ISO 10993-9 pdf download – Biological evaluation of medicaldevices — Part 9: Framework for identification and quantification of potential degradation products

ISO 10993-9 pdf download – Biological evaluation of medicaldevices — Part 9: Framework for identification and quantification of potential degradation products.
ISO 10993-13, Iso 10993-14 and ISO 10993-15 consider only those degradation products generated by a chemical alteration of the linished device. They are not applicable to degradation of the device induced during its intended use by mechanical stress, wear or electromagnetic radiation. For such degradation other methods should be considered.
4.2 Preliminary considerations
Careful consideration of the potential for intended or unintended degradation of a material is essential to the evaluation of the biological safety of a device. Part of this consideration is an assessment of the chemical characteristics and known degradation mechanisms, followed by an assessment of the need for, and design of, experimental degradation studies.
It is neither necessary nor practical to conduct degradation studies for all medical devices. Refer to Annex A to determine when degradation studies should be considered. The assessment of the need for experimental degradation studies shall include a review of the literature and/or documented dinical experience. Guidance on proper reviewing of the literature can be found in ISO 10993-1. Such an assessment can potentially result in the conclusion that no further testing is needed.
Guidance on the biological evaluation of leachables including degradation products is given in ISO 10993-1, ISO 10993-16 and ISO 10993-17. See ISO 10993-18 for guidance on the chemical characterization of materials and their leachables used In medical devices. See lSO/TS 10993-19 for guidance on the physico-chomical, morphological and topographical characterization of materials. Consideration of these standards prior to conducting degradation studies can prove helpful in distinguishing degradation products from other leachables.
NOTE Despite the difference between degradation products and other leachablec, It can be possible to combine a study on degradation products with a study on other leachable components. Distinguishing between degradation products and other types of leachables might not be necessary for further biological evaluation studies. However, when a reduction of the level of leachable components Ls deemed necessary as a risk control measure, this information Is important. Additionally, some degradation products cannot leach from the device but can still Impact the properties of the device.
4.3 Study design
A degradation study plan complete with the purpose of the study shall be designed and documented to address the issues identified in 41.. The approved study plan shall define the analytical methods by which the following characteristics of degradation products are to be investigated:
a) chemical properties;
b) physicochemical properties:
c physical morphology (as applicable).
The approved study plan shall also describe the methods used to generate degradation products. The methods for generating degradation products should be optimized and scientifically justified. The degradation products should be identified and quantified using methods described in ISO 10993-18.
This annex contains aspects that need to be considered in the evaluation of possible degradation. Appropriate practical studies should be considered in the case where essential information is missing on the degradation of devices or materials and the biological effects of potential deradatlon products.
B.2 Description of medical device and/or material
The following should be considered when describing the device or material under study:
a) name of medical device and/or material;
b) function of medical device;
c) intended use;
d) intended biological environment;
e) composition of the material;
f) conditioning of the material (e.g. processing, sterilization);
g) surface condition;
h) dimensions;
i) construction of device or material under study (e.g. single component, single component to be used with others and the nature of their interaction, or multicumponent device — assessment carried out for each component material);
j) contact duration;
k) shelilife;
NOTE For some products storage can impact degradation, and therefore degradation studies to support labelled shelf lire can be Important.
I) other relevant characterizations.
B.3 Assessment of potential and known degradation products
B.3.1 General
l)egradat inn of material can occur within the bulk, or majority, or the material. Degradation can also occur at the surface of the material. Both bulk and surface degradation can occur at the same time and can influence one another.