IEC 60601-1-10:2007

IEC 60601-1-10 ®
Edition 1.1 2013-11
CONSOLIDATED
VERSION
VERSION
CONSOLIDÉE
colour
inside
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

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IEC 60601-1-10 ®
Edition 1.1 2013-11
INTERNATIONAL
STANDARD
VERSION
CONSOLIDÉE
colour
inside
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
INTERNATIONALE
ICS 11.040 ISBN 978-2-8322-1286-8

IEC 60601-1-10 ®
Edition 1.1 2013-11
REDLINE VERSION
VERSION REDLINE
colour
inside
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

– 2 – 60601-1-10 © IEC:2007+A1:2013
CONTENTS
FOREWORD . 4
INTRODUCTION . 7
INTRODUCTION TO THE AMENDMENT . 8

1 Scope, object and related standards . 9
1.1 * Scope . 9
1.2 Object . 9
1.3 Related standards . 9
1.3.1 IEC 60601-1 . 9
1.3.2 Particular standards . 10
2 Normative references . 10
3 Terms and definitions . 10
4 * General requirements . 15
5 ME EQUIPMENT identification, marking and documents . 16
5.1 * Instructions for use . 16
5.2 Technical description. 16
6 Accuracy of controls and instruments and protection against hazardous outputs . 16
6.1 * USABILITY . 16
6.2 ALARM SYSTEMS . 16
6.3 * PCLCS VARIABLE logging . 17
6.4 * DISTRIBUTED PCLCS . 17
7 * PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 17
8 Requirements for PHYSIOLOGIC CLOSED-LOOP CONTROLLER (PCLC) development . 17
8.1 * General . 17
8.2 Attributes/activities of the PCLC development PROCESS . 18
8.2.1 RECORDS and PROCESS scaling . 18
8.2.2 Equipment specifications . 18
8.2.3 * Disturbance management . 21
8.2.4 * PCLC VERIFICATION . 22
8.2.5 * PCLCS VALIDATION . 22

Annex A (informative) General guidance and rationale . 23
Annex B (informative) Description of dynamic performance of a PCLCS . 33
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 37

Bibliography . 38

Index of defined terms used in this collateral standard . 39

Figure 1 – Functional diagram indicating typical components of a PHYSIOLOGIC CLOSED-
LOOP CONTROL SYSTEM (PCLCS) utilizing a PCLC . 11
Figure B.1 – Example of PCLCS dynamic performance with no STEADY-STATE DEVIATION . 34
Figure B.2 – Example of PCLCS dynamic performance with STEADY-STATE DEVIATION . 35

60601-1-10 © IEC:2007+A1:2013 – 3 –
Figure B.3 – Example of PCLCS dynamic performance transient COMMAND VARIABLE . 36

Table A.1 – Examples of ME EQUIPMENT or ME SYSTEMS that incorporate a PCLCS . 23
Table C.2 – ACCOMPANYING DOCUMENTS, instructions for use . 37
Table C.3 – ACCOMPANYING DOCUMENTS, technical description . 37

– 4 – 60601-1-10 © IEC:2007+A1:2013
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
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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.
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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.

This Consolidated version of IEC 60601-1-10 bears the edition number 1.1. It consists of
the first edition (2007) [documents 62A/576/FDIS and 62A/585/RVD] and its amendment
1 (2013) [documents 62A/888/FDIS and 62A/896/RVD]. The technical content is identical
to the base edition and its amendment.
In this Redline version, a vertical line in the margin shows where the technical content
is modified by amendment 1. Additions and deletions are displayed in red, with
deletions being struck through. A separate Final version with all changes accepted is
available in this publication.
This publication has been prepared for user convenience.

60601-1-10 © IEC:2007+A1:2013 – 5 –
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.
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 (*).

– 6 – 60601-1-10 © IEC:2007+A1:2013
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.
The committee has decided that the contents of the base publication and its amendment will
remain unchanged until the stability 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
NOTE The attention of National Committees is drawn to the fact that equipment manufacturers and testing
organizations may need a transitional period following publication of a new, amended or revised IEC or
ISO publication in which to make products in accordance with the new requirements and to equip themselves for
conducting new or revised tests. It is the recommendation of the committee that the content of this publication be
adopted for implementation nationally not earlier than 3 years from the date of publication.

IMPORTANT – The “colour inside” logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct understanding
of its contents. Users should therefore print this publication using a colour printer.

60601-1-10 © IEC:2007+A1:2013 – 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.

– 8 – 60601-1-10 © IEC:2007+A1:2013
INTRODUCTION TO THE AMENDMENT
The first edition of IEC 60601-1-10 was published in 2007. This amendment is intended to
update the references to IEC 60601-1:2005 to include Amendment 1:2012,
to update IEC 60601-1-6:2006 to IEC 60601-1-6:2010, including its Amendment 1 and
to update references to IEC 60601-1-8:2006 to include its Amendment 1:2012. This
amendment also removes the normative reference to IEC 62304:2006. This collateral
standard made reference to IEC 62304 because elements of the software process were not
fully covered by Clause 14 of IEC 60601-1:2005. Amendment 1 to IEC 60601-1:2005
incorporates the needed software process requirement into Clause 14. Therefore, it is
redundant and potentially confusing to have IEC 62304 explicitly called out in this collateral
standard.
60601-1-10 © IEC:2007+A1:2013 – 9 –
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 (IEC 60601-1:2005+A1:2012);

– 10 – 60601-1-10 © IEC:2007+A1:2013
 "this collateral standard" designates IEC 60601-1-10 alone (IEC 60601-1-10:2007
+A1:2013);
 "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, in whole or in part, are normatively referenced in this
document and are indispensable for the its 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
Amendment 1:2012
IEC 60601-1-6:20062010, Medical electrical equipment – Part 1-6: General requirements for
basic safety and essential performance – Collateral Standard: Usability
Amendment 1:2013
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
Amendment 1:2012
IEC 62304:2006, Medical device software – Software life cycle processes
IEC 62366:2007, Medical devices – Application of usability engineering to medical devices
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
+A1:2012, IEC 60601-1-6:20062010+A1:2013, IEC 60601-1-8:2006+A1:2012,
IEC 62366:2007 and the following apply.
NOTE An index of defined term used in this collateral standard is found beginning on page 39.
3.1
ACTUATOR
A
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.

