Tiêu chuẩn quốc tế
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Số hiệu
Standard Number
EN ISO 10993-16:2010
Năm ban hành 2010
Publication date
Tình trạng
A - Còn hiệu lực
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Tên tiếng Anh
Title in English Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010)
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Giá:
Price Liên hệ / Contact us
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Phạm vi áp dụng
Scope of standard This part of ISO 10993 gives principles on how toxicokinetic studies relevant to medical devices should be designed and performed. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.
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