ДСТУ EN 60601-2-47:2017 Изделия медицинские электрические. Часть 2-47. Дополнительные требования безопасности, включая требования к основным характеристикам, амбулаторных электрокардиографических систем (EN 6...

ДСТУ EN 60601-2-47:2017
(EN 60601-2-47:2001, IDT; IEC 60601-2-47:2001, IDT)

Вироби медичні електричні.
Частина 2-47. Додаткові вимоги щодо безпеки,
охоплюючи вимоги до основних характеристик,
амбулаторних електрокардіографічних систем

 
   
 
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

5 Classification

6 Identification, marking and documents

Section two - Environmental conditions

10 Environmental conditions

Section three - Protection against electric shock hazards

20 Dielectric strength

Section four - Protection against mechanical hazards

21 Mechanical strength

Section five - Protection against hazards from unwanted or excessive radiation

36 Electromagnetic compatibility

Section six - Protection against hazards of ignition of flammable anaesthetic mixtures

Section seven - Protection against excessive temperatures and other safety hazards

Section eight - Accuracy of operating data and protection against hazardous output

50 Accuracy of operating dataa

51 Protection against hazardous output

Section nine - Abnormal operation and fault conditions; environmental tests

Section ten - Constructional requirements

56 Components and general assemblyy

Appendix L (normative) References - Publications mentioned in this standard

Annex AA (informative) Guidance 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 references of the relevant European publications

Index of defined terms