ДСТУ EN ISO 8359:2015 Концентратори кисневі медичні. Вимоги щодо безпеки (EN ISO 8359:2009, IDT; ISO 8359:1996, IDT)

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EN ISO 8359:2009

Oxygen concentrators for medical use - Safety requirements
(ISO 8359:1996)

прийнято як національний стандарт
методом «підтвердження» за позначенням
Відповідає офіційному тексту

ДСТУ EN ISO 8359:2015
(EN ISO 8359:2009, IDT; ISO 8359:1996, IDT)

Концентратори кисневі медичні. Вимоги щодо безпеки

З наданням чинності від 2016–01–01

Contents

Section 1 General

1.1 Scope

1.2 Normative references

1.3 Definitions

1.4 General requirements

1.5 General requirements for tests

1.6 Classification

1.7 Identification, marking and documents

1.8 Power input

Section 2 Safety requirements

2.1 Basic safety categories

2.2 Removable protective means

2.3 Environmental conditions

Section 3 Protection against electric shock hazards

3.1 General

3.2 Requirements related to classification

3.3 Limitation of voltage and/or energy

3.4 Enclosures and protective covers

3.5 Separation

3.6 Protective earthing, functional earthing and potential equalization

3.7 Continuous leakage currents and patient auxiliary currents

3.8 Dielectric strength

Section 4 Protection against mechanical hazards

4.1 Mechanical strength

4.2 Moving parts

4.3 Surfaces, corners and edges

4.4 Stability in normal use

4.5 Expelled parts

4.6 Vibration and noise

4.7 Pneumatic and hydraulic power

4.8 Suspended masses

Section 5 Protection against hazards from unwanted or excessive radiation

5.1 X-Radiation

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

5.3 Microwave radiation

5.4 Light radiation (including visual radiation and lasers)

5.5 Infrared radiation

5.6 Ultraviolet radiation

5.7 Acoustical energy (including ultrasonics)

5.8 Electromagnetic compatibility

Section 6 Protection against hazards of explosions in medically used rooms

6.1 Locations and basic requirements

6.2 Marking, accompanying documents

6.3 Common requirements for category AP and category APG equipment

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

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

Section 7 Protection against excessive temperatures and other safety hazards

7.1 Excessive temperatures

7.2 Fire prevention

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

7.4 Pressure vessels and parts subject to pressure

7.5 Human errors

7.6 Electrostatic charges

7.7 Materials in applied parts in contact with the body of the patient

7.8 Interruption of the power supply

Section 8 Accuracy of operating data and protection against hazardous output

8.1 Accuracy of operating data

8.2 Protection against hazardous output

Section 9 Abnormal operation and fault conditions; environmental tests

9.1 Abnormal operation and fault conditions

9.2 Environmental tests

Section 10 Constructional requirements

10.1 General

10.2 Enclosures and covers

10.3 Components and general assembly

10.4 Mains parts, components and layout

10.5 Protective earthing — Terminals and connections

10.6 Construction and layout

Section 11 Additional clauses

11.1 Auditory indicators

11.2 Indication of loss of mains power

Annexes

N Test apparatus

P Rationale statement

Q Bibliography