YY/T 0990-2015 English PDF

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YY/T 0990-2015: Clinical trial guideline for polymer-based dental restorative materials
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 0990-2015	209	Add to Cart	3 days	Clinical trial guideline for polymer-based dental restorative materials	Valid

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Basic data

Standard ID: YY/T 0990-2015 (YY/T0990-2015)
Description (Translated English): Clinical trial guideline for polymer-based dental restorative materials
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C33
Classification of International Standard: 11.060.10
Word Count Estimation: 10,111
Date of Issue: 2015-03-02
Date of Implementation: 2016-01-01
Regulation (derived from): The State Food and Drug Administration Announcement 2015 No. 8
Issuing agency(ies): State Food and Drug Administration
Summary: This Standard specifies the requirements and methods for clinical trials polymer base dental restorative materials. This Standard applies to conduct after the tooth body defection polymer matrix direct restorative dental restorative material, it does not include the evaluation of other new features.

YY/T 0990-2015: Clinical trial guideline for polymer-based dental restorative materials

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Clinical trial guideline for polymer-based dental restorative materials ICS 11.060.10 C33 People's Republic of China Pharmaceutical Industry Standard Guidance on Clinical Trials of Polymer Basement Repair Materials 2015-03-02 release 2016-01-01 Implementation State Food and Drug Administration issued

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of the contents of this document may involve patents. The release of this document The Agency shall not be responsible for the identification of such patents. This standard is proposed by the State Food and Drug Administration. This standard is nationalized by the National Standardization Technical Committee for Dental Materials and Equipment (SAC/TC99). The main drafting of this standard. Peking University School of Stomatology. The main drafters of this standard. Wang Xiaoyan, Yue Lin. Guidance on Clinical Trials of Polymer Basement Repair Materials

1 Scope

This standard specifies the requirements and methods for the clinical trial of polymeric basement restoration materials. This standard applies to the restoration of the posterior tooth defects directly to the polymer base material repair material, does not include the other new features Evaluation.

2 before the clinical trial requirements

2.1 General Medical ethics and subject rights and test personnel requirements should be consistent with the relevant national laws and regulations. 2.2 Test subjects 2.2.1 inclusion criteria 2.2.1.1 Subjects Healthy, 18 years old to 70 years old, sex is not limited, the opening degree is normal. 2.2.1.2 Test teeth Lesion depth to the dentin in the middle of the dental caries, pulp vitality normal, and need to meet the following conditions. a) tooth position. molar (priority) or premolars; b) Type. Class I or Class II; c) hole size. occlusal surface minimum buccal tongue diameter is not less than the cheek tongue cusp spacing of 1/3; adjacent to the hole after the gingival step in the edge of the gingival crown; d) bite. all the filling body in the repair immediately have bite contact; for the natural teeth; bite the relationship between the normal; e) Adjacent contact. All Class II holes are in contact with adjacent teeth and are restored to contact. In the absence of the third molar, the second mill (MO) and near-far (MOD) fillings are acceptable, but far-in (DO) fillers are not incorporated; f) No special staining of teeth. 2.2.2 Exclusion criteria 2.2.2.1 Subjects Subjects meet the following criteria. a) allergies or a variety of drug allergy; dental resin and other polymer-based material history of allergies; b) patients with severe caries; severe periodontitis; poor oral hygiene; salivary gland dysfunction; temporomandibular disorders patient; c) Severe systemic disease; Pregnancy and Intention to Pregnant women of childbearing age and lactating women, patients with mental illness, and test subjects Person who thinks that is not suitable for inclusion. ......

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