ISO 10993-11:2017 pdf download

ISO 10993-11:2017 pdf download.Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
1 Scope
This document specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
ISO 10993-2, Biological evaluation of medical devices — Part 2: Animal welfare requirements
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 10993-1 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http://www.electropedia.org/
— ISO Online browsing platform: available at http: //www.iso.org/obp
3.1 dose
dosage
amount of test sample administered (e.g. mass, volume) expressed per unit of body weight or surface area
3.2 dose-effect
relationship between the dosage and the magnitude of a defined biological effect either in an individual or in a population sample
3.3 dose-response
relationship of dosage to the spectrum of effects related to the exposure
Note 1 to entry: There are two types of dose-response relationships. The first type is the response of an individual to a range of doses. The second type is the distribution of responses of a population of individuals to a range of doses.
4 General considerations
4.1 General
Before a decision to perform a systemic toxicity test is made, ISO 10993-1 shall be taken into account. The decision to perform a test shall be justified on the basis of an assessment of the risk of systemic toxicity. Selection of the appropriate test(s) for a device shall be in accordance with ISO 10993-1, giving due consideration to mode and duration of contact. Testing shall be performed on the final product and/or representative component samples of the final product and/or materials. Test samples shall reflect the conditions under which the device is normally manufactured and processed. If deviations are necessary, they shall be recorded in the test report, together with their justification. For hazard identification purposes, it may be necessary to exaggerate exposure to the test samples. Physical and chemical properties of the test sample including, for example, pH, stability, viscosity, osmolality, buffering capacity, solubility and sterility, are some factors to consider when designing the study. When animal tests are considered, all reasonably and practically available replacement, reduction and refinement alternatives should be identified and implemented to satisfy the provisions of ISO 10993-2. For in vivo acute toxicity testing, in vitro cytotoxicity data are useful in estimating starting doses.