IEC 60601-2-38:1996
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Medical electrical equipment - Part 2: Particular requirementsfor the safety of electrically operated hospital beds
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
12-10-2009
10-30-1996
Committees responsible
National foreword
Foreword
Section 1 - General
1 Scope and object
2 Terminology and definitions
3 General requirements
5 Classification
6 Identification, marking and documents
Section 2 - Environmental conditions
Section 3 - Protection against electrical shock hazards
17 Separation
18 Protective earthing, functional earthing and potential
equalization
Section 4 - Protection against mechanical hazards
21 Mechanical strength
22 Moving parts
23 Surface, corners and edges
24 Stability in normal use
26 Vibration and noise
28 Suspended masses
Section 5 - Protection against hazards from unwanted or
excessive radiation
36 Electromagnetic compatibility
Section 6 - Protection against hazards of ignition of
flammable anaesthetic mixtures
Section 7 - Protection against excessive temperatures and
other safety hazards
44 Overflow, spillage, leakage, humidity, ingress of
liquids, cleaning, sterilization and disinfection
Section 8 - Accuracy of operating data and protection against
hazardous output
Section 9 - Abnormal operation and fault conditions;
environmental tests
52 Abnormal operation and fault conditions
Section 10 - Constructional requirements
54 General
56 Components and general assembly
57 MAINS PARTS, components and layout
Appendix L - References - Publications mentioned in this
standard
Annex AA (informative) Guidance and rationale for particular
subclauses
Annex BB (informative) Possible considerations and tests for
ELECTRICALLY OPERATED HOSPITAL BEDS
Annex ZA (normative) Normative references to international
publications with their corresponding
European publications
Figure 101 - ELECTRICALLY OPERATED HOSPITAL BED, general
arrangement
Figure 102 - Distribution of the SAFE WORKING LOAD for tests
Figure 103 - Lateral stability test: load arrangement (plan
view)
Figure 104 - Longitudinal stability test: load arrangement
(plan view)
Figure 105 - Lateral stability test: load arrangement (end
elevation)
Figure 106 - Longitudinal stability test: load arrangement
(side elevation)
Figure 107 - BED function controls and/or actuators;
guidelines for creating graphic symbols
Figure 108 - Graphic symbols for SAFE WORKING LOAD
Figure 109 - Typical spacings for SQUEEZING and SHEARING
POINTS
Figure 110 - Clearance measurements around barriers
Figure 111 - APPLIED PARTS region and potential equalization
Figure 112 - Minimum angle between the back and leg/upper
leg sections for various configurations of the
MATTRESS SUPPORT PLATFORM
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
Figure BB.1 - Impactor
Figure BB.2 - Loading positions
Figure BB.3 - Loading pad
Figure BB.4 - Recommended range of adjustment for sections of
the MATTRESS SUPPORT PLATFORM
Figure BB.5 - Position of the LIFTING POLE handle
Specifies requirements for safety of electrically operated hospitalbeds. The object of this standard is to keep the safety hazards topatients, operators and the environment as low as possible, and todescribe tests to verify that these requirements are attained.
DevelopmentNote |
Also numbered as BS EN 60601-2.38 & BS 5724-2.38(1997) (10/2003)
|
DocumentType |
Standard
|
Pages |
84
|
PublisherName |
International Electrotechnical Committee
|
Status |
Superseded
|
SupersededBy |
Standards | Relationship |
NEN EN IEC 60601-2-38 : 1997 AMD 1 2000 | Identical |
NEN 10601-2-38 : 1997 | Identical |
I.S. EN 60601-2-38:1998 | Identical |
PN EN 60601-2-38 : 2003 | Identical |
SN EN 60601-2-38 : 1996 AMD 1 2000 | Identical |
AS/NZS 3200.2.38:2007 | Identical |
VDE 0750-2-38 : 2001 | Identical |
UNE-EN 60601-2-38:1997 | Identical |
EN 60601-2-38:1996/A1:2000 | Identical |
DIN EN 60601-2-38 : 2001 | Identical |
NF EN 60601-2-38 : 1999 AMD 1 2006 | Identical |
AS/NZS 3200.2.38:1997 | Identical |
CSA C22.2 No. 60601.2.38 : 2003 | Identical |
AAMI HE75 : 2009(R2013) | HUMAN FACTORS ENGINEERING - DESIGN OF MEDICAL DEVICES |
I.S. EN 61219:1994 | LIVE WORKING - EARTHING OR EARTHING AND SHORT-CIRCUITING EQUIPMENT USING LANCES AS A SHORT-CIRCUITING DEVICE - LANCE EARTHING |
EN 60601-2-52:2010/A1:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-52: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MEDICAL BEDS |
EN 61219:1993 | Live working - Earthing or earthing and short-circuiting equipment using lances as short-circuiting device - Lance earthing |
IEC TR 60788:2004 | Medical electrical equipment - Glossary of defined terms |
ISO/IEEE 11073-10418:2014 | Health informatics — Personal health device communication — Part 10418: Device specialization — International Normalized Ratio (INR) monitor |
DIN EN 1970:2005-10 | ADJUSTABLE BEDS FOR DISABLED PERSONS - REQUIREMENTS AND TEST METHODS |
BS EN ISO 11073-10406:2012 | Health informatics. Personal health device communication Device specialization. Basic electrocardiograph (ECG) (1- to 3-lead ECG) |
BS EN ISO 11073-10418:2014 | Health informatics. Personal health device communication Device specialization. International Normalized Ratio (INR) monitor |
BS EN 60601-2-52 : 2010 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-52: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MEDICAL BEDS |
I.S. EN ISO 11073-10418:2014 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10418: DEVICE SPECIALIZATION: INTERNATIONAL NORMALIZED RATIO (INR) MONITOR (ISO/IEEE 11073-10418:2014, CORRECTED VERSION 2014-05-01) |
EN 60601-2-52:2010/A1:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-52: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MEDICAL BEDS |
PD IEC TR 60788:2004 | Medical electrical equipment. Glossary of defined terms |
I.S. EN ISO 11073-10406:2012 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10406: DEVICE SPECIALIZATION - BASIC ELECTROCARDIOGRAPH (ECG) (1- TO 3-LEAD ECG) (ISO/IEEE 11073-10406:2012) |
I.S. EN 60601-2-52:2010 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-52: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MEDICAL BEDS (IEC 60601-2-52:2009) |
ISO/IEEE 11073-10406:2012 | Health informatics — Personal health device communication — Part 10406: Device specialization — Basic electrocardiograph (ECG) (1- to 3-lead ECG) |
BS EN 1970:2000 | Adjustable beds for disabled persons. Requirements and test methods |
EN ISO 11073-10406:2012 | Health informatics - Personal health device communication - Part 10406: Device specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG) (ISO/IEEE 11073-10406:2012) |
UNI EN ISO 11073-10406 : 2013 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10406: DEVICE SPECIALIZATION - BASIC ELECTROCARDIOGRAPH (ECG) (1- TO 3-LEAD ECG) |
AAMI HE75 : 2009 | HUMAN FACTORS ENGINEERING - DESIGN OF MEDICAL DEVICES |
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