the appropriate places in the text and are indicated by the tags ˜ ™. !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." Annexes A, B and C are given for information and do not form normative parts of this European Standard. Attention is drawn to annex A, concerning A-deviations. This European Standard "Non-invasive sphygmomanometers" consists of the following parts: Part 1: General requirements Part 2: Supplementary requirements for mechanical sphygmomanometers Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems (in course of preparation) According to the CEN/CENELEC Internal Regulations, the following countries are bound to implement this European Standard: 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.
SIST EN 1060-2:2000+A1:2010
EN 1060-2:1995+A1:2009 (E) 4 1 Scope 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. 2 Normative references This European Standard incorporates by dated or undated reference, provisions from other publications.
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
EN 1060-2:1995+A1:2009 (E) 5 6 Units Clause 6 of EN 1060-1:1995 shall apply. 7 Requirements 7.1 Performance 7.1.1 Limits of the error of the cuff pressure indication Subclause 7.1.1 of EN 1060-1:1995 shall apply. 7.1.2 Environmental performance 7.1.2.1 Effect of storage Subclause 7.1.2.1 of EN 1060-1:1995 shall apply. 7.1.2.2 Effect of temperature Subclause 7.1.2.2 of EN 1060-1:1995 shall apply. 7.1.3 Pneumatic system 7.1.3.1 Air leakage Air leakage shall not exceed a pressure drop of 4 mmHg/min (0,5 kPa/min). Testing shall be carried out in accordance with 8.1. 7.1.3.2 Pressure reduction rate Manually operated and self-linearizing deflation valves shall be capable of adjustment to a deflation rate of (2 to 3) mmHg/s ((0,3 to 0,4) kPa/s). Manually operated deflation valves shall be easily adjusted to these values. Self-linearizing valves shall be tested in accordance with 8.2. 7.1.3.3 Rapid exhaust During the rapid exhaust of the pneumatic system, with fully opened valve the time for the pressure reduction from 260 mmHg to 15 mmHg (35 kPa to 2 kPa) shall not exceed 10 s. Testing shall be carried out in accordance with 8.3. 7.1.4 Pressure indicating devices 7.1.4.1 Nominal range and measuring range The nominal range shall be equal to the measuring range. The nominal range for the cuff gauge pressure shall extend from 0 mmHg to at least 260 mmHg (0 kPa to at least 35 kPa). SIST EN 1060-2:2000+A1:2010
EN 1060-2:1995+A1:2009 (E) 6 7.1.4.2 Analogue indication 7.1.4.2.1 Scale The scale shall be designed and arranged so that the measuring values can be read clearly and are easily recognised. Testing shall be carried out by visual inspection. 7.1.4.2.2 First scale mark The graduation shall begin with the first scale mark at 0 mmHg (0 kPa). Testing shall be carried out by visual inspection. 7.1.4.2.3 Scale division Scale divisions shall be either in kilopascals (kPa) or in millimetres of mercury (mmHg) as follows: a) 0,2 kPa for a scale graduated in kPa; b) 2 mmHg for a scale graduated in mmHg. For a scale interval of 2 mmHg (0,2 kPa) each fifth scale mark shall be indicated by greater length and each tenth scale mark shall be numbered. An example of scale division is given in figure 1. Testing shall be carried out by visual inspection.
