30-04-2006, 04:18 PM
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
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