IEC 60601-2-52:2009/Amd 1:2015

Medical electrical equipment — Part 2-52: Particular requirements for the basic safety and essential performance of medical beds — Amendment 1

Appareils électromédicaux — Partie 2-52: Exigences particulières de sécurité de base et de performances essentielles des lits médicaux — Amendement 1

General Information

• Status: Published
• Publication Date: 23-Mar-2015
• ICS: 11.140 - Hospital equipment
• Technical Committee: ISO/TC 173 - Assistive products
• Drafting Committee: ISO/TC 173 - Assistive products
• Current Stage: 6060 - International Standard published
• Due Date: 23-Mar-2017
• Completion Date: 24-Mar-2015

Relations

• Amends: IEC 60601-2-52:2009 - Medical electrical equipment — Part 2-52: Particular requirements for the basic safety and essential performance of medical beds
• Effective Date: 07-Aug-2021

Standards Content (Sample)

IEC 60601-2-52
Edition 1.0 2015-03
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 1
AM ENDEMENT 1

Medical electrical equipment –
Part 2-52: Particular requirements for the basic safety and essential performance
of medical beds

Appareils électromédicaux –
Partie 2-52: Exigences particulières de sécurité de base et de performances
essentielles des lits médicaux

IEC 60601-2-52:2009-12/AMD1:2015-03(en-fr)

---------------------- Page: 1 ----------------------
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IEC 60601-2-52


Edition 1.0 2015-03




INTERNATIONAL



STANDARD




NORME



INTERNATIONALE




A MENDMENT 1

AM ENDEMENT 1





Medical electrical equipment –

Part 2-52: Particular requirements for the basic safety and essential performance

of medical beds




Appareils électromédicaux –

Partie 2-52: Exigences particulières de sécurité de base et de performances


essentielles des lits médicaux













INTERNATIONAL

ELECTROTECHNICAL

COMMISSION


COMMISSION

ELECTROTECHNIQUE


INTERNATIONALE




ICS 11.140 ISBN 978-2-8322-2390-1



Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

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– 2 – IEC 60601-2-52:2009/AMD1:2015
© IEC 2015
FOREWORD
This amendment has been prepared by subcommittee 62D: Electromedical equipment, of IEC
technical committee 62: Electrical equipment in medical practice.
The text of this amendment is based on the following documents:
FDIS Report on voting
62D/1186/FDIS 62D/1232/RVD

Full information on the voting for the approval of this amendment can be found in the report
on voting indicated in the above table.
The committee has decided that the contents of this amendment and the base publication will
remain unchanged until the stability date indicated on the IEC web site under
"http://webstore.iec.ch" in the data related to the specific publication. At this date, the
publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
_____________

201.1.1 * Scope
Replace the existing text of the first paragraph with the following:
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
MEDICAL BEDS as defined in 201.3.212, intended for ADULTS as defined in 201.3.219.
201.1.2 Object
Replace the existing text of the replacement with the following:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for MEDICAL BEDS as defined in 201.3.212 intended for ADULTS as
defined in 201.3.219.
201.3 Terms and definitions
Add the following new term and definition:
201.3.219
* ADULT
PATIENT having a physical size equal to or more than 146 cm, a mass equal to or more than
40 kg and a body mass index (BMI) equal to or more than 17

201.4 General requirements
Replace the existing text of the clause by the following:

---------------------- Page: 4 ----------------------
IEC 60601-2-52:2009/AMD1:2015 – 3 –
© IEC 2015
Clause 4 of the general standard applies, except as follows:
201.4.2.2 * General requirement for RISK MANAGEMENT
Addition:
The MANUFACTURER shall include, in the RISK MANAGEMENT PROCESS, HAZARDS related to
PATIENTS taller than 185 cm.
Compliance is checked by inspection of the RISK MANAGEMENT FILE.

Figure 201.103 – Entrapment test tools
Replace the existing figure by the following new figure:
Dimensions in millimetres
0
Ø120 -0,5
228 ±1
115 ±1
2
2
4
1
3
IEC

Key
1 Total weight 5,1 kg ±0,05 kg
2 Marked centre line
3 Surface roughness 1,6
4 Drilling hole for weight adjustment
Figure 201.103a) – Cone tool schematic
0
Ø60 -0,5

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– 4 – IEC 60601-2-52:2009/AMD1:2015
© IEC 2015
Dimensions in millimetres
+1
318 0
2
4
1 3
IEC

Key
1 Total weight 3,34 kg ±0,05 kg
2 Marked centre line
3 Surface roughness 1,6
4 Drilling hole for weight adjustment
Figure 201.103b) – Cylinder tool schematic
Figure 201.103 – Entrapment test tools
201.7 ME EQUIPMENT identification, marking and documents
201.7.2.2 Identification
Add, after 201.7.2.2.106, the following new subclause:
201.7.2.2.107 Marking on the MEDICAL BED for ADULTS
The MEDICAL BEDS shall be marked on a prominent place with the symbol indicated in Figure
201.106.
IEC

Figure 201.120 – Physical description of an ADULT
0
Ø60 -0,5
Ø43,9 ±0,2

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IEC 60601-2-52:2009/AMD1:2015 – 5 –
© IEC 2015
201.7.9.2 Instructions for use
201.7.9.2.1 General
Add the following new item:
e) a description of the intended PATIENT group(s).

201.7.9.2.2 Warning and safety notices
Add the following new items:
e) The instructions for use shall provide a warning if a MEDICAL BED is limited to a specific
group of PATIENTS.
f) The instructions for use shall provide a warning that incompatible SIDE RAILS and
mattresses can cause an entrapment hazard

201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS
Figure 201.107 – Example of MEDICAL BED with segmented or split SIDE RAIL
Replace the existing figure with the following:
IEC

Only applies when the area C above is < 60 mm.
A represents the different areas A , A , A , A , A and A
x
1 2 3 4 5 6
Key
1 Area of TOOL representing neck diameter (60 mm).
2 Area of TOOL representing chest breadth (318 mm).
3 Area of TOOL representing head breadth (120 mm).

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– 6 – IEC 60601-2-52:2009/AMD1:2015
© IEC 2015
4 MATTRESS SUPPORT PLATFORM
5 HEAD BOARD
6 FOOT BOARD
7 Mattress
8 SIDE RAIL
Figure 201.107 – Example of MEDICAL B
...