EN ISO 81060-1:2012

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

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

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.
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.
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)
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)

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.
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
ISO 81060-1:2007(E)
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ii © ISO 2007 – All rights reserved

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 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

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 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

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 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 bladder, or have an integral bladder
(i.e., the cuff including the bladder are fixed together or are one piece).
3.6
expected service life
maximum period of useful life as defined by the manufacturer
[IEC 60601-1:2005, definition 3.28]

1) To be published. (Revision of ISO 10993-1:2003)
2 © ISO 2007 – All rights reserved

ISO 81060-1:2007(E)
3.7
intended use
use of a product, process or service in accordance with the specifications, instructions and information
provided by the manufacturer
NOTE Intended use should not be confused with normal use. While both include the concept of use as intended by
the manufacturer, intended use focuses on the medical purpose while normal use incorporates not only the medical
purpose, but also maintenance, service, transport, etc.
[IEC 60601-1:2005, definition 3.44]
3.8
manufacturer
natural or legal person with responsibility for the design, manufacture, packaging or labelling of
non-automated sphygmomanometers, or adapting non-automated sphygmomanometers, regardless of
whether these operations are performed by that person or on that person's behalf by a third party
[2]
NOTE 1 ISO 13485 defines “labelling” as written, printed or graphic matter
– affixed to a medical device or any of its containers or wrappers
or
– accompanying a medical device,
related to identification, technical description, and use of the medical device, but excluding shipping documents. In this
part of ISO 81060, that material is described as markings and the accompanying document.
NOTE 2 “Adapting” includes making substantial modifications to a non-automated sphygmomanometer already in use.
NOTE 3 In some jurisdictions, the responsible organization can be considered a manufacturer when involved in the
activities described.
[Modified from IEC 60601-1:2005, definition 3.55]
3.9
* model or type reference
combination of figures, letters or both used to identify a particular model of non-automated
sphygmomanometer or accessory
[Modified from IEC 60601-1:2005, definition 3.66]
3.10
nominal
value quoted for reference purposes that is subject to agreed tolerances
[IEC 60601-1:2005, definition 3.69]
3.11
non-automated sphygmomanometer
instrument used for the non-invasive measurement of the blood pressure by utilizing an inflatable cuff with a
pressure-sensing element, a valve for deflation, and a display used in conjunction with a stethoscope or other
manual methods for estimating blood pressure
NOTE Components of these instruments include manometer, cuff, valve for deflation (often in combination with the
valve for rapidly exhausting the pneumatic system), hand pump or electro-mechanical pump for inflation of the bladder,
and connection hoses. A non-automated sphygmomanometer can also contain electro-mechanical components for
pressure control.
3.12
non-invasive blood pressure measurement
indirect measurement of the blood pressure without arterial puncture
ISO 81060-1:2007(E)
3.13
normal use
operation, including routine inspection and adjustments by any operator, and stand-by, according to the
instructions for use
NOTE Normal use should not be confused with intended use. While both include the concept of use as intended by
the manufacturer, intended use focuses on the medical purpose while normal use incorporates not only the medical
purpose, but maintenance, service, transport, etc., as well.
[IEC 60601-1:2005, definition 3.71]
3.14
operator
person handling equipment
[IEC 60601-1:2005, definition 3.73]
3.15
patient
living being (person or animal) undergoing a medical, surgical or dental procedure
[IEC 60601-1:2005, definition 3.76]
3.16
pneumatic system
part of the non-automated sphygmomanometer that includes all pressurized and pressure-controlling
components
EXAMPLES Cuff, tubing, connectors, valves, transducer and pump.
3.17
portable
term referring to transportable equipment intended to be moved from one location to another while being
carried by one or more persons
[IEC 60601-1:2005, definition 3.85]
3.18
responsible organization
entity accountable for the use and maintenance of a non-automated sphygmomanometer
NOTE 1 The accountable entity can be, for example, a hospital, an individual clinician or a layperson. In home use
applications, the patient, operator and responsible organization can be one and the same person.
NOTE 2 Education and training is included in “use.”
[Modified from IEC 60601-1:2005, definition 3.101]
3.19
stationary
term referring to equipment that is not intended to be moved from one place to another
[IEC 60601-1:2005, definition 3.118]
3.20
type test
test on a representative sample of the non-automated sphygmomanometer with the objective of
determining if the non-automated sphygmomanometer, as designed and manufactured, can meet the
requirements of this document
[Modified from IEC 60601-1:2005, definition 3.135]
4 © ISO 2007 – All rights reserved

