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Biological assessment of medical devices
Biological Evaluation of Medical Devices a€” Guidance on the Conduct of Biological Evaluation within a Risk Management Process
Biological evaluation of medical devices
本文件適用于根據(jù)ISO 10993-1的要求進行醫(yī)療器械生物相容性評價的實施。它不增加或更改ISO 10993-1中的要求。 本指南適用于所有類型醫(yī)療器械的生物相容性評估，包括有源、無源、可植入和非可植入醫(yī)療器械
Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process
總則 GB/T 16886.1一2011 的 B.2.2.2 描述了某一制造商能夠識別與醫(yī)療器械相關(guān)的生物學(xué)危害,估計和評價其風(fēng)險,控制這些風(fēng)險以及監(jiān)視控制有效性的持續(xù)過程。通過權(quán)衡醫(yī)療器械的風(fēng)險和受益來合理保護患者是該生物學(xué)評價計劃的一個基本要素?；颊邚尼t(yī)療器械的使用中獲益的同時也承受潛在的風(fēng)險
Implementation Guidelines for Biological Evaluation in the Risk Management Process of Biological Evaluation of Medical Devices
This Technical Report is applicable to the conduct of biological evaluation of medical devices according to the requirements of ISO 10993-1. It does
Biological evaluation of medical devices -- Guidance on the conduct of biological evaluation within a risk management process
Biological evaluation of medical devices -- Guidance on the conduct of biological evaluation within a risk management process
Biological evaluation of dental materials
Biological evaluation of medical devices – Guidance on the conduct of biological evaluation within a risk management process
This guidance is applicable to the conduct of biological evaluation of medical devices according to the requirements of ISO 10993-1. It does not add
Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process
This guidance is applicable to the conduct of biological evaluation of medical devices according to the requirements of ISO 10993-1. It does not add
Biological evaluation of medical devices - Guideance on the conduct of biological evaluation within a risk management process
ADOPTED_FROM:ISO/TR 15499:2012 <p>This Technical Report is applicable to the conduct of biological evaluation of medical devices according
Biological evaluation of medical devices — Guidance on the conduct of biological evaluation within a risk management process
Biological evaluation of medical devices — Guidance on the conduct of biological evaluation within a risk management process
Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process
Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process
