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Standard Guide for Characterization and Standardization of Polymerizable Collagen-Based Products and Associated Collagen-Cell Interactions
Přeložit název
NORMA vydána dne 1.1.2023
Označení normy: ASTM F3089-23
Poznámka: NEPLATNÁ
Datum vydání normy: 1.1.2023
Kód zboží: NS-1099563
Počet stran: 20
Přibližná hmotnost: 60 g (0.13 liber)
Země: Americká technická norma
Kategorie: Technické normy ASTM
Keywords:
biomaterials, characterization, collagen-cell interactions, collagen polymer material, polymerizable collagen,, ICS Number Code 11.100.99 (Other standards related to laboratory medicine)
Significance and Use |
4.1?The objective of this document is to provide guidance in the production, characterization, testing, and standardization of: (4.2?This guide can be used by the following types of users: 4.2.1?Manufacturers of polymerizable collagens and collagen polymeric materials who wish to set specifications for their products or provide characterization data for customers or users. They may also use the terminology and characterization sections to specify and differentiate the properties of polymerizable collagens and collagen polymeric materials. 4.2.2?Producers of collagen polymeric materials that use polymerizable collagen as starting materials. Producers may use this guide to evaluate and characterize multiple sources of polymerizable collagen. They may also use this guide to assist with evaluation and comparison of single or multiple sources of polymerizable collagen and collagen polymeric materials. 4.2.3?Researchers may use this guide as a reference for properties and test methods that can be used to reproducibly evaluate polymerizable collagens and collagen polymeric materials. 4.3?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) wound and hemostatic dressings, surgical implants or injectables (including in-situ forming), hybrid medical devices, TEMPs, injectable (including in-situ forming) or implantable delivery vehicles for therapeutic cells, molecules, and drugs, and 3D 4.4?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 polymerizable collagen, impurities profile, and comprehensive chemical, physical, and biological characterization and testing. 4.5?The following documents or other relevant guidance documents from appropriate regulatory bodies relating to the production, regulation, and regulatory approval of devices, biologics, drugs, and combination products should be considered when determining if the collagen supplied satisfies requirements for use in medical and research products, including TEMPs, therapeutic delivery vehicles, and 3D FDA CFR: |
21 CFR 3: Product Jurisdiction: |
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/ CFRSearch.cfm?CFRPart=3 |
21 CFR 58: Good Laboratory Practice for Nonclinical Laboratory Studies: |
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/ CFRSearch.cfm?CFRPart=58 |
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FDA/CDRH CFR and Guidances: |
21 CFR Part 803: Medical Device Reporting: |
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/ CFRSearch.cfm?CFRPart=803 |
21 CFR 812: Investigational Device Exemptions: |
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/ CFRSearch.cfm?CFRPart=812 |
21 CFR 814: Premarket Approval of Medical Devices: |
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/ CFRSearch.cfm?CFRPart=814 |
21 CFR 820: Quality System Regulation: |
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/ CFRSearch.cfm?CFRPart=820 |
Design Control Guidance for Medical Device Manufacturers: |
http://www.fda.gov/cdrh/comp/designgd.pdf |
Preproduction Quality Assurance Planning
Recommendations for Medical Device Manufacturers (FDA 90-4236): |
http://www.fda.gov/cdrh/manual/appende.html |
The Review and Inspection of Premarket
Approval Applications under the Bioresearch Monitoring ProgramDraft Guidance for Industry and FDA Staff: |
http://www.fda.gov/cdrh/comp/guidance/1602.pdf |
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FDA/CDRH Search Engines: |
CDRH Guidance Search Engine: |
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfggp/ search.cfm |
