YY/T 1754.1-2020 Translated English of Chinese Standard. (YYT 1754.1-2020, YY/T1754.1-2020, YYT1754.1-2020): Preclinical animal study of medical devices - Part 1: General considerations [Buy--download True-PDF in 3-second: https://play.google.com/books > Sign in > This BOOK > "3-dots" > Export > Save as "*.pdf"]This Part of YY/T 1754 specifies the general considerations for preclinical animal study of medical devices. This Part applies to the design of animal test and the acquisition of data for preclinical medical devices. |
Common terms and phrases
16886 series standards Acute study and/or Animal autopsy animal feeding areas Animal identification Animal test study animal test system animal welfare requirements applicable Biological evaluation blood pressure changes or revisions control group control samples corresponding national standards develop downstream effects of medical electrolyte evaluation of medical Feasibility of medical final clinical design GB/T heart rate histomorphological analysis human body identified imaging including tissue inflammation inspection interference factors interventional operating medical device accessories medical device implant Medical device-related medical devices Reasonable mid-term monitoring number of animals number of test pathologists performance and manipulation personnel placement post-operative Preclinical animal study Procedures for animal Respiratory rate Retrieved object risk Safety of medical samples and control Scanning electron microscope selected animal model simulate the clinical standard operating procedures standards and guidelines Study equipment study of medical study period study protocol surgical systemic effects Terms and definitions test samples tissue section upstream/downstream veterinarian YY/T