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СтандартыASTM

ASTM F748-16

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

Ссылочные документы

ASTM F719-20e1
Действует
Standard Practice for Testing Materials in Rabbits for Primary Skin Irritation — 3 стр.
ASTM F619-20
Действует
Standard Practice for Extraction of Materials Used in Medical Devices — 4 стр.
ASTM E1262-88(2018)
Действует
Standard Guide for Performance of Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay — 5 стр.
ASTM F895-11(2016)
Действует
Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity — 5 стр.
ASTM F981-23
Действует
Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices — 5 стр.
ASTM F2382-24
Действует
Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT) — 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 F2065-00(2010)
Отменен
Standard Practice for Testing for Alternative Pathway Complement Activation in Serum by Solid Materials (Withdrawn 2016) — 7 стр.
ASTM F1984-99(2018)
Действует
Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials — 5 стр.
ASTM F1983-23
Действует
Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications — 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 F1903-18
Действует
Standard Practice for Testing for Cellular Responses to Particles <emph type="bdit" >in vitro</emph> — 5 стр.
ASTM F1439-03(2018)
Действует
Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials — 6 стр.
ASTM F1408-20a
Действует
Standard Practice for Subcutaneous Screening Test for Implant Materials — 5 стр.
ASTM F1027-86(2017)
Отменен
Standard Practice for Assessment of Tissue and Cell Compatibility of Orofacial Prosthetic Materials and Devices (Withdrawn 2023) — 11 стр.
ASTM F813-20
Действует
Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices — 5 стр.
ASTM F763-22
Действует
Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials — 5 стр.
ASTM F756-17
Действует
Standard Practice for Assessment of Hemolytic Properties of Materials — 6 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 F720-17
Действует
Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test — 3 стр.
ASTM F1877-16
Действует
Standard Practice for Characterization of Particles — 15 стр.
ASTM F748-06(2010)
Заменен
Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices — 8 стр.

