Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)

Importancia y uso:

4.1 The objective of this guide is to provide guidance in the characterization of Type I collagen as a starting material for surgical implants and substrates for tissue engineered medical products (TEMPs). This guide contains a listing of physical and chemical parameters that are directly related to the functions of collagen. This guide can be used as an aid in the selection and characterization of the appropriate collagen starting material for the specific use. Not all tests or parameters are applicable to all uses of collagen and users are expected to select and justify a subset of the tests for characterization purposes.

4.2 The collagen covered by this guide may be used in a broad range of applications, forms, or medical products, for example (but not limited to) medical devices, tissue engineered medical products (TEMPs) or cell, drug, or DNA delivery devices for implantation. The use of collagen in a practical application should be based, among other factors, on biocompatibility and physical test data. Recommendations in this guide should not be interpreted as a guarantee of clinical success in any tissue engineered medical product or drug delivery application.

4.3 The following general areas should be considered when determining if the collagen supplied satisfies requirements for use in the above mentioned medical and research applications: source of collagen, impurities profile, and chemical, biological, and physical characterization and testing.

4.4 As this guide is intended for medical products, there are many relevant guidance documents from appropriate regulatory bodies relating to the production, regulation, and regulatory approval of TEMPs products which should be considered when determining if the collagen supplied satisfies requirements for use in TEMPs. While some relevant documents are referenced in this guide, many more are applicable to devices, biologics, drugs, and combination products.

Subcomité:

F04.42

Referida por:

F3515-21, F3510-21, F2027-25, F3223-17, F3225-17R22, F2150-19, F3354-19, F3659-24

Volúmen:

13.01

Número ICS:

11.100.99 (Other standards related to laboratory medicine)

Palabras clave:

biomaterials; characterization; collagen; natural materials; TEMPs;