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
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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:
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/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 . 6060
19 201.16 ME SYSTEMS . 6464
20 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 6464
21 Annex AA (informative) Particular guidance and rationale . 6565
22 AA.1 General guidance . 6565
23 Annex BB (normative) Additional design requirements for Home Care and recommendations
24 for all MEDICAL BEDS . 7979
25 BB.1 General . 7979
26 BB.2 Human factors (ergonomic) . 7979
27 BB.3 Functionality . 8080
28 Annex CC (informative) Particular guidance for assessing risk of entrapment in V-shaped
29 openings . 8383
30 Annex DD (informative) Guidance and recommendations for periodic inspection . 8989
31 DD.1 Inspection Intervals . 8989
32 DD.2 Inspection scope . 8989
33 DD.3 Qualification of personnel . 8989
34 DD.4 Inspection results . 8989
35 DD.5 Inspection record . 9090
36 Bibliography . 9191
37 Index of defined terms used in this particular standard. 9292
IEC CDV 80601-2-89 ED1 – 3 – 62D/2113/CDV
40 FIGURES
41 Figure 201.101 – MEDICAL BED, general arrangement (example, schematic presentation only)
42 . 14
43 Figure 201.102 – Small finger probe ∅ 5,6 . 1616
44 Figure 201.103 – Entrapment test TOOLS . 17
45 Figure 201.104 – Loading pad . 18
46 Figure 201.105 – Impactor . 19
47 Figure 201.106 – Side impactor TOOL . 19
48 Figure 201.107 – Graphical symbol for maximum PATIENT weight and SAFE WORKING LOAD . 20
49 Figure 201.108 – Graphic symbol for machine washable MEDICAL BED . 2020
50 Figure 201.109 – Graphic symbol for jet stream washble MEDICAL BED . 21
51 Figure 201.110 – Graphic symbol for manual cleaning only . 21
52 Figure 201.111 – Description of allowed length of PATIENT . 22
53 Figure 201.112 – Example of equivalent marking for positioning PATIENT in MEDICAL BED . 23
54 Figure 201.113 – MEDICAL BED function controls and/or actuators: guidelines for creating
55 graphical symbols… .
56 Figure 201.114 – Examples of marking on the MEDICAL BED of storage location for wired and
57 wireless PENDANT CONTROLS . 25
58 Figure 201.115 – Example of MEDICAL BED with segmented or split SIDE RAIL . 2929
59 Figure 201.116 – Example of MEDICAL BED with single piece SIDE RAIL and PROTECTION PANEL
60 . 3030
61 Figure 201.117 – Dimension of handle for LIFTING POLE . 3434
62 Figure 201.118 – Allowable spacing for fingers in areas of normal reach around the perimeter
63 of the MATTRESS SUPPORT PLATFORM . 3535
64 Figure 201.119 – Example using barriers for clearance measurement around the perimeter of
65 the MATTRESS SUPPORT PLATFORM to mitigate patient-finger entrapment . 3636
66 Figure 201.120 – Clearance areas . 3737
67 Figure 201.121 – Required minimum radii of edges and corners . 3838
68 Figure 201.122 – Retention of loop and mass . 3939
69 Figure 201.123 – Lateral stability test along the side of the MEDICAL BED . 4242
70 Figure 201.124 – Longitudinal stability test with removable FOOT BOARD . 4242
71 Figure 201.125 – Longitudinal stability test with fixed HEAD/FOOT BOARDS . 4343
72 Figure 201.126 – Distribution of SAFE WORKING LOAD for tests . 4646
73 Figure 201.127 – Position of loading pad and impactor . 4949
74 Figure 201.128 – Impact to slats and solid elements of MEDICAL BEDS . 5151
75 Figure 201.129 – Application of forces for test of SIDE RAIL. 5353
76 Figure 201.130 – Height of SIDE RAIL / PROTECTION PANELS . 5555
77 Figure 201.131 – Configurations of the MATTRESS SUPPORT PLATFORM . …63
78 Figure AA.1 – Example of marking for compatible mattresses specified by the MANUFACTURER
79 . 6767
80 Figure AA.2 – Example of marking for detachable SIDE RAILS specified by the MANUFACTURER .
81 67
82 Figure AA.3 – Resultant forces without mattress . 7070
83 Figure AA.4 – Resultant forces with mattress . 7070
84 Figure AA.5 – Example of 40 mm gap measurement of B . 7070
62D/2113/CDV – 4 – IEC CDV 80601-2-89 ED1
85 Figure AA.6 – Angle measurement example of B . 7070
86 Figure AA.7 – Placement of measurement TOOL for measurement of D . 7171
X
87 Figure AA.8 – Example of area DX measurement that passes . 7272
88 Figure AA.9 – Example of area D measurement that fails (on limit) . 7272
X
89 Figure AA.10 – Example of area DX measurement that fails . 7272
90 Figure AA.11 – Example of potential PATIENT entrapment in area A within the SIDE RAIL . 7373
91 Figure AA.12 – Example of potential PATIENT entrapment in area A below the SIDE RAIL . 7373
92 Figure AA.13 – Example of potential PATIENT entrapment in area B . 7373
93 Figure AA.14 – Example of potential PATIENT entrapment in area C between split SIDE RAIL
94 . 7373
95 Figure AA.15 – Example of potential PATIENT entrapment in area C between SIDE RAIL and
96 HEAD BOARD . 7373
97 Figure AA.16 – Example of potential PATIENT entrapment in area D . 7373
98 Figure AA.17 – Example of potential PATIENT entrapment in area A below a single piece SIDE
99 RAIL . 7474
100 Figure BB.1 – Schematic presentation of under MEDICAL BED clearance. 8181
101 Figure BB.2 – Recommendations and requirements regarding angles for different sections of
102 the MATTRESS SUPPORT PLATFORM . 8282
103 Figure CC.1 – Wedge TOOL . 8484
104 Figure CC.2 – V-shaped opening in relation to B. 8585
105 Figure CC.3 – Pass/fail in relation to area B .
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