YY/T 1512-2017: Translated English of Chinese Standard. YY/T1512-2017: Biological Evaluation of Medical Devices - Guidance on the Conduct of Biological Evaluation within a Risk Management Process
https://www.chinesestandard.net, 10 ago 2018 - 26 páginas
This Standard is applicable to the biological evaluation of medical devices in accordance with the requirements in GB/T 16886.1-2011. This Standard does not add or modify the requirements in GB/T 16886.1-2011. This Standard does not include requirements of regulatory inspection or certification and assessment activities. This Standard is applicable to all the biological evaluation of various types of medical devices, including active, passive, implantable and non-implantable medical devices.
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absorbable materials acceptability additives adopted to replace adopts equivalent international animal test Biocompatibility biological evaluation plan Biological safety assessment biological safety evaluation biological test characteristics chemical characterization data chemical compounds clinical application clinical research Conduct of Biological conducting biological evaluation Degradation Products determined equivalent international standards Evaluation of Medical example existing data expected purposes exposed to patients guidance Identification and Quantification identification of hazards identified in-vitro test system in-vivo intake leachables literature review long-term tests material characterization material compositions Materials GB/T medical device design obtained pollutants possibility of triggering potential processing process Quality Management Systems Quantification of Degradation ratio of dose/TI release rate released from medical replace ISO requirements in GB/T residual risks risk control measures risk estimation Risk Evaluation Risk risk management activity risk management process specific medical device taken into consideration threshold of toxicological toxic effect Toxicokinetic Toxicological Hazard Toxicological Risk ultimate product usage verification