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СтандартыASTM

ASTM F619-20

Действует
Standard Practice for Extraction of Materials Used in Medical Devices — 4 стр.
ОписаниеСсылкиВерсии

Ссылочные документы

ASTM D1239-22a
Действует
Standard Test Method for Resistance of Plastic Films to Extraction by Chemicals — 3 стр.
ASTM D1193-06(2018)
Действует
Standard Specification for Reagent Water — 6 стр.
ASTM D570-22
Действует
Standard Test Method for Water Absorption of Plastics — 4 стр.
ASTM F748-16
Действует
Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices — 7 стр.
ASTM D543-21
Действует
Standard Practices for Evaluating the Resistance of Plastics to Chemical Reagents — 8 стр.
ASTM D1898-68(1989)
Отменен
Standard Practice for Sampling of Plastics (Withdrawn 1998) — 10 стр.
ASTM F619-14
Заменен
Standard Practice for Extraction of Medical Plastics — 4 стр.

На этот документ ссылаются

ASTM F2695-12
Заменен
Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications — 4 стр.
ASTM F719-20
Заменен
Standard Practice for Testing Materials in Rabbits for Primary Skin Irritation — 3 стр.
ASTM F719-20e1
Действует
Standard Practice for Testing Materials in Rabbits for Primary Skin Irritation — 3 стр.
ASTM F619-14
Заменен
Standard Practice for Extraction of Medical Plastics — 4 стр.
ASTM F2148-18
Действует
Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA) — 5 стр.
ASTM F2147-01(2016)
Действует
Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens — 5 стр.
ASTM F750-20
Действует
Standard Practice for Evaluating Acute Systemic Toxicity of Material Extracts by Systemic Injection in the Mouse — 4 стр.
ASTM F749-20
Действует
Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit — 3 стр.
ASTM F1903-18
Действует
Standard Practice for Testing for Cellular Responses to Particles <emph type="bdit" >in vitro</emph> — 5 стр.
ASTM F1905-98(2003)
Отменен
Standard Practice for Selecting Tests for Determining the Propensity of Materials to Cause Immunotoxicity (Withdrawn 2011) — 3 стр.
ASTM F720-17
Действует
Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test — 3 стр.
ASTM F813-20
Действует
Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices — 5 стр.
ASTM F2212-19
Заменен
Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs) — 14 стр.
ASTM F451-16
Заменен
Standard Specification for Acrylic Bone Cement — 11 стр.
ASTM F648-14
Заменен
Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants — 8 стр.
ASTM F2565-13
Заменен
Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications — 4 стр.
ASTM E2097-00(2014)
Отменен
Standard Guide for Determining the Impact of Extractables from Non-Metallic Materials on the Safety of Biotechnology Products (Withdrawn 2022) — 5 стр.
ASTM F3127-16
Заменен
Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices — 16 стр.
ASTM F3089-14
Заменен
Standard Guide for Characterization and Standardization of Polymerizable Collagen-Based Products and Associated Collagen-Cell Interactions — 17 стр.
ASTM F1904-14
Заменен
Standard Practice for Testing the Biological Responses to Particles <emph type="bdit" >in vivo</emph> — 3 стр.
ASTM F756-17
Действует
Standard Practice for Assessment of Hemolytic Properties of Materials — 6 стр.
ASTM F3127-22
Действует
Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices — 17 стр.
ASTM F3089-23
Действует
Standard Guide for Characterization and Standardization of Polymerizable Collagen-Based Products and Associated Collagen-Cell Interactions — 20 стр.
ASTM F2042-18
Действует
Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—;Crosslinking and Fabrication — 7 стр.
ASTM F648-21
Действует
Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants — 9 стр.
ASTM F2212-20
Действует
Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs) — 14 стр.
ASTM F2103-18
Действует
Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications — 9 стр.
ASTM F2064-17
Действует
Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications — 9 стр.
ASTM F1906-98(2003)
Отменен
Standard Practice for Evaluation of Immune Responses In Biocompatibility Testing Using ELISA Tests, Lymphocyte, Proliferation, and Cell Migration (Withdrawn 2011) — 5 стр.
ASTM F2695-12(2020)
Действует
Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications — 4 стр.
ASTM F602-09(2015)
Отменен
Standard Criteria for Implantable Thermoset Epoxy Plastics (Withdrawn 2024) — 4 стр.
ASTM F2565-21
Действует
Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications — 4 стр.
ASTM F451-21
Действует
Standard Specification for Acrylic Bone Cement — 16 стр.
ASTM F2759-19
Действует
Standard Guide for Assessment of the Ultra-High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices — 6 стр.
ASTM F2347-24
Действует
Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications — 9 стр.
ASTM F2347-15
Заменен
Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications — 10 стр.
ASTM F561-19
Действует
Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids — 23 стр.
ASTM F2027-16
Действует
Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products — 7 стр.
ASTM F1904-23
Действует
Standard Guide for Testing the Biological Responses to Medical Device Particulate Debris and Degradation Products <emph type="ital">in vivo</emph> — 10 стр.
ASTM F748-16
Действует
Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices — 7 стр.