ISO 10993-18:2005
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
Biological evaluation of medical devices — Part 18: Chemical characterization of materials
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English, French, Russian
30-06-2005
09-04-2025
ISO 10993-18:2005 describes a framework for the identification of a material and the identification and quantification of its chemical constituents. The chemical characterization information generated can be used for a range of important applications, for example, as part of an assessment of the overall biological safety of a medical device (ISO 10993-1 and 14971), as a measurement of the level of a leachable substance in a medical device in order to allow the assessment of compliance with the allowable limit derived for that substance from health based risk assessment (ISO 10993-17), for judging equivalence of a proposed material to a clinically established material, for judging equivalence of a final device to a prototype device to check the relevance of data on the latter to be used to support the assessment of the former, or for screening of potential new materials for suitability in a medical device for a proposed clinical application.
ISO 10993-18:2005 does not address the identification or quantification of degradation products, which is covered in ISO 10993-9, ISO 10993-13, ISO 10993-14 and ISO 10993-15.
The ISO 10993 series of standards is applicable when the material or device comes into contact with the body directly or indirectly (see 4.2.1 of ISO 10993-1).
ISO 10993-18:2005 is intended for suppliers of materials and manufacturers of medical devices, when carrying out a biological safety assessment.
| DevelopmentNote |
Supersedes ISO/DIS 10993-18 (07/2005)
|
| DocumentType |
Standard
|
| Pages |
17
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| SupersededBy |
| Standards | Relationship |
| DS EN ISO 10993-18 : 2009 | Identical |
| SS-EN ISO 10993-18:2009 | Identical |
| NS EN ISO 10993-18 : 2009 | Identical |
| NF EN ISO 10993-18 : 2009 | Identical |
| DIN EN ISO 10993-18:2009-08 | Identical |
| EN ISO 10993-18:2009 | Identical |
| NBN EN ISO 10993-18 : 2009 | Identical |
| I.S. EN ISO 10993-18:2009 | Identical |
| NEN EN ISO 10993-18 : 2009 | Identical |
| PN EN ISO 10993-18 : 2009 | Identical |
| GOST ISO 10993-18 : 2011 | Identical |
| BS EN ISO 10993-18:2009 | Identical |
| I.S. EN ISO 10993-18:2005 | Equivalent |
| BS EN ISO 10993-18:2005 | Equivalent |
| DIN EN ISO 10993-18:2005-10 | Equivalent |
| ANSI/AAMI BE83:2006(R2011) | Identical |
| UNE-EN ISO 10993-18:2006 | Identical |
| GOST R ISO 10993-18 : 2009 | Identical |
| UNE-EN ISO 10993-18:2009 | Identical |
| AAMI BE83 : 2006 | Identical |
| BS EN ISO 10993-18:2005 | Identical |
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