ISO 81060-1:2007(E)
4 Identification and marking
4.1 * Units of measurement
The cuff pressure shall be indicated in either millimetres of mercury (mmHg) or kilopascals (kPa).
Check compliance by inspection.
4.2 * Legibility of markings
The markings required by 4.4, 4.6, and 4.7 shall be clearly legible under the following conditions:
a) for warning statements, instructive statements, safety signs and drawings on the outside of the non-
automated sphygmomanometer, from the intended position of the person performing the related function;
b) for markings on the inside of the non-automated sphygmomanometer or non-automated
sphygmomanometer parts, from the intended position of the person performing the related function.
Check compliance for a clearly legible marking by the following test.
1) Position the non-automated sphygmomanometer or its part so that the viewpoint is the intended
position of the operator; or the viewpoint is at any point within the base of a cone subtended by an
angle of 30° to the axis normal to the centre of the plane of the marking and at a distance of 1 m.
2) Ensure that the ambient luminance is the least favourable level in the range of 100 lx to 1 500 lx.
3) Ensure that the observer has a visual acuity of 0 on the log Minimum Angle of Resolution (log MAR)
scale or 6/6 (20/20), corrected if necessary.
4) The observer correctly reads the marking from the viewpoint.
4.3 * Durability of markings
The markings required by 4.4 and 4.6 shall be removable only with a tool or by appreciable force and shall be
sufficiently durable to remain clearly legible during the expected service life of the non-automated
sphygmomanometer. In considering the durability of the markings, the effect of normal use shall be taken into
account.
Check compliance by inspection and the following tests.
After all the other tests of this document have been performed:
a) markings are rubbed by hand, without undue pressure, first for 15 s with a cloth soaked with distilled
water, then for 15 s with a cloth soaked with methylated spirits and then for 15 s with a cloth soaked with
isopropyl alcohol.
b) legibility of markings are tested to the requirements of 4.2;
c) adhesive labels shall not have worked loose or become curled at the edges.
4.4 * Marking of non-automated sphygmomanometer
The non-automated sphygmomanometer, the cuff and/or their components shall be marked clearly and legibly
with the following:
a) the name or trademark and address of the manufacturer;
ISO 81060-1:2007(E)
b) model or type reference;
c) * where appropriate, an identification reference to the serial or batch number, or Symbol 5.16 or 5.14 from
ISO 15223-1:2007;
d) the non-automated sphygmomanometer and its parts shall be marked with regard to proper disposal, as
appropriate;
e) * the numbering on the scale or digital display shall not exceed the measurement range as determined in
7.1.2.
The following is additionally required for a non-automated sphygmomanometer containing a mercury
manometer:
f) * safety sign for mandatory action “Refer to instruction manual/booklet” in accordance with M002 of
ISO 7010:2003 and safety sign for warning “General warning” in accordance with W-001 of
ISO 7010:2003;
g) an indication that the tube contains mercury.
Check compliance by inspection.
4.5 * Usability of reading
Means shall be provided to address legibility and parallax error of reading the scale of a non-automated
sphygmomanometer in normal use by ensuring that there is an indication to the operator when the parallax
error results in a reading error that exceeds ± 2 mmHg (0,3 kPa).
Check compliance by the tests of 4.2.
The observer reads the scale with an error of less than ± 2 mmHg (0,3 kPa) from the viewpoint.
4.6 Marking of the cuff
The cuff shall additionally be marked with the following information:
a) indication of the correct positioning for the cuff over the artery;
b) indication the limb circumference for which it is appropriate (see 7.2.4).
Check compliance by inspection.
4.7 Marking of the non-automated sphygmomanometer packaging
The packaging of a non-automated sphygmomanometer, the cuff or their components shall be marked with
the following:
a) details to enable the responsible organization to identify the contents of the packaging;
b) for a sterile non-automated sphygmomanometer, cuff or component, the appropriate Symbol 5.20. 5.21,
5.22, 5.23 or 5.24 from ISO 15223-1:2007;
c) for a non-automated sphygmomanometer, cuff or component with an expiry date, Symbol 5.12 from
ISO 15223-1:2007;
d) for a single use non-automated sphygmomanometer, cuff or component, the words “single use only” or
“do not re-use” or Symbol 5.2 from ISO 15223-1:2007;
6 © ISO 2007 – All rights reserved

