YY/T 1477.2-2016 English PDFUS$159.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 1477.2-2016: Standard test models for primary wound dressing performance evaluation--Part 2: Animal burn model for wound healing evaluation Status: Valid
Basic dataStandard ID: YY/T 1477.2-2016 (YY/T1477.2-2016)Description (Translated English): Standard test models for primary wound dressing performance evaluation--Part 2: Animal burn model for wound healing evaluation Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C48 Word Count Estimation: 8,885 Date of Issue: 2016-07-29 Date of Implementation: 2017-06-01 Regulation (derived from): State Food and Drug Administration Notice 2016 (No.129) Issuing agency(ies): State Food and Drug Administration YY/T 1477.2-2016: Standard test models for primary wound dressing performance evaluation--Part 2: Animal burn model for wound healing evaluation---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. Standard test models for primary wound dress performance performance - Part 2. Animal burn model for wound healing evaluation ICS 11.120.20 C48 People's Republic of China Pharmaceutical Industry Standard Standard Test Model for Evaluating Performance of Contact Woven Dressings Part 2. Evaluating the healing performance of the wound Animal scald model Part 2. Animalburnmodelforwoundhealingevaluation 2016-07-29 released 2017-06-01 implementation State Food and Drug Administration issued ForewordYY/T 1477 "Standard test model for the evaluation of the performance of contact wound dressings", including the following. Part 1. Evaluation of antibacterial activity with in vitro wound model; Part 2. Animal scald model for evaluating the healing performance of wound healing; Part 3. In vitro wound model for evaluating liquid control performance; This part is part 2 of YY/T 1477. This part 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 issuer of this document does not assume responsibility for the identification of these patents. This part of the State Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center. This part of the drafting unit. Shandong Hengxin Detection Technology Development Center, Shandong 赛 赛 Sai Si Pharmaceutical Technology Co., Ltd. The main drafters of this part. Zhang Linlin, Wang Xianmei, Li Chunlai, Zhang Chunxia, Liu Changfeng. Standard Test Model for Evaluating Performance of Contact Woven Dressings Part 2. Evaluating the healing performance of the wound Animal scald model1 ScopeYY/T 1477 This section specifies an overview of the animal scald model, major equipment, laboratory animals, test procedures. This part is suitable for the evaluation of wound healing performance of scald contact wound dressing.2 normative reference documentsThe following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article Pieces. For undated references, the latest edition (including all modifications) applies to this document. GB/T 16886.2 Biological evaluation of medical devices - Part 2. Animal welfare requirements (GB/T 16886.2-2011, ISO 10993-2..2006, IDT)3 OverviewThis standard in accordance with the procedures prescribed in the back of the rat to establish a different scald degree of experimental scald animal model, in a certain period of time A number of scald animal models were used to evaluate the wound healing performance after exposure to wound wound dressings. Appendix A is given An example of an evaluation scheme for healing performance of dressings.4 major equipmentScalding device, constant temperature water bath, thermometer, pathological examination equipment.5 experimental animals5.1 General All animal tests should be carried out in laboratories approved by national accreditation bodies and consistent with all applicable animal safety regulations, And should also meet the requirements of GB/T 16886.2. 5.2 Species and requirements of animals Commonly used experimental animals for the rats, SPF level, 180g ~ 220g. Such as the selection of other strains of rats, should be described in its suitability. Animals should be kept at least 5 days prior to formal testing to suit the laboratory environment. Test animals should indicate species, strain, source, sex, weight and Week age. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 1477.2-2016_English be delivered?Answer: Upon your order, we will start to translate YY/T 1477.2-2016_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 1477.2-2016_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 1477.2-2016_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. 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