EN 60601-1-10:2008

SLOVENSKI STANDARD
01-julij-2008
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Medical electrical equipment - Part 1-10: General requirements for basic safety and
essential performance - Collateral Standard: Requirements for the development of
physiologic closed-loop controllers (IEC 60601-1-10:2007)
Medizinische elektrische Geräte - Teil 1-10: Allgemeine Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Anforderungen
an die Entwicklung von physiologischen geschlossenen Regelkreisen (IEC 60601-1-
10:2007)
Appareils électromédicaux -- Partie 1-10: Exigences générales pour la sécurité de base
et les performances essentielles - Norme collatérale: Exigences pour le développement
des régulateurs physiologiques en boucle fermée (CEI 60601-1-10:2007)
Ta slovenski standard je istoveten z: EN 60601-1-10:2008
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN 60601-1-10
NORME EUROPÉENNE
April 2008
EUROPÄISCHE NORM
ICS 11.040
English version
Medical electrical equipment -
Part 1-10: General requirements for basic safety
and essential performance -
Collateral Standard: Requirements for the development
of physiologic closed-loop controllers
(IEC 60601-1-10:2007)
Appareils électromédicaux -  Medizinische elektrische Geräte -
Partie 1-10: Exigences générales Teil 1-10: Allgemeine Festlegungen
pour la sécurité de base für die Sicherheit einschließlich
et les performances essentielles - der wesentlichen Leistungsmerkmale -
Norme collatérale: Exigences Ergänzungsnorm: Anforderungen
pour le développement des régulateurs an die Entwicklung von physiologischen
physiologiques en boucle fermée geschlossenen Regelkreisen
(CEI 60601-1-10:2007) (IEC 60601-1-10:2007)

This European Standard was approved by CENELEC on 2008-03-01. CENELEC 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 Central Secretariat or to any CENELEC 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 CENELEC member into its own language and notified
to the Central Secretariat has the same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Cyprus, the
Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Central Secretariat: rue de Stassart 35, B - 1050 Brussels

© 2008 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-1-10:2008 E
Foreword
The text of document 62A/576/FDIS, future edition 1 of IEC 60601-1-10, prepared by SC 62A, Common
aspects of electrical equipment used in medical practice, of IEC TC 62, Electrical equipment in medical
practice, and ISO SC 1, Breathing attachments and anaesthetic machines, and SC 3, Lung ventilators
and related devices, of ISO TC 121, Anaesthetic and respiratory equipment, was submitted to the
IEC-CENELEC parallel vote and was approved by CENELEC as EN 60601-1-10 on 2008-03-01
The following dates were fixed:

– latest date by which the EN has to be implemented

at national level by publication of an identical
(dop) 2008-12-01
national standard or by endorsement

– latest date by which the national standards conflicting
(dow) 2011-03-01
with the EN have to be withdrawn
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and covers essential requirements of
EC Directive 93/42/EEC. See Annex ZZ.
This European Standard constitutes a collateral standard to EN 60601-1:2006, hereafter referred to as
the general standard.
In the 60601 series of publications, collateral standards specify general requirements for safety applicable
to:
– a subgroup of MEDICAL ELECTRICAL EQUIPMENT (e.g. radiological equipment); or
– a specific characteristic of all MEDICAL ELECTRICAL EQUIPMENT, not fully addressed in the general
standard (e.g. ALARM SYSTEMS).
In this collateral standard, the following print types are used:
− requirements and definitions: in roman type;
− test specifications: in italic type;
− informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of
tables is also in a smaller type;
− TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS COLLATERAL STANDARD OR AS NOTED: IN
SMALL CAPITALS.
In referring to the structure of this standard, the term
– “clause” means one of the eight numbered divisions within the table of contents, inclusive of all
subdivisions (e.g. Clause 8 includes Subclauses 8.1, 8.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g. 8.1, 8.2 and 8.2.1 are all subclauses of
Clause 8).
References to clauses within this standard are preceded by the term “Clause” followed by the clause
number. References to subclauses within this standard are by number only.
In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination
of the conditions is true.
- 3 - EN 60601-1-10:2008
The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives,
Part 2. For the purposes of this standard, the auxiliary verb
− “shall” means that compliance with a requirement or a test is mandatory for compliance with this
standard;
− “should” means that compliance with a requirement or a test is recommended but is not mandatory for
compliance with this standard;
− “may” is used to describe a permissible way to achieve compliance with a requirement or test.
Clauses, subclauses and definitions for which a rationale is provided in informative Annex A are marked
with an asterisk (*).
Annexes ZA and ZZ have been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 60601-1-10:2007 was approved by CENELEC as a European
Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards indicated:
ISO 9000 NOTE Harmonized as EN ISO 9000:2005 (not modified).
ISO 14001 NOTE Harmonized as EN ISO 14001:2004 (not modified).
ISO 14021 NOTE Harmonized as EN ISO 14021:2001 (not modified).
ISO 14040 NOTE Harmonized as EN ISO 14040:2006 (not modified).
__________
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

