ISO. Biological evaluation of medical device

New York: ISO. 2003. — 22 p.ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
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Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 10993-1 was prepared by Technical Committee ISO/TC 194, Biological evaluation of medical devices.
This third edition cancels and replaces the second edition (ISO 10993-1:1997), of which it constitutes a minor
revision.
ISO 10993 consists of the following parts, under the general title Biological evaluation of medical devices:
— Evaluation and testing
— Animal welfare requirements
— Tests for genotoxicity, carcinogenicity and reproductive toxicity
— Selection of tests for interactions with blood
— Tests for in vitro cytotoxicity
— Tests for local effects after implantation
— Ethylene oxide sterilization residuals
— Selection and qualification of reference materials for biological tests
— Framework for identification and quantification of potential degradation products
— Tests for irritation and delayed-type hypersensitivity
— Tests for systemic toxicity
— Sample preparation and reference materials
— Identification and quantification of degradation products from polymeric medical devices
— Identification and quantification of degradation products from ceramics
— Identification and quantification of degradation products from metals and alloys
— Toxicokinetic study design for degradation products and leachables
— Establishment of allowable limits for leachable substances
— Chemical characterization of materials
Future parts will deal with other relevant aspects of biological testing.