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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 2-25: 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.
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
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