Medical Writing Medical Devices Does standardisation improve animal testing of medical devices?

Volume 26, Issue 2 - Medical Devices

Does standardisation improve animal testing of medical devices?

Abstract

Abstract

Compliance with European regulatory standards in animal research could be viewed as a way of dotting the i’s and crossing the t’s, rather than actually holding the research to scientific scrutiny. Standardisation is important and needs improvement for in vivo testing of medical devices, so that it can be more than basic guidelines. Innovative research must go beyond the requirements set out in regulatory standards to enable research practices to be improved and updated
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References

  1. De Jong WH, Carraway JW, Geertsma RE. In vivo and in vitro testing for the biological safety evaluation of biomaterials and medical devices. Biocompatibility and Performance of Medical Devices. 2012; 120–58 Available from: http://
  2. Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices. OJ L. 1990; 189: 17 Available from: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG: 1990L0385:20071011:en:PDF
  3. Council Directive 93/42/EEC concerning medical devices. OJ L. 1993; 169: 1. Available from: http://eur-lex.europa.eu/LexUriServ/ LexUriServ.do?uri=CONSLEG: 1993L0042:20071011:en:PDF
  4. Council Directive 98/79/EC on in vitro diagnostic medical devices. OJ L. 1998; 331:1 Available from: http://eur-lex.europa.eu/legalcontent/EN/TXT/HTML/?uri=CELEX: 31998L0079&from=EN
  5. ISO 13485. Medical devices. Quality management systems. Requirements for regulatory purposes. 2016 Available from: https://www.iso.org/standard/59752.html
  6. ISO 10993-6. Biological evaluation of medical devices. Tests for local effects after implantation. 2016. Available from: https://www.iso.org/standard/61089.html
  7. Derveaux S, Vandesompele J, Hellemans J. How to do successful gene expression analysis using real-time PCR. Methods. 2010;50(4):227–30 Available from: http://
  8. BS EN ISO 10993-11. Biological evaluation of medical devices. Tests for systemic toxicity. 2006. Available from: https://www.iso.org/standard/35977.html
  9. Whittaker JP, Charron KD, McCalden RW, Macdonald SJ, Bourne RB. Comparison of steady state femoral head penetration rates bet ween two highly cross-linked poly ethy - lenes in total hip arthroplasty. J Arthro - plasty. 25(5):680-6, 2010 Available from: http://
  10. ISO 10993-5. Biological evaluation of medical devices. Tests for in vitro cytotoxicity. 2009 Available from: https://www.iso.org/ standard/36406.html

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