prEN IEC 80601-2-52:2024
(Main)Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds
Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds
Appareil électromédicaux - Partie 2-52: Exigences particulières de sécurité de base et de performances essentielles des lits médicaux
Medicinska električna oprema - 2-52. del: Posebne zahteve za osnovno varnost in bistvene lastnosti medicinskih postelj
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-maj-2024
Medicinska električna oprema - 2-52. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti medicinskih postelj
Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and
essential performance of medical beds
Appareil électromédicaux - Partie 2-52: Exigences particulières de sécurité de base et de
performances essentielles des lits médicaux
Ta slovenski standard je istoveten z: prEN IEC 80601-2-52:2024
ICS:
11.140 Oprema bolnišnic Hospital equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
62D/2114/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 80601-2-52 ED1
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2024-03-01 2024-05-24
SUPERSEDES DOCUMENTS:
62D/1759A/CD, 62D/1782A/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”
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:
Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential
performance of medical beds
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.
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.
62D/2114/CDV – 2 – IEC CDV 80601-2-52:2024
1 CONTENTS
2 FOREWORD . 5
3 INTRODUCTION . 8
4 201.1 Scope, object and related standards . 9
5 201.2 Normative references . 11
6 201.3 Terms and definitions . 11
7 201.4 General requirements . 15
8 201.5 General requirements for testing of ME EQUIPMENT . 15
9 201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 17
10 201.7 ME EQUIPMENT identification, marking and documents . 18
11 201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 24
12 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 25
13 201.10 Protection against unwanted and excessive radiation HAZARDS . 50
14 201.11 Protection against excessive temperatures and other HAZARDS . 50
15 201.12 Accuracy of controls and instruments and protection against hazardous
16 outputs . 53
17 201.13 HAZARDOUS SITUATIONS and fault conditions . 54
18 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 54
19 201.15 Construction of ME EQUIPMENT . 55
20 201.16 ME SYSTEMS . 59
21 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 59
22 Annexes. 59
23 Annex AA (informative) Particular guidance and rationale . 60
24 Annex BB (normative) Design requirements and recommendations for MEDICAL BEDS . 76
25 Annex CC (informative) Particular guidance for assessing risk of entrapment in v -
26 shaped openings . 80
27 Annex DD (informative) Guidance and recommendations for periodic inspection . 86
28 Bibliography . 88
29 Index of defined terms used in this particular standard . 89
31 FIGURES
32 Figure 201.101 – MEDICAL BED, general arrangement . 14
33 Figure 201.102 – Entrapment test tools . 16
34 Figure 201.103 – Loading pad . 17
35 Figure 201.104 – Impactor . 17
36 Figure 201.105 – Ball chain loop and spherical mass . 18
37 Figure 201.106 – Graphic symbol for maximum PATIENT weight and SAFE WORKING LOAD . 19
38 Figure 201.107 – Graphic symbol for mass; weight . 19
39 Figure 201.108 – Graphic symbol for machine washable MEDICAL BED . 19
40 Figure 201.109 – Graphic symbol for jet stream washable MEDICAL BED . 20
41 Figure 201.110 – Graphic symbol for manual cleaning only . 20
42 Figure 201.111 – Physical description of an ADULT . 21
IEC CDV 80601-2-52:2024 – 3 – 62D/2114/CDV
43 Figure 201.112 – MEDICAL BED function controls and/or actuators: guidelines for
44 creating graphical symbols . 22
45 Figure 201.113 – Example of MEDICAL BED with segmented or split SIDE RAIL . 26
