SIST EN IEC 80601-2-49:2019/A1:2024

Medizinische elektrische Geräte - Teil 2-49: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von multifunktionalen Patientenüberwachungsgeräten (IEC 80601-2-49:2018/AMD1:2024)

Appareils électromédicaux - Partie 2-49: Exigences particulières pour la sécurité de base et les performances essentielles des moniteurs multifonctions des patients (IEC 80601-2-49:2018/AMD1:2024)

Medicinska električna oprema - 2-49. del: Posebne zahteve za osnovno varnost in bistvene lastnosti večfunkcijske opreme za nadzor pacientov - Dopolnilo A1 (IEC 80601-2-49:2018/AMD1:2024)

General Information

• Status: Published
• Public Enquiry End Date: 31-Jan-2023
• Publication Date: 27-Oct-2024
• ICS: 11.040.55 - Diagnostic equipment
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 23-Oct-2024
• Due Date: 28-Dec-2024
• Completion Date: 28-Oct-2024
• Ref Project: EN IEC 80601-2-49:2019/A1:2024 - Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors

Relations

• Refers: SIST ISO 12129-2:2002 - Plain bearings -- Part 2: Tolerances on form and position and surface roughness for shafts, flanges and thrust collars
• Effective Date: 10-Feb-2026
• Refers: SIST EN ISO 5165:2018 - Petroleum products - Determination of the ignition quality of diesel fuels - Cetane engine method (ISO 5165:2017)
• Effective Date: 09-Feb-2026
• Refers: SIST EN ISO 20847:2004 - Petroleum products - Determination of sulfur content of automotive fuels - Energy-dispersive X-ray fluorescence spectrometry (ISO 20847:2004)
• Effective Date: 09-Feb-2026
• Refers: SIST EN 60601-1-8:2008/A1:2014 - 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
• Effective Date: 03-Feb-2026
• Refers: SIST EN 60601-1-6:2010 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (IEC 60601-1-6:2010)
• Effective Date: 03-Feb-2026
• Refers: SIST EN 60601-1-6:2010/A2:2021 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (IEC 60601-1-6:2010/A2:2020)
• Effective Date: 03-Feb-2026
• Refers: SIST EN 60601-1:2007/A1:2014 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
• Effective Date: 03-Feb-2026
• Refers: SIST EN 60601-1:2007 - Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
• Effective Date: 03-Feb-2026
• Refers: SIST EN 60601-1-6:2010/A1:2015 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
• Effective Date: 03-Feb-2026
• Refers: SIST EN 60601-1-12:2015/A1:2020 - Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment (IEC 60601-1-12:2014/A1:2020)
• Effective Date: 03-Feb-2026
• Refers: SIST EN 60601-1-11:2015/A1:2021 - 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 60601-1-11:2015/A1:2020)
• Effective Date: 03-Feb-2026
• Refers: SIST EN 60601-1-2:2015 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
• Effective Date: 03-Feb-2026
• Refers: SIST EN 60601-1-2:2015/A1:2021 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests (IEC 60601-1-2:2014/A1:2020)
• Effective Date: 03-Feb-2026
• Refers: SIST EN 60601-1:2007/A2:2021 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005/A2:2020)
• Effective Date: 03-Feb-2026
• Refers: SIST EN 60601-1-8:2008/A2:2021 - 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 60601-1-8:2006/A2:2020)
• Effective Date: 03-Feb-2026

Overview

SIST EN IEC 80601-2-49:2019/A1:2024 is the Slovenian adoption of the European amendment to the international standard IEC 80601-2-49. This amendment details the particular requirements for the basic safety and essential performance of multifunction patient monitors used in medical environments. These devices play a vital role in monitoring multiple physiological parameters in healthcare settings such as hospitals and clinics.

This standard is crucial for manufacturers, regulatory authorities, and healthcare providers, supporting harmonization of safety and performance criteria across Europe and internationally. It addresses evolving technical requirements, ensures alignment with updated collateral and general standards in the IEC 60601-1 series, and helps keep medical electrical equipment compliant with the latest safety trends.