60601-1-10 © IEC:2007+A1:2013 – 11 –
3.2
COMMAND OVERSHOOT
y
co
for a step response, the maximum positive deviation of the PHYSIOLOGIC VARIABLE (y), from the
COMMAND VARIABLE (c)
NOTE See also Annex B.
v
p
PCLC
c ex m y
w
+
C D E A P
-
f
F
IEC  2068/07
Elements VARIABLES
PCLC PHYSIOLOGIC CLOSED-LOOP CONTROLLER
A ACTUATOR m MANIPULATED VARIABLE
C COMMAND TRANSFER ELEMENT w REFERENCE VARIABLE
COMPARING ELEMENT
D 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
p
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
C
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
c
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
D
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.

– 12 – 60601-1-10 © IEC:2007+A1:2013
3.6
CONTROL TRANSFER ELEMENT
E
part of a PCLC that provides an output having a deterministic relationship to the FEEDBACK
VARIABLE (f) (see, for example, Figure 1, E)
3.7
CONTROLLER OUTPUT VARIABLE
x
VARIABLE of the CONTROL TRANSFER ELEMENT (E), which is also an input VARIABLE of the
ACTUATOR (A) (see, for example, Figure 1, x)
3.8
* DISTRIBUTED PCLCS
PCLCS that involves more than one item of equipment of a ME SYSTEM
NOTE The parts of a DISTRIBUTED PCLCS can be widely separated in distance.
3.9
* DISTURBANCE VARIABLE
v
VARIABLE acting on a PCLCS that is independent of the other VARIABLES of the PCLCS (see, for
example, Figure 1, v and v )
p
NOTE 1 DISTURBANCE VARIABLES are undesired, independent, and most frequently unpredictable from the
perspective of the PCLC. The MANUFACTURER or OPERATOR can be aware of DISTURBANCE VARIABLES.
NOTE 2 The MANUFACTURER needs to identify the DISTURBANCE VARIABLES that are relevant to the PCLC, but their
values are usually unpredictable.
3.10
ERROR VARIABLE
e
difference between the REFERENCE VARIABLE (w) and the FEEDBACK VARIABLE (f) (see, for
example, Figure 1, e)
[IEC 60050-351, definition 351-27-04]
3.11
* FALLBACK MODE
mode of operation (or state) into which the PCLCS transitions when the PCLC stops operating
due to detection of a fault
3.12
FEEDBACK VARIABLE
f
MEASURING TRANSFER ELEMENT (F) (see, for example, Figure 1, f)
output of the
[IEC 60050-351, definition 351-27-03, modified]
3.13
INTERPATIENT VARIABILITY
variability of the PATIENT TRANSFER ELEMENT between PATIENTS
EXAMPLE The reaction of PATIENTS to the same amount of a certain drug can vary widely.
3.14
INTRAPATIENT VARIABILITY
variability of the PATIENT TRANSFER ELEMENT within the same PATIENT over time
EXAMPLE The reaction of a PATIENT to a dose of a drug that varies widely during the day.

60601-1-10 © IEC:2007+A1:2013 – 13 –
3.15
MANIPULATED VARIABLE
m
output of the ACTUATOR (A), which is also an input VARIABLE of the PATIENT TRANSFER ELEMENT
(see, for example, Figure 1, m)
[IEC 60050-351, definition 351-27-07, modified]
3.16
MEASURING TRANSFER ELEMENT
F
part of a PCLCS that provides an output having a determined relationship to the PHYSIOLOGIC
VARIABLE (y) (see, for example, Figure 1, F)
EXAMPLE 1 thermocouple
EXAMPLE 2 current transformer
EXAMPLE 3 strain gauge
EXAMPLE 4 pH electrode
EXAMPLE 5 pulse oximeter
EXAMPLE 6 respiratory gas monitor
EXAMPLE 7 heart rate monitor
EXAMPLE 8 blood pressure monitor
EXAMPLE 9 EEG monitor
EXAMPLE 10 EMG monitor
EXAMPLE 11 cardiac output monitor
3.17
* PATIENT DISTURBANCE VARIABLE
v
p
DISTURBANCE VARIABLE, independent of the MANIPULATED VARIABLE (m), which changes the
PATIENT TRANSFER ELEMENT (P) (see, for example, Figure 1, v )
p
3.18
PATIENT TRANSFER ELEMENT
P
relationship of the change of the PHYSIOLOGIC VARIABLE (y) in response to a change in the
MANIPULATED VARIABLE (m) (see, for example, Figure 1, P)
3.19
PHYSIOLOGIC CLOSED-LOOP CONTROL SYSTEM
PCLCS
part of ME EQUIPMENT or ME SYSTEM used to adjust a PHYSIOLOGIC VARIABLE (y) relative to a
COMMAND VARIABLE (c) using a FEEDBACK VARIABLE (f) (see, for example, Figure 1)
3.20
* PHYSIOLOGIC CLOSED-LOOP CONTROLLER
PCLC
element of a PHYSIOLOGIC CLOSED-LOOP CONTROL SYSTEM in which a FEEDBACK VARIABLE (f) is
compared with a REFERENCE VARIABLE (w), and their difference is transformed to set the
CONTROLLER OUTPUT VARIABLE (x) (see, for example, Figure 1, PCLC)

