ISO 10993
Encyclopedia
The ISO 10993 set entails a series of standards for evaluating the biocompatibility
of a medical device
prior to a clinical study . These documents were preceded by the Tripartite agreement and is a part of the harmonisation
of the safe use evaluation
of medical devices .
Biocompatibility
Biocompatibility is related to the behavior of biomaterials in various contexts. The term may refer to specific properties of a material without specifying where or how the material is used , or to more empirical clinical success of a whole device in...
of a medical device
Medical device
A medical device is a product which is used for medical purposes in patients, in diagnosis, therapy or surgery . Whereas medicinal products achieve their principal action by pharmacological, metabolic or immunological means. Medical devices act by other means like physical, mechanical, thermal,...
prior to a clinical study . These documents were preceded by the Tripartite agreement and is a part of the harmonisation
Harmonisation
Harmonisation may refer to:* In music, the implementation of harmony, usually by using chords, including harmonized scales* Harmonisation of law, the process of establishing common laws and standards across the European Union...
of the safe use evaluation
Evaluation
Evaluation is systematic determination of merit, worth, and significance of something or someone using criteria against a set of standards.Evaluation often is used to characterize and appraise subjects of interest in a wide range of human enterprises, including the arts, criminal justice,...
of medical devices .
List of the standards in the 10993 series
- ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing in the risk management process
- ISO 10993-2:2006 Biological evaluation of medical devices Part 2: Animal welfare requirements
- ISO 10993-3:2003 Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
- ISO 10993-4:2002/Amd 1:2006 Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood
- ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
- ISO 10993-6:2007 Biological evaluation of medical devices Part 6: Tests for local effects after implantation
- ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
- ISO 10993-8:2001 Biological evaluation of medical devices Part 8: Selection of reference materials
- ISO 10993-9:1999 Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
- ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and delayed-type hypersensitivity
- ISO 10993-11:2006 Biological evaluation of medical devices Part 11: Tests for systemic toxicity
- ISO 10993-12:2007 Biological evaluation of medical devices Part 12: Sample preparation and reference materials (available in English only)
- ISO 10993-13:1998 Biological evaluation of medical devices Part 13: Identification and quantification of degradation products from polymeric medical devices
- ISO 10993-14:2001 Biological evaluation of medical devices Part 14: Identification and quantification of degradation products from ceramics
- ISO 10993-15:2000 Biological evaluation of medical devices Part 15: Identification and quantification of degradation products from metals and alloys
- ISO 10993-16:1997 Biological evaluation of medical devices Part 16: Toxicokinetic study design for degradation products and leachables
- ISO 10993-17:2002 Biological evaluation of medical devices Part 17: Establishment of allowable limits for leachable substances
- ISO 10993-18:2005 Biological evaluation of medical devices Part 18: Chemical characterization of materials
- ISO/TS 10993-19:2006 Biological evaluation of medical devices Part 19: Physico-chemical, morphological and topographical characterization of materials
- ISO/TS 10993-20:2006 Biological evaluation of medical devices Part 20: Principles and methods for immunotoxicology testing of medical devices