Alternatives to the Animal Testing of Medical Devices

Anon. (1994). ECVAM News & Views. ATLA 22, 7–11.

Anon. (1993). Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. Official Journal of the European Communities L169, 1–43.

Anon. (1992). ISO 10993: Biological Evaluation of Medical Devices (first part of series). Geneva: International Organisation for Standardisation (ISO).

Anon. (1993). EN 30993: Biological Evaluation of Medical Devices (first part of series). Brussels: European Committee for Standardisation (CEN).

Schmalz G. (1995). Biological evaluation of medical devices: a review of EU regulations, with emphasis on in vitro screening for biocompatibility. ATLA 23, 469–473.

Anon. (1977). Primary Acute Toxicity Screening Protocols for Biomaterials., 63 pp. Memphis, Tennessee, USA: The Materials Science Toxicology Laboratories, The University of Tennessee Center for the Health Sciences.

Anon. (1995). Biological Reactivity Tests In Vivo, United States Pharmacopeia, Twenty-third Revision, pp. 1699–1703. Rockville, MD, USA: United States Pharmacopeial Convention, Inc.

Anon. (1987). OECD Guidelines for Testing of Chemicals. Paris: OECD.

Schmalz G. , and Browne R.M. (1995). The biological evaluation of medical devices used in dentistry: the influence of the European Union on the preclinical screening of dental materials. International Dental Journal 45, 275–278.

Arenholt-Bindslev D. , and Schmalz G. eds. (1994). Proceedings of the International Symposium: Biological Testing of Dental Materials (August 1993, Holding, Denmark). Journal of Dentistry 22, Suppl. 2, 1–33.

Anon. (1986). Tripartite Biocompatibility Guidance for Medical Devices. Appendix C, pp. 1–8. Monitor International Drug and Device Regulatory. Washington, DC, USA:

Anon. (1980). DIN 58 361, Teil 4: Transfusions-behältnisse und Zubehör: Blutbeutel aus Kunst-stoffen, Sicherheitstechnische Anforderungen, Prüfung, Überwachung und Kennzeichnung., 12 pp. Berlin: Beuth Verlag.

Anon. (1989). DIN 58 362, Teil 1: Infusionsgeräte und Zubehör: Infusionsgeräte für Schwerkraftinfusion, Benennungen, Anforderungen, Prüfung., 12 pp. Berlin: Beuth Verlag.

Anon. (1982). DIN 58 363, Teil 15: Infusionsbehältnisse und Zubehör: Infusionsbeutel und -flaschen, Sicherheitstechnische Anforderungen und Prüfung (updated in 1992). 7 pp. Berlin: Beuth Verlag.

Anon. (1986). DIN 58 367, Teil 1: Transfusion, Infusion, Injektion: Gummiteile, Anforderungen, Prüfung., 7 pp. Berlin: Beuth Verlag.

Schmalz G. (1994). The use of cell cultures for toxicity testing of dental materials: advantages and limitations. Journal of Dentistry 22, Suppl. 2, 6–11.

Anon. (1994). ISO/DIS 7405. Dentistry: Preclinical Evaluation of Biocompatibility of Medical Devices Used in Dentistry: Test Methods (revision of ISO/TR 7405). 15 pp. Geneva: International Organisation for Standardisation (ISO).

Anon. (1986). Council Directive of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes. Official Journal of the European Communities L358, 1–29.

Browne R.M. (1994). Animal tests for biocompatibility of dental materials: relevance, advantages and limitations. Journal of Dentistry 22, Suppl. 2, 21–24.

Goldberg M. , Lasfargues J.J. , and Legrand J.M. (1994). Clinical testing of dental materials: histological considerations. Journal of Dentistry 22, Suppl. 2, 25–28.

Kjellstrand P. , and Boberg U. (1991). Testing of polymer materials: what methods should be used? ATLA 19, 222–225.

Kjellstrand P. , Lilliehorn P. , & Rydhög G. (1994). Toxicity testing of polymer materials for dialysis equipment: is there a need for in vivo testing? Cell Biology and Toxicology 10, 137–142.

Slivka S.R. , and Ziegler F. (1993). Use of an in vitro skin model for determining epidermal and dermal contributions to irritant responses. Journal of Toxicology — Cutaneous and Ocular Toxicology 12, 29–37.

Reuling N. , Pohl-Reuling B. , and Keil M. (1991). Histomorphometrical studies on the histocompatibility of dental alloys. Deutsche Zahnärtztliche Zeitschrift 46, 215–219.

Schmalz G. , and Schmalz C. (1981). Toxicity tests on dental filling materials. International Dental Journal 31, 185–192.

Schmalz G. (1982). Korrelationsanalysen zwischen Zellkulturen und Tierversuch. Deutsche Zahnärtztliche Zeitschrift 37, 184–186.

Anon. (1996). Guidance for the Preparation of a Premarket Notification (510 [K]) for Direct Filling Composites, 13 pp. Rockville, MD, USA: Food and Drug Adminstration, Center for Devices and Radiological Health Office of Device Evaluation.

Schmalz G. , Arenholt-Bindslev D. , and Schweikl H. (1995). An epithelium-fibroblast coculture for testing the irritancy of dental alloys. Journal of Dentistry Research 74, 540.