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ASTM F3089-14

Standard Guide for Characterization and Standardization of Polymerizable Collagen-Based Products and Associated Collagen-Cell Interactions

Automaticky přeložený název:

Standardní Průvodce pro charakterizaci a standardizaci polymerizabilních na bázi kolagenu Výrobky a související kolagenem interakcí mezi buňkami

NORMA vydána dne 1.5.2014

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Provedení	PDF - okamžité stažení - 1 919.40 Kč Tištěné - 1 919.40 Kč
Dostupnost	SKLADEM
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1 919.40 Kč

Informace o normě:

Označení normy: ASTM F3089-14
Poznámka: NEPLATNÁ
Datum vydání normy: 1.5.2014
Kód zboží: NS-54925
Počet stran: 17
Přibližná hmotnost: 51 g (0.11 liber)
Země: Americká technická norma
Kategorie: Technické normy ASTM

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Kategorie - podobné normy:

Anotace textu normy ASTM F3089-14 :

Keywords:
biomaterials, characterization, collagen-cell interactions, collagen polymer, self-assembly, tunable, ICS Number Code 11.100.99 (Other standards related to laboratory medicine)

Doplňující informace

Significance and Use

4.1 The objective of this document is to provide guidance in the production, characterization, testing, and standardization of: (a) collagen polymers as a starting material for surgical implants, substrates for tissue-engineered medical products (TEMPs), vehicles for therapeutic cells and molecules, and 3D in-vitro tissue systems for basic research, drug development, and toxicity testing; and 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) wound and hemostatic dressings, surgical implants or injectables, hybrid medical devices, tissue-engineered medical products (TEMPs), injectable or implantable delivery vehicles for therapeutic cells, molecules, and drugs, and 3D in-vitro tissue systems or models for basic research, drug development, and toxicity testing. The practical application of the collagen polymers and associated self-assembled collagen-based materials should be based, among other factors, on biocompatibility, application-specific performance measures, as well as chemical, physical, and biological test data. Recommendations in this guide should not be interpreted as a guarantee of success for any research or medical 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 polymer, impurities profile, and comprehensive chemical, physical, and biological characterization and testing.

4.4 The following documents or other relevant guidances 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 in-vitro tissue systems:

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

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 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.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

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. Scope

1.1 This guide for characterizing polymerizable collagens is intended to provide characteristics, properties, test methods, and standardization approaches for use by producers, manufacturers, and researchers to identify specific collagen polymer formulations and associated self-assembled collagen-based products produced with these formulations. This guide will focus on the characterization of polymer forms of Type I collagen, which is the most abundant collagen in mammalian connective tissues and organs, including skin, bone, tendon, and blood vessels. Type I collagen may be derived from a variety of sources including, but not limited to, animal or cadaveric tissues, cell culture, recombinant, and chemical synthesis. This guide is intended to focus on purified Type I collagen polymers 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, drug development, and toxicity testing. Polymerizable or self-assembly implies that the collagen composition exhibits spontaneous macromolecular assembly from its components in the absence of the addition of exogenous factors including cross-linking agents. Self-assembling collagen polymers may include, but are not limited to: (1) tissue-derived atelocollagens, monomers, and oligomers; (2) collagen proteins and peptides produced using recombinant technology; and 1.2 The ability of self-assembled collagen 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 (1, 2)² and basic research studies 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 the Environmental Protection Agency (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 the EPA 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 and health practices and determine the applicability of regulatory limitations prior to use.

2. Referenced Documents

F1903-18	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)
F895-11(2016)	Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
F981-23	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
F813-20	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
F749-20	Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit
E1298-06	Standard Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products (Withdrawn 2014)
F619-20	Standard Practice for Extraction of Materials Used in Medical Devices
F756-17	Standard Practice for Assessment of Hemolytic Properties of Materials
F763-22	Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials
F720-17	Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test
F748-16	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	International Conference on Harmonization (ICH), Quality of Biotechnological Products: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin, Consensus Guideline ICH Viral Safety Document: Step 5
FDA	Guidance for Industry Pyrogen and Endotoxins Testing: Questions and Answers, DHHS, June 2012
F2148-18	Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA)
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
U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER), 1997	Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use, 94D-0259
FDA	Interim Guidance for Human and Veterinary Drug Products and Biologicals, Kinetic LAL techniques, DHHS, July 15, 1991
ANSI/AAMI/ISO 11737-1: 2006	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
F1983-23	Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications
European Pharmacopeia 5.0
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
Federal Register, Vol. 66	No. 13, Jan. 19, 2001/Rules and Regulations, p. 5447
Federal Register, Vol. 72	No. 8, Jan. 12, 2007, pp. 1581-1619, Proposed Rule: Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants
21 CFR 312	Investigational New Drug Application
21 CFR Part 1271, Part C	Suitability Determination for Donors of Human Cell and Tissue-based Products, Proposed Rule
ICH S1A	Guideline for Industry S1A The Need for Long-term Rodent Carcinogenicity Studies of Pharmaceuticals 61 FR 8153 (1996)
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
Guidance for Screening and Testing of Donors of Human Tissue Intended for Transplantation	Availability. Federal Register/Vol. 62, No. 145/July 29, 1997/Notices Draft Guidance for Preclinical and Clinical Investigations of Urethral Bulking Agents used in the Treatment of Urinary Incontinence. November 29, 1995. (ODE/DRARD/ULDB), Document No. 850
Guidance for Industry and for FDA Reviewers	Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices), November 6, 1998, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health
CFR?610.13(b)	Rabbit Pyrogen Assay
ICH M3	Guidance for Industry M3 Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals 62 FR 62922 (1997)
F1905-98	Standard Practice for Selecting Tests for Determining the Propensity of Materials to Cause Immunotoxicity
F1906-98	Standard Practice for Evaluation of Immune Responses In Biocompatibility Testing Using ELISA Tests, Lymphocyte, Proliferation, and Cell Migration
F1904-23	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
F1251-89(1995)	Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices
F1439-03(2018)	Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials