SIST EN ISO 81060-1:2012
(Main)Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007)
Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007)
This part of ISO 81060 specifies requirements for non-automated sphygmomanometers, as defined in 3.11, and their accessories, which, by means of inflatable cuffs, are used for the non-invasive blood pressure measurement by operator observation. This part of ISO 81060 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. The part of ISO 81060 covers non-invasive blood pressure measurement devices with a pressure-sensing element and display used in conjunction with means of detecting blood flow. Requirements for non-invasive blood pressure measurement equipment with electrically-powered pressure sensing elements and/or displays used in conjunction with other automatic methods determining blood pressure are specified in IEC 60601-2-30. Requirements for invasive blood pressure measurement equipment that directly measure blood pressure are specified in document IEC 60601-2-34.
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 benutzt 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 Druckanzeige, die in Verbindung mit einem Hilfsmittel zur Feststellung des Blutflusses benutzt 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 benutzt werden, sind im Dokument ISO 80601-2-30 (VDE 0750-2-30)[7] festgelegt.
Anforderungen an invasive Blutdruckmessgeräte, die den Blutdruck direkt messen, sind im Dokument EN 60601-2-34[8] festgelegt.
BEISPIEL 2 Messeinrichtung, einschließlich angeschlossenen Druckaufnehmern, die zur invasiven Druckmessung des Kreislaufs benutzt 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
Relations
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 consists of the following parts, under the general title Non-invasive sphygmomanometers:
Part 1: Requirements and test methods for non-automated measurement type
Part 2: Clinical validation of automated measurement type
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: 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 the United Kingdom.
Endorsement notice
The text of ISO 81060-1:2007 has been approved by CEN as a EN ISO 81060-1:2012 without any
modification.
3
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SIST EN ISO 81060-1:2012
EN ISO 81060-1:2012 (E)
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 (1/3)
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) of
Qualifying remarks/Notes
EN Directive 93/42/EEC
6.4.3, 8.3, 8.4, 8.5 7.2 Prevention of risks related to
mercury leakage and spillage only.
Packaging is not addressed.
Design and manufacture are
addressed via tests on finished
products.
8.3, 8.4, 8.5 7.5 (first sentence) Only prevention of risks due to
mercury leakage
10.1, 10.2 8.1 Only reduction of the risk of
infection to a commonly accepted
level is addressed (not “as far as
possible”).
Manufacturing processes are not
addressed.
Easy handling is not addressed.
10.3 8.4
4.7 b) 8.7 ER 8.7 is partially addressed.
6.2, 7.1.2, 7.2.4, 7.2.5, 7.2.6, 12.2.1 c) 9.1
st
6.3, 7.2.3 9.2 (1 indent) Prevention of injury due to rough
surfaces and prevention of injury
due to excessive pressure are
addressed.
6.2, 6.3, 6.4 9.2 ER 9.2 is partially addressed.
6.2 9.3 Only addressed for electrical
devices via IEC 60601-1, Clauses
11 and 13.
4.4 e), 6.2, 7.1.1, 7.1.2, 7.2.1, 7.2.2, 7.4, 10.1 For electrical devices, see also
8.1, 9, 12.2.1 b), 12.2.1 l), 12.2.1 n), 12.2.1 IEC 60601-1 Clause 12, as
q), 12.3.b), 12.3.c) required in Clause 6.2 of the
present standard.
4
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SIST EN ISO 81060-1:2012
EN ISO 81060-1:2012 (E)
Table ZA.1 — (2/3)
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) of
Qualifying remarks/Notes
EN Directive 93/42/EEC
4.2, 4.3, 4.4 e), 4.5, 6.2, 10.2 For electrical devices, see also
IEC 60601-1 Clauses 7 and 12, as
required in Clause 6.2 of the
present standard.
4.1, 6.2 10.3 For electrical devices, see also
IEC 60601-1 subclause 7.4.3, as
required in Clause 6.2 of the
present standard.
6.2 12.1 Only addressed for electrical
devices via IEC 60601-1, Clause
14.
6.2 12.1 a) Only addressed for electrical
devices via IEC 60601-1, Clause
14.
6.2 12.5 Only addressed for electrical
devices via IEC 60601-1, Clause
17.
6.2 12.6 Only addressed for electrical
devices via IEC 60601-1, Clause
8.
6.2, 6.3 12.7.1 For electrical devices, see also
IEC 60601-1 Clauses 9 and 15, as
required in Clause 6.2 of the
present standard.
6.2 12.7.2 Only addressed for electrical
devices via IEC 60601-1, Clause
9.
6.2 12.7.3 Only addressed for electrical
devices via IEC 60601-1, Clause
9.
6.2 12.7.4 Only addressed for electrical
devices via IEC 60601-1, Clauses
8 and 15.
6.2 12.7.5 Only addressed for electrical
devices via IEC 60601-1, Clause
11.
12.2.1 f), 12.2.1 h) 12.9
4, 6.2, 12 13.1
4.4, 4.7, 12.2.1 h) 13.2
4.4 a), 6.2, 12.1 13.3 a) The part of ER 13.3.a) relating to
the authorized representative is
not addressed.
4.4 b), 4.7 a) 13.3 b)
4.7 b) 13.3 c)
5
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SIST EN ISO 81060-1:2012
EN ISO 81060-1:2012 (E)
Table ZA.1 — (3/3)
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) of
Qualifying remarks/Notes
EN Directive 93/42/EEC
4.4 c) 13.3 d) The presumption of conformity is
only provided if the batch number
is preceded by the word “LOT”.
4.7 c) 13.3 e)
4.7 d) 13.3 f) The presumption of conformity is
only provided if the indication of
single use is consistent across the
Community.
4.7 e) 13.3 i)
4.6 a), 4.6 b) 13.3 j)
12.2.1 m), 12.2.1 n) 13.3 k)
6.2 13.3 l)
4.7 b) 13.3 m)
4.6 b), 4.7 f), 12.2.1 a) 13.4
4.4 b), 4.4 c), 6.2 13.5
12.1, 12.2.1 g), 12.2.1 p), 12.2.1 r), 12.2.1 s) 13.6 a) This Essential Requirement is
partially addressed.
12.2.1.e), 12.2.1 k), 12.2.1 l), 12.2.4 13.6 c)
12.2.1 e), 12.2.1 j), 12.2.1 k), 12.2.1 o), 13.6 d)
12.2.1 s), 12.2.3
6.2 13.6 f) ER 13.6 f) is addressed only for
electrical devices via IEC 60601-1.
12.2.2 13.6 h) The part of ER 13.6 h) relating to
“single use” is not addressed.
12.2.1 c), k) 13.6 i) For electrical devices, see also
IEC 60601-1 Clause 7, as required
in Clause 6.2 of the present
standard.
4.4 d), 6.2, 12.2.1 t), 12.2.5 13.6 n)
6
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SIST EN ISO 81060-1:2012
EN ISO 81060-1:2012 (E)
For devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC on
Machinery, in accordance with Article 3 of Directive 93/42/EEC the following table ZA.2 details the relevant
essential requirements of Directive 2006/42/EC on Machinery to the extent to which they are more specific
than those of Directive 93/42/EEC along with the corresponding clauses of this European Standard. Table
ZA.2, however, does not imply any citation in the OJEU under the machinery directive and thus does not
provide presumption of conformity for the machinery directive.
NOTE Table ZA.2 is only applicable to electrical devices.
