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I.S. EN 60601-2-38:1998

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 REQUIREMENTS FOR THE SAFETY OF ELECTRICALLY OPERATED HOSPITAL BEDS
Available format(s)

Hardcopy , PDF

Superseded date

04-29-2010

Language(s)

English

Published date

01-01-1998

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

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
Annexes
L References - Publications mentioned in this standard
AA (informative) Guidance and rationale for particular
                 subclauses
BB (informative) Possible considerations and tests for
                 ELECTRICALLY OPERATED HOSPITAL BEDS
Annex ZA (normative) Normative references to international
                     publications with their corresponding
                     European publications

Gives requirements for safety of ELECTRICALLY OPERATED HOSPITAL beds.

DocumentType
Standard
Pages
92
PublisherName
National Standards Authority of Ireland
Status
Superseded
SupersededBy

ISO 2204:1979 Acoustics Guide to International Standards on the measurement of airborne acoustical noise and evaluation of its effects on human beings
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
EN 60601-1-1:2001 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
EN 60601-1-2:2015 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60529:1989+AMD1:1999+AMD2:2013 CSV Degrees of protection provided by enclosures (IP Code)
ISO 14971-1:1998 Medical devices Risk management Part 1: Application of risk analysis
EN 60601-1-4:1996/A1:1999 MEDICAL ELECTRICAL EQUIPMENT - GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS
EN 60529:1991/AC:2016-12 DEGREES OF PROTECTION PROVIDED BY ENCLOSURES (IP CODE) (IEC 60529 EDITION 2.2 CORRIGENDUM 2:2015)
IEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
IEC 60601-1-4:1996+AMD1:1999 CSV Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems

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