46 Figure 201.114 – Example of MEDICAL BED with single piece SIDE RAIL . 27
47 Figure 201.115 – Allowable spacing for fingers in areas of normal reach around the
48 perimeter of the MATTRESS SUPPORT PLATFORM . 32
49 Figure 201.116 – Example using barriers for clearance measurement around the
50 perimeter of the MATTRESS SUPPORT PLATFORM to mitigate PATIENT finger entrapment . 33
51 Figure 201.117 – Clearance areas . 34
52 Figure 201.118 – Retention of loop and mass . 36
53 Figure 201.119 – Lateral stability test along the side of the MEDICAL BED . 38
54 Figure 201.120 – Longitudinal stability test with removable FOOT BOARD . 38
55 Figure 201.121 – Longitudinal stability test with fixed HEAD/FOOT BOARD . 39
56 Figure 201.122 – Distribution of SAFE WORKING LOAD / maximum PATIENT weight for tests . 42
57 Figure 201.123 – Position of Dynamic loading (see Figure 201.103 for loading pad) . 45
58 Figure 201.124 – Application of forces for test of SIDE RAIL . 46
59 Figure 201.125 – Height of SIDE RAIL . 49
60 Figure 201.126 Direction of movement for rough handling test . 55
61 Figure 201.127 – Configurations of the MATTRESS SUPPORT PLATFORM . 57
62 Figure AA.1 – Example of marking to select recommended mattresses specified by the
63 MANUFACTURER . 62
64 Figure AA.2 – Example of marking for detachable SIDE RAILS specified by the
65 MANUFACTURER . 63
66 Figure AA.3 – Examples of marking on the MEDICAL BED of storage location for wired
67 and wireless PENDANT CONTROLS . 63
68 Figure AA.4 – Resultant forces without mattress . 66
69 Figure AA.5 – Resultant forces with mattress . 66
70 Figure AA.6 – Example of 60 mm gap measurement of B . 66
71 Figure AA.7 – Angle measurement example of B . 66
72 Figure AA.8 – Placement of measurement TOOL for measurement of D . 68
73 Figure AA.9 – Example of area D measurement that passes . 68
74 Figure AA.10 – Example of area D measurement that fails (on limit) . 68
75 Figure AA.11 – Example of area D measurement that fails . 68
76 Figure AA.12 – Example of potential PATIENT entrapment in area A within the SIDE RAIL . 69
77 Figure AA.13 – Example of potential PATIENT entrapment in area A below the SIDE RAIL . 69
78 Figure AA.14 – Example of potential PATIENT entrapment in area B . 69
79 Figure AA.15 – Example of potential PATIENT entrapment in area C between split SIDE
80 RAIL . 69
81 Figure AA.16 – Example of potential PATIENT entrapment in area C between SIDE RAIL
82 and HEAD BOARD . 69
83 Figure AA.17 – Example of potential PATIENT entrapment in area D . 69
84 Figure AA.18 – Example of potential PATIENT entrapment in area A below a single piece
85 SIDE RAIL . 69
86 Figure AA.19 – Concept of potential PATIENT foot-first entrapment tool for area A below
87 a single piece SIDE RAIL . 70
88 Figure BB.1 – Schematic presentation of under MEDICAL BED clearance . 78
62D/2114/CDV – 4 – IEC CDV 80601-2-52:2024
89 Figure BB.2 – Recommendations and requirements regarding angles for different
90 sections of the MATTRESS SUPPORT PLATFORM . 79
91 Figure CC.1 – Wedge tool . 81
92 Figure CC.2 – V-shaped opening in relation to B . 82
93 Figure CC.3 – Pass/fail in relation to area B . 83
94 Figure CC.4 – Positioning of wedge tool . 84
95 Figure CC.5 – Pass/fail in relation to area C between HEAD BOARD and FOOT BOARD . 84
96 Figure CC.6 – Pass/fail in relation to area C between split SIDE RAILS . 85
98 TABLES
99 Table 201.101 – Protection against PATIENT entrapment . 28
100 Table 201.102 – Protection against inadvertent PATIENT falls . 50
101 Table 24 – Allowable maximum temperatures for skin contact with MEDICAL BED APPLIED
102 PARTS . 51
IEC CDV 80601-2-52:2024 – 5 – 62D/2114/CDV
104 INTERNATIONAL ELECTROTECHNICAL COMMISSION
105 ____________
107 MEDICAL ELECTRICAL EQUIPMENT –
109 Part 2-52: Particular requirements for the basic safety
110 and essential performance of medical beds for adults
...
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