Adopts ISO 8359:1996 to specify safety requirements for continuous-flow oxygen concentrators. Does not apply to oxygen concentrators intended to supply gas to several patients via a piped medical gas installation or to those intended for use in the presence of flammable anaesthetic and/or cleaning agents.
Table of contents
Header
About this publication
Preface
Introduction
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
