IEC 80601-2-30:2009/AMD1:2013

Amendment 1 - Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated type non-invasive sphygmomanometers

Amendement 1 - Appareils électromédicaux - Partie 2-30: Exigences particulières pour la sécurité de base et les performances essentielles des sphygmomanomètres non invasifs automatiques

General Information

• Status: Published
• Publication Date: 30-Jul-2013
• ICS: 11.040.01 - Medical equipment in general
• ICS: 19.040 - Environmental testing
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Drafting Committee: JWG 7 - TC 62/SC 62D/JWG 7
• Current Stage: DELPUB - Deleted Publication
• Completion Date: 22-Mar-2018

Relations

• Amends: IEC 80601-2-30:2009 - Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
• Effective Date: 05-Sep-2023
• Revised: IEC 80601-2-30:2018 - Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
• Effective Date: 05-Sep-2023

Standards Content (Sample)

IEC 80601-2-30
Edition 1.0 2013-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AMENDMENT 1
AMENDEMENT 1
Medical electrical equipment –
Part 2-30: Particular requirements for the basic safety and essential performance
of automated non-invasive sphygmomanometers

Appareils électromédicaux –
Partie 2-30: Exigences particulières pour la sécurité de base et les performances
essentielles des sphygmomanomètres non invasifs automatiques

IEC 80601-2-30:2009/A1:2013
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IEC 80601-2-30
Edition 1.0 2013-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AMENDMENT 1
AMENDEMENT 1
Medical electrical equipment –

Part 2-30: Particular requirements for the basic safety and essential performance

of automated non-invasive sphygmomanometers

Appareils électromédicaux –
Partie 2-30: Exigences particulières pour la sécurité de base et les performances

essentielles des sphygmomanomètres non invasifs automatiques

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX L
ICS 11.040 ISBN 978-2-8322-1003-1

– 2 – 80601-2-30 Amend.1 © IEC:2013

FOREWORD
This amendment has been prepared by subcommittee 62D: Electromedical equipment of IEC

technical committee 62: Electrical equipment in medical practice.

The text of this amendment is based on the following documents:

FDIS Report on voting
62D/1072/FDIS 62D/1079/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 standard has been approved by 14 P-
members out of 15 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 National Committees and Member Bodies 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
_____________
80601-2-30 Amend.1 © IEC:2013 – 3 –

INTRODUCTION TO THE AMENDMENT
This amendment deals primarily with editorial corrections and clarifications, clarifies

requirements for operation in the loss of SUPPLY MAINS and references new and updated

collateral standards.
To meet needs for change which were identified by users of this particular standard, it was

necessary to amend the standard before the previously approved maintenance cycle date.

201.1 Scope, object and related standards
Add at the end of footnote 1), “including Amendment 1:2012”.
201.1.1 Scope
In the first paragraph, replace “intermittent” with “non-continuous”.
201.2 Normative references
Replace the initial instruction concerning amendment of the reference to IEC 60601-1-2 by the
same instruction in the plural form, as follows:
Amendment of the following references:
Add, after the existing reference to IEC 60601-1-2:2007, the following new references:
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
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
Add to the list of references under the existing instruction "Addition:" the following new
references:
IEC 60601-1-11:2010, Medical electrical equipment – Part 1-11: General requirements for
basic safety and essential performance – Collateral standard: Requirements for medical
electrical equipment and medical electrical systems used in the home healthcare environment
IEC 62366:2007, Medical devices – Application of usability engineering to medical devices
Replace the existing reference to ISO 81060-2 by the following:
ISO 81060-2:2013, Non-invasive sphygmomanometers – Part 2: Clinical investigation of
automated measurement type
– 4 – 80601-2-30 Amend.1 © IEC:2013

201.3 Terms and definitions
Replace the existing first paragraph with the following:

For the purposes of this document, the terms and definitions given in

IEC 60601-1:2005+A1:2012, IEC 60601-1-2:2007, IEC 60601-1-8:2006+A1:2012, and

IEC 60601-2-2:2009 apply, except as follows:

