IEC 60601-2-30:1999

Medical electrical equipment - Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment

Specifies particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment, with special attention being paid to the avoidance of hazards due to the inflation process.

General Information

• Status: Replaced
• Publication Date: 21-Dec-1999
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Current Stage: DELPUB - Deleted Publication
• Completion Date: 28-Jan-2009

Relations

• Replaced By: IEC 80601-2-30:2009 - Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
• Effective Date: 05-Sep-2023

Standards Content (Sample)

INTERNATIONAL IEC
STANDARD
60601-2-30
Second edition
1999-12
Medical electrical equipment –
Part 2-30:
Particular requirements for the safety,
including essential performance,
of automatic cycling non-invasive
blood pressure monitoring equipment
Appareils électromédicaux –
Partie 2-30:
Règles particulières de sécurité et performances
essentielles des appareils de surveillance
de la pression sanguine prélevée indirectement,
automatiquement et périodiquement

Reference number
Numbering
As from 1 January 1997 all IEC publications are issued with a designation in the
60000 series.
Consolidated publications
Consolidated versions of some IEC publications including amendments are

available. For example, edition numbers 1.0, 1.1 and 1.2 refer, respectively, to the
base publication, the base publication incorporating amendment 1 and the base

publication incorporating amendments 1 and 2.

Validity of this publication
The technical content of IEC publications is kept under constant review by the IEC,
thus ensuring that the content reflects current technology.
Information relating to the date of the reconfirmation of the publication is available
in the IEC catalogue.
Information on the subjects under consideration and work in progress undertaken
by the technical committee which has prepared this publication, as well as the list
of publications issued, is to be found at the following IEC sources:
• IEC web site*
•
Catalogue of IEC publications
Published yearly with regular updates
(On-line catalogue)*
• IEC Bulletin
Available both at the IEC web site* and as a printed periodical
Terminology, graphical and letter symbols
For general terminology, readers are referred to IEC 60050: International
Electrotechnical Vocabulary (IEV).
For graphical symbols, and letter symbols and signs approved by the IEC for
general use, readers are referred to publications IEC 60027: Letter symbols to be
used in electrical technology, IEC 60417: Graphical symbols for use on equipment.
Index, survey and compilation of the single sheets and IEC 60617: Graphical symbols
for diagrams.
* See web site address on title page.

INTERNATIONAL IEC
STANDARD
60601-2-30
Second edition
1999-12
Medical electrical equipment –
Part 2-30:
Particular requirements for the safety,
including essential performance,
of automatic cycling non-invasive
blood pressure monitoring equipment
Appareils électromédicaux –
Partie 2-30:
Règles particulières de sécurité et performances
essentielles des appareils de surveillance
de la pression sanguine prélevée indirectement,
automatiquement et périodiquement

 IEC 1999  Copyright - all rights reserved
No part of this publication may be reproduced or utilized in any form or by any means, electronic or
mechanical, including photocopying and microfilm, without permission in writing from the publisher.
International Electrotechnical Commission 3, rue de Varembé Geneva, Switzerland
Telefax: [phone] e-mail: [e-mail] IEC web site http://www.iec.ch
Commission Electrotechnique Internationale
PRICE CODE
X
International Electrotechnical Commission
For price, see current catalogue

– 2 – 60601-2-30 © IEC:1999(E)

CONTENTS
Page
FOREWORD . 4

INTRODUCTION .6

Clause
SECTION ONE – GENERAL
1 Scope and object. 7
2 Terminology and definitions . 8
3 General requirements . 9
4 General requirements for tests . 10
5 Classification. 10
6 Identification, marking and documents . 10
SECTION TWO – ENVIRONMENTAL CONDITIONS
SECTION THREE – PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
14 Requirements related to classification. 11
17 Separation. 12
19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS . 12
20 Dielectric strength . 12
SECTION FOUR – PROTECTION AGAINST MECHANICAL HAZARDS
21 Mechanical strength . 12
22 Moving parts. 13
SECTION FIVE – PROTECTION AGAINST HAZARDS
FROM UNWANTED OR EXCESSIVE RADIATION

36 ELECTROMAGNETIC COMPATIBILITY. 14
SECTION SIX – PROTECTION AGAINST THE HAZARDS OF IGNITION
OF FLAMMABLE ANAESTHETIC MIXTURES
SECTION SEVEN – PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
42 Excessive temperatures . 17
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning,
sterilization and disinfection, and compatibility . 18
45 Pressure vessels and parts subject to PRESSURE. 18
49 Interruption of the power supply. 18

60601-2-30 © IEC:1999(E) – 3 –

SECTION EIGHT – ACCURACY OF OPERATING DATA AND PROTECTION

AGAINST HAZARDOUS OUTPUT
50 Accuracy of operating data . 19

51 Protection against hazardous output . 19

SECTION NINE – ABNORMAL OPERATION AND FAULT CONDITIONS;