ISO 81060-1:2007(E)
e) any special storage and/or handling instructions;
f) the intended use of the cuff.
Check compliance by inspection.
5 General requirements for testing non-automated sphygmomanometers
5.1 * Type tests
The tests described in this standard are type tests.
5.2 * Representative sample
Type tests are performed on a representative sample of the item being tested.
NOTE Multiple samples can be utilized simultaneously if the validity of the results is not significantly affected.
5.3 Environmental conditions
General conditions of normal use shall include the following.
a) Unless otherwise specified in this part of ISO 81060, the non-automated sphygmomanometer complies
with this part of ISO 8106 under the least favourable working conditions within the environmental
temperature range of 10 °C to 40 °C and the relative humidity range of 15 % to 85 % (non-condensing).
b) The non-automated sphygmomanometer is shielded from other influences (for example, draught), which
might affect the validity of the tests.
5.4 Repairs and modifications
In the event of the necessity for repairs or modifications after a failure or a probability of future failure during
the sequence of tests, the testing laboratory and the supplier of the non-automated sphygmomanometer for
the test can agree, either upon the presentation of a new sample on which all tests influencing the result are
performed again or, preferably, upon making all the necessary repairs or modifications after which only
relevant tests are repeated.
5.5 * Humidity preconditioning treatment
Prior to the tests described in Clause 7, the non-automated sphygmomanometer or its parts shall be subjected
to a humidity preconditioning treatment.
Set up the complete non-automated sphygmomanometer or its parts. Detach covers used during transport
and storage.
Perform the humidity preconditioning treatment in a humidity cabinet containing air with a relative humidity of
85 % ± 5 %. Maintain the temperature of the air in the cabinet, at all places where a non-automated
sphygmomanometer can be located, within 2 °C of any convenient temperature, T, in the range of + 20 °C to
+ 32 °C. Before being placed in the humidity cabinet, bring the non-automated sphygmomanometer to a
temperature between T and T + 4 °C, and maintain this temperature for at least 4 h before the humidity
treatment.
Keep the non-automated sphygmomanometer and its parts in the humidity cabinet for 48 h.
ISO 81060-1:2007(E)
Where the risk management process suggests that the non-automated sphygmomanometer can be exposed
to high humidity for extended periods (such as a non-automated sphygmomanometer intended for outdoor
use), extend the period appropriately.
After the treatment, re-assemble the non-automated sphygmomanometer, if necessary.
6 General requirements
6.1 General
Equipment or parts thereof using materials or having forms of construction different from those detailed in this
part of ISO 81060, shall be accepted as equivalent if it can be demonstrated that an equivalent degree of
safety and performance is obtained.
Planning and design of products applying this part of ISO 81060 should consider the environmental impact
from the product during its life cycle. See also Annex B. Environmental aspects are addressed in Annex C.
NOTE Additional aspects of environmental impact are addressed in ISO 14971.
Check compliance by inspection of the risk management file.
6.2 Electrical safety
Non-automated sphygmomanometers that utilize electrical power shall meet the applicable requirements in
IEC 60601-1, in addition to the requirements in this part of ISO 81060.
Check compliance by application of the tests of IEC 60601-1.
6.3 Mechanical safety
Rough surfaces, sharp corners and edges that can cause injury or damage shall be avoided or covered.
Particular attention shall be paid to flange or frame edges and the removal of burrs.
Check compliance by inspection.
6.4 Mechanical strength
6.4.1 * Non-automated sphygmomanometers
Non-automated sphygmomanometers or their parts shall have adequate mechanical strength when subjected
to mechanical stress caused by normal use, pushing, impact, dropping and rough handling. Stationary non-
automated sphygmomanometers are exempt from the requirements of this subclause.
The non-automated sphygmomanometer shall function normally following a free fall from a distance, d, of
25 cm.
A non-automated sphygmomanometer that is marked “Shock Resistant” shall function normally following a
free fall fr
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