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Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 1445-2016: Tissue engineering medical device products--Terminology Status: Valid
Basic dataStandard ID: YY/T 1445-2016 (YY/T1445-2016)Description (Translated English): Tissue engineering medical device products--Terminology Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C35 Classification of International Standard: 11.040.40 Word Count Estimation: 18,194 Date of Issue: 2016-07-29 Date of Implementation: 2017-06-01 Issuing agency(ies): State Food and Drug Administration YY/T 1445-2016: Tissue engineering medical device products--Terminology---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 - Terminology ICS 11.040.40 C35 People's Republic of China Pharmaceutical Industry Standard Tissue engineering medical device product terminology 2016-07-29 released 2017-06-01 implementation State Food and Drug Administration issued Directory Preface III 1 Scope 1 2 normative reference document 1 3 Terms and definitions 1 4 meaning and use 6 Appendix A (informative) Organizational Engineering 8 Reference 9 ForewordThis 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 issuer of this document does not assume responsibility for the identification of these patents. This standard is proposed by the State Food and Drug Administration. This standard by the National Surgical Implant and Orthopedic Equipment Standardization Technical Committee Organizational Engineering Medical Device Products Subcommittee (SAC/TC110/SC3). The drafting unit of this standard. China Food and Drug Administration Research Institute. The main drafters of this standard. Chen Liang, Wang Zhaoxu, Fang Yu, Liu Li, Ke Linnan, Feng Xiaoming, Wang Chunren. Tissue engineering medical device product terminology1 ScopeThis standard specifies the basic terminology and definitions of tissue engineering medical device products. Note. In order to standardize the language of tissue engineering medical device product standards, this standard specifies the relevant terms and definitions.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. Pharmacopoeia of the People's Republic of China (2015)3 terms and definitions3.1 Tissue engineering Combine the principles and techniques of life sciences and engineering to develop substitutes or grafts with biologically active functions for substitution, Repair or regenerate tissue, organ and/or its structure and function of interdisciplinary. Note 1. rewrite YY/T 0606.3-2007, definition 3.1. Note 2. Refer to Appendix A for related terms of tissue engineering terms and definitions. 3.2 Tissue engineering medical products tissueengineeredmedicalproduct Medical products prepared by tissue engineering techniques and processes for the replacement, repair or regeneration of tissues, organs and/or their structures and functions, Does not include traditional tissue and organ transplantation as well as somatic and gene therapy products. Note. rewrite YY/T 0606.3-2007, definition 3.2. 3.3 Tissue Engineering Medical Device Products tissueengineeredmedicaldeviceproduct Tissue engineering medical products defined as medical devices are called tissue engineering medical device products. 3.4 Drug combination product drug-devicecombinationproduct Consisting of drugs and medical devices and produced as a single entity. Note. Tissue engineering medical device products may be pharmaceutical combination products. 3.5 Organization The same source, functionally related cells by cell interstitials in a certain way combined and play a specific function of the cell population. Note. The four basic organizations of the body for the epithelial tissue, connective tissue, muscle tissue and nerve tissue. [YY/T 0606.4-2007, definition 2.1] 3.6 Rejuvenate With the normal tissue, organ and/or its structure and function similar to the new tissue, the organ in the body of the formation process. Note. In this standard, regeneration occurs based on the biological effects of cellular and molecular levels (including DNA). ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 1445-2016_English be delivered?Answer: Upon your order, we will start to translate YY/T 1445-2016_English as soon as possible, and keep you informed of the progress. The lead time is typically 2 ~ 4 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of YY/T 1445-2016_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 1445-2016_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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