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oSIST prEN IEC 60601-2-91:2024

(Main)

Particular requirement for basic safety and essential performance of non-thermal plasma wound treatment equipment

Particular requirement for basic safety and essential performance of non-thermal plasma wound treatment equipment

Exigences particulières pour la sécurité de base et les performances essentielles des appareils de traitement des plaies par plasma non thermique

Posebne zahteve za osnovno varnost in bistveno delovanje opreme za zdravljenje ran z netermično plazmo

General Information

Status
Not Published
Public Enquiry End Date
15-Feb-2024
ICS
11.040.99 - Other medical equipment
11.140 - Hospital equipment
Technical Committee
IEMO - Electrical equipment in medical practice
Current Stage
4020 - Public enquire (PE) (Adopted Project)
Start Date
01-Dec-2023
Due Date
19-Apr-2024
Ref Project
prEN IEC 60601-2-91:2023 - Particular requirement for basic safety and essential performance of non-thermal plasma wound treatment equipment

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SLOVENSKI STANDARD
oSIST prEN IEC 60601-2-91:2024
01-februar-2024
Posebne zahteve za osnovno varnost in bistveno delovanje opreme za zdravljenje
ran z netermično plazmo
Particular requirement for basic safety and essential performance of non-thermal plasma
wound treatment equipment
Exigences particulières pour la sécurité de base et les performances essentielles des
appareils de traitement des plaies par plasma non thermique
Ta slovenski standard je istoveten z: prEN IEC 60601-2-91:2023
ICS:
11.040.99 Druga medicinska oprema Other medical equipment
11.140 Oprema bolnišnic Hospital equipment
oSIST prEN IEC 60601-2-91:2024 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN IEC 60601-2-91:2024

---------------------- Page: 2 ----------------------
oSIST prEN IEC 60601-2-91:2024
62D/2091/CDV

COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 60601-2-91 ED1
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2023-11-24 2024-02-16
SUPERSEDES DOCUMENTS:
62D/2020/CD, 62D/2045A/CC

IEC SC 62D : PARTICULAR MEDICAL EQUIPMENT, SOFTWARE, AND SYSTEMS
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.
Recipients of this document are invited to submit, with their comments, notification of any relevant “In Some Countries” clau ses to
be included should this proposal proceed. Recipients are reminded that the CDV stage is the final stage for submitting ISC c lauses.
(SEE AC/22/2007 OR NEW GUIDANCE DOC).

TITLE:
Particular requirement for basic safety and essential performance of non-thermal plasma wound treatment
equipment

PROPOSED STABILITY DATE: 2029

NOTE FROM TC/SC OFFICERS:

Copyright © 2023 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 permission in writi ng from IEC.

---------------------- Page: 3 ----------------------
oSIST prEN IEC 60601-2-91:2024
IEC CDV 60601-2-91 © IEC:2023 – 2 – 62D/2091/CDV

1 201.1 Scope, object and related standards . 6
2 201.1.1 Scope . 6
3 201.1.2 Object . 6
4 201.1.3 Collateral standards . 6
5 201.1.4 Particular standards . 6
6 201.2 Normative references . 7
7 201.3 Terms and definitions . 7
8 201.4 General requirements . 8
9 201.5 General requirements for testing ME EQUIPMENT . 8
10 201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 8
11 201.7 ME EQUIPMENT identification, marking and documents . 8
12 201.8 Protection against electrical HAZARDS from ME EQUIPMENT and ME SYSTEMS . 8
13 201.9 Protection against mechanical HAZARDS from ME EQUIPMENT and ME SYSTEMS . 12
14 201.10 Protection against unwanted and excessive radiation HAZARDS . 12
15 201.11 Protection against excessive temperature and other HAZARDS . 12
16 201.12 Accuracy of control
...

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