AAMI ISO 16142-2 : 2017現行
MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS
出版：Association for the Advancement of Medical Instrumentation
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基本信息
標準編號： AAMI ISO 16142-2 : 2017
標準類別：Standard
出版單位：Association for the Advancement of Medical Instrumentation
標準頁數：0
標準簡介
Covers the essential principles of safety and performance, identifies significant standards and guides that can be used in the assessment of conformity of a medical device to the recognized essential principles that when met, indicate a medical device is safe and performs as intended.
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