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
EN 1060-2:1995+A1:2009 (E) 7 Testing shall be carried out in accordance with 8.4. 7.2 Safety 7.2.1 Electrical safety Subclause 7.2.1 of EN 1060-1:1995 shall apply. 7.2.2 Resistance to vibration and shock Subclause 7.2.2 of EN 1060-1:1995 shall apply. 7.2.3 Mechanical safety It shall be possible to abort the blood pressure measurement at any time by activating the manual rapid exhaust valve, which shall be easily accessible. 7.2.4 Tamper proofing Tamper proofing of the manometer shall be achieved by requiring the use of a tool or the breaking of a seal. Testing shall be carried out by inspection. 7.3 Additional requirements for mercury manometer 7.3.1 Internal diameter of the tube containing mercury The nominal internal diameter of the tube containing mercury shall be at least 3,5 mm. The tolerance on diameter shall not exceed ± 0,2 mm. (See also 9.3 b)). Testing shall be carried out in accordance with 8.5. 7.3.2 Portable devices A portable device shall be provided with an adjusting or locking mechanism to secure it in the specified position for use. Testing shall be carried out by visual inspection. 7.3.3 Tube containing mercury and reservoir A locking device shall be placed between the reservoir and the tube to prevent the spillage of mercury during transport. Testing shall be carried out by visual inspection. 7.3.4 Stopping device in the tube containing mercury and reservoir A stopping device shall be incorporated in the reservoir and the tube, which shall prevent the mercury from being spilled during transport and use. The delay in the setting of the mercury column due to the stopping device shall not exceed 1,5 s for the flow of mercury from 200 mmHg to 50 mmHg (from 25 kPa to 5 kPa) when the pressure in the system drops rapidly from 200 mmHg to 0 mmHg (from 25 kPa to 0 kPa). Testing shall be carried out in accordance with 8.6 and 8.7. SIST EN 1060-2:2000+A1:2010
EN 1060-2:1995+A1:2009 (E) 8 7.3.5 Quality of the mercury The mercury shall have a purity of not less than 99,99 % according to the declaration of the supplier of the mercury. 7.3.6 Gauge The scale marks shall be inscribed on the tube containing mercury. If numbered at each fifth scale mark, the numbering shall be alternately on the right and left-hand side of, and adjacent to, the tube. Testing shall be carried out by visual inspection. 7.4 Additional requirements for aneroid manometer 7.4.1 Scale mark at zero If a tolerance zone is shown at zero it shall not exceed ± 3 mmHg (± 0,4 kPa) and shall be clearly marked. A scale mark at zero shall be indicated. NOTE Graduations within the tolerance zone are optional. Testing shall be carried out by visual inspection. 7.4.2 Zero The movement of the elastic sensing element including the pointer shall not be obstructed within 6 mmHg (0,8 kPa) below zero. Neither the dial nor the pointer shall be adjustable by the user. Testing shall be carried out by visual inspection. 7.4.3 Pointer The pointer shall cover between 1/3 and 2/3 of the length of the shortest scale mark of the scale. At the place of indication it shall be not thicker than the scale mark. The distance between pointer and dial shall not exceed 2 mm. Testing shall be carried out by visual inspection. 7.4.4 Hysteresis error The hysteresis error throughout the pressure range shall be within the range 0 mmHg to 4 mmHg (0 kPa to 0,5 kPa). Testing shall be carried out in accordance with 8.8. 7.4.5 Construction and materials The construction of the aneroid manometer and the material for the elastic sensing elements shall ensure an adequate stability of the measurement. The elastic sensing elements shall be aged with respect to pressure and temperature. SIST EN 1060-2:2000+A1:2010
EN 1060-2:1995+A1:2009 (E) 9 The difference in the pressure indication of the aneroid manometer before and after 10 000 alternating pressure cycles shall be not more than 3 mmHg (0,4 kPa) throughout the pressure range. Testing shall be carried out in accordance with 8.9. 8 Test methods 8.1 Method of test for air leakage of the pneumatic system 8.1.1 Apparatus 8.1.1.1 Rigid metal cylinder 8.1.1.2 Pressure generator, e.g. ball pump (hand pump) with a deflation valve. 8.1.1.3 Time measuring device, e.g. stopwatch 8.1.2 Procedure Wrap the cuff around the cylinder (8.1.1.1) of an appropriate size (see clause 4). NOTE Electro-mechanical pumps which are part of the device may be used for the test. Carry out the test over the whole measuring range at at least five equally spaced pressure steps (e.g. 50 mmHg, 100 mmHg, 150 mmHg, 200 mmHg and 250 mmHg). Test the air leakage over a period of 5 min (8.1.1.3), and determine the measured value from this. Wait at least 60 s before reading each value. 8.1.3 Expression of results Express the air leakages as the rate of the pressure reduction per minute. 8.2 Method of test for pressure reduction rate for self-linearizing valves 8.2.1 Apparatus 8.2.1.1 T-piece connector 8.2.1.2 Calibrated reference manometer, with signal output and an error less than 0.8 mmHg (0,1 kPa). 8.2.1.3 Artificial limbs NOTE The intention is to use artificial limbs, but as these are still under con
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