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.

NOTE  When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.
Publication Year Title EN/HD Year
IEC 60601-1 2005 Medical electrical equipment - EN 60601-1 2006
Part 1: General requirements for basic safety
and essential performance
IEC 60601-1-6 2006 Medical electrical equipment - EN 60601-1-6 2007
Part 1-6: General requirements for basic
safety and essential performance - Collateral
Standard: Usability
IEC 60601-1-8 2006 Medical electrical equipment - EN 60601-1-8 2007
Part 1-8: General requirements for basic
safety and essential performance - Collateral
Standard: General requirements, tests and
guidance for alarm systems in medical
electrical equipment and medical electrical
systems
IEC 62304 2006 Medical device software - Software life-cycle EN 62304 2006
processes
1) 2)
ISO 14971 - Medical devices - Application of risk EN ISO 14971 2007
management to medical devices
1)
Undated reference.
2)
Valid edition at date of issue.

- 5 - EN 60601-1-10:2008
Annex ZZ
(informative)
Coverage of Essential Requirements of EC Directives

This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and within its scope the standard covers all
relevant essential requirements as given in Annex I of the EC Directive 93/42/EEC.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EC Directives may be applicable to the products falling within
the scope of this standard.
IEC 60601-1-10
Edition 1.0 2007-11
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 1-10: General requirements for basic safety and essential performance –
Collateral Standard: Requirements for the development of physiologic
closed-loop controllers
Appareils électromédicaux –
Partie 1-10: Exigences générales pour la sécurité de base et les performances
essentielles – Norme collatérale: Exigences pour le développement des
régulateurs physiologiques en boucle fermée

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
W
CODE PRIX
ICS 11.040 ISBN 2-8318-9448-4
– 2 – 60601-1-10 © IEC:2007
CONTENTS
FOREWORD.4
INTRODUCTION.7

1 Scope, object and related standards.8
1.1 * Scope .8
1.2 Object .8
1.3 Related standards .8
1.3.1 IEC 60601-1 .8
1.3.2 Particular standards .9
2 Normative references .9
3 Terms and definitions .9
4 * General requirements .14
5 ME EQUIPMENT identification, marking and documents .14
5.1 * Instructions for use .14
5.2 Technical description.15
6 Accuracy of controls and instruments and protection against hazardous outputs .15
6.1 * USABILITY .15
6.2 ALARM SYSTEMS .15
6.3 * PCLCS VARIABLE logging .15
6.4 * DISTRIBUTED PCLCS .16
7 * PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .16
8 Requirements for PHYSIOLOGIC CLOSED-LOOP CONTROLLER (PCLC) development.16
8.1 * General.16
8.2 Attributes/activities of the PCLC development PROCESS .17
8.2.1 RECORDS and PROCESS scaling .17
8.2.2 Equipment specifications .17
8.2.3 * Disturbance management.20
8.2.4 * PCLC VERIFICATION.21
8.2.5 * PCLCS VALIDATION .21

Annex A (informative) General guidance and rationale.22
Annex B (informative) Description of dynamic performance of a PCLCS .32
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS.36

Bibliography.37

Index of defined terms used in this collateral standard.38

Figure 1 – Functional diagram indicating typical components of a PHYSIOLOGIC CLOSED-
LOOP CONTROL SYSTEM (PCLCS) utilizing a PCLC .
...