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ISO 10993-18
Biological evaluation of medical devices Part 18: Chemical characterization of materials - First Edition
Organization:
ISO - International Organization for Standardization
Year: 2005
Abstract: 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 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.
This part of ISO 10993 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 10993-1:2003).
This part of ISO 10993 is intended for suppliers of materials and manufacturers of medical devices, when carrying out a biological safety assessment.
— 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.
This part of ISO 10993 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 10993-1:2003).
This part of ISO 10993 is intended for suppliers of materials and manufacturers of medical devices, when carrying out a biological safety assessment.
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| contributor author | ISO - International Organization for Standardization | |
| date accessioned | 2017-09-04T18:50:47Z | |
| date available | 2017-09-04T18:50:47Z | |
| date copyright | 2005.07.01 | |
| date issued | 2005 | |
| identifier other | KVSEIBAAAAAAAAAA.pdf | |
| identifier uri | https://yse.yabesh.ir/std/handle/yse/232219 | |
| description abstract | 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 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. This part of ISO 10993 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 10993-1:2003). This part of ISO 10993 is intended for suppliers of materials and manufacturers of medical devices, when carrying out a biological safety assessment. | |
| language | English | |
| title | ISO 10993-18 | num |
| title | Biological evaluation of medical devices Part 18: Chemical characterization of materials - First Edition | en |
| type | standard | |
| page | 24 | |
| status | Active | |
| tree | ISO - International Organization for Standardization:;2005 | |
| contenttype | fulltext |