Key Topics

• Basic Safety: Specifies essential safety requirements that multifunction patient monitors must meet to protect patients, operators, and maintenance staff from potential electrical, mechanical, or biological hazards.
• Essential Performance: Outlines the functions that must be maintained to avoid unacceptable risk during normal use and foreseeable misuse.
• Alarm System Requirements: Updates requirements for alarm system capacity, logging, and event tracing to help healthcare professionals respond quickly and appropriately to critical patient conditions.
• Normative References: Integrates updated references to key IEC 60601 series such as IEC 60601-1 (general requirements), IEC 60601-1-2 (electromagnetic disturbances), IEC 60601-1-6 (usability), IEC 60601-1-8 (alarms), and others.
• Usability and Human Factors: Ensures that interfaces and controls for multifunction patient monitors are designed for clarity, accessibility, and minimal user error.
• Terminology and Definitions: Incorporates updated definitions and terminology consistent with the latest IEC amendments, supporting clear communication and implementation.

Applications

Multifunction patient monitors are used in a wide range of healthcare settings, including:

• Critical Care Units: For continuous monitoring of cardiac, respiratory, and other vital signs.
• Operating Theatres: Supporting anesthesiology and perioperative monitoring.
• Emergency Departments: Enabling rapid assessment and ongoing monitoring during acute care.
• Home Healthcare Environments: With specific requirements ensuring monitors are safe for non-clinical settings.
• Transport and Emergency Services: Providing robust performance in demanding and mobile environments.

Compliance with SIST EN IEC 80601-2-49:2019/A1:2024:

• Ensures medical equipment can be marketed and used across EU member states and beyond,
• Reduces risks for patients and users by maintaining essential safety and performance levels,
• Supports procurement, device approval, and risk management processes in organizations.

Related Standards

This standard is closely related to the following key publications:

• IEC 60601-1: General requirements for basic safety and essential performance of medical electrical equipment.
• IEC 60601-1-2: Requirements for electromagnetic disturbances and testing methodologies.
• IEC 60601-1-6: Usability and human factor engineering for medical electrical equipment.
• IEC 60601-1-8: Requirements for medical equipment alarm systems.
• IEC 60601-1-11: Medical electrical equipment intended for home healthcare.
• IEC 60601-1-12: Requirements for emergency medical services environments.

By ensuring compatibility and alignment with these collateral and general standards, SIST EN IEC 80601-2-49:2019/A1:2024 enables manufacturers and users to achieve comprehensive compliance and safety for multifunction patient monitors in the healthcare sector.

For manufacturers, regulatory compliance according to this updated amendment is fundamental for market access, quality assurance, and patient safety.

Standards Content (Sample)

SLOVENSKI STANDARD
01-december-2024
Medicinska električna oprema - 2-49. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti večfunkcijske opreme za nadzor pacientov - Dopolnilo A1 (IEC
80601-2-49:2018/AMD1:2024)
Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and
essential performance of multifunction patient monitors (IEC 80601-2-
49:2018/AMD1:2024)
Medizinische elektrische Geräte - Teil 2-49: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von multifunktionalen
Patientenüberwachungsgeräten (IEC 80601-2-49:2018/AMD1:2024)
Appareils électromédicaux - Partie 2-49: Exigences particulières pour la sécurité de base
et les performances essentielles des moniteurs multifonctions des patients (IEC 80601-2
-49:2018/AMD1:2024)
Ta slovenski standard je istoveten z: EN IEC 80601-2-49:2019/A1:2024
ICS:
11.040.55 Diagnostična oprema Diagnostic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN IEC 80601-2-49:2019/A1

