prEN IEC 63322:2024
(Main)Security of medical electrical equipment containing high-activity sealed radioactive sources
Security of medical electrical equipment containing high-activity sealed radioactive sources
Sécurité des appareils électromédicaux contenant des sources radioactives scellées de haute activité
Varnost medicinske električne opreme, ki vsebuje visokoaktivne zaprte radioaktivne vire
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN IEC 63322:2024
01-maj-2024
Varnost medicinske električne opreme, ki vsebuje visokoaktivne zaprte
radioaktivne vire
Security of medical electrical equipment containing high-activity sealed radioactive
sources
Sécurité des appareils électromédicaux contenant des sources radioactives scellées de
haute activité
Ta slovenski standard je istoveten z: prEN IEC 63322:2024
ICS:
11.040.50 Radiografska oprema Radiographic equipment
oSIST prEN IEC 63322:2024 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN IEC 63322:2024
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oSIST prEN IEC 63322:2024
62C/907/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 63322 ED1
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2024-03-08 2024-05-31
SUPERSEDES DOCUMENTS:
62C/873/CD, 62C/891A/CC
IEC SC 62C : EQUIPMENT FOR RADIOTHERAPY, NUCLEAR MEDICINE AND RADIATION DOSIMETRY
SECRETARIAT: SECRETARY:
Germany Ms Regina Geierhofer
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”
clauses 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:
Security of Medical Electrical Equipment Containing High-Activity Sealed Radioactive Sources
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.
Restricted Information and Basic Personal Data
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 63322:2024
62C/907/CDV – 2 – IEC CDV 63322 © IEC 2023
1 CONTENTS
2
3 FOREWORD . 6
4 INTRODUCTION . 8
5 1 Scope, object and related standards . 9
6 1.1 Scope . 9
7 1.2 Object . 9
8 1.3 Related standards . 9
9 2 Normative references . 10
10 3 Terms and definitions . 10
11 4 Overview of requirements and responsibilities . 14
12 4.1 ASSUMPTION OF THREAT . 14
13 4.2 VULNERABILITY ASSESSMENT . 15
14 4.3 Required physical resistance of three groups of ME EQUIPMENT. 15
15 4.4 SECURITY CULTURE . 16
16 4.5 Responsibilities for the security of ME EQUIPMENT of SECURITY GROUPs A, B
17 and C . 16
18 4.5.1 Overview of Requirements for the MANUFACTURER .
...
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