Skip to main content

Regulatory Aspects in the Use of Titanium-based Materials for Medical Applications

  • Chapter
Titanium in Medicine

Part of the book series: Engineering Materials ((ENG.MAT.))

  • 3010 Accesses

Abstract

Biomaterials are regulated not as such but as constituents of medical devices. The aim of regulating medical devices is to ensure that only devices for which the safety and effectiveness have been demonstrated are provided to patients.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Subscribe and save

Springer+ Basic
$34.99 /Month
  • Get 10 units per month
  • Download Article/Chapter or eBook
  • 1 Unit = 1 Article or 1 Chapter
  • Cancel anytime
Subscribe now

Buy Now

Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 89.00
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 119.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

Similar content being viewed by others

References

  1. United States of America, Federal Food, Drug and Cosmetic Act of 1938, as amended. U. S. Code, Title 21, Sections 301–902, in particular Sections 301–503 and 513–521, Washington, D. C.: U. S. Government Printing Office, Superintendent of Documents

    Google Scholar 

  2. 2. United States of America, Code of Federal Regulations, Title 21 (Food and Drugs), Chapter I, Sub-chapters A and H, Washington, D. C.: U. S. Government Printing Office, Superintendent of Documents

    Google Scholar 

  3. Council of the European Communities (1990) Council directive of 20 June 1990 on the approximation of the laws of the member states relating to active implantable medical devices (90/385/EEC). Official Journal of the European Communities No. L 189, amended (1993) ibid. No. L 169

    Google Scholar 

  4. Council of the European Communities (1993) Council directive 93/42/EEC of 14 June 1993 concerning medical devices. Official Journal of the European Communities No. L 169

    Google Scholar 

  5. International Organization for Standardization (1994) Quality systems - Model for quality assurance in design, development, production, installation and servicing. International Standard ISO 9001

    Google Scholar 

  6. International Organization for Standardization (1994) Quality systems - Model for quality assurance in production, installation and servicing. International Standard ISO 9002

    Google Scholar 

  7. 7. United States of America, Quality system regulation. Code of Federal Regulations, Title 21 (Food and Drugs), Part 820, Washington, D. C.: U. S. Government Printing Office, Superintendent of Documents

    Google Scholar 

  8. European Committee for Standardisation (1995) Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001. European Standard EN 46001, 2nd ed.

    Google Scholar 

  9. European Committee for Standardisation (1995) Quality systems - Medical devices - Particular requirements for the application of EN ISO 9002. European Standard EN 46002, 2nd ed.

    Google Scholar 

  10. International Organization for Standardization (1996) Quality systems - Medical devices - Particular requirements for the application of ISO 9001. International Standard ISO 13485

    Google Scholar 

  11. International Organization for Standardization (1996) Quality systems - Medical devices - Particular requirements for the application of ISO 9002. International Standard ISO 13488.

    Google Scholar 

  12. European Committee for Standardisation (1994) Guidance for the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for non-active medical devices. European Standard EN 724

    Google Scholar 

  13. European Committee for Standardisation (1994) Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for the active (including active implantable) medical device industry. European Standard EN 50103

    Google Scholar 

  14. International Organization for Standardization (1999) Quality systems - Medical devices - Guidance on the application of ISO 13485 and ISO 13488. International Standard ISO 14969

    Google Scholar 

  15. U. S. Food and Drug Administration (1996) Medical device quality systems manual: A small entity compliance guide. Publication FDA 97–4179, Rockville, Md.: U. S. Department of Health and Human Services, Food and Drug Administration

    Google Scholar 

  16. International Organization for Standardization (1999) Medical devices - Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices. Technical Report ISO/TR 16142

    Google Scholar 

  17. 17. American Society for Testing and Materials. Annual Book of ASTM Standards, Vol. 13.01: Medical Devices, Emergency Medical Services, issued annually, West Conshohocken, Pa.: American Society for Testing and Materials

    Google Scholar 

  18. U. S. Food and Drug Administration (1998) Guidance on the recognition and use of consensus standards. Rockville, Md.: U. S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health

    Google Scholar 

  19. U. S. