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YY/T 1445-2016: Tissue engineering medical device products--Terminology
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| YY/T 1445-2016 | English | 359 |
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Tissue engineering medical device products--Terminology
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YY/T 1445-2016
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Basic data | Standard 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
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 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 terminology
1 Scope
This 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 documents
The 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 definitions
3.1
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).
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