Table ZA.2 – Relevant Essential Health and Safety Requirements from Directive 2006/42/EC on
machinery that are addressed by this European Standard
(according to article 3 of amended Directive 93/42/EEC)
Clause(s)/sub-clause(s) of this Essential Health and Safety Qualifying remarks/Notes
EN Requirements (EHSRs) of
Directive 2006/42/EC
4.5, 6.2 1.2.2
Only partly addressed
6.2 1.5.1
7.2.6, 7.3 1.5.4
Errors of fitting are only reduced to
a commonly accepted level, but
are not made “impossible”
6.2 1.5.5
6.2 1.5.6
6.2 1.5.7
6.2 1.6.3
Only partly addressed
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
7
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SIST EN ISO 81060-1:2012
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SIST EN ISO 81060-1:2012
INTERNATIONAL ISO
STANDARD 81060-1
First edition
2007-12-01
Non-invasive sphygmomanometers —
Part 1:
Requirements and test methods for
non-automated measurement type
Sphygmomanomètres non invasifs —
Partie 1: Exigences et méthodes d'essai pour type à mesurage non
automatique
Reference number
ISO 81060-1:2007(E)
©
ISO 2007
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SIST EN ISO 81060-1:2012
ISO 81060-1:2007(E)
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ii © ISO 2007 – All rights reserved
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SIST EN ISO 81060-1:2012
ISO 81060-1:2007(E)
Contents Page
Foreword. v
Introduction . vi
1 * Scope. 1
2 Normative references . 1
3 Terms and definitions. 2
4 Identification and marking . 5
4.1 * Units of measurement. 5
4.2 * Legibility of markings . 5
4.3 * Durability of markings. 5
4.4 * Marking of non-automated sphygmomanometer. 5
4.5 * Usability of reading . 6
4.6 Marking of the cuff. 6
4.7 Marking of the non-automated sphygmomanometer packaging. 6
5 General requirements for testing non-automated sphygmomanometers . 7
5.1 * Type tests. 7
5.2 * Representative sample . 7
5.3 Environmental conditions. 7
5.4 Repairs and modifications. 7
5.5 * Humidity preconditioning treatment . 7
6 General requirements. 8
6.1 General. 8
6.2 Electrical safety. 8
6.3 Mechanical safety . 8
6.4 Mechanical strength . 8
7 Requirements . 10
7.1 Pressure indicating means . 10
7.2 Pneumatic system . 11
7.3 * Tamper proofing or unauthorized access . 14
7.4 Dynamic response in normal use . 14
8 Additional requirements for non-automated sphygmomanometer with mercury
manometer. 15
8.1 * Internal diameter of the tube containing mercury . 15
8.2 * Portable non-automated sphygmomanometer . 15
8.3 * Prevention of mercury spillage during transport. 15
8.4 * Prevention of mercury spillage in normal use . 15
8.5 Quality of the mercury. 16
9 Non-automated sphygmomanometers with aneroid manometer . 16
9.1 * Scale mark at zero. 16
9.2 * Zero. 16
9.3 Hysteresis error . 16
9.4 * Construction and materials. 17
10 Cleaning, sterilization and disinfection. 17
10.1 Reusable non-automated sphygmomanometer and parts. 17
10.2 Non-automated sphygmomanometer and parts requiring processing before use . 17
10.3 Non-automated sphygmomanometer and parts delivered sterile . 18
11 Biocompatibility. 18
© ISO 2007 – All rights reserved iii
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SIST EN ISO 81060-1:2012
ISO 81060-1:2007(E)
12 Information supplied by the manufacturer. 18
12.1 Accompanying document . 18
12.2 Instructions for use. 18
12.3 Technical description . 21
Annex A (informative) Rationale and guidance . 23
Annex B (informative) Advice regarding non-automated sphygmomanometers with a mercury
manometer. 31
Annex C (informative) Environmental aspects . 32
Annex D (informative) Reference to the essential principals. 33
Annex E (informative) Terminology — Alphabetized index of defined terms . 35
Bibliography . 36
iv © ISO 2007 – All rights reserved
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SIST EN ISO 81060-1:2012
ISO 81060-1:2007(E)
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 81060-1 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 3, Lung ventilators and related equipment.
