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ISO 10993-1-2009 pdf free download
ISO 10993-1-2009 pdf free download.Biological evaluation of medical devices — Part 1:Evaluation and testing within a risk management process
Evaluation biologique des dispositifs médicaux — Partie 1: Evaluation et essais au sein d’un processus de gestion du risque.
6.1 Material characterization
Material characterization is a crucial first step in the biological evaluation process. The extent of chemical characterization required depends on what pre-clinical and clinical safety and toxicological data exist, and on the nature and duration of body contact with the medical device; but, as a minimum, the characterization shall address the constituent chemicals of the device and possible residual process aids or additives used in its manufacture. Material characterization is described in ISO 10993-18 and ISOITS 10993-19.
Figure 1 indicates how the different steps in the chemical characterization process link to the overall biological evaluation decision points.
If the combination of all materials, chemicals and processes has an established history of safe use in the intended application, then further characterization and biological evaluation might not be necessary.
The identity and quantity of novel materials and chemicals present should be established or measured.
For device extractables and leachables that have known toxicological data relevant to the intended dose and for which route and frequency of exposure that indicate adequate safety margins exist, the need for further testing is likely to be minimal or non-existent. For devices that have known leachable chemical mixtures, potential synergies of the leachable chemicals should be considered.
The results of the risk assessment can lead to the conclusion that additional material characterization is necessary, for example, where the margin of safety is not considered adequate if the entire amount of a particular chemical were to leach out. In such cases, appropriate extraction testing, simulating clinical exposure, can be used to estimate the degree of clinical exposure to the chemical constituent. The acceptability of the level of leachables shall be established in accordance with ISO 10993-17.
Where the potential for degradation exists under the conditions or manufacture, sterilization, transport, storage, and use of the device, the presence and nature of degradation products shall be characterized in accordance with ISO 10993-9, ISO 10993-13, ISO 10993-14, and ISO 10993-15.
6.2 Biological evaluation tests
Assess all reasonably and practicably available information and compare to the data set(s) needed to assess the biological safety of the device (see Annex A and Clause 4). Identify any additional data or testing needed to complete the data sets required to perform the risk assessment.ISO 10993-1-2009 pdf free download.
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