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

Specifies requirements for the development (analysis, design, verification and validation) of a physiologic closed-loop controller (PCLC) as part of a physiologic closed-loop control system (PCLCS) in medical electrical equipment and medical electrical systems to control a physiologic variable.[]This collateral standard applies to various types of PCLC, e.g. linear and non-linear, adaptive, fuzzy, neural networks.[]This collateral standard applies to a closed-loop controller that sets the controller output variable in order to adjust (i.e., change or maintain) the measured physiologic variable by relating it to the reference variable.

Medizinische elektrische Geräte - Teil 1-10: Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Anforderungen an die Entwicklung von physiologischen geschlossenen Regelkreisen

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

Spécifie les exigences pour le développement (analyse, conception, vérification et validation) d'un régulateur physiologique en boucle fermée (RPBF) en tant que partie d'un système physiologique de commande en boucle fermée (SPCBF) dans les appareils em et les systèmes em pour la commande d'une variable physiologique.[]La présente norme collatérale s'applique aux différents types de RPBF, par exemple linéaire et non-linéaire, adaptatifs, fuzzy, réseaux de neurones.[]La présente norme collatérale s'applique à un régulateur en boucle fermée qui règle la variable de sortie du régulateur afin d'ajuster (c'est-à-dire, changer ou maintenir) la variable physiologique mesurée en effectuant une comparaison avec la variable de référence.

Medicinska električna oprema - 1-10 del: Splošne zahteve za osnovne varnostne in bistvene lastnosti - Spremljevalni standard: Zahteve za razvoj fizioloških krmilnikov s sklenjeno zanko (IEC 60601-1-10:2007)

General Information

Status
Published
Publication Date
23-Apr-2008
Current Stage
6060 - Document made available
Due Date
24-Apr-2008
Completion Date
24-Apr-2008

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SLOVENSKI STANDARD
SIST EN 60601-1-10:2008
01-julij-2008
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ELVWYHQHODVWQRVWL6SUHPOMHYDOQLVWDQGDUG=DKWHYH]DUD]YRMIL]LRORãNLK
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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
SIST EN 60601-1-10:2008 en,fr

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

---------------------- Page: 1 ----------------------
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
---------------------- Page: 2 ----------------------
EN 60601-1-10:2008 - 2 -
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.
---------------------- Page: 3 ----------------------
- 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).
__________
---------------------- Page: 4 ----------------------
EN 60601-1-10:2008 - 4 -
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
Undated reference.
Valid edition at date of issue.
---------------------- Page: 5 ----------------------
- 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.
---------------------- Page: 6 ----------------------
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
CODE PRIX
ICS 11.040 ISBN 2-8318-9448-4
---------------------- Page: 7 ----------------------
– 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 ......................................................................10

Figure B.1 – Example of PCLCS dynamic performance with no STEADY-STATE DEVIATION........33

Figure B.2 – Example of PCLCS dynamic performance with STEADY-STATE DEVIATION.............34

Figure B.3 – Example of PCLCS dynamic performance transient COMMAND VARIABLE...............35

---------------------- Page: 8 ----------------------
60601-1-10 © IEC:2007 – 3 –

Table A.1 – Examples of ME EQUIPMENT or ME SYSTEMS that incorporate a PCLCS ...................22

Table C.2 – ACCOMPANYING DOCUMENTS, instructions for use.................................................36

Table C.3 – ACCOMPANYING DOCUMENTS, technical description ..............................................36

---------------------- Page: 9 ----------------------
– 4 – 60601-1-10 © IEC:2007
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
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
FOREWORD

1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising

all national electrotechnical committees (IEC National Committees). The object of 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, IEC publishes International Standards, Technical Specifications,

Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC

Publication(s)”). 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. 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 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 IEC National Committees.

3) IEC Publications have the form of recommendations for international use and are accepted by IEC National

Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC

Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any

misinterpretation by any end user.

4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications

transparently to the maximum extent possible in their national and regional publications. Any divergence

between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in

the latter.

5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any

equipment declared to be in conformity with an IEC Publication.

6) All users should ensure that they have the latest edition of this publication.

