IEC 60601-1-10:2007/Amd 2:2020

General Information

Status
Published
Publication Date
20-Sep-2020
Current Stage
5060 - Close of voting Proof returned by Secretariat
Start Date
20-Jun-2020
Completion Date
19-Jun-2020
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FINAL
IEC
AMENDMENT
DRAFT
60601-1-10:2007
FDAM 2
ISO/TC 121/SC 3
Medical electrical equipment —
Secretariat: ANSI
Voting begins on:
Part 1-10:
2020-04-24
General requirements for basic
Voting terminates on:
safety and essential performance —
2020-06-19
Collateral standard: Requirements
for the development of physiologic
closed-loop controllers
AMENDMENT 2
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
AMENDEMENT 2
This draft is submitted to a parallel vote in ISO and in IEC.
RECIPIENTS OF THIS DRAFT ARE INVITED TO
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
IEC 60601-1-10:2007/FDAM 2:2020(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. IEC 2020
---------------------- Page: 1 ----------------------
– 2 – IEC FDIS 60601-1-10:2007/AMD2
© IEC 2020
FOREWORD

This amendment has been prepared by subcommittee 62A: Common aspects of electrical

equipment used in medical practice, of IEC technical committee 62: Electrical equipment in

medical practice, and ISO subcommittee 3: Respiratory devices and related equipment used for

patient care, of ISO technical committee 121: Anaesthetic and respiratory equipment.

It is published as a double logo amendment.
The text of this amendment is based on the following documents of IEC:
FDIS Report on voting
62A/XXXX/FDIS 62A/XXXX/RVD

Full information on the voting for the approval of this amendment can be found in the report on

voting indicated in the above table. In ISO, the amendment has been approved by XXX P

members out of YYY having cast a vote.

The committee has decided that the contents of this amendment and the base publication 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 users of this document 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 mandatory implementation nationally not earlier than 3 years from the date of publication.

_____________
---------------------- Page: 2 ----------------------
IEC FDIS 60601-1-10:2007/AMD2 – 3 –
© IEC 2020
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.

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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– 4 – IEC FDIS 60601-1-10:2007/AMD2
© IEC 2020
1.1 * Scope

Replace the existing second paragraph and note with the following new paragraph and example:

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.

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.
1.3.1 IEC 60601-1

Replace, in the first two dashes of the existing second paragraph, the parentheses, added by

Amendment 1, with the words ", including any amendments".
2 Normative references

Replace the existing references to IEC 60601-1, IEC 60601-1-6, IEC 60601-1-8, IEC 62366 and

ISO 14971, modified by Amendment 1, by the following new references:

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

and essential performance
Amendment 1:2012
Amendment 2:2020

IEC 60601-1-6:2010, 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 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

Add the following new normative reference:
ISO 9000:2015, Quality management systems – Fundamentals and vocabulary
3 Terms and definitions
Replace the existing first paragraph with the following new paragraph:
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.
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IEC FDIS 60601-1-10:2007/AMD2 – 5 –
© IEC 2020

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

LOOP CONTROL SYSTEM (PCLCS) utilizing a PCLC

Add, to the definition of symbol "y" in the existing key, the word "controlled" before "PHYSIOLOGIC

VARIABLE".
3.4
* COMMAND VARIABLE
Add the following new note:
NOTE A COMMAND VARIABLE may be a range or a function (e.g. clinical protocol).
3.20
* PHYSIOLOGIC CLOSED-LOOP CONTROLLER
Add the following new notes:

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
Replace the existing definition with the following new definition:
PATIENT VARIABLE intended to be controlled
Delete the existing note.
3.23
RELATIVE OVERSHOOT

Add, after "PHYSIOLOGIC VARIABLE" in the existing Note 1, the words "or FEEDBACK VARIABLE".

Add the following new term and definition:
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

Add, before the word "substances" in the existing two bullets of the first paragraph, the words

"or removed" in two places.

Add, after the existing dash "PATIENT TRANSFER ELEMENT, including any hysteresis" of the first

paragraph, the following new dash:
– uncertainty of the model of the PATIENT TRANSFER ELEMENT;
5.1 * Instructions for use
Replace, in the existing second paragraph, "Table C.2" with "Table C.1".
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– 6 – IEC FDIS 60601-1-10:2007/AMD2
© IEC 2020
5.2 Technical description
Add, before the first existing paragraph, the following new paragraph:

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.
Replace, in the existing first paragraph, "Table C.3" with "Table C.2".
Add, after the existing paragraph, the following new paragraph:
Compliance is checked by inspection of the technical description.
SABILITY
6.1 * U

Replace the three existing dashes after "the current value of:" with the following new dashes:

– COMMAND VARIABLE or REFERENCE VARIABLE;
– CONTROLLER OUTPUT VARIABLE or MANIPULATED VARIABLE;
– PHYSIOLOGIC VARIABLE or FEEDBACK VARIABLE; and
– any PATIENT VARIABLE that is used by the PCLC;
6.3 * PCLCS VARIABLE logging
Replace the existing first paragraph with the following new paragraphs:

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;
– the CONTROLLER OUTPUT VARIABLE or MANIPULATED VARIABLE;
– the PHYSIOLOGIC VARIABLE or FEEDBACK VARIABLE; and
– any PATIENT VARIABLE that is used by the PCLC.

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.
8.2.1 RECORDS and PROCESS scaling

Replace, in the existing first paragraph, replace "IEC 62304:2006" with "Clause 14 of the

general standard".
8.2.2.1 * Application specification

Replace the existing subclause, including its title, with the following new subclause and title:

8.2.2.1 * USE SPECIFICATION

The MANUFACTURER shall prepare the USE SPECIFICATION, as required in IEC 62366-1, of the

ME EQUIPMENT or ME SYSTEM that incorporates a PCLC.

A summary of the USE SPECIFICATION shall be included in the instructions for use.

Compliance is checked by inspection of the USABILITY ENGINEERING FILE and the instructions for

use.
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IEC FDIS 60601-1-10:2007/AMD2 – 7 –
© IEC 2020
8.2.2.2 * State VARIABLES

Replace the existing subclause, including its title, with the following new subclause and title:

8.2.2.2 * PCLCS attributes
MANUFACTURER shall characterize attributes of the following:
The
– the COMMAND VARIABLE or REFERENCE VARIABLE;
– the CONTROLLER OUTPUT VARIABLE or MANIPULATED VARIABLE;
– the PHYSIOLOGIC VARIABLE or FEEDBACK VARIABLE; and
– the PATIENT VARIABLE that is used by the PCLC.
The MANUFACTURER shall characterize the limitations and ranges of
...

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