ДСТУ EN 60601-2-23:2019 Изделия медицинские электрические. Часть 2-23. Дополнительные требования насчет безопасности и основных рабочих характеристик аппаратуры сквозькожного контроля парциального давления (E...



ДСТУ EN 60601-2-23:2019
(EN 60601-2-23:2000, IDT; IEC 60601-2-23:1999, IDT)

Вироби медичні електричні. Частина 2-23. Додаткові вимоги
щодо безпеки та основних робочих характеристик апаратури
крізьшкірного контролювання парціального тиску

 

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

Contents

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

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 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, disinfection and compatibility

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 56 Components and general assembly

57 Mains parts, components and layout

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

Annex AA (informative) General guidance and rationale

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

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