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 testhttps://www.chinesestandard.net, 2019 M03 30 - 13 páginas 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. |
Contenido
| 3 | |
Scope | 6 |
Test materials | 7 |
Materials that may not be tested for oral mucosal irritation | 8 |
Postoperative observation of animals | 10 |
Test report | 12 |
References | 13 |
Términos y frases comunes
5.4 Control sample abnormal ADD the requirement anesthesia anesthetic average score 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 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 Mild 2 Moderate Moderate 3 Severe mucosa is 14 mucous irritation test 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 tissue Reaction Score total number toxicity test wafer wet the material YY/T