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oSIST prEN IEC 80601-2-89:2024

(Main)

Medical electrical equipment - Part 2-89: Particular requirements for the basic safety and essential performance of medical beds for children

Medical electrical equipment - Part 2-89: Particular requirements for the basic safety and essential performance of medical beds for children

Appareils électromédicaux - Partie 2-89: Exigences particulières pour la sécurité de base et les performances essentielles des lits médicaux pour enfants

Medicinska električna oprema - 2-89. del: Posebne zahteve za osnovno varnost in bistvene lastnosti medicinskih postelj za otroke

General Information

Status
Not Published
Public Enquiry End Date
23-May-2024
ICS
11.140 - Hospital equipment
Technical Committee
IEMO - Electrical equipment in medical practice
Current Stage
4020 - Public enquire (PE) (Adopted Project)
Start Date
06-Mar-2024
Due Date
24-Jul-2024
Completion Date
22-May-2024
Ref Project
prEN IEC 80601-2-89:2024 - Medical electrical equipment - Part 2-89: Particular requirements for the basic safety and essential performance of medical beds for children

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SLOVENSKI STANDARD
oSIST prEN IEC 80601-2-89:2024
01-maj-2024
Medicinska električna oprema - 2-89. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti medicinskih postelj za otroke
Medical electrical equipment - Part 2-89: Particular requirements for the basic safety and
essential performance of medical beds for children
Ta slovenski standard je istoveten z: prEN IEC 80601-2-89:2024
ICS:
11.140 Oprema bolnišnic Hospital equipment
oSIST prEN IEC 80601-2-89:2024 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN IEC 80601-2-89:2024

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oSIST prEN IEC 80601-2-89:2024
62D/2113/CDV

COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 80601-2-89 ED1
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2024-03-01 2024-05-24
SUPERSEDES DOCUMENTS:
62D/1758A/CD, 62D/1783A/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
clauses. (SEE AC/22/2007 OR NEW GUIDANCE DOC).

TITLE:
Medical electrical equipment - Part 2-89: Particular requirements for the basic safety and essential
performance of medical beds for children

PROPOSED STABILITY DATE: 2030

NOTE FROM TC/SC OFFICERS:

Copyright © 2024 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 80601-2-89:2024
62D/2113/CDV – 2 – IEC CDV 80601-2-89 ED1

1 CONTENTS
2 FOREWORD.5
3 INTRODUCTION .7
4 201.1 Scope, object and related standards .7
5 201.2 Normative references .9
6 201.3 Terms and definitions . 10
7 201.4 General requirements . 15
8 201.5 General requirements for testing of ME EQUIPMENT . 1616
9 201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 2020
10 201.7 ME EQUIPMENT identification, marking and documents . 20
11 201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 27
12 201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS . 28
13 201.10 Protection against unwanted and excessive radiation HAZARDS . 5656
14 201.11 Protection against excessive temperatures and other HAZARDS . 5656
15 201.12 Accuracy of controls and instruments and protection against hazardous outputs . 5959
16 201.13 HAZARDOUS SITUATIONS and fault conditions . 6060
17 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 6060
18 201.15 Construction of ME EQUIPMENT .
...

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