7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and

members of its technical committees and IEC National Committees for any personal injury, property damage or

other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and

expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC

Publications.

8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is

indispensable for the correct application of this publication.

9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of

patent rights. IEC shall not be held responsible for identifying any or all such patent rights.

International standard IEC 60601-1-10 has been prepared by IEC subcommittee 62A:

Common aspects of electrical equipment used in medical practice, of IEC technical committee

62: Electrical equipment in medical practice, and ISO subcommittees SC1: Breathing

attachments and anaesthetic machines, and SC3: Lung ventilators and related devices of ISO

technical committee 121: Anaesthetic and respiratory equipment.
It is published as double logo standard.

This first edition constitutes a collateral standard to IEC 60601-1: Medical electrical

equipment – Part 1: General requirements for safety and essential performance hereafter

referred to as the general standard.
---------------------- Page: 10 ----------------------
60601-1-10 © IEC:2007 – 5 –
The text of this collateral standard is based on the following documents:
FDIS Report on voting
62A/576/FDIS 62A/585/RVD

Full information on the voting for the approval of this collateral standard can be found in the

report on voting indicated in the above table. In ISO, the standard has been approved by

18 P-members out of 19 having cast a vote.

This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.

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: roman type.
– test specifications: 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: 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.

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 (*).

A list of all parts of the IEC 60601 series, published under the general title: Medical electrical

equipment, can be found on the IEC website.
---------------------- Page: 11 ----------------------
– 6 – 60601-1-10 © IEC:2007

The committee has decided that the contents of this publication will remain unchanged until

the maintenance result date indicated on the IEC web site under "http://webstore.iec.ch" in

the data related to the specific publication. At this date, the publication will be

• reconfirmed;
• withdrawn;
• replaced by a revised edition, or
• amended
---------------------- Page: 12 ----------------------
60601-1-10 © IEC:2007 – 7 –
INTRODUCTION

The use of PHYSIOLOGIC CLOSED-LOOP CONTROLLERS in ME EQUIPMENT and ME SYSTEMS are

expected to provide a successful strategy to improve PATIENT safety and reduce healthcare

costs [9][10][11][12][13] . New RISKS that are not directly addressed by previous standards

are emerging in the development of this equipment. MANUFACTURERS employ a variety of

methods to validate the safety and integrity of control systems with varying degrees of

success. Classical methods of software VALIDATION for PHYSIOLOGIC CLOSED-LOOP

CONTROLLERS can be insufficient to ensure performance with acceptable RISKS under all

clinical and physiologic conditions.
—————————
Figures in square brackets refer to the Bibliography.
---------------------- Page: 13 ----------------------
– 8 – 60601-1-10 © IEC:2007
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
1 Scope, object and related standards
1.1 * Scope

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of

MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as

ME EQUIPMENT and ME SYSTEMS.

This collateral standard specifies requirements for the development (analysis, design,

VERIFICATION and VALIDATION) of a PHYSIOLOGIC CLOSED-LOOP CONTROLLER (PCLC) as part of a

PHYSIOLOGIC CLOSED-LOOP CONTROL SYSTEM (PCLCS) in ME EQUIPMENT and ME SYSTEMS to
control a PHYSIOLOGIC VARIABLE.

NOTE A PHYSIOLOGIC VARIABLE can be a body chemistry (e.g. electrolytes, blood glucose), a physical property

(e.g. PATIENT temperature, electrophysiologic, hemodynamic), or a pharmaceutical concentration.

This collateral standard applies to various types of PCLC, e.g. linear and non-linear, adaptive,

fuzzy, neural networks.
This collateral standard does not specify:
− additional mechanical requirements; or
− additional electrical requirements.

This collateral standard applies to a closed-loop controller (see Figure 1) that sets the

CONTROLLER OUTPUT VARIABLE in order to adjust (i.e., change or maintain) the measured

PHYSIOLOGIC VARIABLE by relating it to the REFERENCE VARIABLE.

A closed-loop controller that maintains a physical or chemical VARIABLE, using feedback that is

not measured from a PATIENT, is outside the scope of this standard.
1.2 Object

The object of this collateral standard is to specify general requirements that are in addition to

those of the general standard and to serve as the basis for particular standards.

1.3 Related standards
1.3.1 IEC 60601-1

For ME EQUIPMENT and ME SYSTEMS, this collateral standard complements IEC 60601-1.

When referring to IEC 60601-1 or to this collateral standard, either individually or in

combination, the following conventions are used:
− "the general standard" designates IEC 60601-1 alone;
− "this collateral standard" designates IEC 60601-1-10 alone;
---------------------- Page: 14 ----------------------
60601-1-10 © IEC:2007 – 9 –

− "this standard" designates the combination of the general standard and this collateral

standard.
1.3.2 Particular standards

A requirement in a particular standard takes priority over the corresponding requirement in

this collateral standard.
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.

IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic

safety and essential performance

IEC 60601-1-6:2006, Medical electrical equipment – Part 1-6: General requirements for basic

safety and essential performance – Collateral Standard: Usability

IEC 60601-1-8:2006, Medical electrical equipment – 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 processes
ISO 14971, Medical devices – Application of risk management to medical devices
3 Terms and definitions

For the purposes of this document, the terms and definitions given in IEC 60601-1:2005,

IEC 60601-1-6:2006, IEC 60601-1-8:2006 and the following apply.

NOTE An index of defined term used in this collateral standard is found beginning on page 38.

3.1
ACTUATOR

part of a PCLCS that performs a specified output function (see, for example, Figure 1, A)

EXAMPLE 1 A heater delivers thermal energy.
EXAMPLE 2 An infusion pump delivers a fluid or drug.
EXAMPLE 3 An anaesthetic agent vaporizer delivers a vapour concentration.
EXAMPLE 4 A ventilator delivers an inspiratory volume.
3.2
COMMAND OVERSHOOT

for a step response, the maximum positive deviation of the PHYSIOLOGIC VARIABLE (y), from the

COMMAND VARIABLE (c)
NOTE See also Annex B.
---------------------- Page: 15 ----------------------
– 10 – 60601-1-10 © IEC:2007
PCLC
c m
w ex y
C D E A P
IEC 2068/07
Elements VARIABLES
PCLC PHYSIOLOGIC CLOSED-LOOP CONTROLLER
A ACTUATOR
m MANIPULATED VARIABLE
C COMMAND TRANSFER ELEMENT w REFERENCE VARIABLE
D COMPARING ELEMENT e ERROR VARIABLE
E CONTROL TRANSFER ELEMENT x CONTROLLER OUTPUT VARIABLE
F MEASURING TRANSFER ELEMENT f FEEDBACK VARIABLE
P PATIENT TRANSFER ELEMENT y PHYSIOLOGIC VARIABLE
v PATIENT DISTURBANCE VARIABLE
c COMMAND VARIABLE
NOTE DISTURBANCE VARIABLES (v), not shown, can act on any element or VARIABLE.

Figure 1 – Functional diagram indicating typical components of a PHYSIOLOGIC CLOSED-

LOOP CONTROL SYSTEM (PCLCS) utilizing a PCLC
3.3
* COMMAND TRANSFER ELEMENT

part of a PCLCS that provides an output having a deterministic relationship to the COMMAND

VARIABLE (c) (see, for example, Figure 1, C)
3.4
* COMMAND VARIABLE

VARIABLE which, after signal conversion or other processing by the COMMAND TRANSFER

ELEMENT (C), gives the REFERENCE VARIABLE (w) (see, for example, Figure 1, c)
3.5
* COMPARING ELEMENT

element with two inputs and one output, the output VARIABLE being the difference between the

input VARIABLES (see, for example, Figure 1, D)
[IEC 60050-351, definition 351-28-03, modified]

NOTE The difference can be simple subtraction, classification within a value range, or a complex relationship

such as results from a neural network calculation.
3.6
CONTROL TRANSFER ELEMENT

part of a PCLC that provides an output having a deterministic relationship to the FEEDBACK

VARIABLE (f) (see, for example, Figure 1, E)
---------------------- Page: 16 ----------------------
60601-1-10 © IEC:
...

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