На этот документ ссылаются

BS EN ISO 10993-6:2009
Заменен
Biological evaluation of medical devices. Tests for local effects after implantation — 32 стр.
BS EN ISO 10993-6:2016
Действует
Biological evaluation of medical devices. Tests for local effects after implantation — 44 стр.
ASTM F2229-12
Заменен
Standard Specification for Wrought, Nitrogen Strengthened 23Manganese-21Chromium-1Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S29108) — 6 стр.
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 F1581-08(2012)
Заменен
Standard Specification for Composition of Anorganic Bone for Surgical Implants — 4 стр.
ASTM F1581-08(2016)
Заменен
Standard Specification for Composition of Anorganic Bone for Surgical Implants — 4 стр.
ASTM F619-14
Заменен
Standard Practice for Extraction of Medical Plastics — 4 стр.
ASTM F813-07(2012)
Заменен
Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices — 5 стр.
ASTM F750-87(2012)
Заменен
Standard Practice for Evaluating Material Extracts by Systemic Injection in the Mouse — 3 стр.
ASTM F2148-18
Действует
Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA) — 5 стр.
ASTM F895-11
Заменен
Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity — 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 F755-99(2011)
Заменен
Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants — 3 стр.
ASTM F2567-06(2010)
Отменен
Standard Practice for Testing for Classical Pathway Complement Activation in Serum by Solid Materials (Withdrawn 2016) — 10 стр.
ASTM F2313-10
Заменен
Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70 % Glycolide — 10 стр.
ASTM F1855-00(2011)
Заменен
Standard Specification for Polyoxymethylene (Acetal) for Medical Applications — 2 стр.
ASTM F2901-13
Заменен
Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices — 3 стр.
ASTM F997-10
Заменен
Standard Specification for Polycarbonate Resin for Medical Applications — 3 стр.
ASTM F2103-11
Заменен
Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications — 8 стр.
ASTM F748-06(2010)
Заменен
Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices — 8 стр.
ASTM F2150-13
Заменен
Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products — 12 стр.
ASTM F1635-11
Заменен
Standard Test Method for <i>in vitro</i> Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants — 7 стр.
ASTM F756-13
Заменен
Standard Practice for Assessment of Hemolytic Properties of Materials — 5 стр.
ASTM F2148-13
Заменен
Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA) — 5 стр.
ASTM F2579-10
Заменен
Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants — 11 стр.
ASTM F623-99(2013)
Заменен
Standard Performance Specification for Foley Catheter — 8 стр.
ASTM F2315-11
Заменен
Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels — 8 стр.
ASTM F1378-12
Заменен
Standard Specification for Shoulder Prostheses — 5 стр.
ASTM F1984-99(2013)
Заменен
Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials — 5 стр.
ASTM F2759-11
Заменен
Standard Guide for Assessment of the Ultra High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices — 6 стр.
ASTM F2042-00(2011)
Заменен
Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—;Crosslinking and Fabrication — 7 стр.
ASTM F1903-10
Заменен
Standard Practice for Testing For Biological Responses to Particles <i>In Vitro</i> — 4 стр.
ASTM F749-13
Заменен
Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit — 3 стр.
ASTM F451-08
Заменен
Standard Specification for Acrylic Bone Cement — 11 стр.
ASTM F2212-11
Заменен
Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs) — 13 стр.
ASTM F2065-00(2010)
Отменен
Standard Practice for Testing for Alternative Pathway Complement Activation in Serum by Solid Materials (Withdrawn 2016) — 7 стр.
ASTM F1439-03(2013)
Заменен
Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials — 6 стр.
ASTM F1984-99(2018)
Действует
Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials — 5 стр.
ASTM F895-11(2016)
Действует
Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity — 5 стр.
ASTM F2847-10
Заменен
Standard Practice for Reporting and Assessment of Residues on Single Use Implants — 9 стр.
ASTM F2902-12
Заменен
Standard Guide for Assessment of Absorbable Polymeric Implants — 13 стр.
ASTM F2739-08
Заменен
Standard Guide for Quantitating Cell Viability Within Biomaterial Scaffolds — 6 стр.
ASTM F2064-14
Заменен
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 F2848-16
Заменен
Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns — 5 стр.
ASTM F2739-16
Заменен
Standard Guide for Quantifying Cell Viability within Biomaterial Scaffolds — 7 стр.
ASTM F1378-17
Заменен
Standard Specification for Shoulder Prostheses — 6 стр.
ASTM F1378-18
Заменен
Standard Specification for Shoulder Prostheses — 6 стр.
ASTM F2739-19
Действует
Standard Guide for Quantifying Cell Viability and Related Attributes within Biomaterial Scaffolds — 8 стр.
ASTM F2902-16
Заменен
