Biomaterials Standards

[Guest]

Found at http://www.saiglobal.com/

ISO 1942-1:1989/Amd 5:1993
Dental vocabulary - Part 1: General and clinical terms - Amendment 5

ASTM F2150-02e1
Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products

ASTM F1251-89(2003)
Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices

ASTM F1538-03
Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation

ASTM F1983-99(2003)
Standard Practice for Assessment of Compatibiltiy of Absorbable/Resorbable Biomaterials for Implant Applications

ASTM F719-81(2002)e1
Standard Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation

ASTM F981-04
Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone

[Guest]

Found at http://www.saiglobal.com/

Standards Australia
AS 5833-2005
Implants for surgery - Acrylic resin cements

International Organization for Standardization Standards
ISO/TS 22911:2005
Dentistry - Preclinical evaluation of dental implant systems - Animal test methods

International Organization for Standardization Standards
ISO 16428:2005
Implants for surgery - Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices

Standards Australia
AS ISO 10993.12-2004
Biological evaluation of medical devices - Sample preparation and reference materials

Standards Australia
AS ISO 10993.17-2004
Biological evaluation of medical devices - Establishment of allowable limits for leachable substances

International Organization for Standardization Standards
ISO 22803:2004
Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file

Standards Australia
AS ISO 14155.1-2004
Clinical investigations of medical devices for human subjects - General requirements

International Organization for Standardization Standards
ISO 16429:2004
Implants for surgery - Measurements of open-circuit potential to assess corrosion behaviour of metallic implantable materials and medical devices over extended time periods

Standards Australia
AS 2320.4-2003
Implants for surgery - Metallic materials - Cobalt-chromium-molybdenum casting alloy

Standards Australia
AS 2320.5-2003
Implants for surgery - Metallic materials - Wrought cobalt-chromium-tungsten-nickel alloy

Standards Australia
AS 2320.6-2003
Implants for surgery - Metallic materials - Wrought cobalt-nickel-chromium-molybdenum alloy

Standards Australia
AS 2320.3-2003
Implants for surgery - Metallic materials - Wrought titanium 6-aluminium 4-vanadium alloy

International Organization for Standardization Standards
ISO 10993-3:2003
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

Standards Australia
AS ISO 14630-2003
Non-active surgical implants - General requirements

Standards Australia
AS ISO 10993.4-2003
Biological evaluation of medical devices - Selection of tests for interactions with blood

Standards Australia
AS ISO 14602-2003
Non-active surgical implants - Implants for Osteosynthesis - Particular requirements

Standards Australia
AS ISO 11979.8-2003
Opthalmic implants - Intraocular lenses - Fundamental requirements

Standards Australia
AS ISO 7198-2003
Cardiovascular implants - Tubular vascular prostheses

Standards Australia
AS ISO 5840-2003
Cardiovascular implants - Cardiac valve prostheses

Standards Australia
AS ISO 10993.7-2003
Biological evaluation of medical devices - Ethylene oxide sterilization residuals

Standards Australia
AS ISO 11979.7-2003
Opthalmic implants - Intraocular lenses - Clinical investigations

Standards Australia
AS ISO 10993.15-2003
Biological evaluation of medical devices - Identification and quantification of degradation products from metals and alloys

Standards Australia
AS EN 12442.2-2003
Animal tissues and their derivatives utilized in the manufacture of medical devices - Controls on sourcing, collection and handling

Standards Australia
AS ISO 10993.8-2003
Biological evaluation of medical devices - Selection and qualification of reference materials for biological tests

Standards Australia
AS ISO 25539.1-2003
Cardiovascular implants - Endovascular devices - Endovascular prostheses

Standards Australia
AS ISO 10993.14-2003
Biological evaluation of medical devices - Identification and quantification of degradation products from ceramics

Standards Australia
AS ISO 11979.4-2003
Opthalmic implants - Intraocular lenses - Labelling and information

Standards Australia
AS ISO 14708.1-2003
Implants for surgery - Active implantable medical devices - General requirements for safety, marking and for information to be provided by the manufacturer

Standards Australia
AS ISO 11979.2-2003
Opthalmic implants - Intraocular lenses - Optical properties and test methods

Standards Australia
AS ISO 11979.1-2003
Opthalmic implants - Intraocular lenses - Vocabulary

