BS EN ISO 10993-11:2009 pdf free download.Biological evaluation of medical devices -Part11:Tests for systemic toxicity.
Systemic toxicity is a potential adverse effect of the use of medical devices. Generalized effects, as well as organ and organ system effects can result from absorption, distribution and metabolism of leachates from the device or its materials to parts of the body with which they are not in direct contact. This part of ISO 10993 addresses the evaluation of generalized systemic toxicity, not specific target organ or organ system toxicity, even though these effects may result from the systemic absorption and distribution of toxicants.
Because of the broad range of medical devices, and their materials and intended uses, this part of ISO 10993 is not overly prescriptive. Whilst it addresses specific methodological aspects to be considered in the design of systemic toxicity tests, proper study design must be uniquely tailored to the nature of the device’s materials and its intended clinical application.
Other elements of this part of ISO 10993 are prescriptive in nature, including those aspects that address compliance with good laboratory practices and elements for inclusion in reporting.
While some systemic toxicity tests (e.g. long term implantation or dermal toxicity studies) can be designed to study systemic effects as well as local, carcinogenic or reproductive effects, this document focuses only on those aspects of such studies, which are intended to address systemic effects. Studies which are intended to address other toxicological endpoints are addressed in ISO 10993-3, ISO 10993-6, ISO 10993-10 and ISO/TS 10993-20.
Pyrogenicity (see Annex F) represents an additional systemic effect which has historically been included in this part of ISO 10993. However, efforts are being taken to address pyrogenicity in a dedicated, stand-alone standard.
Finally, toxicology is an imperfect science. The outcome of any single test should not be the sole basis for making a determination of whether a device is safe for its intended use.
I Scope
This part of ISO 10993 specifies requirements and gives guidance on procedures Ic be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.
2 Normative references
The following referenced documents are indispensable for the application of this document. 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
ISO 10993-2, Biological evaluation of medical devices — Part 2: Animal welfare requirements
ISO 10993-12, Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
4 General considerations
4.1 General
Selection of the appropriate test(s) for a device shall be in accordance with ISO 10993-I, 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.BS EN ISO 10993-11:2009 pdf download.