BS EN ISO 10993-18:2020 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).
- 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).
- Judging equivalence of a proposed material to a clinically established material.
- 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.
-Screening of potential new materials for suitability in a medical device for a proposed clinical application.
BS EN ISO 10993-18:2020 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.
This part of ISO 10993 is intended for suppliers of materials and manufacturers of medical devices, when
carrying out a biological safety assessment.
Cross References:ISO 22442-2
ASTM F2129-17b
ISO 10993-9
ISO 5832-1
ISO 5725-1
ISO 10993-14
ISO 10993-13
ISO/TR 10993-22
EN 455-3
ISO 10993-2
ISO 10993-15
ISO 22442-1
ISO 22442-3
ISO/TS 10993-19
ISO/TS 21726
ISO 10993-12:2012
All current amendments available at time of purchase are included with the purchase of this document. | File Size : | 1
file
, 3.1 MB |
| ISBN(s) : | 9780539163582 |
| Note : | This product is unavailable in Ukraine, Russia, Belarus |
| Number of Pages : | 84 |
| Product Code(s) : | 30431216, 30431216 |
| Published : | 12/14/2020 |