Standard Guide for Assessment of Absorbable Polymeric Implants — 14 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 F2229-20
Заменен
Standard Specification for Wrought, Nitrogen Strengthened 23Manganese-21Chromium-1Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S29108) — 6 стр.
ASTM F451-16
Заменен
Standard Specification for Acrylic Bone Cement — 11 стр.
ASTM F2665-09(2014)
Заменен
Standard Specification for Total Ankle Replacement Prosthesis — 7 стр.
ASTM F648-14
Заменен
Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants — 8 стр.
ASTM F2820-12
Заменен
Standard Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications — 6 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 F2848-17
Заменен
Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns — 5 стр.
ASTM F1781-15
Заменен
Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants — 5 стр.
ASTM F1813-13
Заменен
Standard Specification for Wrought Titanium<span class='unicode'>–;</span>12 Molybdenum<span class='unicode'>–;</span>6 Zirconium<span class='unicode'>–;</span>2 Iron Alloy for Surgical Implant (UNS R58120) — 5 стр.
ASTM F1713-08(2013)
Заменен
Standard Specification for Wrought Titanium-13Niobium-13Zirconium Alloy for Surgical Implant Applications (UNS R58130) — 5 стр.
ASTM F1925-09
Заменен
Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants — 9 стр.
ASTM F1925-17
Заменен
Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants — 9 стр.
ASTM F702-10
Заменен
Standard Specification for Polysulfone Resin for Medical Applications — 4 стр.
ASTM F763-04(2016)
Заменен
Standard Practice for Short-Term Screening of Implant Materials — 4 стр.
ASTM F703-18
Заменен
Standard Specification for Implantable Breast Prostheses — 10 стр.
ASTM F619-20
Действует
Standard Practice for Extraction of Materials Used in Medical Devices — 4 стр.
ASTM F2051-00(2022)
Действует
Standard Specification for Implantable Saline-Filled Breast Prostheses — 6 стр.
ASTM F1441-03(2022)
Действует
Standard Specification for Soft-Tissue Expander Devices — 5 стр.
ASTM F1441-03(2014)
Заменен
Standard Specification for Soft-Tissue Expander Devices — 5 стр.
ASTM F881-94(2014)
Заменен
Standard Specification for Silicone Elastomer Facial Implants — 3 стр.
ASTM F2051-00(2014)
Заменен
Standard Specification for Implantable Saline Filled Breast Prosthesis — 6 стр.
ASTM E2524-08(2013)
Заменен
Standard Test Method for Analysis of Hemolytic Properties of Nanoparticles (Withdrawn 2022) — 5 стр.
ASTM E2524-22
Действует
Standard Test Method for Analysis of Hemolytic Properties of Nanoparticles — 6 стр.
ASTM F703-18(2022)
Действует
Standard Specification for Implantable Breast Prostheses — 10 стр.
ASTM F1828-17
Заменен
Standard Specification for Ureteral Stents — 8 стр.
ASTM F1828-97(2014)
Заменен
Standard Specification for Ureteral Stents — 6 стр.
ASTM F641-09(2014)
Заменен
Standard Specification for Implantable Epoxy Electronic Encapsulants — 4 стр.
ASTM F3089-14
Заменен
Standard Guide for Characterization and Standardization of Polymerizable Collagen-Based Products and Associated Collagen-Cell Interactions — 17 стр.
ASTM F1713-08(2021)e1
Действует
Standard Specification for Wrought Titanium-13Niobium-13Zirconium Alloy for Surgical Implant Applications (UNS R58130) — 5 стр.
ASTM F2579-18
Действует
Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants — 12 стр.
ASTM F1357-14
Заменен
Standard Specification for Articulating Total Wrist Implants — 5 стр.
ASTM F1357-14(2019)
Заменен
Standard Specification for Articulating Total Wrist Implants — 5 стр.
ASTM F1828-22
Действует
Standard Specification for Ureteral Stents — 8 стр.
ASTM F1027-86(2012)
Заменен
Standard Practice for Assessment of Tissue and Cell Compatibility of Orofacial Prosthetic Materials and Devices — 11 стр.
ASTM F2066-13e1
Заменен
Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150) — 6 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 F2887-12
Заменен
Standard Specification for Total Elbow Prostheses — 9 стр.
ASTM F2887-17
Заменен
Standard Specification for Total Elbow Prostheses — 9 стр.
ASTM F2901-19
Действует
Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices — 5 стр.
ASTM F2808-23
Действует
Standard Test Method for Performing Behind-the-Knee (BTK) Test for Evaluating Skin Irritation Response to Products and Materials That Come Into Repeated or Extended Contact with Skin — 24 стр.
ASTM F2808-10
Заменен
Standard Test Method for Performing Behind-the-Knee (BTK) Test for Evaluating Skin Irritation Response to Products and Materials That Come Into Repeated or Extended Contact with Skin — 23 стр.
ASTM F702-18
Действует
Standard Specification for Polysulfone Resin for Medical Applications — 4 стр.
ASTM F2315-18
Действует
Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels — 8 стр.
ASTM F1088-04a(2010)
Заменен
Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation — 2 стр.
ASTM F1185-03(2014)
Заменен
Standard Specification for Composition of Hydroxylapatite for Surgical Implants — 3 стр.