NEN EN ISO 8359 : 2009 AMD 1 2012

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 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 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 Main 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

Defines safety requirements for continuous-flow oxygen concentrators. Not applicable to oxygen concentrators for supply of gas to several patients by means of a piped medical gas installation or for use with flammable anaesthetic and/or cleaning agents.