SIST EN IEC 60601-2-76:2019/A1:2023

Medical electrical equipment - Part 2-76: Particular requirements for the basic safety and essential performance of low energy ionized gas haemostasis equipment (IEC 60601-2-76:2018/AMD1:2023)

Medizinische elektrische Geräte - Teil 2-76: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Geräten zur Koagulation mittels ionisierten Gasen (IEC 60601-2-76:2018/AMD1:2023)

Appareils électromédicaux - Partie 2-76: Exigences particulières pour la sécurité de base et les performances essentielles des appareils d’hémostase à gaz ionisé à faible pouvoir calorifique (IEC 60601-2-76:2018/AMD1:2023)

Medicinska električna oprema - 2-76. del: Posebne zahteve za osnovno varnost in bistvene lastnosti opreme za hemostazijo z nizkoenergijskim ioniziranim plinom - Dopolnilo A1 (IEC 60601-2-76:2018/AMD1:2023)

General Information

• Status: Published
• Public Enquiry End Date: 31-Jul-2022
• Publication Date: 17-Oct-2023
• ICS: 11.040 - Medical equipment
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 13-Oct-2023
• Due Date: 18-Dec-2023
• Completion Date: 18-Oct-2023
• Ref Project: EN IEC 60601-2-76:2019/A1:2023 - Medical electrical equipment - Part 2-76: Particular requirements for the basic safety and essential performance of low energy ionized gas haemostasis equipment

Relations

• Amends: SIST EN IEC 60601-2-76:2019 - Medical electrical equipment - Part 2-76: Particular requirements for the basic safety and essential performance of low energy ionized gas haemostasis equipment (IEC 60601-2-76:2018)
• Effective Date: 26-Jul-2021

Overview

The SIST EN IEC 60601-2-76:2019/A1:2023 amendment outlines the updated particular requirements for the basic safety and essential performance of low energy ionized gas haemostasis equipment. This European Standard, aligned with IEC 60601-2-76:2018/AMD1:2023, is part of the IEC 60601 series that governs medical electrical equipment safety. Published by CLC and approved by CENELEC in October 2023, this amendment enhances the previous 2019 edition to ensure compliance with the latest safety and risk management protocols.

This standard is crucial for manufacturers and stakeholders involved in the design, testing, and certification of medical devices that utilize low energy ionized gas for haemostasis, aiming to minimize risks to patients and operators while ensuring reliable device performance.

Key Topics

• Basic Safety Requirements: Specifies essential safety benchmarks to protect patients and medical personnel during use. This includes electrical safety, mechanical safety, and protection against potential hazards.

• Essential Performance: Defines the critical functions the equipment must reliably perform, ensuring haemostasis effectiveness without compromising safety.

• Risk Management Integration: Mandates alignment with IEC 60601-1 and its amendments (2005, AMD1:2012, AMD2:2020) for comprehensive risk identification, reduction, and control throughout the equipment lifecycle.

• Terminology and Definitions: Updates terminology related to voltage, current, hazards, harmful situations, and risk to improve clarity and consistency across documentation and testing procedures.

• Harmonization with International and European Standards: Incorporates references to IEC 60601-1 and related collateral standards to create a unified safety framework for medical electrical devices.

• Implementation Timeline: Specifies the deadlines for mandatory national adoption (by July 2024) and withdrawal of conflicting standards (by October 2026).

Applications

Low energy ionized gas haemostasis equipment compliant with SIST EN IEC 60601-2-76:2019/A1:2023 is widely used across various medical domains, including:

• Surgical Procedures: For precise coagulation during minimally invasive and open surgeries to control bleeding while minimizing thermal damage to tissue.

• Ambulatory Care: Devices designed for outpatient interventions requiring effective haemostasis with enhanced safety features.

• Electrosurgical Instrumentation: Integration into surgical tools that employ ionized gas for energy delivery, ensuring equipment safety and performance standards are met.

• Medical Device Manufacturing: Serves manufacturers in design validation, essential performance testing, and safety certification to meet regulatory requirements in Europe and globally.

• Clinical Risk Management: Enables hospitals and healthcare providers to evaluate equipment in alignment with established risk frameworks, ensuring patient safety and device reliability.

