materialtest
cytotoxicitytest(iso10993-5)
irritation anddelayed type hypersensitivity (iso 10993-10)
systemictoxicity(iso 10993-11)
4
riskanalysis
5
reregarding design and construction
5.1
moving parts andtraps
5.2
biocompatibilityand toxicity of materials
5.3
contaminant ofmaterials
5.4
cleaning
5.5
ergonomicalprinciples
6
reregarding construction and environmental properties
6.1
ancillaries
6.2
accessibleedges, corners and surfaces
6.3
manoeuvrable forindoor or outdoor use
7
protectionagainst mechanical and thermal risks
7.1
static loading,fatigue(825,000 cycles), low temperature
7.2
maximum limitsof adjustment ranges
7.3
folding andadjusting mechanisms
8
informationsupplied by the manufacturer