201.3.207
HOME HEALTHCARE ENVIRONMENT
Replace the existing definition with the following:
dwelling place in which a PATIENT lives or other places where PATIENTS are present, excluding
professional healthcare facility environments where OPERATORS with medical training are
continually available when PATIENTS are present
NOTE 1 Professional healthcare facilities include hospitals, physician offices, freestanding surgical centres,
dental offices, freestanding birthing centres, limited care facilities, multiple treatment facilities and emergency
medical services.
NOTE 2 For the purpose of this particular standard, nursing homes are considered the HOME HEALTHCARE
ENVIRONMENT.
NOTE 3 Other places where PATIENTS are present include the outdoor environment and in vehicles.
EXAMPLES In a car, bus, train, boat or plane, in a wheelchair or walking outdoors.
[SOURCE: IEC 60601-1-11:2010, definition 3.2]
201.3.216
SELF-MEASUREMENT AUTOMATIC MODE
Replace the existing definition with the following:
mode of AUTOMATED SPHYGMOMANOMETER that is manually initiated and overseen by the
OPERATOR and in which a limited number of repeated DETERMINATIONS are made over a limited
period
201.3.217
SHORT-TERM AUTOMATIC MODE
Replace the existing definition with the following:
mode of AUTOMATED SPHYGMOMANOMETER that is manually initiated by the OPERATOR and in
which rapid repetitive automatic DETERMINATIONS are made within a specified time period

Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements
Replace, in the third row, the phrase "Limits of the change in the error" with "Reproducibility".
201.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts
201.7.2.102 Automated sphygmomanometers for home healthcare environment
Replace the existing title and text of this subclause by the following:
201.7.2.102 AUTOMATED SPHYGMOMANOMETERS for the HOME HEALTHCARE ENVIRONMENT
Vacant.
80601-2-30 Amend.1 © IEC:2013 – 5 –

201.7.9.2.13 Maintenance
Replace in the note, the reference "(see 201.12.1.107)" with "(see 201.12.1.106)"

201.8.5.5.101 * Patient connections of automated sphygmomanometer

Replace the existing title with the following:

201.8.5.5.101 * PATIENT CONNECTIONS of AUTOMATED SPHYGMOMANOMETERS

201.11.8.102 SUPPLY MAINS
Replace the existing second paragraph with the following:
When SUPPLY MAINS is restored, the AUTOMATED SPHYGMOMANOMETER:
a) shall continue in the same mode of operation with all OPERATOR settings unchanged, or
b) shall
• remain inoperative, and
• if provided with SHORT-TERM AUTOMATIC MODE or LONG-TERM AUTOMATIC MODE, be
equipped with an ALARM SYSTEM that includes a TECHNICAL ALARM CONDITION that
indicates the AUTOMATED SPHYGMOMANOMETER is inoperative.
Replace the final paragraph with the following:
Restore the SUPPLY MAINS and determine that the AUTOMATED SPHYGMOMANOMETER:
– continues in the same mode of operation with all OPERATOR settings unchanged; or
– remains inoperative and, if equipped with SHORT-TERM AUTOMATIC MODE or LONG-TERM
AUTOMATIC MODE, that a TECHNICAL ALARM CONDITION is generated.
201.12.1.103 * NOMINAL BLOOD PRESSURE indication range
In the last sentence of the compliance check, replace “60 mmHg (8,0 kPa)” with “40 mmHg
(5,3 kPa)”
201.12.1.105 * Maximum pressure in SINGLE FAULT CONDITION
Add at the beginning of the first paragraph, “In any automatic cycling mode of operation,”.
201.12.1.107 Limits of the change in error of the blood pressure determination

Replace the title and entire existing text of the subclause with the following:
201.12.1.107 * Reproducibility of the BLOOD PRESSURE DETERMINATION
The laboratory reproducibility of the BLOOD PRESSURE DETERMINATION of the AUTOMATED
SPHYGMOMANOMETER shall be less than or equal to 3,0 mmHg (0,4 kPa).
Compliance is checked with the following test:
Two samples of the AUTOMATED SPHYGMOMANOMETER of the same MODEL OR TYPE REFERENCE
are needed to perform this test PROCEDURE.
NOTE At the beginning of this compliance test neither sample has been subjected to the mechanical stress tests
of the general standard and the collateral standards. Step h) subjects AUTOMATED SPHYGMOMANOMETER A to the
stress tests and the laboratory limits of the change in error of the BLOOD PRESSURE DETERMINATION are compared
before and after these mechanical stresses.
a) Label one sample of the AUTOMATED SPHYGMOMANOMETER as A and the other sample as B.

– 6 – 80601-2-30 Amend.1 © IEC:2013

b) Prior to performing the other tests of this standard, adjust a PATIENT SIMULATOR to

generate signals in such a way that the AUTOMATED SPHYGMOMANOMETER displays

approximately a DIASTOLIC BLOOD PRESSURE value of 40 mmHg (5,3 kPa) and a SYSTOLIC

BLOOD PRESSURE value of 70 mmHg (9,33 kPa) at a pulse rate of 140 beats/min in

NEONATAL MODE and a DIASTOLIC BLOOD PRESSURE va
...