NORME EUROPÉENNE
EUROPÄISCHE NORM October 2024
ICS 11.040.55
English Version
Medical electrical equipment - Part 2-49: Particular requirements
for the basic safety and essential performance of multifunction
patient monitors
(IEC 80601-2-49:2018/AMD1:2024)
Appareils électromédicaux - Partie 2-49 : Exigences Medizinische elektrische Geräte - Teil 2-49: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des moniteurs multifonctions des patients wesentlichen Leistungsmerkmale von multifunktionalen
(IEC 80601-2-49:2018/AMD1:2024) Patientenüberwachungsgeräten
(IEC 80601-2-49:2018/AMD1:2024)
This amendment A1 modifies the European Standard EN IEC 80601-2-49:2019; it was approved by CENELEC on 2024-10-16. CENELEC
members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this amendment 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 CEN-CENELEC
Management Centre or to any CENELEC member.
This amendment 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 CEN-CENELEC Management Centre has the same status as
the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Türkiye and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2024 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 80601-2-49:2019/A1:2024 E

European foreword
The text of document 62D/2146/FDIS, future edition 1 of IEC 80601-2-49/AMD1, prepared by SC 62D
"Particular medical equipment, software, and systems" of IEC/TC 62 "Medical equipment, software,
and systems" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2025-10-31
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2027-10-31
document have to be withdrawn
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 80601-2-49:2018/AMD1:2024 was approved by CENELEC
as a European Standard without any modification.
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 1 Where an International Publication has been modified by common modifications, indicated by (mod), the
relevant EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available
here: www.cencenelec.eu.
The Annex ZA of EN IEC 80601-2-49:2019 applies with the following changes:
Publication Year Title EN/HD Year

Replace the existing references to IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 60601-1, IEC
60601-1-11 and IEC 60601-1-12 with the following new references:

IEC 60601-1 2005 Medical electrical equipment - Part 1: EN 60601-1 2006
General requirements for basic safety and
essential performance
- -  + corrigendum Mar. 2010
+ A1 2012  + A1 2013
- -  + A12 2014
+ A2 2020  + A2 2021
- -  + A13 2024
IEC 60601-1-2 2014 Medical electrical equipment - Part 1-2: EN 60601-1-2 2015
General requirements for basic safety and
essential performance - Collateral
Standard: Electromagnetic disturbances -
Requirements and tests
+ A1 2020  + A1 2021
IEC 60601-1-6 2010 Medical electrical equipment - Part 1-6: EN 60601-1-6 2010
General requirements for basic safety and
essential performance - Collateral
standard: Usability
+ A1 2013  + A1 2015
+ A2 2020  + A2 2021
IEC 60601-1-8 2006 Medical electrical equipment - Part 1-8: EN 60601-1-8 2007
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
+ A1 2012  + A1 2013
- -  + AC 2014
+ A2 2020  + A2 2021
IEC 60601-1-11 2015 Medical electrical equipment - Part 1-11: EN 60601-1-11 2015
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
+ A1 2020  + A1 2021
IEC 60601-1-12 2014 Medical Electrical Equipment - Part 1-12: EN 60601-1-12 2015
General requirements for basic safety and
essential performance - Collateral
Standard: Requirements for medical
electrical equipment and medical electrical
systems used in the emergency medical
services environment
+ A1 2020  + A1 2020
IEC 80601-2-49
Edition 1.0 2024-09
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 1
AM ENDEMENT 1
Medical electrical equipment –

Part 2-49: Particular requirements for the basic safety and essential performance

of multifunction patient monitors

Appareils électromédicaux –
Partie 2-49: Exigences particulières pour la sécurité de base et les performances

essentielles des moniteurs multifonctions des patients

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.55 ISBN 978-2-8322-9641-7

– 2 – IEC 80601-2-49:2018/AMD1:2024
© IEC 2024
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-49: Particular requirements for the basic safety
and essential performance of multifunction patient monitors

AMENDMENT 1
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 itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
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 document may be the subject of patent
rights. IEC shall not be held responsible for identifying any or all such patent rights.
Amendment 1 to IEC 80601-2-49:2018 has been prepared by subcommittee 62D: Particular
medical equipment, software, and systems, of IEC technical committee 62: Medical equipment,
software, and systems.
The text of this Amendment is based on the following documents:
Draft Report on voting
62D/2146/FDIS 62D/2164/RVD
Full information on the voting for its approval can be found in the report on voting indicated in
the above table.
The language used for the development of this Amendment is English.

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