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Biological safety test selector
Choose the site that contacts the body and for how long, and the biological evaluations you must run come back with the notice behind them. Tables 1 and 2 of the annex to 「의료기기의 생물학적 안전에 관한 공통기준규격」 are reproduced as they stand, and the rules that live outside the table (multiple sites, multiple durations, no contact, waivers, re-evaluation) are quoted with their source.
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1 Does it contact the body?
2 Contact site — Select every site it contacts
3 Contact duration
Rules outside the table — notice text
Is your product on the borderline?
If the contact site or duration is unclear, or the product touches several sites at once, the range of testing changes. A change of raw material or of sterilisation method is also a reason to re-evaluate. In those cases read the notice together with your risk management results.
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