CDRH Premarket Approval (PMA) Search Engine: |
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/ pma.cfm |
CDRH 510(k) Search Engine: |
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/ pmn.cfm |
CDRH Recognized STANDARDS Search Engine: |
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/ search.cfm |
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FDA/CBER CFR and Guidances: |
21 CFR 312: Investigational New Drug Application: |
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/ CFRSearch.cfm?CFRPart=312 |
21 CFR 314: Applications for FDA Approval to Market a New Drug: |
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/ CFRSearch.cfm?CFRPart=31 |
21 CFR 610: General Biological Products Standards: |
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/ CFRSearch.cfm?CFRPart=610 |
21 CFR 1271: Human Cells, Tissues and Cellular and Tissue-Based Products: |
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/ CFRSearch.cfm?CFRPart=1271 |
Cellular & Gene Therapy Guidances and Other Publications: |
http://www.fda.gov/cber/genetherapy/gtpubs.htm |
Human Tissue Guidances and Other Publications: |
http://www.fda.gov/cber/tissue/docs.htm |
CBER Product Approval Information: |
http://www.fda.gov/cber/efoi/approve.htm |
21 CFR 600, 601 BLA Regulations: |
http://www.access.gpo.gov/nara/cfr/waisidx_07/21cfrv7_07.html |
21 CFR 210, 211 GMP Regulations: |
http://www.access.gpo.gov/nara/cfr/waisidx_07/21cfr210_07.html |
1.1?This guide is intended to provide characteristics, properties, test methods, and standardization approaches for evaluation and identification of specific polymerizable collagen formulations and collagen polymeric materials produced with these formulations.
1.2?This guide focuses on characterization of purified polymerizable forms of type I collagen, which is the most abundant collagen in mammalian connective tissues and organs, including skin, bone, tendon, and blood vessels. Polymerizable type I collagen may be derived from a variety of sources including, but not limited to, animal or cadaveric tissues, cell culture, recombinant cell culture, and chemical synthesis.
1.2.1?This guide covers evaluation of polymerizable collagens and collagen polymeric materials prepared from polymerizable collagens for use as a starting material for wound and hemostatic dressings, surgical implants, substrates for tissue-engineered medical products (TEMPs), delivery vehicles for therapeutic cells or molecules, and 3D in-vitro tissue systems for basic research, diagnostics, drug development, and toxicity testing. Most collagen products on the market today are regulated as devices since their primary intended purpose is not achieved through chemical action within or on the body. However, a medical product comprising polymerizable collagens or collagen polymeric materials may be regulated as a device, biologic, drug, or combination product depending on its intended use and primary mode of action.
1.2.2?Polymerizable collagen or collagen self-assembly implies that the collagen composition exhibits spontaneous macromolecular assembly from its components without the addition of exogenous factors such as cross-linking agents. Polymerizable collagens may include but are not limited to: (1.2.3?This guide may serve as a template for characterization and standardization of type I fibrillar collagen or other collagen types that demonstrate polymerization or self-assembly.
1.3?This guide does not provide a significant basis for assessing the biological safety (biocompatibility) of polymerizable collagens and collagen polymeric materials. While the ability of collagen polymeric materials to guide cellular responses through provision of cellular adhesion and proteolytic domains as well as physical constraints (for example, structural, cell-matrix traction force) has been well documented through extensive clinical and basic research studies 1.4?The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.5?The following precautionary caveat pertains only to the test method portion, Sections 6 and 7, 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.
