ДСТУ EN 60601-2-33:2016 Изделия медицинские электрические. Часть 2-33. Дополнительные требования по безопасности и основным рабочим характеристикам медицинского диагностического магнитно-резонансного оборудов...

ДСТУ EN 60601-2-33:2016
(EN 60601-2-33:2002, IDT)

Вироби медичні електричні. Частина 2-33. Додаткові вимоги щодо безпеки та
основних робочих характеристик медичного діагностувального
магнітно-резонансного обладнання

 
   
 
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

3 General requirements

6 Identification, marking and documents

Section two: Environmental conditions

Section three: Protection against electric shock hazards

Section four: Protection against mechanical hazards

26 Vibration and noise

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

45 Pressure vessels and parts subject to pressure

49 Interruption of the power supply

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

51 Protection against hazardous output

Section nine: Abnormal operation and fault conditions; environmental tests

52 Abnormal operation and fault conditions

Section ten: Constructional requirements

59 Construction and layout

Figures

Tables

Appendix L References - Publications mentioned in this standard

Annex AA (informative) Examples of warning signs and prohibitive signs

Annex BB (informative) Guidance and rationale for particular subclauses

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

Annex ZB (normative) Other international publications mentioned in this standard with the references of the relevant European publications

Bibliography

Index of defined terms