– 14 – 60601-1-10 © IEC:2007+A1:2013
3.21
PHYSIOLOGIC VARIABLE
y
quantity or condition from a PATIENT whose value is subject to change and can usually be
measured
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.
3.22
* REFERENCE VARIABLE
w
input VARIABLE to a COMPARING ELEMENT (D) in a PCLC that sets the desired value of the
PHYSIOLOGIC VARIABLE (y) (see, for example, Figure 1, w)
[IEC 60050-351, definition 351-27-02, modified]
3.23
RELATIVE OVERSHOOT
y
ro
for a step response, the maximum transient deviation from the final steady-state value of the
PHYSIOLOGIC VARIABLE (y), expressed as the difference between the final and the initial steady-
state values
NOTE 1 The initial steady-state value is the value of the PHYSIOLOGIC VARIABLE prior to applying the step.
NOTE 2 See also Annex B.
[IEC 60050-351, definition 351-24-30, modified]
3.24
RESPONSE TIME
T
r
time required for the step response of the PHYSIOLOGIC VARIABLE (y) to move from its initial
value to a specified percentage of the final steady-state value
NOTE 1 The time is measured from the point in time that the step is applied.
NOTE 2 The conventional value for the percentage is 90 %.
NOTE 3 See also Annex B.
3.25
SETTLING TIME
T
st
duration of the time interval between the instant of a step change in one of the input
VARIABLES and the instant when the PHYSIOLOGIC VARIABLE (y) does not deviate by more than a
specified tolerance from the difference between its final and initial steady-state values
NOTE 1 The conventional value for the tolerance is 5 %.
NOTE 2 See also Annex B.
[IEC 60050-351, definition 351-24-29, modified]
3.26
STEADY-STATE DEVIATION
y
sd
deviation between PHYSIOLOGIC VARIABLE (y) and COMMAND VARIABLE (c) when transient effects
have subsided and the COMMAND VARIABLE is maintained constant
NOTE See also Annex B.
60601-1-10 © IEC:2007+A1:2013 – 15 –
3.27
TRACKING ERROR
E
tr
deviation of the PHYSIOLOGIC VARIABLE (y) from the COMMAND VARIABLE (c) as a function of time
NOTE See also Annex B.
3.28
VARIABLE
quantity or condition whose value is subject to change and can usually be measured
[IEC 60050-351, definition 351-21-01]
4 * General requirements
When performing the HAZARD identification step of the RISK MANAGEMENT PROCESS required by
4.2 of the general standard, the analysis shall consider HAZARDS from a PCLC in the PCLCS with
particular emphasis placed on the following:
– * latency times;
– ACTUATOR, including starting and stopping;
– MANIPULATED VARIABLE:
 safe ranges of delivered substances and energy, and
 cumulative effects of delivered substances and energy;
– PATIENT TRANSFER ELEMENT, including any hysteresis;
PHYSIOLOGIC VARIABLE;
–
– INTERPATIENT VARIABILITY;
INTRAPATIENT VARIABILITY;
–
– DISTURBANCE VARIABLE, including the PATIENT DISTURBANCE VARIABLE;
MEASURING TRANSFER ELEMENT;
–
– FEEDBACK VARIABLE;
– the necessary resolution and duration of the log required to analyze the performance of a
PCLCS (see 6.3);
– * for a DISTRIBUTED PCLCS, additional parameters which can influence the PCLC
performance (see 6.4); and
– for a PCLCS with more than one PCLC, interaction between CONTROL TRANSFER ELEMENTS.
NOTE See also 8.1.
Compliance is checked by inspection of the RISK MANAGEMENT FILE.
5 ME EQUIPMENT identification, marking and documents
5.1 * Instructions for use
In addition to the requirements in 7.9.2.5 of the general standard for the ME EQUIPMENT
description, the instructions for use shall contain the following:
– PCLCS basic theory of operation; and
– essential assumptions, conditions, or premises built into the PCLC sufficient for OPERATORS
to develop a mental model of the operation of the PCLCS.

– 16 – 60601-1-10 © IEC:2007+A1:2013
See Table C.2 for a cross-reference to the subclauses of this collateral standard that specify
requirements for information to be included in the instructions for use portion of the
ACCOMPANYING DOCUMENTS.
Compliance is checked by inspection of the instructions for use and the USABILITY
ENGINEERING FILE according to IEC 60601-1-6.
5.2 Technical description
See Table C.3 for a cross-reference to the subclauses of this collateral standard that specify
requirements for information to be included in the technical description portion of the
ACCOMPANYING DOCUMENTS.
6 Accuracy of controls and instruments and protection against hazardous
outputs
6.1 * USABILITY
A PCLCS shall indicate the following information continuously or by OPERATOR action:
– the current value of:
– COMMAND VARIABLE or REFERENCE VARIABLE,
– CONTROLLER OUTPUT VARIABLE or MANIPULATED VARIABLE, and
– PHYSIOLOGIC VARIABLE or FEEDBACK VARIABLE;
– the PCLC mode of operation; and
– an indication over time of the values of the above displayed VARIABLES over time.
However, the indication over time may be omitted if its absence does not lead to an
unacceptable RISK (see also 6.3).
The PHYSIOLOGIC VARIABLE or FEEDBACK VARIABLE shall be indicated in the same units of
measure as the COMMAND VARIABLE or REFERENCE VARIABLE.
To minimize RISKS arising from NORMAL USE, the presentation format and the choice between
indicating the information continuously or by OPERATOR action shall be based on the USABILITY
ENGINEERING PROCESS according to IEC 60601-1-6.
Compliance is checked by functional testing and an inspection of the USABILITY ENGINEERING
FILE and the RISK MANAGEMENT FILE.
6.2 ALARM SYSTEMS
ME EQUIPMENT and ME SYSTEMS that incorporate a PCLC shall include an ALARM SYSTEM that
informs the OPERATOR when the PCLCS assumes a FALLBACK MODE.
NOTE See IEC 60601-1-8.
Compliance is checked by functional testing.
6.3 * PCLCS VARIABLE logging
ME EQUIPMENT or ME SYSTEMS that incorporate a PCLC shall provide a means to log the values
of at least the COMMAND VARIABLE or REFERENCE VARIABLE, CONTROLLER OUTPUT VARIABLE or
MANIPULATED VARIABLE, and PHYSIOLOGIC VARIABLE or FEEDBACK VARIABLE. The log is necessary
to analyze the performance of the PCLCS. The resolution and duration of the log shall be
based on HAZARDS identified in Clause 4. The log should be capable of storing the information
for a reasonable period of time.
NOTE The log is necessary to analyze the performance of the PCLCS.

