EN 60601-2-38:1996/A1:2000

Medical electrical equipment - Part 2-38: Particular requirements for the safety of electrically operated hospital beds

EN following parallel vote * Superseded by EN 60601-2-52:2010

Medizinische elektrische Geräte - Teil 2-38: Besondere Festlegungen für die Sicherheit von elektrisch betriebenen Krankenhausbetten

Appareils électromédicaux - Partie 2-38: Règles particulières de sécurité des lits d'hôpital électriques

Medicinska električna oprema - 2-38. del: Posebne varnostne zahteve za električno nastavljive bolnišnične postelje - Dopolnilo A1 (IEC 60601-2-38:1996/A1:1999)

General Information

• Status: Withdrawn
• Publication Date: 19-Mar-2000
• Withdrawal Date: 31-Dec-2002
• ICS: 11.140 - Hospital equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62D - IEC_SC_62D
• Parallel Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 01-Apr-2013
• Completion Date: 01-Apr-2013
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Mandate: M/432 - Standardisation Mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC amending Directive 90/385/EEC and Directive 93/42/EEC relating to Medical Devices
• Ref Project: SIST EN 60601-2-38:1998/A1:2002 - Medical electrical equipment - Part 2-38: Particular requirements for the safety of electrically operated hospital beds - Amendment A1 (IEC 60601-2-38:1996/A1:1999)

Relations

• Replaced By: EN 60601-2-52:2010 - Medical electrical equipment - Part 2-52: Particular requirements for basic safety and essential performance of medical beds (IEC 60601-2-52:2009)
• Effective Date: 28-Jan-2023
• Amends: EN 60601-2-38:1996 - Medical electrical equipment - Part 2-38: Particular requirements for the safety of electrically operated hospital beds
• Effective Date: 29-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-38:1998/A1:2002
01-februar-2002
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQHYDUQRVWQH]DKWHYH]DHOHNWULþQR
QDVWDYOMLYHEROQLãQLþQHSRVWHOMH'RSROQLOR$,(&$
Medical electrical equipment - Part 2-38: Particular requirements for the safety of
electrically operated hospital beds - Amendment A1 (IEC 60601-2-38:1996/A1:1999)
Medizinische elektrische Geräte - Teil 2-38: Besondere Festlegungen für die Sicherheit
von elektrisch betriebenen Krankenhausbetten (IEC 60601-2-38:1996/A1:1999)
Appareils électromédicaux - Partie 2-38: Règles particulières de sécurité des lits d'hôpital
électriques (CEI 60601-2-38:1996/A1:1999)
Ta slovenski standard je istoveten z: EN 60601-2-38:1996/A1:2000
ICS:
11.140 Oprema bolnišnic Hospital equipment
SIST EN 60601-2-38:1998/A1:2002 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

INTERNATIONAL IEC
STANDARD
60601-2-38
1996
AMENDMENT 1
1999-12
Amendment 1
Medical electrical equipment –
Part 2-38:
Particular requirements for the safety
of electrically operated hospital beds
Amendement 1
Appareils électromédicaux –
Partie 2-38:
Règles particulières de sécurité
des lits d'hôpital électriques
 IEC 1999  Copyright - all rights reserved
International Electrotechnical Commission 3, rue de Varembé Geneva, Switzerland
Telefax: [phone] e-mail: [e-mail] IEC web site http://www.iec.ch
Commission Electrotechnique Internationale
PRICE CODE
P
International Electrotechnical Commission
For price, see current catalogue

---------------------- Page: 2 ----------------------

– 2 – 60601-2-38 Amend. 1 © IEC:1999(E)
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 standard is based on the following documents:
FDIS Report on voting
62D/336/FDIS 62D/346/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.
__________
Page 3
CONTENTS
Add the title of clause 23, as follows:
23  Surface, corners and edges
Add, on page 5, the titles of the new figures:
Figure 113 – Application of forces for test of SIDE RAILS
Figure 114 – Examples (only) of BEDS with segmented SIDE RAILS and single-piece SIDE RAILS
Figure 115 – Test cone
Page 13
2.1.109 SQUEEZING and SHEARING POINTS
Modify the title of the defined term to read:
SQUEEZING and SHEARING POINTS (FOR FINGERS)
Add, after 2.1.109, the following new definition:
*2.1.110 PATIENT ENTRAPMENT
The ability for a PATIENT to insert his/her head, neck or chest cavity into a permanent opening
in the BED and/or its ACCESSORIES or into a temporary opening created during NORMAL USE,
from which the PATIENT cannot remove that portion of his/her anatomy.
*2.2.101 ELECTRICALLY OPERATED HOSPITAL BED (hereinafter referred to as BED)
Replace the text of the definition by the following text and note:
BED and its accessories intended for use in the diagnosis, treatment or monitoring of an adult
PATIENT whilst under medical supervision.
NOTE For an explanation of the basis for the definition of “adult”, see Rationale in annex AA.

---------------------- Page: 3 ----------------------

60601-2-38 Amend. 1 © IEC:1999(E) – 3 –
Add, after 2.2.101, the following new definition:
*2.2.102 LIFTING POLE
Device suspended above the BED and intended to allow the PATIENT to change position by
gripping it.
3 General requirements
3.101
Add, on page 15, the following new text at the end of this subclause:
Compliance with this requirement is checked by the following test:
If alternative means of construction have been employed or if a requirement of this Particular
Standard has not been met, in order to provide benefit to the PATIENT, a risk assessment shall
be performed (in accordance with ISO 14971-1) to demonstrate that the overall level of safety
has not been compromised.
Page 15
6.1 Marking on the outside of EQUIPMENT or EQUIPMENT PARTS
*u) Mechanical stability
Replace the text of this item by the following:
The BED and its ACCESSORIES (intended to support and/or immobilise masses) shall be marked
with their own SAFE WORKING LOAD. (See figure 108.)
Page 17
6.8.2 Instructions for use
a) General information
Replace the second dashed item by the following:
– The instructions for use shall indicate the SAFE WORKING LOAD of the BED and its ACCESSORIES
intended to support masses and which can be removed during NORMAL USE.
Add the following new dashed items:
BED ACCESSORIES
– The instructions for use for the shall include a list of all which may be
attached to or used with the BED.
– The instructions for use shall indicate any restriction with regard to the characteristics of the
PATIENT (such as clinical condition, weight or size, etc.) necessary to insure safe operation
...