I.S. EN 60601-2-38:1998
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTRICALLY OPERATED HOSPITAL BEDS
Hardcopy , PDF
29-04-2010
English
01-01-1998
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.
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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Superseded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 |
| Standards | Relationship |
| EN 60601-2-38:1996/A1:2000 | Identical |
| UNE-EN 60601-2-38:1997 | Identical |
| BS EN 60601-2-38:1997 | Identical |
| DIN EN 60601-2-38 : 2001 | Identical |
| NF EN 60601-2-38 : 1999 AMD 1 2006 | Identical |
| IEC 60601-2-38:1996 | Identical |
| SN EN 60601-2-38 : 1996 AMD 1 2000 | Identical |
| 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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