Material test
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Cytotoxicity Test(ISO 10993-5)
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Irritation and delayed type hypersensitivity (ISO 10993-10)
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Systemic toxicity(ISO 10993-11)
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4
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Risk analysis
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5
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Requirements regarding design and construction
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5.1
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Moving parts and traps
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5.2
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Biocompatibility and Toxicity of Materials
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5.3
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Contaminant of Materials
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5.4
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Cleaning
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5.5
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Ergonomical Principles
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6
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Requirements regarding construction and environmental properties
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6.1
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Ancillaries
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6.2
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Accessible edges, corners and surfaces
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6.3
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Manoeuvrable for indoor or outdoor use
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7
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Protection against mechanical and thermal risks
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7.1
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Static loading, fatigue(825,000 cycles), low temperature
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7.2
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Maximum limits of adjustment ranges
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7.3
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Folding and adjusting mechanisms
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8
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Information supplied by the manufacturer
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