ДСТУ EN 60601-2-30:2015 Вироби медичні електричні. Частина 2-30. Окремі вимоги щодо безпеки приладів для автоматичного циклічного неінвазивного контролювання тиску крові (EN 60601-2-30:2000, IDT)



ДСТУ EN 60601-2-30:2015
(EN 60601-2-30:2000, IDT)

Вироби медичні електричні. Частина 2-30. Окремі вимоги щодо безпеки приладів для
автоматичного циклічного неінвазивного контролювання тиску крові

 

 
   
 
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

4 General requirements for tests

5 Classification

6 Identification, marking and documents

Section two - 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

21 Mechanical strength

22 Moving parts

Section five - Protection against hazards from unwanted or excessive radiation

36 Electromagnetic compatibility

Section six - Protection against the 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, and compatibility

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

50 Accuracy of operating data

51 Protection against hazardous output

Section nine - Abnormal operation and fault conditions; environmental tests

Section ten - Constructional requirements

56 Components and general assembly

57 mains parts, components and lay-out

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

Annex AA (informative) General guidance and rationale

Annex BB (informative) Alarm diagrams

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