Related Standards

SIST EN IEC 60601-2-76:2019/A1:2023 is closely aligned and should be used in conjunction with relevant standards such as:

• IEC 60601-1 (Latest Editions and Amendments): General requirements for basic safety and essential performance of medical electrical equipment, serving as the foundational document.

• Collateral Standards in the IEC 60601 Series: Address additional aspects such as electromagnetic compatibility, usability, and specific application requirements.

• ISO/IEC Directives: Guiding document development and version control to maintain international consistency and quality.

• National Implementation Protocols: Ensure harmonized application of this amendment across European member states and alignment with local regulatory directives.

By adhering to SIST EN IEC 60601-2-76:2019/A1:2023, manufacturers and healthcare providers reinforce commitment to the highest standards of safety, performance, and risk mitigation in medical electrical equipment utilizing low energy ionized gas for haemostasis. This standard supports innovation while prioritizing patient safety and regulatory compliance worldwide.

Standards Content (Sample)

SLOVENSKI STANDARD
01-december-2023
Medicinska električna oprema - 2-76. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti opreme za hemostazijo z nizkoenergijskim ioniziranim plinom -
Dopolnilo A1 (IEC 60601-2-76:2018/AMD1:2023)
Medical electrical equipment - Part 2-76: Particular requirements for the basic safety and
essential performance of low energy ionized gas haemostasis equipment (IEC 60601-2-
76:2018/AMD1:2023)
Medizinische elektrische Geräte - Teil 2-76: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Geräten zur Koagulation mittels
ionisierten Gasen (IEC 60601-2-76:2018/AMD1:2023)
Appareils électromédicaux - Partie 2-76: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils d’hémostase à gaz ionisé à faible pouvoir
calorifique (IEC 60601-2-76:2018/AMD1:2023)
Ta slovenski standard je istoveten z: EN IEC 60601-2-76:2019/A1:2023
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN IEC 60601-2-76:2019/A1

NORME EUROPÉENNE
EUROPÄISCHE NORM October 2023
ICS 11.040
English Version
Medical electrical equipment - Part 2-76: Particular requirements
for the basic safety and essential performance of low energy
ionized gas haemostasis equipment
(IEC 60601-2-76:2018/AMD1:2023)
Appareils électromédicaux - Partie 2-76: Exigences Medizinische elektrische Geräte - Teil 2-76: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des appareils d'hémostase à gaz ionisé à faible wesentlichen Leistungsmerkmale von Niedrigenergie-
pouvoir calorifique Ionengas-Hämostasegeräten
(IEC 60601-2-76:2018/AMD1:2023) (IEC 60601-2-76:2018/AMD1:2023)
This amendment A1 modifies the European Standard EN IEC 60601-2-76:2019; it was approved by CENELEC on 2023-10-05. 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
© 2023 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 60601-2-76:2019/A1:2023 E

European foreword
The text of document 62D/2047/FDIS, future IEC 60601-2-76/AMD1, prepared by SC 62D
"Electromedical equipment" of IEC/TC 62 "Electrical equipment in medical practice" was submitted to
the IEC-CENELEC parallel vote and approved by CENELEC as EN IEC 60601-2-76:2019/A1:2023.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2024-07-05
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2026-10-05
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 60601-2-76:2018/AMD1:2023 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 60601-2-76:2019 applies with the following changes:

Publication Year Title EN/HD Year

Replace the existing reference to IEC 60601-1:2005 with the following:

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
IEC 60601-2-76 ®
Edition 1.0 2023-08
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AMENDMENT 1
AMENDEMENT 1
Medical electrical equipment –

Part 2-76: Particular requirements for the basic safety and essential performance

of low energy ionized gas haemostasis equipment

Appareils électromédicaux –
Partie 2-76: Exigences particulières pour la sécurité de base et les performances

essentielles des appareils d’hémostase à gaz ionisé à faible pouvoir calorifique

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040  ISBN 978-2-8322-7464-4

– 2 – IEC 60601-2-76:2018/AMD1:2023
© IEC 2023
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-76: Particular requirements for the basic safety and essential
performance of low energy ionized gas haemostasis equipment

AMENDMENT 1
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for sta
...