SIST EN 60601-2-38:1998/A1:2002
(Amendment)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)
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)
EN following parallel vote
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)
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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 60601-2-38:1998/A1:2002
01-februar-2002
0HGLFLQVNDHOHNWULþQDRSUHPDGHO 3RVHEQHYDUQRVWQH]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.
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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: +41 22 919 0300 e-mail: inmail@iec.ch IEC web site http://www.iec.ch
Commission Electrotechnique Internationale
PRICE CODE
P
International Electrotechnical Commission
For price, see current catalogue
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– 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.
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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
of the BED.
– The instructions for use shall provide a warning that the BED should be left in its lowest
position when unattended in order to reduce the risk of injury due to falls whilst getting into
BED BED
or out of the , or whilst lying on the .
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– 4 – 60601-2-38 Amend. 1 © IEC:1999(E)
– When the requirements of dimensions D and/or E of figure 114 of this Particular Standard
are met only when the MATTRESS SUPPORT PLATFORM is in the flat position, the instructions
for use shall include a warning that, when a PATIENT’s condition (such as disorientation due
to medication or clinical condition) could lead to PATIENT ENTRAPMENT, the MATTRESS
SUPPORT PLATFORM should be left in the flat position whilst unattended (except when
required otherwise by medical staff for special or particular circumstances).
– The instructions for use for ACCESSORIES shall list the BED type or model with which the
ACCESSORIES may be used (except when required otherwise by medical staff for special or
particular circumstances).
Page 19
18 Protective earthing, functional earthing and potential equalization
*e) Addition:
Replace the first dashed item by the following:
– The ACCESSIBLE METAL PARTS of APPLIED PARTS with conductive connections to parts which
might become LIVE and which are intended for use together with MEDICAL ELECTRICAL
EQUIPMENT connected intravascularly or intracardially to the PATIENT shall be provided with
a means for potential equalization connection.
21 Mechanical strength
21. 3 Replace the text of this subclause of the General Standard by the following:
*21.3 BED parts used for the support and/or immobilisation of the PATIENT or for the support of
masses which could be hazardous to the PATIENT shall be designed and manufactured so as to
minimise the risk of physical injuries and of accidental loosening of fixings. Fixings for
ACCESSORIES shall be so designed that the risk of incorrect attachment which could create a
SAFETY HAZARD is minimised.
Add, after 21.3.101, the following new subclause:
*21.3.102 The SAFE WORKING LOAD of a LIFTING POLE shall be at least 750 N.
Add the following new subclause:
21.4 Replace the text of this subclause of the General Standard by the following:
SIDE RAILS shall be equipped with a means to lock or latch them into the raised/closed position.
The operation of the lock or latch mechanism shall be so designed that accidental unlocking or
unlatching cannot occur in NORMAL USE and that SIDE RAILS will not remain raised/closed when
they are not locked/latched.
*21.6.102 Threshold test
Replace, on page 21, the text of the third paragraph of this subclause by the following:
The BED, with the SIDE RAILS in the closed/raised and locked/latched position, with all other
ACCESSORIES NORMAL USE SAFE WORKING
intended for during transport attached and with the
LOAD in place, shall be moved ten times in the forward direction as in NORMAL USE. All castors
shall impact a solid vertical plane obstruction which is fixed flat on the floor, with a rectangular
cross-section, 20 mm high and 80 mm deep, at a speed of 0,4 m/s ± 0,1 m/s, without loss of
function, and without unlocking/unlatching of the SIDE RAILS.
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60601-2-38 Amend. 1 © IEC:1999(E) – 5 –
Page 21
22 Moving parts
Replace the text of this subclause by the following:
22.2.101
22.2.101 Exposed SQUEEZING and SHEARING POINTS which could constitute a SAFETY HAZARD
are permissible for moveable parts below the MATTRESS SUPPORT PLATFORM if their distance
from the outermost rigid edge of the MATTRESS SUPPORT PLATFORM (towards the inside) is
200 mm or greater. The 200 mm distance shall be measured around any barrier which
separates the PATIENT from a SAFETY HAZARD. (See figures 109 and 110.)
Parts moved vertically which could create a SAFETY HAZARD shall maintain perpendicular
clearances to the floor of at least 120 mm unless their distance from the outermost rigid edge
of the MATTRESS SUPPORT PLATFORM (towards the inside) is 120 mm or greater.
