I.S. EN 60601-2-25:1995&A1:1999
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 2-25: Particular requirements for the safety of electrocardiographs
Hardcopy , PDF
12-02-2022
English
19-02-2015
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.
Dates of withdrawal of national standards are available from NSAI.
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FOREWORD
INTRODUCTION
SECTION ONE: GENERAL
Clause
1 Scope and object
2 Terminology and definitions
4 General requirements for tests
5 Classification
6 Identification, marking and documents
SECTION TWO: ENVIRONMENTAL CONDITIONS
10 Environmental conditions
SECTION THREE: PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
17 Separation
19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS
20 Dielectric strength
SECTION FOUR: PROTECTION AGAINST MECHANICAL HAZARDS
SECTION FIVE: PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
34 Ultraviolet radiation
SECTION SIX: PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES
SECTION SEVEN: PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS
42 Excessive temperatures
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection
SECTION EIGHT: ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT
51Protection against hazardous output
SECTION NINE: ABNORMAL OPERATION AND FAULT CONDITIONS;ENVIRONMENTAL TESTS
SECTION TEN: CONSTRUCTIONAL REQUIREMENTS
56Components and general assembly
57MAINS PARTS, components and layout
APPENDIX D Symbols on marking (Symbols to indicate protection against the effects of the discharge of a cardiac defibrillator)
Annexe AAGeneral guidance and rationale
This Particular International Standard specifies the particular safety requirements for ELECTROCARDIOGRAPHS as defined in 2.102, intended for the production of detachable ELECTROCARDIOGRAMS for diagnostic purposes
| Committee |
SC 62D
|
| DocumentType |
Standard
|
| ISBN |
2-8318-4753-2
|
| Pages |
88
|
| ProductNote |
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| IEC 60601-2-25:1993/AMD1:1999 | Identical |
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