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

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 function 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.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 TEMPs. These are source of collagen, chemical and physical characterization and testing, and impurities profile.4.4 The following documents or other appropriate guidances from appropriate regulatory bodies relating to the production, regulation, and regulatory approval of TEMPs products should be considered when determining if the collagen supplied satisfies requirements for use in TEMPs:FDA CFR:21 CFR 3: Product Jurisdiction:   http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/    CFRSearch.cfm?CFRPart=321 CFR 58: Good Laboratory Practice for Nonclinical Laboratory Studies:   http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/    CFRSearch.cfm?CFRPart=58 FDA/CDRH CFR and Guidances:21 CFR Part 803: Medical Device Reporting:   http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/    CFRSearch.cfm?CFRPart=80321 CFR 812: Investigational Device Exemptions:    http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/    CFRSearch.cfm?CFRPart=81221 CFR 814: Premarket Approval of Medical Devices :   http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/    CFRSearch.cfm?CFRPart=81421 CFR 820: Quality System Regulation:   http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/    CFRSearch.cfm?CFRPart=820Design Control Guidance for Medical Device Manufacturers:   http://www.fda.gov/cdrh/comp/designgd.pdfPreproduction Quality Assurance Planning Recommendations for Medical Device Manufacturers (FDA 90-4236):   http://www.fda.gov/cdrh/manual/appende.htmlThe Review and Inspection of Premarket Approval Applications under the Bioresearch Monitoring Program—Draft Guidance for Industry and FDA Staff:   http://www.fda.gov/cdrh/comp/guidance/1602.pdf FDA/CDRH Search Engines:CDRH Guidance Search Engine:   http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfggp/search.cfmCDRH Premarket Approval (PMA) Search Engine:   http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfmCDRH 510(k) Search Engine:   http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfmCDRH Recognized STANDARDS Search Engine :   http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm FDA/CBER CFR and Guidances:21 CFR 312: Investigational New Drug Application :   http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/    CFRSearch.cfm?CFRPart=31221 CFR 314: Applications for FDA Approval to Market a New Drug:   http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/    CFRSearch.cfm?CFRPart=3121 CFR 610: General Biological Products Standards:   http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/    CFRSearch.cfm?CFRPart=61021 CFR 1271: Human Cells, Tissues and Cellular and Tissue-Based Products:   http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/    CFRSearch.cfm?CFRPart=1271Cellular & Gene Therapy Guidances and Other Publications:   http://www.fda.gov/cber/genetherapy/gtpubs.htmHuman Tissue Guidances and Other Publications:   http://www.fda.gov/cber/tissue/docs.htmCBER Product Approval Information:   http://www.fda.gov/cber/efoi/approve.htm21 CFR 600, 601 BLA Regulations:   http://www.access.gpo.gov/nara/cfr/waisidx_07/21cfrv7_07.html21 CFR 210, 211 GMP Regulations:   http://www.access.gpo.gov/nara/cfr/waisidx_07/21cfr210_07.html1.1 This guide for characterizing collagen-containing biomaterials is intended to provide characteristics, properties, and test methods for use by producers, manufacturers, and researchers to more clearly identify the specific collagen materials used. With greater than 20 types of collagen and the different properties of each, a single document would be cumbersome. This guide will focus on the characterization of Type I collagen, which is the most abundant collagen in mammals, especially in skin and bone. Collagen isolated from these sources may contain other types of collagen, for example, Type III and Type V. This guide does not provide specific parameters for any collagen product or mix of products or the acceptability of those products for the intended use. The collagen may be from any source including, but not limited to, animal or cadaveric sources, human cell culture, or recombinant sources. The biological, immunological, or toxicological properties of the collagen may vary, depending on the source material. The properties of the collagen prepared from each of the above sources must be thoroughly investigated, as the changes in the collagen properties as a function of source materials is not thoroughly understood. This guide is intended to focus on purified Type I collagen as a starting material for surgical implants and substrates for tissue engineered medical products (TEMPs); some methods may not be applicable for gelatin or tissue implants. This guide may serve as a template for characterization of other types of collagen.1.2 The biological response to collagen in soft tissue has been well documented by a history of clinical use (1, 2)2 and laboratory studies (3-6). Biocompatibility and appropriateness of use for a specific application(s) is the responsibility of the product manufacturer.1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.4 Warning—Mercury has been designated by EPA and many state agencies as a hazardous material that can cause central nervous system, kidney, and liver damage. Mercury, or its vapor, may be hazardous to health and corrosive to materials. Caution should be taken when handling mercury and mercury-containing products. See the applicable product Material Safety Data Sheet (MSDS) for details and EPA’s website (http://www.epa.gov/mercury/faq.htm) for additional information. Users should be aware that selling mercury or mercury-containing products, or both, in your state may be prohibited by state law.1.5 The following precautionary caveat pertains only to the test method portion, Section 5, of this guide. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.