ISO/TS 20993:2006

Withdrawn

Biological evaluation of medical devices Guidance on a risk-management process

Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Withdrawn date

03-20-2019

Language(s)

English

Published date

07-26-2006

Publisher

International Organization for Standardization

ISO/TS 20993:2006 describes a process by which a manufacturer can identify the biological hazards associated with medical devices, estimate and evaluate the risks, control these risks and monitor the effectiveness of the control.

DocumentType	Technical Specification
Pages	4
PublisherName	International Organization for Standardization
Status	Withdrawn

07/30160957 DC : 0

EN ISO 10993-5 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 5: TESTS FOR IN VITRO CYTOTOXICITY

ISO 10993-3:2014	Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
ISO 10993-4:2017	Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
ISO 10993-16:2017	Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
ISO/TS 10993-20:2006	Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices
ISO 10993-13:2010	Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
ISO 10993-2:2006	Biological evaluation of medical devices — Part 2: Animal welfare requirements
ISO 10993-14:2001	Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics
ISO 10993-8:2000	Biological evaluation of medical devices Part 8: Selection and qualification of reference materials for biological tests
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 10993-10:2010	Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
ISO 10993-11:2017	Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
ISO 10993-12:2012	Biological evaluation of medical devices Part 12: Sample preparation and reference materials
ISO 10993-7:2008	Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
ISO 10993-17:2002	Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 10993-9:2009	Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
ISO 14971:2007	Medical devices Application of risk management to medical devices
ISO 10993-6:2016	Biological evaluation of medical devices Part 6: Tests for local effects after implantation