60601-1-10 © IEC:2007+A1:2013 – 17 –
EXAMPLE 1 The intended duration of use on a single PATIENT.
EXAMPLE 2 The sample rate.
EXAMPLE 3 The minimum resolvable unit of data.
The MANUFACTURER shall disclose the following in the instructions for use:
– the resolution and duration of the log and the VARIABLES stored;
– whether the log is maintained when the ME EQUIPMENT or ME SYSTEM is powered down; and
– what happens to the contents of the log after the ME EQUIPMENT or ME SYSTEM has
experienced a total loss of power (SUPPLY MAINS and/or INTERNAL ELECTRICAL POWER
SOURCE) for a finite duration.
Compliance is checked by inspection of the instructions for use and functional testing.
6.4 * DISTRIBUTED PCLCS
The details necessary for the safe use of a DISTRIBUTED PCLCS shall be disclosed in the
technical description. A DISTRIBUTED PCLCS is a permitted form of a PCLCS.
A PCLCS is permitted to send or receive VARIABLES or other data to or from other parts of a
DISTRIBUTED PCLCS. One or more parts of a DISTRIBUTED PCLCS are permitted to be located
outside of the PATIENT ENVIRONMENT. Data are permitted to be transmitted between different
parts of a DISTRIBUTED PCLCS by wire, by telemetry or by other means.
Compliance is checked by inspection of the technical description.
7 * PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
For ME EQUIPMENT and ME SYSTEMS that incorporate a PCLC and incorporate PEMS, when the
requirements of Clause 14 of the general standard apply to PEMS, the requirements of
IEC 62304:2006 shall apply to the software for each PROGRAMMABLE ELECTRONIC SUBSYSTEM
(PESS) in addition to the other requirements of Clause 14 of the general standard.
Compliance is checked by application of the requirements of IEC 62304:2006.
8 Requirements for PHYSIOLOGIC CLOSED-LOOP CONTROLLER (PCLC) development
8.1 * General
A PCLC development PROCESS shall be conducted to avoid unacceptable RISK to the PATIENT,
OPERATOR and other persons related to operation of the ME EQUIPMENT or ME SYSTEM with a
PCLC in NORMAL CONDITION and any SINGLE FAULT CONDITION.
If the PCLC development PROCESS detailed in this standard has been complied with, then the
RESIDUAL RISKS associated with the use of the PCLCS are presumed to be acceptable, until
such time that there is OBJECTIVE EVIDENCE to the contrary.
In any SINGLE FAULT CONDITION that would create an unacceptable RISK related to the
performance of the PCLC, the PCLCS shall assume a FALLBACK MODE.
NOTE A FALLBACK MODE can be reached, for example, by stopping operation, by setting the CONTROLLER OUTPUT
VARIABLE to a safe value, or by going into open-loop control. See also 8.2.2.3.
ME EQUIPMENT or ME SYSTEMS that incorporate a PCLC may also operate without using the
PCLC. ME EQUIPMENT or ME SYSTEMS that incorporate a PCLC and can also operate in a mode
without using the PCLC shall clearly indicate which mode of operation is in use.

– 18 – 60601-1-10 © IEC:2007+A1:2013
Compliance with this subclause is considered to exist when compliance with 8.2 is
demonstrated.
8.2 Attributes/activities of the PCLC development PROCESS
8.2.1 RECORDS and PROCESS scaling
In addition to the RECORDS and documents required by ISO 14971 and IEC 62304:2006, the
RECORDS and documents produced from application of the PCLC development PROCESS shall
be established and maintained to provide evidence of conformity to requirements of this
collateral standard and shall form part of the RISK MANAGEMENT FILE.
The PCLC development PROCESS may vary in form and extent based on the nature of the PCLC,
its intended OPERATOR and its INTENDED USE. In the case of a modification to a PCLC design,
the PCLC development PROCESS may be scaled up or scaled down, based on the significance
of the modification as determined by the results of the RISK ANALYSIS.
Compliance is checked by inspection of the RISK MANAGEMENT FILE.
8.2.2 Equipment specifications
8.2.2.1 * Application specification
The MANUFACTURER shall specify the application of the ME EQUIPMENT or ME SYSTEM that
incorporates a PCLC.
This specification shall include:
– intended medical indication;
EXAMPLE 1 Condition(s) or disease(s) to be screened, monitored, treated, diagnosed or prevented.
– intended PATIENT population;
EXAMPLE 2 age
EXAMPLE 3 weight
EXAMPLE 4 health
EXAMPLE 5 condition
– intended part of the body or type of tissue applied to or interacted with;
– if applicable, intended OPERATOR PROFILE;
– intended conditions of use; and
EXAMPLE 6 environment
EXAMPLE 7 frequency of use
EXAMPLE 8 location
EXAMPLE 9 mobility
– required devices.
EXAMPLE 10 additional monitoring
NOTE This specification contains elements of the INTENDED USE.
A summary of this specification shall be included in the instructions for use.
Compliance is checked by inspection of the RISK MANAGEMENT FILE and the instructions for
use.
60601-1-10 © IEC:2007+A1:2013 – 19 –
8.2.2.2 * State VARIABLES
The MANUFACTURER shall characterize the following attributes:
– COMMAND VARIABLE or REFERENCE VARIABLE;
– CONTROLLER OUTPUT VARIABLE or MANIPULATED VARIABLE;
– PHYSIOLOGIC VARIABLE or FEEDBACK VARIABLE;
– the limits of the range of the PATIENT TRANSFER ELEMENT; and
– the PCLC modes of operation.
Compliance is checked by inspection of the RISK MANAGEMENT FILE.
8.2.2.3 * FALLBACK MODE
The MANUFACTURER shall specify all FALLBACK MODES of the PCLCS. In the FALLBACK MODE there
shall be no unacceptable RISK.
NOTE A FALLBACK MODE can be reached, for example, by stopping operation, by setting the CONTROLLER OUTPUT
VARIABLE to safe values, or by going into open loop control.
A summary of any FALLBACK MODES shall be included in the instructions for use.
Compliance is checked by inspection of the RISK MANAGEMENT FILE and the instructions for
use.
8.2.2.4 * Specification of operating conditions
The operating conditions under which the performance specifications of the PCLC can be
ensured shall be specified.
Compliance is checked by inspection of the RISK MANAGEMENT FILE.
8.2.2.5 * Limitation of the MANIPULATED VARIABLE
If necessary, measures shall be taken or means shall be provided to eliminate, control, or
decrease RISKS to accept
...

