IEC/FDIS 80601-2-89

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: Titre manque

General Information

• Status: Not Published
• ICS: 11.140 - Hospital equipment
• Technical Committee: ISO/TC 173 - Assistive products
• Drafting Committee: ISO/TC 173 - Assistive products
• Current Stage: 5060 - Close of voting Proof returned by Secretariat
• Start Date: 02-Sep-2025
• Completion Date: 01-Sep-2025

Standards Content (Sample)

FINAL DRAFT
International
Standard
IEC/FDIS
80601-2-89
ISO/TC 173
Medical electrical equipment —
Secretariat: SIS
Part 2-89:
Voting begins on:
2025-07-07
Particular requirements for
the basic safety and essential
Voting terminates on:
2025-09-01
performance of medical beds for
children
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
This draft is submitted to a parallel vote in ISO and in IEC.
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
FINAL DRAFT
International
Standard
IEC/FDIS
80601-2-89
ISO/TC 173
Medical electrical equipment —
Secretariat: SIS
Part 2-89:
Voting begins on:
Particular requirements for 2025-07-07
the basic safety and essential
Voting terminates on:
2025-09-01
performance of medical beds for
children
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
© ISO 2025
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
This draft is submitted to a parallel vote in ISO and in IEC.
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
ISO copyright office
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Phone: [phone]
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Published in Switzerland Reference number
© IEC 2025 – All rights reserved
ii
IEC FDIS 80601-2-89 © IEC 2025
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
201.1 Scope, object and related standards . 7
201.2 Normative references . 9
201.3 Terms and definitions. 10
201.4 General requirements . 16
201.5 *General requirements for testing of ME EQUIPMENT . 17
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 22
201.7 ME EQUIPMENT identification, marking and documents . 22
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 30
201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS . 31
201.10 Protection against unwanted and excessive radiation HAZARDS . 63
201.11 Protection against excessive temperatures and other HAZARDS . 63
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 66
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 67
201.14 Programmable electrical medical systems (PEMS) . 68
201.15 Construction of ME EQUIPMENT . 68
201.16 ME SYSTEMS . 72
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 72
Annexes . 73
Annex AA (informative) Particular guidance and rationale . 74
Annex BB (normative) Additional design requirements and recommendations for
MEDICAL BEDS . 89
Annex CC (informative) Particular guidance for assessing RISK of entrapment in V-
shaped openings . 93
Annex DD (informative) Guidance and recommendations for periodic inspection . 99
Bibliography . 101
Index of defined terms . 103

