ДСТУ EN ISO 10651-2:2015 Аппараты искусственной вентиляции легких медицинские. Дополнительные требования безопасности и основных рабочих характеристик. Часть 2. Аппараты для медицинской помощи на дому для пац...

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Державне підприємство
«Український науково-дослідний і навчальний центр
проблем стандартизації, сертифікації та якості»
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EN ISO 10651-2:2009

Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2:
Home care ventilators for ventilator-dependent patients (ISO 10651-2:2004)

прийнято як національний стандарт
методом «підтвердження» за позначенням
 

ДСТУ EN ISO 10651-2:2015
(EN ISO 10651-2:2009, IDT; ISO 10651-2:2009, IDT)

Апарати штучної вентиляції легенів медичні. Додаткові вимоги щодо безпеки та основних робочих
характеристик. Частина 2. Апарати для медичної допомоги вдома для пацієнтів, підключених до апарата
штучної вентиляції легенів

З наданням чинності від 2016–01–01

Contents

Foreword

Introduction

1 Scope

2 Normative references

3 Terms and definitions

4 General requirements and requirements for tests

5 Classification

6 Identification, marking and documents

6.1 Marking on the outside of equipment or equipment parts

6.3 Marking of controls and instruments

6.6 Identification of medical gas cylinders and connections

6.101 Test method for legibility

7 Power input

7.101 Pneumatic power

8 Basic safety categories

9 Removable protective means

10 Environmental conditions

10.101 Pneumatic driving-power supplies

11 Not used

12 Not used

13 General

14 Requirements related to classification

14.2 Class II Equipment

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

19.4 Tests

20 Dielectric strength

21 Mechanical strength

22 Moving parts

23 Surfaces, 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 radiation

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

43.2 Oxygen-enriched atmospheres

43.101 Compatibility with pressurized oxygen

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

44.3 Spillage

44.7 Cleaning, sterilization and disinfection

44.8 Compatibility with substances used with the equipment

45 Pressure vessels and parts subject to pressure

46 Human errors

47 Electrostatic charges

48 Biocompatibility

49 Interruption of the power supply

49.101 Internal electrical power source

49.102 Additional external backup power source

49.103 Spontaneous breathing during power failure

49.104 Accidental operation of the on/off-switch

50 Accuracy of operating data

51 Protection against hazardous output

51.101 Failure of air and oxygen supply systems

51.102 Adjustable ventilator breathing system pressure limitation

51.103 Maximum ventilator breathing system pressure limitation

51.104 Measurement of airway pressure

51.105 High-inspiratory pressure alarm condition

51.106 Expiratory monitoring

51.107 Hypoventilation alarm condition

51.108 Continuing pressure alarm condition

51.109 Respiration-rate alarm condition

52 Abnormal operation and fault conditions

53 Environmental tests

54 General

54.3 Protection against inadvertent adjustments

55 Enclosures and covers

56 Components and general assembly

56.3 Connections — General

56.101 Reservoir bags and breathing tubes

56.102 Humidifiers and heat and moisture exchangers

56.103 Pulse oximeters and capnometers

56.104 Oxygen monitor and alarm condition

56.105 Integrated monitoring equipment

57 Mains parts, components and layout

57.3 Power supply cords

58 Protective earthing — Terminals and connections

59 Construction and layout

101 Alarm systems

201.12 Alarm condition logging

102 Appendices of IEC 60601-1:1988

Annex AA (informative) Rationale

Annex BB (informative) Reference to the essential principles

Bibliography