IEC 60601-1-10
Edition 1.2 2020-07
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
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

IEC IEC 60601-1-10:2007-11+AMD1:2013-11+AMD2:2020-07 CSV(en-fr)

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IEC 60601-1-10
Edition 1.2 2020-07
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
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
INTERNATIONALE
ICS 11.040.01 ISBN 978-2-8322-8710-1

IEC 60601-1-10
Edition 1.2 2020-07
REDLINE VERSION
VERSION REDLINE
colour
inside
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

IEC IEC 60601-1-10:2007-11+AMD1:2013-11+AMD2:2020-07 CSV(en-fr)

– 2 – IEC 60601-1-10.2007+AMD1:2013
+AMD2:2020 CSV © IEC 2020
CONTENTS
FOREWORD . 4
INTRODUCTION . 7
INTRODUCTION to Amendment 1 . 7
INTRODUCTION to Amendment 2 . 7
1 Scope, object and related standards . 9
1.1 * Scope . 9
1.2 Object . 9
1.3 Related standards . 9
1.3.1 IEC 60601-1 . 9
1.3.2 Particular standards . 10
2 Normative references . 10
3 Terms and definitions . 10
4 * General requirements . 15
5 ME EQUIPMENT identification, marking and documents . 16
5.1 * Instructions for use . 16
5.2 Technical description. 16
6 Accuracy of controls and instruments and protection against hazardous outputs . 17
6.1 * USABILITY . 17
6.2 ALARM SYSTEMS . 17
6.3 * PCLCS VARIABLE logging . 17
6.4 * DISTRIBUTED PCLCS . 18
7 * PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 18
8 Requirements for PHYSIOLOGIC CLOSED-LOOP CONTROLLER (PCLC) development . 18
8.1 * General . 18
8.2 Attributes/activities of the PCLC development PROCESS . 19
8.2.1 RECORDS and PROCESS scaling . 19
8.2.2 Equipment specifications . 19
8.2.3 * Disturbance management . 22
8.2.4 * PCLC VERIFICATION . 23
8.2.5 * PCLCS VALIDATION . 23
Annex A (informative) General guidance and rationale . 25
Annex B (informative) Description of dynamic performance of a PCLCS . 36
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 40
Bibliography . 41
Index of defined terms used in this collateral standard . 42

Figure 1 – Functional diagram indicating typical components of a PHYSIOLOGIC CLOSED-
LOOP CONTROL SYSTEM (PCLCS) utilizing a PCLC . 11
Figure B.1 – Example of PCLCS dynamic performance with no STEADY-STATE DEVIATION . 37
Figure B.2 – Example of PCLCS dynamic performance with STEADY-STATE DEVIATION . 38
Figure B.3 – Example of PCLCS dynamic performance transient COMMAND VARIABLE . 39

Table A.1 – Examples of ME EQUIPMENT or ME SYSTEMS that incorporate a PCLCS . 25

IEC 60601-1-10.2007+AMD1:2013 – 3 –
+AMD2:2020 CSV © IEC 2020
Table C.21 – ACCOMPANYING DOCUMENTS, instructions for use . 40
Table C.32 – ACCOMPANYING DOCUMENTS, technical description . 40

– 4 – IEC 60601-1-10.2007+AMD1:2013
+AMD2:2020 CSV © IEC 2020
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
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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
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3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
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between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
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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.
This consolidated version of the official IEC Standard and its amendments has been
prepared for user convenience.
IEC 60601-1-10 edition 1.2 contains the first edition (2007-11) [documents 62A/576/FDIS
and 62A/585/RVD], its amendment 1 (2013-11) [documents 62A/888/FDIS and
62A/896/RVD] and its amendment 2 (2020-07) [documents 62A/1394/FDIS and
62A/1409/RVD].
In this Redline version, a vertical line in the margin shows where the technical content
is modified by amendments 1 and 2. Additions are in green text, deletions are in
strikethrough red text. A separate Final version with all changes accepted is available
in this publication.
IEC 60601-1-10.2007+AMD1:2013 – 5 –
+AMD2:2020 CSV © IEC 2020
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.
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 (*).

– 6 – IEC 60601-1-10.2007+AMD1:2013
+AMD2:2020 CSV © IEC 2020
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.
The committee has decided that the contents of the base publication and its amendments will
remain unchanged until the stability 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
NOTE The attention of National Committees is drawn to the fact that equipment manufacturers and testing
organizations may need a transitional period following publication of a new, amended or revised IEC or
ISO publication in which to make products in accordance with the new requirements and to equip themselves for
conducting new or revised tests. It is the recommendation of the committee that the content of this publication be
adopted for implementation nationally not earlier than 3 years from the date of publication.

IMPORTANT – The “colour inside” logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct understanding
of its contents. Users should therefore print this publication using a colour printer.

IEC 60601-1-10.2007+AMD1:2013 – 7 –
+AMD2:2020 CSV © IEC 2020
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.