Add, after clause 22, the following text:
23 Surfaces, corners and edges
This clause of the General Standard applies except as follows:
Addition:
*23.101 Protection against PATIENT ENTRAPMENT
Openings within the perimeter of SIDE RAILS, and between SIDE RAILS and parts of the BED, shall
meet the dimensional requirements of figure 114 where a risk of PATIENT ENTRAPMENT exists.
Compliance is checked by the following test:
After completion of the tests required in 28.4.103, the dimensional requirements of items A and
F of figure 114 are checked by inserting the test cone shown in figure 115, with a force of 50 N,
at the points indicated in figure 114, without allowing the cone to pass through the opening.
SIDE RAILS
The tests are performed with the in the raised/closed position, and with the worst
case NORMAL USE configuration and positions of ACCESSORIES.
A risk assessment shall also be performed (in accordance with ISO 14971-1) to evaluate the
SIDE RAILS with regard to entrapment and all other safety issues. When SIDE RAILS cover less
than the full length of the MATTRESS SUPPORT PLATFORM, they shall be positioned toward the
head end.
24 Stability in NORMAL USE
24.3 Addition:
Add the following new item:
*bb) The BED shall not become unstable when the LIFTING POLE is loaded as in NORMAL USE.
Compliance is checked by the following test:
Without the SAFE WORKING LOAD of the BED in place, the LIFTING POLE in its worst case position
of NORMAL USE shall be loaded with its SAFE WORKING LOAD. The BED and LIFTING POLE shall not
overbalance.
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– 6 – 60601-2-38 Amend. 1 © IEC:1999(E)
Page 23
28 Suspended masses
Add the following three new subclauses:
*28.4.101 ACCESSORIES, and their attachment points and fixings shall be designed with the
SAFETY FACTORS
following :
– two times the SAFE WORKING LOAD for all ACCESSORIES.
Compliance is checked by the following test:
With the ACCESSORY in its worst case NORMAL USE position, attach a static load equal to two
times its SAFE WORKING LOAD for 1 h. There shall be no SAFETY HAZARD or loss of function.
For LIFTING POLES, a sudden movement of the POLE or its handle shall be considered a SAFETY
HAZARD.
28.4.102 SIDE RAIL latches/locks shall remain secure when subjected to the forces of
NORMAL USE.
Compliance is checked by the following test:
A force (as specified in figure 113) shall be applied to the worst case position for locking/
latching of the SIDE RAIL in the direction of unlatching/unlocking, without the SIDE RAIL becoming
unlatched/unlocked or creating any other SAFETY HAZARD.
28.4.103 SIDE RAILS shall be designed to withstand the forces applied during NORMAL USE
without creating a SAFETY HAZARD.
Compliance is checked by the following test:
Static forces are applied for a duration of 30 s, 10 times in each indicated direction and at the
SIDE RAIL
worst case point, to each while it is in its raised/closed position, as shown in
figure 113. The dimensional requirements of 23.101 shall be tested after the load is removed,
SIDE RAILS
and the shall not unlatch/unlock during the test.
36 Electromagnetic compatibility
Replace the text of this clause by the following:
The Collateral Standard IEC 60601-1-2 applies except as follows:
36.202 Immunity
Replace the text of the fourth paragraph by the following:
Failure conditions for all immunity tests for BEDS shall be the failure to comply with any
requirement established in this Collateral Standard, or the creation of any hazard.
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60601-2-38 Amend. 1 © IEC:1999(E) – 7 –
Page 27
52 Abnormal operation and fault conditions
Add, after 52.5.102, the following new subclause:
*52.5.103 Failure of PROGRAMMABLE SYSTEMS or subsystems which control the motion of the
BED and which could cause an unintended movement of the BED or result in the creation of any
hazard identified in this standard.
Compliance is checked by the following test:
The requirements of IEC 60601-1-4 shall be applied to the relevant (as described above)
PROGRAMMABLE SYSTEMS
.
Page 49
Add the following new figures:
A
D
E
C
F
B
IEC 1767/99
A: 500 N
B: 750 N
C: 500 N
D: 500 N
E: 500 N
F: 500 N
Figure 113 – Application of forces for test of SIDE RAILS
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– 8 – 60601-2-38 Amend. 1 © IEC:1999(E)
D
D E
G
x G
x+1
C
A
A F
B
IEC 1768/99
Example (only) of a BED with segmented SIDE RAILS
G D
D
A
C
F
A
B
IEC 1769/99
Example (only) of a BED with sing
...
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