YY/T 1576-2017 English PDFUS$199.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 1576-2017: Tissue engineering medical device products - Standard practice for implantation assessment of absorbable/resorbable biomaterials Status: Valid
Basic dataStandard ID: YY/T 1576-2017 (YY/T1576-2017)Description (Translated English): Tissue engineering medical device products - Standard practice for implantation assessment of absorbable/resorbable biomaterials Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C45 Classification of International Standard: 11.040.40 Word Count Estimation: 10,172 Date of Issue: 2017-08-18 Date of Implementation: 2018-09-01 Regulation (derived from): China Food & Drug Administration Announcement 2017 No. 99 Issuing agency(ies): State Food and Drug Administration YY/T 1576-2017: Tissue engineering medical device products - Standard practice for implantation assessment of absorbable/resorbable biomaterials---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. Tissue engineering medical device products-Standard practice for implantation assessment of absorbable/resorbable biomaterials ICS 11.040.40 C45 People's Republic of China pharmaceutical industry standards Tissue engineering medical device products Absorbable biomaterial implantation test 2017-08-18 Posted 2018-09-01 implementation State Food and Drug Administration released Directory Preface Ⅰ 1 Scope 1 2 Normative references 1 3 Summary 1 4 Significance and purpose 1 5 experimental animals and parts 2 6 implant sample 2 7 implantation step 2 8 histological evaluation 4 9 Report 4 Appendix A (informative) Note 5 Reference 6 ForewordThis standard was drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of this document may be patentable. The issuing agencies of this document do not bear the responsibility of identifying these patents. This standard proposed by the State Food and Drug Administration. This standard by the National Surgical Implants and Orthopedic Instruments Standardization Technical Committee Organization Engineering Medical Devices Products Technical Committee Focused. This standard was drafted. China Food and Drug Control Research Institute. The main drafters of this standard. Chen Liang, Wang Zhao Xu, Shao Anliang, Zhang Na, Wang Chunren. Tissue engineering medical device products Absorbable biomaterial implantation test1 ScopeThis standard specifies the implantable test program to evaluate the tissue response to absorbable biomaterials. This standard applies only to clinical use is expected, Absorbable biomaterials with a residence time in bone or soft tissue greater than 30 days and less than 3 years. Note. Biomaterials absorbed in a shorter period of time may be based on other criteria that specify the time of implantation. For slow degradation, only three years before being absorbed students Materials, should carefully consider the applicability of this standard. Tissue reactions caused by degradable materials are expected to differ from non-degradable absorbent materials. In most cases , Chronic inflammation can be observed during degradation of the biomaterials, but local histology will recover or repair after the material has degraded and absorbed. therefore, Minimal tissue response, often equivalent to "biocompatible," requires longer implant time.2 Normative referencesThe following documents for the application of this document is essential. For dated references, only the dated version applies to this article Pieces. For undated references, the latest edition (including all amendments) applies to this document. Biological evaluation of medical devices - Part 6. Local response test after implantation (ISO 10993-6..1996). 2007, IDT) GB/T 16886.11-2011 Biological evaluation of medical devices - Part 11. Systemic toxicity tests (ISO 10993-11.2006, IDT)3 summaryIt is recommended that small experimental animals, such as mice, rats, hamsters or rabbits, be preferentially selected and will be evaluated under the most stringent conditions The final sample is implanted in its most relevant tissue anatomical site. Depending on the particular considerations of a particular study, larger experimental animals such as dogs, goats or sheep may be selected for use. Species of experimental animals The selection should also consider the availability of historical data on the biological evaluation of similar medical devices/biomaterials in order to contribute to the fraction of the data available Analysis and comparison. All animal tests should be carried out in accordance with the relevant regulatory requirements by the nationally approved agency.4 meaning and purpose4.1 This standard as a screening test guide for the evaluation of human implanted in the body and is expected to more than 30 days, 3 years to absorb the degradation of biological materials Local tissue reaction. For the description of this standard, please refer to Appendix A. 4.2 The evaluation of non-absorbable biomaterials local reactions after implantation test should be GB/T 16886.6-2015 requirements. This section In the experimental program and the standard criteria for non-absorbent bio-material test program similar to the analysis of the host reaction should consider biological The degradability of the material and the effect of the degradation products on the inflammatory response of the local tissue and the repair process of the implant site. 4.3 The biomaterials to be tested should be in the form of the final product intended for use, including sterilization. The ratio of material/organism to be The clinical use of the device is relevant. The ratio of material surface area or mass to animal body weight is recommended to be 1, 10, 50 times. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 1576-2017_English be delivered?Answer: Upon your order, we will start to translate YY/T 1576-2017_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. 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