INTRODUCTION to Amendment 1
The first edition of IEC 60601-1-10 was published in 2007. This amendment is intended to
update the references to IEC 60601-1:2005 to include Amendment 1:2012,
to update IEC 60601-1-6:2006 to IEC 60601-1-6:2010, including its Amendment 1 and
to update references to IEC 60601-1-8:2006 to include its Amendment 1:2012. This
amendment also removes the normative reference to IEC 62304:2006. This collateral
standard made reference to IEC 62304 because elements of the software process were not
fully covered by Clause 14 of IEC 60601-1:2005. Amendment 1 to IEC 60601-1:2005
incorporates the needed software process requirement into Clause 14. Therefore, it is
redundant and potentially confusing to have IEC 62304 explicitly called out in this collateral
standard.
INTRODUCTION to Amendment 2
The first edition of IEC 60601-1-10 was published in 2007 and amended in 2013. Since the
publication of IEC 60601-1-10:2007+A1:2013, the IEC Subcommittee (SC) 62A Secretariat
has been collecting issues from a variety of sources including comments from National
Committees. At the November 2015 meeting of IEC/SC 62A in Kobe, Japan, the
subcommittee initiated a process to identify high-priority issues that need to be considered in
an amendment and should not wait until the second edition of IEC 60601-1-10, which is
presently targeted for publication sometime after 2024.
Those issues selected for inclusion on the final "short list" to be addressed in Amendment 2
were those approved by a 2/3 majority of the National Committees present and voting at the
Frankfurt meeting of SC 62A. At the meeting held on 10 October 2016, 13 items were
presented to the National Committees present. All 13 items received the required 2/3 majority
of the National Committees present and voting and have been included in the "short list" for
consideration in preparing Amendment 2. All remaining issues have been placed on a "long
list" for consideration in the second edition of IEC 60601-1-10.
The "short list" of issues was documented in the design specification for Amendment 2. As
IEC 60601-1-10 was jointly developed with ISO/TC 121/SC 3, the work was assigned to
IEC/SC 62A-ISO/TC 121/SC 3 Joint Working Group (JWG) 5. JWG 5 was directed to consider
each issue described in Clause 6 of the design specification and develop an appropriate
solution for the identified problem. That final solution in this amendment can encompass any
technical solution proposed by the author of the issue or it can involve a different solution
developed by the expert group. The expert group can also have recommended that no change
to the standard was justified by the problem statement.
—————————
)
Figures in square brackets refer to the Bibliography.

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Because this is an amendment to IEC 60601-1-10:2007, the style in force at the time of
publication of IEC 60601-1-10 has been applied to this amendment. The style specified in
ISO/IEC Directives Part 2:2018 has only been applied when implementing the new style
guidance would not result in additional editorial changes. For example, references to
amendments take the following form: "IEC 60601-1:2005+A1:2012+A2:2020".
Users of this document should note that when constructing the dated references to specific
elements in a standard, such as definitions, amendments are only referenced if they modified
the text being cited. For example, if a reference is made to a definition that has not been
modified by an amendment, then the reference to the amendment is not included in the dated
reference.
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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

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) to control at least one PATIENT VARIABLE
(i.e. a PHYSIOLOGIC VARIABLE) 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.
EXAMPLE A PATIENT VARIABLE can be a measure of body chemistry (e.g. electrolytes or blood glucose value), a
physical property (e.g. body temperature, electrophysiologic characteristic, hemodynamic quantity), 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.

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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 (IEC 60601-1:2005+A1:2012),
including any amendments;
− "this collateral standard" designates IEC 60601-1-10 alone (IEC 60601-1-10:2007
+A1:2013), including any amendments;
− "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, in whole or in part, are normatively referenced in this
document and are indispensable for the its 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
Amendment 1:2012
Amendment 2:2020
IEC 60601-1-6:20062010, Medical electrical equipment – Part 1-6: General requirements for
basic safety and essential performance – Collateral Standard: Usability
Amendment 1:2013
Amendment 2:2020
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
Amendment 1:2012
Amendment 2:2020
IEC 62304:2006, Medical device software – Software life cycle processes
IEC 62366:2007, Medical devices – Application of usability engineering to medical devices
IEC 62366-1:2015, Medical devices – Part 1: Application of usability engineering to medical
devices
Amendment 1:2020
ISO 14971:2019, Medical devices – Application of risk management to medical devices
ISO 9000:2015, Quality management systems – Fundamentals and vocabulary
3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005
+A1:2012, IEC 60601-1-6:20062010+A1:2013, IEC 60601-1-8:2006+A1:2012,
IEC 62366:2007 and the following apply.

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For the purposes of this document, the terms and definitions given in
IEC 60601-1:2005+A1:2012+A2:2020, IEC 60601-1-6:2010+A1:2013+A2:2020, IEC 60601-1-
8:2006+A1:2012+A2:2020, IEC 62366-1:2015+A1:2020, ISO 9000:2015 and the following
apply.
NOTE An index of defined term used in this collateral standard is found beginning on page 42.
3.1
ACTUATOR
A
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
y
co
PHYSIOLOGIC VARIABLE (y), from the
for a step response, the maximum positive deviation of the
COMMAND VARIABLE (c)
NOTE See also Annex B.
v
p
PCLC
c m
w e x y
+
C D E A P
-
f
F
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 CONTROLLED PHYSIOLOGIC VARIABLE
v PATIENT DISTURBANCE VARIABLE
p
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

