Стандарты ASTM

ASTM F619-20

Действует

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

Описание Ссылки Версии

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Standard Practice for Sampling of Plastics (Withdrawn 1998) — 10 стр.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Standard Practice for Selecting Tests for Determining the Propensity of Materials to Cause Immunotoxicity (Withdrawn 2011) — 3 стр.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 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 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 F748-16

Действует

Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices — 7 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 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 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.