EN IEC 60601-2-2:2018/FprA1:2022

Amendment 1 - Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

No scope available

Medizinische elektrische Geräte - Teil 2-2: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Hochfrequenz-Chirurgiegeräten

Appareils électromédicaux - Partie 2-2: Exigences particulières pour la sécurité de base et les performances essentielles des appareils d'électrochirurgie à courant haute fréquence et des accessoires d'électrochirurgie à courant haute fréquence

Medicinska električna oprema - 2-2. del: Posebne zahteve za osnovno varnost in bistvene lastnosti visokofrekvenčne kirurške opreme in visokofrekvenčnega kirurškega pribora - Dopolnilo A1

General Information

• Status: Not Published
• Publication Date: 26-Apr-2023
• ICS: 11.040.30 - Surgical instruments and materials
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 5060 - Voting results sent to TC, SR - Formal Approval
• Start Date: 27-Jan-2023
• Completion Date: 27-Jan-2023
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Ref Project: SIST EN IEC 60601-2-2:2018/kFprA1:2022 - Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

Relations

• Amends: EN IEC 60601-2-2:2018 - Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
• Effective Date: 01-Jun-2021

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN IEC 60601-2-2:2018/oprA1:2022
01-junij-2022
Medicinska električna oprema - 2-2. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti visokofrekvenčne kirurške opreme in visokofrekvenčnega
kirurškega pribora - Dopolnilo A1
Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and
essential performance of high frequency surgical equipment and high frequency surgical
accessories
Medizinische elektrische Geräte - Teil 2-2: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Hochfrequenz-Chirurgiegeräten
Appareils électromédicaux - Partie 2-2: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils d'électrochirurgie à courant haute
fréquence et des accessoires d'électrochirurgie à courant haute fréquence
Ta slovenski standard je istoveten z: EN IEC 60601-2-2:2018/prA1:2022
ICS:
11.040.30 Operacijski instrumenti in Surgical instruments and
materiali materials
SIST EN IEC 60601-2-2:2018/oprA1:2022 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN IEC 60601-2-2:2018/oprA1:2022

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SIST EN IEC 60601-2-2:2018/oprA1:2022
62D/1944/CDV

COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 60601-2-2/AMD1 ED6
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2022-04-15 2022-07-08
SUPERSEDES DOCUMENTS:
62D/1861/CD, 62D/1902A/CC

IEC SC 62D : ELECTROMEDICAL EQUIPMENT
SECRETARIAT: SECRETARY:
United States of America Ms Ladan Bulookbashi
OF INTEREST TO THE FOLLOWING COMMITTEES: PROPOSED HORIZONTAL STANDARD:


Other TC/SCs are requested to indicate their interest, if any, in
this CDV to the secretary.
FUNCTIONS CONCERNED:
EMC ENVIRONMENT QUALITY ASSURANCE SAFETY
SUBMITTED FOR CENELEC PARALLEL VOTING NOT SUBMITTED FOR CENELEC PARALLEL VOTING
Attention IEC-CENELEC parallel voting
The attention of IEC National Committees, members of
CENELEC, is drawn to the fact that this Committee Draft for Vote
(CDV) is submitted for parallel voting.
The CENELEC members are invited to vote through the
CENELEC online voting system.

This document is still under study and subject to change. It should not be used for reference purposes.
Recipients of this document are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.

TITLE:
Amendment 1 - Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and
essential performance of high frequency surgical equipment and high frequency surgical accessories

PROPOSED STABILITY DATE: 2027

NOTE FROM TC/SC OFFICERS:
The 6th Edition of IEC 60601-2-2 was published in 2017. This amendment is intended to align the standard to IEC
60601-1:2005/AMD2:2020. Additional issues reported from the National Committees and other interested parties
since the publication in 2017 are addressed. National Committees are invited to submit votes and comments on the
amended parts at this stage.
Copyright © 2022 International Electrotechnical Commission, IEC. All rights reserved. It is permitted to download this
electronic file, to make a copy and to print out the content for the sole purpose of preparing National Committee positions. You
may not copy or "mirror" the file or printed version of the document, or any part of it, for any other purpose without permis sion
in writing from IEC.

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SIST EN IEC 60601-2-2:2018/oprA1:2022
62D/1944/CDV – 2 – IEC CDV 60601-2-2 AMD1 © IEC:2021
1 INTERNATIONAL ELECTROTECHNICAL COMMISSION
2 ____________
3
4 MEDICAL ELECTRICAL EQUIPMENT –
5
6 Part 2-2: Particular requirements for the basic safety and essential
7 performance of high frequency surgical equipment and high frequency
8 surgical accessories
9
10 AMENDMENT 1
11
12
13 FOREWORD
14 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
15 all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international
16 co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and
17 in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports,
18 Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their
19 preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with
20 may participate in this preparatory work. International, governmental and non-governmental organizations liaising
21 with the IEC also participate in this preparation. IEC collaborates close
...