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3.3
* COMMAND TRANSFER ELEMENT
C
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
c
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)
NOTE A COMMAND VARIABLE may be a range or a function (e.g. clinical protocol).
3.5
* COMPARING ELEMENT
D
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
E
part of a PCLC that provides an output having a deterministic relationship to the FEEDBACK
VARIABLE (f) (see, for example, Figure 1, E)
3.7
CONTROLLER OUTPUT VARIABLE
x
VARIABLE of the CONTROL TRANSFER ELEMENT (E), which is also an input VARIABLE of the
ACTUATOR (A) (see, for example, Figure 1, x)
3.8
* DISTRIBUTED PCLCS
PCLCS that involves more than one item of equipment of a ME SYSTEM
NOTE The parts of a DISTRIBUTED PCLCS can be widely separated in distance.
3.9
* DISTURBANCE VARIABLE
v
VARIABLE acting on a PCLCS that is independent of the other VARIABLES of the PCLCS (see, for
)
example, Figure 1, v and v
p
NOTE 1 DISTURBANCE VARIABLES are undesired, independent, and most frequently unpredictable from the
perspective of the PCLC. The MANUFACTURER or OPERATOR can be aware of DISTURBANCE VARIABLES.
NOTE 2 The MANUFACTURER needs to identify the DISTURBANCE VARIABLES that are relevant to the PCLC, but their
values are usually unpredictable.
3.10
ERROR VARIABLE
e
difference between the REFERENCE VARIABLE (w) and the FEEDBACK VARIABLE (f) (see, for
example, Figure 1, e)
[IEC 60050-351, definition 351-27-04]

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3.11
* FALLBACK MODE
mode of operation (or state) into which the PCLCS transitions when the PCLC stops operating
due to detection of a fault
3.12
FEEDBACK VARIABLE
f
output of the MEASURING TRANSFER ELEMENT (F) (see, for example, Figure 1, f)
[IEC 60050-351, definition 351-27-03, modified]
3.13
INTERPATIENT VARIABILITY
variability of the PATIENT TRANSFER ELEMENT between PATIENTS
EXAMPLE The reaction of PATIENTS to the same amount of a certain drug can vary widely.
3.14
INTRAPATIENT VARIABILITY
variability of the PATIENT TRANSFER ELEMENT within the same PATIENT over time
EXAMPLE The reaction of a PATIENT to a dose of a drug that varies widely during the day.
3.15
MANIPULATED VARIABLE
m
output of the ACTUATOR (A), which is also an input VARIABLE of the PATIENT TRANSFER ELEMENT
(see, for example, Figure 1, m)
[IEC 60050-351, definition 351-27-07, modified]
3.16
MEASURING TRANSFER ELEMENT
F
part of a PCLCS that provides an output having a determined relationship to the PHYSIOLOGIC
VARIABLE (y) (see, for example, Figure 1, F)
EXAMPLE 1 thermocouple
EXAMPLE 2 current transformer
EXAMPLE 3 strain gauge
EXAMPLE 4 pH electrode
EXAMPLE 5 pulse oximeter
EXAMPLE 6 respiratory gas monitor
EXAMPLE 7 heart rate monitor
EXAMPLE 8 blood pressure monitor
EXAMPLE 9 EEG monitor
EXAMPLE 10 EMG monitor
EXAMPLE 11 cardiac output monitor

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3.17
* PATIENT DISTURBANCE VARIABLE
v
p
DISTURBANCE VARIABLE, independent of the MANIPULATED VARIABLE (m), which changes the
PATIENT TRANSFER ELEMENT (P) (see, for example, Figure 1, v )
p
3.18
PATIENT TRANSFER ELEMENT
P
relationship of the change of the PHYSIOLOGIC VARIABLE (y) in response to a change in the
MANIPULATED VARIABLE (m) (see, for example, Figure 1, P)
3.19
PHYSIOLOGIC CLOSED-LOOP CONTROL SYSTEM
PCLCS
part of ME EQUIPMENT or ME SYSTEM used to adjust a PHYSIOLOGIC VARIABLE (y) relative to a
COMMAND VARIABLE (c) using a FEEDBACK VARIABLE (f) (see, for example, Figure 1)
3.20
* PHYSIOLOGIC CLOSED-LOOP CONTROLLER
PCLC
element of a PHYSIOLOGIC CLOSED-LOOP CONTROL SYSTEM in which a FEEDBACK VARIABLE (f) is
compared with a REFERENCE VARIABLE (w), and their difference is transformed to set the
CONTROLLER OUTPUT VARIABLE (x) (see, for example, Figure 1, PCLC)
NOTE 1 A PCLC may utilize multiple PHYSIOLOGIC VARIABLES and COMMAND VARIABLES as well as multiple
CONTROLLER OUTPUT VARIABLES.
NOTE 2 A PATIENT VARIABLE may be used as an input to adjust the parameters of the CONTROL TRANSFER
ELEMENT.
3.21
PHYSIOLOGIC VARIABLE
y
quantity or condition from a PATIENT whose value is subject to change and can usually be
measured
PATIENT VARIABLE intended to be controlled
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.
3.22
* REFERENCE VARIABLE
w
input VARIABLE to a COMPARING ELEMENT (D) in a PCLC that sets the desired value of the
PHYSIOLOGIC VARIABLE (y) (see, for example, Figure 1, w)
[IEC 60050-351, definition 351-27-02, modified]
3.23
RELATIVE OVERSHOOT
y
ro
for a step response, the maximum transient deviation from the final steady-state value of the
PHYSIOLOGIC VARIABLE (y), expressed as the difference between the final and the initial steady-
state values
NOTE 1 The initial steady-state value is the value of the PHYSIOLOGIC VARIABLE or FEEDBACK VARIABLE prior to
applying the step.
NOTE 2 See also Annex B.
[IEC 60050-351, definition 351-24-30, modified]

