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IEC 60601-2-38:1996

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Medical electrical equipment - Part 2: Particular requirementsfor the safety of electrically operated hospital beds
Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Superseded date

12-10-2009

Published date

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

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 1970:2000/A1:2005 ADJUSTABLE BEDS FOR DISABLED PERSONS - REQUIREMENTS AND TEST METHODS
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
EN ISO 11073-10418:2014/AC:2016 Health informatics - Personal health device communication - Part 10418: Device specialization - International Normalized Ratio (INR) monitor - Technical Corrigendum 1 (ISO/IEEE 11073-10418:2014/Cor 1:2016)

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