YY/T 0991-2015 English PDFUS$149.00 ยท In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 0991-2015: Clinical trial guideline for orthodontic brackets Status: Valid
Basic dataStandard ID: YY/T 0991-2015 (YY/T0991-2015)Description (Translated English): Clinical trial guideline for orthodontic brackets Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C33 Classification of International Standard: 11.060.10 Word Count Estimation: 7,748 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 orthodontic bracket of the patient population in clinical trials, medical ethics and subject interests, test procedures, observation and evaluation of clinical trials evaluating the results of assessment, clinical trial reports. This Standard applies to the clinical treatment of orthodontic brackets used products. YY/T 0991-2015: Clinical trial guideline for orthodontic brackets---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 orthodontic brackets ICS 11.060.10 C33 People's Republic of China pharmaceutical industry standards Orthodontic Clinical Trials Directory Issued on. 2015-03-02 2016-01-01 implementation China Food and Drug Administration released ForewordThis standard was drafted in accordance with GB/T 1.1-2009 given rules. Please note that some of the content of this document may involve patents. Distribution of this document Institutions should not bear the responsibility to identify these patents. This standard was proposed by the China Food and Drug Administration. This standard by the National Standardization Technical Committee materials and oral appliances and equipment (SAC/TC99) centralized. This standard is mainly drafted by. Peking University School of Stomatology. The main drafters of this standard. Zhou Yanheng Jiang long exchange, Lee towering. Orthodontic Clinical Trials Directory1 Test RangeThis standard specifies the orthodontic brackets clinical trial patient population, medical ethics and the interests of the subject during the test, observation and evaluation of clinical Test results of the evaluation assessment, clinical trial reports. This standard applies to the clinical treatment of orthodontic brackets used in the product.2 clinical trials and hospital personnel requirements2.1 Clinical trials should have qualified in medical institutions worked. 2.2 Clinical trials should have a project leader associate professional titles, the test should orthodontic specialist in clinical work for 5 years the above. 2.3 clinical trials is the use by staff of medical institutions from the project leader blinded panel of experts meets the above qualifications randomly selected. 2.4 Clinical trials should national GCP training (drug clinical trial guidelines) qualification. 2.5 multi-center clinical validation should be performed simultaneously by two or more different hospitals (including two), the hospital should be nationally recognized qualification.3 study population3.1 inclusion criteria 3.1.1 permanent dentition subjects, male or female, minors should guardian's consent. 3.1.2 Reserved 24 teeth, orthodontic treatment needs and desires are. 3.2 Exclusion criteria (belonging to the following circumstances) 3.2.1 body has severe cardiovascular disease, liver and kidney diseases, blood diseases, endocrine diseases, lung diseases, neurological diseases such as swollen Tumors, diabetes, autoimmune diseases, chronic hepatitis or AIDS. 3.2.2 related allergies, or allergies to metals, ceramics, plastics and other allergies. 3.2.3 pregnancy, breast-feeding women. 3.2.4 Use of other immunomodulatory agents or by systemic steroid. 3.2.5 progressive periodontitis, severe periodontitis and the risk of alveolar mucosa lesions. 3.2.6 temporomandibular joint disease. 3.2.7 occlusal abnormalities such as bruxism, clenching. 3.2.8 large number of missing teeth or a lot of tooth tissue loss. 3.2.9 orthodontic treatment of psychiatric disease or who have unrealistic demands. Selected three months before 3.2.10 have participated in clinical trials by other materials.4 Medical Ethics and a subject interestsClinical trials required to obtain review by the ethics committee, and all participants should be informed consent and signed informed consent in clinical trials. Participants are free to withdraw at any time in clinical trials. Subjects related information should be kept confidential. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 0991-2015_English be delivered?Answer: Upon your order, we will start to translate YY/T 0991-2015_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of YY/T 0991-2015_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 0991-2015_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.Question 3: Does the price include tax/VAT?Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countriesQuestion 4: Do you accept my currency other than USD?Answer: Yes. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay. |
