YY/T 1445-2016Tissue engineering medical device products--Terminology (English PDF)

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

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

Tissue engineering medical products defined as medical devices are called tissue engineering medical device products.

3.4 Drug combination product

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).