EN IEC 63322:2025

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.

oSIST prEN IEC 63322:2024
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:
electronic file, to make a copy and to print out the content for the sole purpose of preparing National Committee positions.
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You may not copy or "mirror" the file or printed version of the document, or any part of it, for any other purpose without
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oSIST prEN IEC 63322:2024
62C/907/CDV – 2 – IEC CDV 63322 © IEC 2023
1 CONTENTS
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 . 16
19 4.5.2 Overview of Requirements for the RESPONSIBLE ORGANIZATION . 16
20 5 Testing the compliance of ME EQUIPMENT of SECURITY GROUPs A, B and C with the
21 requirements of this standard . 17
22 5.1 TYPE TESTs and SITE TESTs . 17
23 5.1.1 Test grades . 17
24 5.2 Determination of the physical resistance . 18
25 5.2.1 Calculation of RESISTANCE VALUEs to determine compliance with the
26 required RESISTANCE GRADE . 18
27 5.3 Certificate of compliance . 19
28 5.3.1 Complying with the required RESISTANCE GRADE of the SECURED ME
29 EQUIPMENT . 19
30 6 Requirements for security of ME EQUIPMENT belonging to SECURITY GROUPS A, B
31 and C . 19
32 6.1 SECURITY GROUP of the ME EQUIPMENT . 19
33 6.2 VULNERABILITY ASSESSMENT performed by the MANUFACTURER . 20
34 6.3 Requirements for the SECURITY ARRANGEMENT of ME EQUIPMENT of SECURITY
35 GROUP A, B and C . 21
36 6.3.1 Resistance requirements for STATIONARY ME EQUIPMENT of SECURITY
37 GROUPs A, B and C . 21
38 6.3.2 Resistance requirements for MOBILE ME EQUIPMENT of SECURITY GROUPs
39 A, B and C . 22
40 6.4 Requirements for INTRUSION detection for STATIONARY and MOBILE ME
41 EQUIPMENT . 22
42 6.5 Requirements on the interface between the system designed to detect
43 INTRUSION on the ME EQUIPMENT and the security system of the RESPONSIBLE
44 ORGANIZATION . 23
45 6.6 ACCOMPANYING DOCUMENTATION . 23
46 6.6.1 SITE SECURITY GUIDE provided by the MANUFACTURER . 23
47 6.6.2 Technical documentation . 23
48 6.7 Markings and identifications provided by the MANUFACTURER . 23
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oSIST prEN IEC 63322:2024
IEC CDV 63322 © IEC 2023 – 3 – 62C/907/CDV
49 6.7.1 A label showing compliance with the requirements of this standard . 23
50 6.7.2 A label showing that the ME EQUIPMENT is equipped with a system
51 designed to detect INTRUSION attempts . 24
52 6.8 Replacement of an attacked security component. 24
53 7 Requirements for the security of the location in which ME EQUIPMENT in SECURITY
54 GROUPS A, B and C is used or stored . 24
55 7.1 VULNERABILITY ASSESSMENT . 24
56 7.2 General requirements when ME EQUIPMENT is placed in a SECURE ROOM . 25
57 7.2.1 Anchoring . 25
58 7.3 Markings and identifications provided by the RESPONSIBLE ORGANIZATION . 25
59 7.4 ACCESS CONTROL system. 26
60 7.5 Emergency procedures in the case of a security event . 26
61 7.6 Emergency during ongoing treatment . 26
62 7.7 SITE SECURITY MANUAL. 26
63 Annex A (informative) Background material . 28
64 A.1 Introduction . 28
65 A.2 Scope, object and related standards (Clause 1) . 28
66 A.2.1 Object . 29
67 A.2.2 Related standards . 29
68 A.3 Normative references (Clause 2) . 30
69 A.4 Terms and definitions (Clause 3) . 30
70 A.5 Overview of requirements and responsibilities (Clause 4) . 30
71 A.5.1 ASSUMPTION OF THREAT . 31
72 A.5.2 Vulnerability assessment . 31
73 A.6 General requirements for testing of ME EQUIPMENT of SECURITY GROUPS A, B
74 and C (Clause 5) . 32
75 A.7 Requirements for security of ME EQUIPMENT of SECURITY GROUPS A, B and C . 34
76 A.7.1 SECURITY GROUP of ME EQUIPMENT . 34
77 A.7.2 VULNERABILITY ASSESSMENT performed by the MANUFACTURER . 34
78 A.7.3 Resistance requirements for STATIONARY and MOBILE ME EQUIPMENT of
79 SECURITY GROUP A, B and C . 34
80 A.7.4 Interface requirements between the INTRUSION DETECTION SYSTEM on the
81 ME EQUIPMENT and the external security system of the RESPONSIBLE
82 ORGANIZATION . 35
83 A.7.5 ACCOMPANYING DOCUMENTATION . 35
84 A.8 Requirements for security of the location in which the ME EQUIPMENT of
85 SECURITY GROUPS A, B and C is used or stored (Clause 7) . 35
86 A.8.1 VULNERABILITY ASSESSMENT performed by the RESPONSIBLE
87 ORGANIZATION . 35
88 A.8.2 SITE SECURITY MANUAL . 36
89 A.8.3 ACCESS CONTROL . 36
90 Annex B (normative) Testing of physical resistance of SECURED ME EQUIPMENT . 38
91 The relationship between EN 1143-1:2019 and IEC 63322 . 38
92 Test specifications . 39
93 B.1 Scope . 39
94 B.2 Classification and requirements . 39
95 B.2.1 Classification . 39
96 B.2.2 General requirements . 39
97 B.3 Technical documentation . 40
98 B.4 Test specimen . 41
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oSIST prEN IEC 63322:2024
62C/907/CDV – 4 – IEC CDV 63322 © IEC 2023
99 B.5 Tool attack test . 41
100 B.5.1 Principle . 41
101 B.5.2 Testing team. 41
102 B.5.3 Apparatus . 42
103 B.5.4 Test criteria . 43
104 B.5.5 Testing programme . 43
105 B.5.6 Test conditions . 43
106 B.5.7 Procedure . 44
107 B.5.8 Operating time measuring .
...