Standards Australia
AS ISO 10993.10-2003
Biological evaluation of medical devices - Tests for irritation and delayed type hypersensitivity

Standards Australia
AS ISO 11979.5-2003
Opthalmic implants - Intraocular lenses - Biocompatibility

Standards Australia
AS ISO 11979.3-2003
Opthalmic implants - Intraocular lenses - Mechanical properties and test methods

Standards Australia
AS ISO 14949-2003
Implants for surgery - Two-part addition-cure silicone elastomers

Standards Australia
AS ISO 15539-2003
Cardiovascular implants - Endovascular prostheses

Standards Australia
AS ISO 16061-2003
Instrumentation for use in association with non-active surgical implants - General requirements

Standards Australia
AS EN 12442.1-2003
Animal tissues and their derivatives utilized in the manufacture of medical devices - Analysis and management of risk

Standards Australia
AS ISO 11979.6-2003
Opthalmic implants - Intraocular lenses - Shelf-life and transport stability

Standards Australia
AS EN 12442.3-2003
Animal tissues and their derivatives utilized in the manufacture of medical devices - Validation of the elimination and/or inactivation of viruses and transmissible agents

Standards Australia
AS 2255-2003
Implants for surgery - Metal bone screws with hexagonal drive connection, spherical under-surface of head, asymmetrical thread - Dimensions

Standards Australia
AS 2320.2-2003
Implants for surgery - Metallic materials - Unalloyed titanium

International Organization for Standardization Standards
ISO 10993-12:2002
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials

International Organization for Standardization Standards
ISO 10993-4:2002
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood

Standards Australia
AS EN 540-2002
Clinical investigation of medical devices for human subjects

Standards Australia
AS ISO 10993.13-2002
Biological evaluation of medical devices - Identification and quantification of degradation products from polymeric medical devices

Standards Australia
AS EN 45502.1-2002
Active implantable medical devices - General requirements for safety, marking and information to be provided by the manufacturer

Standards Australia
AS ISO 10993.1-2002
Biological evaluation of medical devices - Evaluation and testing

Standards Australia
AS EN 50103-2002
Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for the active (including active implantable) medical device industry.

Standards Australia
AS ISO 10993.3-2002
Biological evaluation of medical devices - Tests for genotoxicity, carcinogenicity and reproductive toxicity

Standards Australia
AS ISO 10993.6-2002
Biological evaluation of medical devices - Tests for local effects after implantation

Standards Australia
AS ISO 10993.11-2002
Biological evaluation of medical devices - Tests for systemic toxicity

Standards Australia
AS ISO 10993.16-2002
Biological evaluation of medical devices - Toxicokinetic study design for degradation products and leachables

Standards Australia
AS ISO 10993.5-2002
Biological evaluation of medical devices - Tests for in vitro cytotoxicity

Standards Australia
AS ISO 10993.9-2002
Biological evaluation of medical devices - Framework for identification and quantification of potential degradation products

International Organization for Standardization Standards
ISO/TS 20225:2001
Global medical device nomenclature for the purpose of regulatory data exchange

International Organization for Standardization Standards
ISO/TS 14569-2:2001
Dental materials - Guidance on testing of wear - Part 2: Wear by two- and/or three body contact

International Organization for Standardization Standards
ISO 13779-2:2000
Implants for surgery - Hydroxyapatite - Part 2: Coatings of hydroxyapatite

International Organization for Standardization Standards
ISO 10993-16:1997
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables

International Organization for Standardization Standards
ISO 10993-6:1994
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation

International Organization for Standardization Standards
ISO/TR 11175:1993
Dental implants - Guidelines for developing dental implants

International Organization for Standardization Standards
ISO 1942-1:1989/Amd 5:1993
Dental vocabulary - Part 1: General and clinical terms - Amendment 5

[Guest]

More from http://www.astm.org/

F2451-05 Standard Guide forin vivo Assessment of Implantable Devices Intended to Repair or Regenerate Articular Cartilage

F1538-03 Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation

F2150-02e1 Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products

F1251-89(2003) Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices

F2212-02 Standard Guide for Characterization of Type I Collagen as a Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)

F1983-99(2003) Standard Practice for Assessment of Compatibiltiy of Absorbable/Resorbable Biomaterials for Implant Applications

