ДСТУ EN 60601-2-4:2019 Вироби медичні електричні. Частина 2-4. Додаткові вимоги щодо безпеки та основних робочих характеристик серцевих дефібриляторів (EN 60601-2-4:2003, IDT; IEC 60601-2-4:2002, IDT)

ДСТУ EN 60601-2-4:2019
(EN 60601-2-4:2003, IDT; IEC 60601-2-4:2002, IDT)

Вироби медичні електричні. Частина 2-4. Додаткові вимоги щодо безпеки
та основних робочих характеристик серцевих дефібриляторів

 
   
 
Не є офіційним виданням.
Офіційне видання розповсюджує національний орган стандартизації
(ДП «УкрНДНЦ» http://uas.gov.ua)

Contents

Introduction

SECTION ONE - GENERAL

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

14 Requirements related to classification

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

36 Electromagnetic compatibility (EMC)

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, disinfection and compatibility

46 Human errors

SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION AGAINST
HAZARDOUS OUTPUT

50 Accuracy of operating data

51 Protection against hazardous output

SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS;
ENVIRONMENTAL TESTS

52 Abnormal operation and fault conditions

SECTION TEN - CONSTRUCTIONAL REQUIREMENTS

56 Components and general assembly

57 Mains parts, components and layout

SECTION 101 - ADDITIONAL REQUIREMENTS RELATING TO SAFETY

101 Charging time

102 Internal electrical power source

103 Endurance

104 Synchronizer

105 Recovery of the monitor/ECG input after defibrillation

106 Disturbance to the monitor from charging or internal discharging

Appendix L References - Publications mentioned in this Standard

Annex AA (informative) General guidance and rationale

Annex BB (informative) Automated external defibrillators: background and rationale

Annex ZA (normative) Normative references to international publications with their corresponding European publications

Annex ZB (informative) Other international publications mentioned in this standard with the reference of the European publications