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BS EN IEC 80601-2-89:2026 - TC Tracked Changes. Medical electrical equipment - Particular requirements for the basic safety and essential performance of medical beds for children, 2026
- A-30401756.pdf [Go to Page]
- undefined
- European foreword
- Endorsement notice
- Annex ZA (normative) Normative references to international publications with their corresponding European publications [Go to Page]
- CONTENTS
- FOREWORD
- INTRODUCTION
- 201.1 Scope, object and related standards
- 201.2 Normative references
- 201.3 Terms and definitions
- Figures [Go to Page]
- Figure 201.101 – COT, general arrangement (example, schematic presentation only)
- Figure 201.102 – CRIB, general arrangement (example, schematic presentation only)
- Figure 201.103 – medical bed, general arrangement (example, schematic presentation only)
- Figure 201.104 – head down tilt, Example
- 201.4 General requirements [Go to Page]
- Figure 201.105 – foot down tilt, Example
- 201.5 *General requirements for testing of me equipment [Go to Page]
- Figure 201.106 – Small finger probe ∅ 5,6
- Figure 201.107 – Entrapment test tools
- Figure 201.108 – Loading pad
- Figure 201.109 – Impactor
- 201.6 Classification of me equipment and me systems
- 201.7 me equipment identification, marking and documents [Go to Page]
- Figure 201.110 – Side impactor tool
- Figure 201.111 – Graphic symbol for maximum patient weight and safe working load
- Figure 201.112 – Graphic symbol for mass; weight
- Figure 201.113 – Graphic symbol for machine washable medical bed
- Figure 201.114 – Graphic Symbol for jet stream washable medical beds
- Figure 201.115 – Graphic symbol for manual cleaning only
- Figure 201.116 – Description of allowed length of patient
- Figure 201.117 – Example of marking for positioning patient in medical bed
- Figure 201.118 – medical bed function controls and actuators: guidelines for creating graphic symbols
- Figure 201.119 – Examples of marking on the medical bed of storage location for wired and wireless pendant controls
- 201.8 Protection against electrical hazards from me equipment
- 201.9 Protection against mechanical hazards of me equipment and me systems [Go to Page]
- Figure 201.120 – Example of medical bed with segmented or split side rail
- Figure 201.121 – Example of medical bed with single piece side rail and protection panel
- Tables [Go to Page]
- Table 201.101 – Protection against patient entrapment
- Figure 201.122 – Dimension of handle for lifting pole
- Figure 201.123 – Allowable spacing for fingers in areas of normal reach around the perimeter of the mattress support platform
- Figure 201.124 – Example using barriers for clearance measurement around the perimeter of the mattress support platform to mitigate patient-finger entrapment
- Figure 201.125 – Clearance areas
- Figure 201.126 – Required minimum radii of edges and corners
- Figure 201.127 – Retention of loop and mass
- Figure 201.128 – Lateral stability test along the side of the medical bed
- Figure 201.129 – Longitudinal stability test with removable foot board
- Figure 201.130 – Longitudinal stability test with fixed head boards and foot boards
- Table 201.102 – Minimum safe working loads
- Figure 201.131 – Distribution of safe working loadper maximum patient weight for tests
- Figure 201.132 – Position of loading pad and impactor (see Figure 201.108 for loading pad and Figure 201.109 for impactor)
- Figure 201.133 – Impact to slats and solid elements of medical beds
- Figure 201.134 – Application of forces for test of side rail
- Figure 201.135 – Height of protection panels, side rail and protection perimeter
- Table 201.103 – Protection against inadvertent patient falls and climbing out of medical bed
- 201.10 Protection against unwanted and excessive radiation hazards
- 201.11 Protection against excessive temperatures and other hazards [Go to Page]
- Table 201.104 – Allowable maximum temperatures for skin contact with medical bed applied parts
- Table 201.105 – Machine washable compliance PROCEDURE
- 201.12 Accuracy of controls and instruments and protection against hazardous outputs
- 201.13 hazardous situations and fault conditions for me equipment
- 201.14 Programmable electrical medical systems (PEMS)
- 201.15 Construction of me equipment [Go to Page]
- Figure 201.136 – Direction of movement for rough handling test
- Figure 201.137 – Configurations of the mattress support platform
- 201.16 me systems
- 201.17 Electromagnetic compatibility of me equipment and me systems [Go to Page]
- Figure 201.138 – Small parts cylinder
- Annexes
- Annex AA (informative) Particular guidance and rationale [Go to Page]
- Figure AA.1 – Example of marking for compatible mattresses specified by the manufacturer
- Figure AA.2 – Example of marking for detachable side rails specified by the manufacturer
- Table AA.1 – Protection against patient entrapment in non-moving parts
- Figure AA.3 –Resultant forces without mattress
- Figure AA.4 –Resultant forces with mattress
- Figure AA.5 –40 mm gap measurement of B
- Figure AA.6 –Angle measurement example of B
- Figure AA.7 – Placement of a measurement tool for the measurement of DX
- Figure AA.8 – Example of area DX measurement that passes
- Figure AA.9 – Example of area DX measurement that fails (on limit)
- Figure AA.10 – Example of area DX measurement that fails
- Figure AA.11 – Example of potential patient entrapment in area A within the side rail
- Figure AA.12 – Example of potential patient entrapment in area A below the side rail
- Figure AA.13 – Example of potential patient entrapment in area B
- Figure AA.14 – Example of potential patient entrapment in area C between segmented or split side rail
- Figure AA.15 – Example of potential patient entrapment in area C between side rail and head board
- Figure AA.16 – Example of potential patient entrapment in area D
- Figure AA.17 – Example of potential patient entrapment in area A below a single piece side rail
- Table AA.2 – Height of protective barriers according to age
- Annex BB (normative) Additional design requirements and recommendations for medical beds [Go to Page]
- Figure BB.1 – Schematic presentation of under medical bed clearance
- Figure BB.2 – Angles for different sections of the mattress support platform
- Annex CC (informative) Particular guidance for assessing risk of entrapment in V-shaped openings [Go to Page]
- Figure CC.1 – Wedge tool
- Figure CC.2 – V-shaped opening in relation to B
- Figure CC.3 – Acceptance criteria in relation to area B
- Figure CC.4 – Positioning of wedge tool
- Figure CC.5 – Acceptance criteria in relation to area C between head board and foot board
- Figure CC.6 – Acceptance criteria in relation to area C between segmented or split side rails
- Annex DD (informative) Guidance and recommendations for periodic inspection
- Bibliography
- Index of defined terms [Go to Page]