prEN IEC 60601-2-39:2022

Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment

Medizinische elektrische Geräte - Teil 2-39: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Peritoneal-Dialyse-Geräten

Appareils électromédicaux - Partie 2-39: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de dialyse péritonéale

Medicinska električna oprema - 2-39. del: Posebne zahteve za osnovno varnost in bistvene lastnosti opreme za trebušno dializo

General Information

• Status: Not Published
• Publication Date: 02-Jun-2024
• ICS: 11.040.99 - Other medical equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 4060 - Enquiry results established and sent to TC, SR, BTTF - Enquiry
• Start Date: 03-Feb-2023
• Completion Date: 03-Feb-2023
• Ref Project: oSIST prEN IEC 60601-2-39:2023 - Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment

Relations

• Revises: EN IEC 60601-2-39:2019 - Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
• Effective Date: 21-Oct-2021

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN IEC 60601-2-39:2023
01-januar-2023
Medicinska električna oprema - 2-39. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti opreme za trebušno dializo
Medical electrical equipment - Part 2-39: Particular requirements for basic safety and
essential performance of peritoneal dialysis equipment
Medizinische elektrische Geräte - Teil 2-39: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Peritoneal-Dialyse-Geräten
Appareils électromédicaux - Partie 2-39: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils de dialyse péritonéale
Ta slovenski standard je istoveten z: prEN IEC 60601-2-39:2022
ICS:
11.040.99 Druga medicinska oprema Other medical equipment
oSIST prEN IEC 60601-2-39:2023 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN IEC 60601-2-39:2023

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oSIST prEN IEC 60601-2-39:2023

62D/1992/CDV

COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 60601-2-39 ED4
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2022-11-11 2023-02-03
SUPERSEDES DOCUMENTS:
62D/1913/CD, 62D/1934A/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:
Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential
performance of peritoneal dialysis equipment

PROPOSED STABILITY DATE: 2028

NOTE FROM TC/SC OFFICERS:

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
permission in writing from IEC.

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oSIST prEN IEC 60601-2-39:2023
62D/1992/CDV – 2 – IEC/CDV 60601-2-39:Ed. 4 © IEC 2022
1 CONTENTS
2 CONTENTS . 2
3 FOREWORD . 3
4 INTRODUCTION . 6
5 Scope, object and related standards . 7
6 Normative references . 9
7 Terms and definitions . 9
8 General requirements . 11
9 General requirements for testing ME EQUIPMENT . 15
10 Classification of ME EQUIPMENT and ME SYSTEMS . 15
11 ME EQUIPMENT identification, marking and documents . 15
12 Protection against electrical HAZARDS from ME EQUIPMENT . 19
13 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 20
14 Protection against unwanted and excessive radiation HAZARDS . 20
15 Protection against excessive temperatures and other HAZARDS . 20
16 Accuracy of controls and instruments and protection against hazardous outputs . 23
17 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 25
18 PROGRAMMABLE ELECTRICAL M
...