Standard Practice for Testing for Cellular Responses to Particles in vitro |
|
ISO 10993–10 |
Biological Evaluation of Medical Devices--Part 10: Tests for Irritation and Delayed-Type Hypersensitivity |
USP 30/NF 19 |
Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin |
ICH S2B |
Guidance for Industry S2B Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals 62 FR 62472 (1997) |
ICH S5A |
Guideline for Industry S5A Detection of Toxicity to Reproduction for Medicinal Products 59 FR 48746 (1994) |
Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity |
|
Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices |
|
ISO 13408–1 |
Aseptic Processing of Health Care Products--Part 1: General Requirements |
ISO 14971 |
Medical Devices--Application of Risk Management to Medical Devices |
ISO 22442–1 |
Animal Tissues and their Derivatives Utilized in the Manufacture of Medical Devices--Part 1: Analysis and Management of Risk |
Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices |
|
ISO 10993–17 |
Methods for Establishment of Allowable Limits for Leachable Substances Using Health-Based Risk Assessment |
Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit |
|
Standard Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products (Withdrawn 2014) |
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Standard Practice for Extraction of Materials Used in Medical Devices |
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Standard Practice for Assessment of Hemolytic Properties of Materials |
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Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials |
|
Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test |
|
Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices |
|
ISO 22442–2 |
Animal Tissues and their Derivatives Utilized in the Manufacture of Medical Devices--Part 2: Controls on Sourcing, Collection, and Handling |
ISO 22442–3 |
Animal Tissues and their Derivatives Utilized in the Manufacture of Medical Devices--Part 3: Validation and the Elimination and/or Inactivation of Virus and Transmissable Agents |
United States Pharmacopeia (USP), Edition XXX (30) |
|
ICH S2A |
Guideline for Industry S2A Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals 61 FR 18199 (1996) |
ICH S1C(R) |
Guidance for Industry Addendum to Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addition of a Limit Dose and Related Notes 62 FR 64259 (1997) |
ICH Q1A ICH |
Harmonized Tripartite Guidance for Stability Testing of New Drug Substances and Products (September 23, 1994) |
U.S. Food and Drug Administration (FDA and Committee for Proprietary Medicinal Products (CPMP), 1998 |
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FDA |
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Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA) |
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U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER), 1993 |
Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals |
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Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use, 94D-0259 |
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Sterilization of Medical Devices--Microbiological Methods--Part 1: Estimation of Bioburden on Product |
ANSI/AAMI/ISO 11737-2: 1998 |
Sterilization of Medical Devices--Microbiological Methods--Part 2: Tests of Sterility Performed in the Validation of a Sterilization Process |
AAMI TIR No. 19-1998 |
Guidance for ANSI/AAMI/ISO 10993-7: 1995, Biological Evaluation of Medical Devices--Part 7: Ethylene Oxide Sterilization Residuals |
AAMI/ISO 14160-1998 |
Sterilization of Single-Use Medical Devices Incorporating Materials of Animal Origin--Validation and Routine Control of Sterilization by Liquid Chemical Sterilants |
AAMI ST67/CDV-2: 1999 |
Sterilization of Medical Devices--Requirements for Products Labeled Sterile |
Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications |
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European Pharmacopeia 5.0 |
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21 CFR Part 820 |
Quality System Regulation |
Federal Register Vol. 43 |
No. 141, Friday, July 21, 1978 |
21 CFR Parts 207, 807, and 1271 |
Human Cells, Tissues and Cellular and Tissue-Based Products, Establishment Registration and Listing |
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ICH S1A |
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ICH S1B |
Guidance for Industry S1B Testing for Carcinogenicity of Pharmaceuticals 63 FR 8983 (1998) |
ICH S1C |
Guideline for Industry S1C Dose Selection for Carcinogenicity Studies of Pharmaceuticals 60 FR 11278 (1995) |
ICH S5B |
Guidance for Industry S5B Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility 61 FR 15360 (1996) |
Current Good Tissue Practice for Manufacturers of Human Cellular and Tissue-Based Products |
Inspection and Enforcement. Proposed Rule. Federal Register/Vol. 66, No. 5/January 8, 2001/Proposed Rules, pp. 1552-1559 |
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CFR?610.13(b) |
Rabbit Pyrogen Assay |
ICH M3 |
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Standard Practice for Selecting Tests for Determining the Propensity of Materials to Cause Immunotoxicity |
|
Standard Practice for Evaluation of Immune Responses In Biocompatibility Testing Using ELISA Tests, Lymphocyte, Proliferation, and Cell Migration |
|
Standard Guide for Testing the Biological Responses to Medical Device Particulate Debris and Degradation Products in vivo |
|
ISO 10993–9 |
Framework for Identification and Quantification of Potential Degradation Products |
ISO 10993–1 |
Biological Evaluation of Medical Devices--Part 1: Evaluation and Testing with a Risk Management Process |
ISO 10993–3 |
Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity |
Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices |
|
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