ДСТУ EN ISO 8185:2015 Увлажнители дыхательных путей для медицинского применения. Дополнительные требования к респираторным системам увлажнения (EN ISO 8185:2009, IDT ISO 8185:2007, IDT)

ПІДТВЕРДЖУВАЛЬНЕ ПОВІДОМЛЕННЯ

Державне підприємство
«Український науково-дослідний і навчальний центр
проблем стандартизації, сертифікації та якості»
(   
(ДП «УкрНДНЦ»))

Наказ від 25.12.2015 № 208

EN ISO 8185:2009

Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems
(ISO 8185:2007)

прийнято як національний стандарт
методом «підтвердження» за позначенням
 

ДСТУ EN ISO 8185:2015
(EN ISO 8185:2009, IDT ISO 8185:2007, IDT)

Зволожувачі дихальних шляхів для медичного застосування. Додаткові вимоги до респіраторних систем
зволоження

З наданням чинності від 2016–01–01

Contents

Foreword

Introduction

1 Scope

2 Normative references

3 Terms and definitions

4 General requirements and general requirements for tests

5 Classification

6 Identification, marking and documents

7 Power input

8 Basic safety categories

9 Removable protective means

10 Environmental conditions

11 Not used

12 Not used

13 General

14 Requirements related to classification

15 Limitation of voltage and/or energy

16 Enclosures and protective covers

17 Separation

18 Protective earthing, functional earthing and potential equalization

19 Continuous leakage currents and patient auxiliary currents

20 Dielectric strength

21 Mechanical strength

22 Moving parts

23 Surface, corners and edges

24 Stability in normal use

25 Expelled parts

26 Vibration and noise

27 Pneumatic and hydraulic power

28 Suspended masses

29 X-Radiation

30 Alpha, beta, gamma, neutron radiation and other particle radiation

31 Microwave radiation

32 Light radiation (including lasers)

33 Infra-red radiation

34 Ultraviolet energy

35 Acoustical energy (including ultrasonics)

36 Electromagnetic compatibility

37 Locations and basic requirements

38 Marking, accompanying documents

39 Common requirements for category AP and category APG equipment

40 Requirements and tests for category AP equipment, parts and components thereof

41 Requirements and tests for category APG equipment, parts and components thereof

42 Excessive temperatures

43 Fire prevention

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

45 Pressure vessels and parts subject to pressure

46 Human error

47 Electrostatic charges

48 Biocompatibility

49 Interruption of power supply

50 Accuracy of operating data

51 Protection against hazardous output

52 Abnormal operation and fault conditions

53 Environmental tests

54 General

55 Enclosure and covers

56 Components and general assembly

57 Mains parts, components and layout

58 Protective earthing — Terminals and connections

59 Construction and layout

101 Humidification system output

102 Liquid container

103 Alarm systems

Annex AA (informative) Rationale

Annex BB (normative) Determination of the accuracy of the displayed temperature

Annex CC (informative) Specific enthalpy calculations

Annex DD (normative) Temperature sensors and mating ports

Annex EE (normative) Determination of humidification system output

Annex FF (normative) Standard temperature sensor

Annex GG (informative) Environmental aspects

Annex HH (informative) Reference to the essential principals of safety and performance

Annex II (informative) Terminology — Index of defined terms

Bibliography