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3.24
RESPONSE TIME
T
r
time required for the step response of the PHYSIOLOGIC VARIABLE (y) to move from its initial
value to a specified percentage of the final steady-state value
NOTE 1 The time is measured from the point in time that the step is applied.
NOTE 2 The conventional value for the percentage is 90 %.
NOTE 3 See also Annex B.
3.25
SETTLING TIME
T
st
duration of the time interval between the instant of a step change in one of the input
VARIABLES and the instant when the PHYSIOLOGIC VARIABLE (y) does not deviate by more than a
specified tolerance from the difference between its final and initial steady-state values
NOTE 1 The conventional value for the tolerance is 5 %.
NOTE 2 See also Annex B.
[IEC 60050-351, definition 351-24-29, modified]
3.26
STEADY-STATE DEVIATION
y
sd
deviation between PHYSIOLOGIC VARIABLE (y) and COMMAND VARIABLE (c) when transient effects
have subsided and the COMMAND VARIABLE is maintained constant
NOTE See also Annex B.
3.27
TRACKING ERROR
E
tr
deviation of the PHYSIOLOGIC VARIABLE (y) from the COMMAND VARIABLE (c) as a function of time
NOTE See also Annex B.
3.28
VARIABLE
quantity or condition whose value is subject to change and can usually be measured
[IEC 60050-351, definition 351-21-01]
3.29
PATIENT VARIABLE
*
PATIENT attribute, characteristic, quantity or condition that is measured
EXAMPLE A PATIENT VARIABLE can be a measure of body chemistry (e.g. electrolytes or blood glucose value), a
physical property (e.g. body temperature, electrophysiologic characteristic, hemodynamic quantity), or a
pharmaceutical concentration.
4 * General requirements
When performing the HAZARD identification step of the RISK MANAGEMENT PROCESS required by
4.2 of the general standard, the analysis shall consider HAZARDS from a PCLC in the PCLCS with
particular emphasis placed on the following:
– * latency times;
– ACTUATOR, including starting and stopping;

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– MANIPULATED VARIABLE:
• safe ranges of delivered or removed substances and energy, and
• cumulative effects of delivered or removed substances and energy;
– PATIENT TRANSFER ELEMENT, including any hysteresis;
– uncertainty of the model of the PATIENT TRANSFER ELEMENT;
– PHYSIOLOGIC VARIABLE;
– INTERPATIENT VARIABILITY;
– INTRAPATIENT VARIABILITY;
– DISTURBANCE VARIABLE, including the PATIENT DISTURBANCE VARIABLE;
– MEASURING TRANSFER ELEMENT;
– FEEDBACK VARIABLE;
– the necessary resolution and duration of the log required to analyze the performance of a
PCLCS (see 6.3);
– * for a DISTRIBUTED PCLCS, additional parameters which can influence the PCLC
performance (see 6.4); and
– for a PCLCS with more than one PCLC, interaction between CONTROL TRANSFER ELEMENTS.
NOTE See also 8.1.
Compliance is checked by inspection of the RISK MANAGEMENT FILE.
5 ME EQUIPMENT identification, marking and documents
5.1 * Instructions for use
In addition to the requirements in 7.9.2.5 of the general standard for the ME EQUIPMENT
description, the instructions for use shall contain the following:
– PCLCS basic theory of operation; and
– essential assumptions, conditions, or premises built into the PCLC sufficient for OPERATORS
to develop a mental model of the operation of the PCLCS.
See Table C.21 for a cross-reference to the subclauses of this collateral standard that specify
requirements for information to be included in the instructions for use portion of the
ACCOMPANYING DOCUMENTS.
Compliance is checked by inspection of the instructions for use and the USABILITY
ENGINEERING FILE according to IEC 60601-1-6.
5.2 Technical description
In addition to the requirements in 7.9.3 of the general standard, the technical description shall
contain the PCLCS block diagram and theory of operation.
See Table C.32 for a cross-reference to the subclauses of this collateral standard that specify
requirements for information to be included in the technical description portion of the
ACCOMPANYING DOCUMENTS.
Compliance is checked by inspection of the technical description.

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6 Accuracy of controls and instruments and protection against hazardous
outputs
6.1 * USABILITY
A PCLCS shall indicate the following information continuously or by OPERATOR action:
– the current value of:
– COMMAND VARIABLE or REFERENCE VARIABLE,
– CONTROLLER OUTPUT VARIABLE or MANIPULATED VARIABLE, and
– PHYSIOLOGIC VARIABLE or FEEDBACK VARIABLE; and
– any PATIENT VARIABLE that is used by the PCLC;
– the PCLC mode of operation; and
– an indication over time of the values of the above displayed VARIABLES over time.
However, the indication over time may be omitted if its absence does not lead to an
unacceptable RISK (see also 6.3).
The PHYSIOLOGIC VARIABLE or FEEDBACK VARIABLE shall be indicated in the same units of
measure as the COMMAND VARIABLE or REFERENCE VARIABLE.
To minimize RISKS arising from NORMAL USE, the presentation format and the choice between
indicating the information continuously or by OPERATOR action shall be based on the USABILITY
ENGINEERING PROCESS according to IEC 60601-1-6.
Compliance is checked by functional testing and an inspection of the USABILITY ENGINEERING
FILE and the RISK MANAGEMENT FILE.
6.2 ALARM SYSTEMS
ME EQUIPMENT and ME SYSTEMS that incorporate a PCLC shall include an ALARM SYSTEM that
informs the OPERATOR when the PCLCS assumes a FALLBACK MODE.
NOTE See IEC 60601-1-8.
Compliance is checked by functional testing.
6.3 * PCLCS VARIABLE logging
ME EQUIPMENT or ME SYSTEMS that incorporate a PCLC shall provide a means to log the values
of at least the COMMAND VARIABLE or REFERENCE VARIABLE, CONTROLLER OUTPUT VARIABLE or
MANIPULATED VARIABLE, and PHYSIOLOGIC VARIABLE or FEEDBACK VARIABLE. The log is necessary
to analyze the performance of the PCLCS. The resolution and duration of the log shall be
based on HAZARDS identified in Clause 4. The log should be capable of storing the information
for a reasonable period of time.
ME EQUIPMENT or ME SYSTEMS that incorporate a PCLC shall provide a means to log the values
of at least
– the COMMAND VARIABLE or REFERENCE VARIABLE;
CONTROLLER OUTPUT VARIABLE or MANIPULATED VARIABLE;
– the
– the PHYSIOLOGIC VARIABLE or FEEDBACK VARIABLE; and
PATIENT VARIABLE that is used by the PCLC.
– any
The log is necessary to analyze the performance of the PCLCS. The resolution and duration of
the log shall be based on HAZARDS identified in Clause 4. The log should be capable of storing
the information for a reasonable period of time.

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