YY/T 0127.13-2018 Translated English of Chinese Standard. (YYT 0127.13-2018, YY/T0127.13-2018, YYT0127.13-2018): Biological evaluation of medical devices used in dentistry - Part 13: Oral mucous irritation test [Buy--download True-PDF in 3-second: https://play.google.com/books > Sign in > This BOOK > "3-dots" > Export > Save as "*.pdf"]https://www.chinesestandard.net, 30 Mar 2019 - 13 halaman This part of YY/T 0127 specifies the oral mucous irritation test method for medical devices. This part is intended to evaluate the irritating effects onto the oral mucosal tissue of short-term, long-term and long-lasting oral medical devices that are in contact with oral mucosal tissue or other medical devices that are in contact with oral mucosal tissue. |
Isi
3 | |
Scope | 6 |
Test materials | 7 |
Materials that may not be tested for oral mucosal irritation | 8 |
Postoperative observation of animals | 10 |
Evaluation of results | 12 |
References | 13 |
Istilah dan frasa umum
5.4 Control sample abnormal ADD the requirement anesthesia anesthetic average score biocompatibility of medical Biological evaluation method Biological evaluation test Biological test methods blunt without burrs buccal mucosa check the cheek cheek pouch collar method contact with oral control side Cytotoxicity tests dental materials Dentine dentistry diameter dip the material epithelial Epithelium erythema eschar Evaluation of biocompatibility evaluation of dental evaluation of medical evaluation test method eyes to observe free of oral GB/T hyperplasia long-lasting contact devices long-term and long-lasting long-term contact devices medical devices membrane irritation test method of dental mucosa is 14 mucous irritation test mucous membrane irritation Multiple-contact method observe the cheek One-contact method oral mucosal irritation oral mucosal tissue Reaction degree Reaction scoring system repeated placement short-term contact devices stimulation index Suture contact method test group test piece test report test sample test side tested for oral total number toxicity test wafer wet the material YY/T