F2347-03 Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications

F2027-00e1 Standard Guide for Characterization and Testing of Substrate Materials for Tissue-Engineered Medical Products

F981-04 Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone

F719-81(2002)e1 Standard Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation

F2064-00(2006) Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Products Application

F748-04 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices

F2211-04 Standard Classification for Tissue Engineered Medical Products (TEMPs)

F763-04 Standard Practice for Short-Term Screening of Implant Materials

F2103-01 Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications

F2042-00(2005) Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication

F1906-98(2003) Standard Practice for Evaluation of Immune Responses In Biocompatibility Testing Using ELISA Tests, Lymphocyte, Proliferation, and Cell Migration

F881-94(2000) Standard Specification for Silicone Elastomer Facial Implants

F2450-04 Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue Engineered Medical Products

F2393-04 Standard Specification for High-Purity Dense Magnesia Partially Stabilized Zirconia (Mg-PSZ) for Surgical Implant Applications

F2386-04 Standard Guide for Preservation of Tissue Engineered Medical Products (TEMPs)

F2315-03 Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels

F2224-03 Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants

F2091-01(2006) Standard Specification for Acetabular Prostheses

F2083-06 Standard Specification for Total Knee Prosthesis

F2068-03 Standard Specification for Femoral Prostheses—Metallic Implants

F2066-01 Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150)

F2051-00 Standard Specification for Implantable Saline Filled Breast Prosthesis

F1873-98 Standard Specification for High-Purity Dense Yttria Tetragonal Zirconium Oxide Polycrystal (Y-TZP) for Surgical Implant Applications

F1813-01 Standard Specification for Wrought Titanium - 12 Molybdenum - 6 Zirconium - 2 Iron Alloy for Surgical Implant (UNS R58120)

F1781-03 Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants

F1672-95(2005) Standard Specification for Resurfacing Patellar Prosthesis

F1580-01 Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants

F1542-94(2000) Standard Specification for the Requirements and Disclosure of Self-Closing Aneurysm Clips

F1472-02a Standard Specification for Wrought Titanium -6Aluminum -4Vanadium Alloy for Surgical Implant Applications (UNS R56400)

F1441-03 Standard Specification for Soft-Tissue Expander Devices

F1439-03 Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials

F1377-04 Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)

F1357-99(2004) Standard Specification for Articulating Total Wrist Implants

F1350-02 Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673)

F1341-99 Standard Specification for Unalloyed Titanium Wire UNS R50250, UNS R50400, UNS R50550, UNS R50700, for Surgical Implant Applications

F1185-03 Standard Specification for Composition of Hydroxylapatite for Surgical Implants

F1088-04a Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation

F961-03 Standard Specification for Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy Forgings for Surgical Implants [UNS R30035]

F799-02 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)

F755-99(2005) Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants

F754-00 Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Polymer Fabricated in Sheet, Tube, and Rod Shapes

F703-96(2002) Standard Specification for Implantable Breast Prostheses

F688-05 Standard Specification for Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035)

F648-04 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants

F641-98a(2003) Standard Specification for Implantable Epoxy Electronic Encapsulants

F620-00 Standard Specification for Alpha Plus Beta Titanium Alloy Forgings for Surgical Implants

F603-00 Standard Specification for High-Purity Dense Aluminum Oxide for Surgical Implant Application

F562-02 Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)

F561-05a Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids

F560-05 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications(UNS R05200, UNS R05400)

F451-99ae1 Standard Specification for Acrylic Bone Cement

F139-03 Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673)

F138-03 Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)

F136-02a Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)

F75-01 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)

F67-00 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)

D7026-04 Standard Guide for Sampling and Reporting of Results for Determination of Biobased Content of Materials via Carbon Isotope Analysis

D5747-95a(2002) Standard Practice for Tests to Evaluate the Chemical Resistance of Geomembranes to Liquids

[bioman]

hi glen,

have you got copies of these standards or can you tell me where to get my hands on them?

i am particularly interested in the following standard:

ASTM F981-04
Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone

[Guest]

i know you can buy the standards online but they are not exactly cheap.

in some cases your local university might have an online subscription that will allow you to have unlimited access too all of the applicable standards (usually downloadable as PDF's).

its worth asking your university librarian about this.

best of luck, glen [img]style_emoticons/<#EMO_DIR#>/smile.gif[/img]