ISO 81060 consists of the following parts, under the general title Non-invasive sphygmomanometers:
⎯ Part 1: Requirements and test methods for non-automated measurement type
The preparation of a second part covering clinical evaluation for the automated measurement type is planned.
[7]
For automated measurement type non-invasive sphygmomanometers, see IEC 60601-2-30 .
© ISO 2007 – All rights reserved v
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SIST EN ISO 81060-1:2012
ISO 81060-1:2007(E)
Introduction
The minimum safety requirements specified in this part of ISO 81060 are considered to provide a practical
degree of safety in the operation of non-automated sphygmomanometers.
The requirements are followed by specifications for the relevant tests.
A “rationale and guidance” section giving some explanatory notes, where appropriate, about the more
important requirements is included in Annex A.
It is considered that knowledge of the reasons for these requirements will not only facilitate the proper
application of this part of ISO 81060 but will, in due course, expedite any revision necessitated by changes in
clinical practice or as a result of developments in technology. However, Annex A does not form part of the
requirements of this part of ISO 81060.
Throughout this document, text for which a rationale is provided in Annex A is indicated by an asterisk (*).
vi © ISO 2007 – All rights reserved
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SIST EN ISO 81060-1:2012
INTERNATIONAL STANDARD ISO 81060-1:2007(E)
Non-invasive sphygmomanometers —
Part 1:
Requirements and test methods for non-automated
measurement type
1 * Scope
This part of ISO 81060 specifies requirements for non-automated sphygmomanometers, as defined in 3.11,
and their accessories, which, by means of inflatable cuffs, are used for the non-invasive blood pressure
measurement by operator observation.
This part of ISO 81060 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.
The part of ISO 81060 covers non-invasive blood pressure measurement devices with a pressure-sensing
element and display used in conjunction with means of detecting blood flow.
EXAMPLE 1 A stethoscope for detecting Korotkoff sounds, Doppler ultrasound or other manual methods.
Requirements for non-invasive blood pressure measurement equipment with electrically-powered pressure
sensing elements and/or displays used in conjunction with other automatic methods determining blood
[7]
pressure are specified in IEC 60601-2-30 .
Requirements for invasive blood pressure measurement equipment that directly measure blood pressure are
[8]
specified in document IEC 60601-2-34 .
EXAMPLE 2 Measuring equipment, including associated transducers, that is used for the invasive measurement of
circulatory system pressures.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 594-1, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical
equipment — Part 1: General requirements
ISO 594-2, Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment —
Part 2: Lock fittings
ISO 7010:2003, Graphical symbols — Safety colours and safety signs — Safety signs used in workplaces and
public areas
© ISO 2007 – All rights reserved 1
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SIST EN ISO 81060-1:2012
ISO 81060-1:2007(E)
1)
ISO 10993-1 , Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management system
ISO 14937, Sterilization of health care products — General requirements for characterization of a sterilizing
agent and the development, validation and routine control of a sterilization process for medical devices
ISO 15223-1:2007, Medical devices — Symbols to be used with medical device labels, labelling and
information to be supplied — Part 1: General requirements
IEC 60601-1, Medical electrical equipment — Part 1: General requirements for basic safety and essential
performance
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply. For convenience, an
alphabetized list of the sources of all defined terms used in this document is given in Annex E.
3.1
accompanying document
document accompanying a non-automated sphygmomanometer or accessory and containing information
for those accountable for the installation, use and maintenance of the non-automated sphygmomanometer
or accessory, the operator or the responsible organization, particularly regarding safety
[Modified from ISO 14971:2007, definition 2.1]
3.2
bladder
that part of the cuff that is inflatable
3.3
blood pressure
pressure in the systemic arterial system of the body
3.4
clearly legible
capable of being read by a person with normal vision
[IEC 60601-1:2005, definition 3.15]
3.5
cuff
part of the non-automated sphygmomanometer that is wrapped around the limb of the patient
NOTE A cuff might comprise a bladder and an inelastic part that encloses the blad
...
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