ISO 10993 - Biological Evaluation of Medical

Before implantation several in vitro tests were performed. For evaluation of a possible toxic reaction, we investigated the material and the whole devices in vitro with cell culture methods. Direct contact and extraction tests with a mouse fibroblasts cell line (L 929) and a neuroblastoma cell line (neuro-2-a) were performed according to the international standard ISO 10993 ( Biological Evaluation of Medical Devices ). The materials and devices showed no toxicity, i.e. no significant differences in membrane integrity of the cell membranes, mitochondrial activity and DNA synthesis rate. The neuro-2-a cell line is so sensitive that even small changes in process technology are detectable. The flexible polyimide structures proved to be non toxic. 

FDA, Use of International Standard ISO-10993, Biological evaluation of medical devices part 1 Evaluation and testing, C.f.D.E.a.R.C. U.S. Food and Drug Administration, Editor. Washington, DC, 1995. 

Part 4 of ISO 10993 (Biological evaluation of medical devices—Part 4 Selection of tests for interactions with blood) deals with the requirements of evaluating interactions of medical devices with blood. 

Biocompatibility involves adherence to ISO 10993 Biological Evaluation of Medical Devices or USP Class VI standards, hemocompatibility, platelet retention, and reduced protein binding. Moreover, food contact standards are typically applied to healthcare applications. The US Food and Drug Administration oversees adherence to the standards of the US Food, Drug, and Cosmetics Act In Europe, the European Union Directive 2002/72/EC is applicable. 

USDHHS, 2013. Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1 Evaluation and Testing . 

ISO (1993). Biological Evaluation of Medical Devices. Part 3 Tests for Genotoxicity, Carcinogenicity, and Reproductive Toxicity. ISO 10993-3. 

Biological evaluation of medical devices—Part 5 Tests for cytotoxicity in vitro methods. ISO 10993-5 1992(E). International Standards Organization, 1992. 

Bollen and Harling (see Further Reading section) provide an overview of how to conduct a risk assessment for a medical device and discuss the use of ISO 14971, one of the newest standards in this area, for risk management. This publication also covers ISO 10993, which (as discussed above) covers the biological evaluation of medical devices. A hypothetical risk evaluation of a medical device is also described. 

ISO 10993-I8 200s5 Biological evaluation of medical devices. Part 18 Chemical characterizations of material... 

ISO 9924-2 2000 Rubber and rubber products — Determination of the composition of vulcanizates and uncured compounds by thermogravimetry — Part 2 Acrylonitrile-butadiene and halobutyl rubbers ISO 10356 1996 Cinematography — Storage and handling of nitrate-base motion-picture films ISO 10993-17 2002 Biological evaluation of medical devices — Part 17 Establishment of allowable limils for leachable substances... 

ISO 10993-10 2010 (2015) Biological Evaluation of Medical Devices— Part 10 Tests for Irritation and Skin Sensitization. http //www.iso.org/iso/catalogue detail csnumber=40884 (accessed on October 14, 2015). 

Biological Evaluation of Medical Devices, Parts 1-20, ISO 10993, Intemational Organization for Standardization. 

AAMI Standards and Recommended Practices, Vol. 4 Biological Evaluation of Medical Devices AAMUANSI/ISO 10993, Association for the Advancement of Medical Instrumentation (AAMI), Arlington, VA. US. 

ISO 10993 consists of the following parts, under the general title Biological evaluation of medical devices ... 

Biocompatibility ISO 10993-1 = Biological evaluation of medical devices— Part 1 Evaluation and testing within a risk management process... 

ISO 10993-5 Biological evaluation of medical devices— Part 5 Tests for in vitro cytotoxicity... 

ISO 10993-10 Biological evaluation of medical devices— Part 10 Tests for irritation and skin sensitization... 

AAMI/ISO 10993-1 1997, Biologic evaluation of medical devices-Part 1 Evaluation and testing. 

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