Figure 201.101 – COT, general arrangement (example, schematic presentation only) . 12
Figure 201.102 – CRIB, general arrangement (example, schematic presentation only) . 12
Figure 201.103 – MEDICAL BED, general arrangement (example, schematic presentation
only) . 14
Figure 201.104 – HEAD DOWN TILT, Example . 15
Figure 201.105 – FOOT DOWN TILT, Example . 16
Figure 201.106 – Small finger probe ∅ 5,6 . 17
Figure 201.107 – Entrapment test TOOLS . 19
Figure 201.108 – Loading pad . 20
Figure 201.109 – Impactor . 21
Figure 201.110 – Side impactor TOOL . 22
Figure 201.111 – Graphic symbol for maximum PATIENT weight and SAFE WORKING LOAD . 23
IEC FDIS 80601-2-89 © IEC 2025
Figure 201.112 – Graphic symbol for mass; weight . 23
Figure 201.113 – Graphic symbol for machine washable MEDICAL BED . 23
Figure 201.114 – Graphic Symbol for jet stream washable MEDICAL BEDS . 24
Figure 201.115 – Graphic symbol for manual cleaning only . 24
Figure 201.116 – Description of allowed length of PATIENT . 25
Figure 201.117 – Example of marking for positioning PATIENT in MEDICAL BED . 26
Figure 201.118 – MEDICAL BED function controls and actuators: guidelines for creating
graphic symbols . 27
Figure 201.119 – Examples of marking on the MEDICAL BED of storage location for wired
and wireless PENDANT CONTROLS . 28
Figure 201.120 – Example of MEDICAL BED with segmented or split SIDE RAIL . 32
Figure 201.121 – Example of MEDICAL BED with single piece SIDE RAIL and PROTECTION
PANEL . 33
Figure 201.122 – Dimension of handle for LIFTING POLE . 38
Figure 201.123 – Allowable spacing for fingers in areas of normal reach around the
perimeter of the MATTRESS SUPPORT PLATFORM . 40
Figure 201.124 – Example using barriers for clearance measurement around the
perimeter of the MATTRESS SUPPORT PLATFORM to mitigate PATIENT-finger entrapment . 41
Figure 201.125 – Clearance areas . 42
Figure 201.126 – Required minimum radii of edges and corners . 43
Figure 201.127 – Retention of loop and mass . 44
Figure 201.128 – Lateral stability test along the side of the MEDICAL BED . 47
Figure 201.129 – Longitudinal stability test with removable FOOT BOARD . 47
Figure 201.130 – Longitudinal stability test with fixed HEAD BOARDS and FOOT BOARDS . 48
Figure 201.131 – Distribution of SAFE WORKING LOAD per maximum PATIENT weight for
tests . 52
Figure 201.132 – Position of loading pad and impactor (see Figure 201.108 for loading
pad and Figure 201.109 for impactor) . 55
Figure 201.133 – Impact to slats and solid elements of MEDICAL BEDS . 57
Figure 201.134 – Application of forces for test of SIDE RAIL. 59
Figure 201.135 – Height of PROTECTION PANELS, SIDE RAIL and PROTECTION PERIMETER . 62
Figure 201.136 – Direction of movement for rough handling test . 69
Figure 201.137 – Configurations of the MATTRESS SUPPORT PLATFORM . 70
Figure 201.138 – Small parts cylinder . 72
Figure AA.1 – Example of marking for compatible mattresses specified by the
MANUFACTURER . 76
Figure AA.2 – Example of marking for detachable SIDE RAILS specified by the
MANUFACTURER . 76
Figure AA.3 – Resultant forces without mattress . 79
Figure AA.4 – Resultant forces with mattress . 79
Figure AA.5 – 40 mm gap measurement of B . 79
Figure AA.6 – Angle measurement example of B . 79
Figure AA.7 – Placement of a measurement TOOL for the measurement of D . 80
X
Figure AA.8 – Example of area D measurement that passes . 81
X
Figure AA.9 – Example of area D measurement that fails (on limit) . 81
X
IEC FDIS 80601-2-89 © IEC 2025
Figure AA.10 – Example of area D measurement that fails . 81
X
Figure AA.11 – Example of potential PATIENT entrapment in area A within the SIDE RAIL . 82
Figure AA.12 – Example of potential PATIENT entrapment in area A below the SIDE RAIL . 82
Figure AA.13 – Example of potential PATIENT entrapment in area B . 82
Figure AA.14 – Example of potential PATIENT entrapment in area C between split
SIDE RAIL . 82
Figure AA.15 – Example of potential PATIENT entrapment in area C between SIDE RAIL
and HEAD BOARD . 82
Figure AA.16 – Example of potential PATIENT entrapment in area D . 82
Figure AA.17 – Example of potential PATIENT entrapment in area A below a single
piece SIDE RAIL . 83
Figure BB.1 – Schematic presentation of under MEDICAL BED clearance. 91
Figure BB.2 – Recommendations and requirements regarding angles for different
sections of the mattress support platform . 92
Figure CC.1 – Wedge TOOL . 94
Figure CC.2 – V-shaped opening in relation to B. 95
Figure CC.3 – Acceptance criteria in relation to area B . 95
Figure CC.4 – Positioning of wedge TOOL. 96
Figure CC.5 – Acceptance criteria in relation to area C between HEAD BOARD and FOOT
BOARD . 97
Figure CC.6 – Acceptance criteria in relation to area C between split SIDE RAILS . 98

Table 201.101 – Protection against PATIENT entrapment . 34
Table 201.102 – Minimum SAFE WORKING LOADS .
...