DS/EN ISO 10993-18
Biological evaluation of medical devices - Part 18: Chemical characterization of materials
inactive
| Organization: | DS |
| Publication Date: | 25 July 2005 |
| Status: | inactive |
| Page Count: | 30 |
| ICS Code (Biological evaluation of medical devices): | 11.100.20 |
scope:
This document describes a framework for the identification and, where necessary, quantification of the chemical constituents of a material to provide information required for inclusion in an assessment of the biological safety of medical devices. This part of ISO 10993 does not address the identification or quantification of degradation products, which are covered in ISO 10993 part 9, 13, 14 and 15. ISO 10993-18 is intended for suppliers of materials and manufacturers of medical devices, when carrying out a biological safety assessment.
Document History
August 1, 2023
Biological evaluation of medical devices – Part 18: Chemical characterization of medical device materials within a risk management process – Amendment 1: Determination of the uncertainty factor (ISO 10993-18:2020/Amd 1:2022)
This document specifies a framework for the identification, and if necessary, quantification of constituents of a medical device, allowing the identification of biological hazards and the estimation...
June 3, 2020
Biological evaluation of medical devices – Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)
This document specifies a framework for the identification, and if necessary, quantification of constituents of a medical device, allowing the identification of biological hazards and the estimation...
June 15, 2009
Biological evaluation of medical devices - Part 18: Chemical characterization of materials
This part of ISO 10993 describes a framework for the identification of a material and the identification and quantification of its chemical constituents. The chemical characterization information...
DS/EN ISO 10993-18
July 25, 2005
Biological evaluation of medical devices - Part 18: Chemical characterization of materials
This document describes a framework for the identification and, where necessary, quantification of the chemical constituents of a material to provide information required for inclusion in an...
Biological evaluation of medical devices – Part 18: Chemical characterization of medical device materials within a risk management process – Évaluation biologique (ISO/DIS 10993-18:2018)
This document specifies a framework for the identification of biological hazards and the estimation and control of biological risks from material constituents, using a stepwise approach to the...
Biological evaluation of medical devices – Part 18: Chemical characterization of medical device materials within a risk management process (ISO/FDIS 10993-18:2019)
This document specifies a framework for the identification of biological hazards and the estimation and control of biological risks from material constituents, using a stepwise approach to the...
Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)
This part of ISO 10993 describes a framework for the identification of a material and the identification and quantification of its chemical constituents. The chemical characterization information...
Biological evaluation of medical devices – Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)
This document specifies a framework for the identification, and if necessary, quantification of constituents of a medical device, allowing the identification of biological hazards and the estimation...
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