ENVIRONMENTAL TESTS
SECTION TEN – CONSTRUCTIONAL REQUIREMENTS

56 Components and general assembly . 25
57 MAINS PARTS, components and lay-out. 26
Annex L (normative) References – Publications mentioned in this standard. 34
Annex AA (informative) General guidance and rationale. 35
Annex BB (informative) Alarm diagrams. 42
Figure 101 – Test for protection against defibrillator discharge . 27
Figure 102 – Safety means, SINGLE FAULT CONDITION, adult (neonatal) determination . 28
Figure 103 – Safety means, SINGLE FAULT CONDITION, adult (neonatal) determination . 28
Figure 104 – Maximum inflation time, NORMAL CONDITION and SINGLE FAULT CONDITION,
adult (neonatal) determination . 29
Figure 105 – LONG TERM AUTOMATIC MODE NORMAL CONDITION, adult (neonatal) determination . 29
Figure 106 – LONG TERM AUTOMATIC MODE SINGLE FAULT CONDITION, adult (neonatal)
determination . 30
Figure 107 – SHORT TERM AUTOMATIC MODE, adult (neonatal) determination . 30
Figure 108 – Test layout . 31
Figure 109 – ESU test layout . 32
Figure 110 – Patient simulator . 33

– 4 – 60601-2-30 © IEC:1999(E)

INTERNATIONAL ELECTROTECHNICAL COMMISSION

___________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-30: Particular requirements for the safety, including essential

performance, of automatic cycling non-invasive blood pressure

monitoring equipment
FOREWORD
1) The IEC (International Electrotechnical Commission) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of the IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, the IEC publishes International Standards. Their preparation is
entrusted to technical committees; any IEC National Committee interested in the subject dealt with may
participate in this preparatory work. International, governmental and non-governmental organizations liaising
with the IEC also participate in this preparation. The IEC collaborates closely with the International Organization
for Standardization (ISO) in accordance with conditions determined by agreement between the two
organizations.
2) The formal decisions or agreements of the IEC on technical matters express, as nearly as possible, an
international consensus of opinion on the relevant subjects since each technical committee has representation
from all interested National Committees.
3) The documents produced have the form of recommendations for international use and are published in the form
of standards, technical specifications, technical reports or guides and they are accepted by the National
Committees in that sense.
4) In order to promote international unification, IEC National Committees undertake to apply IEC International
Standards transparently to the maximum extent possible in their national and regional standards. Any
divergence between the IEC Standard and the corresponding national or regional standard shall be clearly
indicated in the latter.
5) The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with one of its standards.
6) Attention is drawn to the possibility that some of the elements of this International Standard may be the subject
of patent rights. The IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 60601-2-30 has been prepared by sub-committee 62D: Electro-
medical equipment, of IEC technical committee 62: Electrical equipment in medical practice.
This second edition of IEC 60601-2-30 cancels and replaces the first edition published in 1995,
and constitutes a technical revision.

The text of this standard is based on the following documents:
FDIS Report on voting
62D/339/FDIS 62D/350/RVD
Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 3.
Annexes AA and BB are for information only.

60601-2-30 © IEC:1999(E) – 5 –

In this Particular Standard, the following print types are used:

– requirements, compliance with which can be tested, and definitions: in roman type;

– notes, explanations, advice, introductions, general statements, exceptions and references: in smaller type;

– test specifications, headings of subclauses and headings of items: in italic type;

–TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD OR THIS PARTICULAR STANDARD: SMALL

CAPITALS.
The committee has decided that this publication remains valid until 2005. At this date, in

accordance with the committee's decision, the publication will be

• reconfirmed;
• withdrawn;
• replaced by a revised edition, or
• amended.
– 6 – 60601-2-30 © IEC:1999(E)

INTRODUCTION
This Particular Standard concerns the safety of automatic cycling non-invasive blood pressure

monitoring equipment. It amends and supplements IEC 60601-1 (second edition 1988),

hereinafter referred to as the General Standard. The requirements of this Particular Standard

take priority over those of the General Standard, entitled “Medical electrical equipment –

Part 1: General requirements for safety”.

A “General guidance and rationale” for the requirements of this Particular Standard is included

in annex AA.
It is considered that a knowledge of the reasons for these requirements will not only facilitate
the proper application of the standard but will, in due course, expedite any revision
necessitated by changes in clinical practice or as a result of developments in technology.
However, this annex does not form part of the requirements of this Standard.
An asterisk (*) by a clause or subclause number indicates that some explanatory notes are
given in annex AA.
60601-2-30 © IEC:1999(E) – 7 –

MEDICAL ELECTRICAL EQUIPMENT –

Part 2-30: Particular requirements for the safety, including essential

performance, of automatic cycling non-invasive blood pressure

monitoring equipment
SECTION ONE – GENERAL
The clauses and subclauses of this section of the General Standard apply except as follows:
1 Scope and object
This clause of the General Standard applies except as follows:
*1.1 Scope
Addition:
This Particular Standard specifies requirements for the safety, including essential performance,
of AUTOMATIC CYCLING NON-INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT as defined in
2.102, hereinafter referred to as EQUIPMENT. The EQUIPMENT may be attended or unattended.
This Particular Standard does not apply to blood pressure measuring equipment which uses
finger transducers or to semi-automatic blood pressure measuring equipment, typically in which
each determination needs to be initiated manually.
1.2 Object
Replacement:
The object of this Particular Standard is to establish particular requirements for the safety,
including essential performance, of AUTOMATIC CYCLING NON-INVASIVE BLOOD PRESSURE
MONITORING
...