Material test

Cytotoxicity Test(ISO 10993-5)        

Irritation and delayed type hypersensitivity (ISO 10993-10)

Systemic toxicity(ISO 10993-11)

4

Risk analysis

5

Requirements regarding design and construction

5.1

Moving parts and traps

5.2

Biocompatibility and Toxicity of Materials

5.3

Contaminant of Materials

5.4

Cleaning

5.5

Ergonomical Principles

6

Requirements regarding construction and environmental properties

6.1

Ancillaries

6.2

Accessible edges, corners and surfaces

6.3

Manoeuvrable for indoor or outdoor use

7

Protection against mechanical and thermal risks

7.1

Static loading, fatigue(825,000 cycles), low temperature

7.2

Maximum limits of adjustment ranges

7.3

Folding and adjusting mechanisms

8

Information supplied by the manufacturer