ДСТУ EN 60601-2-46:2019 Изделия медицинские электрические. Часть 2-46. Дополнительные требования по безопасности и основным рабочим характеристикам операционных столов (EN 60601-2-46:1998, IDT; IEC 60601-2-46...

ДСТУ EN 60601-2-46:2019
(EN 60601-2-46:1998, IDT; ІЕС 60601-2-46:1998, IDT)

Вироби медичні електричні.
Частина 2-46. Додаткові вимоги щодо безпеки
та основних робочих характеристик операційних столів

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

Contents

Foreword

Introduction

Section 1. General

1 Scope and object

2 Terminology and definitions

4 General requirements for tests

5 Classification

6 Identification, marking and documents

Section 2. Environmental conditions

Section 3. Protection against electric shock hazards

17 Separation

18 Protective earthing, functional earthing and potential equalization

19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS

20 Dielectric strength

Section 4. Protection against mechanical hazards

21 Mechanical strength

22 Moving parts

24 Stability in NORMAL USE

Section 5. Protection against hazards from unwanted or excessive radiation

29 X-Radiation

36 Electromagnetic compatibility

Section 6. Protection against hazards of ignition of flammable anaesthetic mixtures

39 Common requirements for CATEGORY AP and CATEGORY APG EQUIPMENT

Section 7. Protection against excessive temperatures and other safety hazards

44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection

49 Interruption of the power supply

Section 8. Accuracy of operating data and protection against hazardous output

50 Accuracy of operating data

Section 9. Abnormal operation and fault conditions; environmental tests Section

10. Constructional requirements

56 Components and general assembly

Appendix L References — Publications mentioned in this standard

Annex AA (informative) General guidance and rationale to clause

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

European publications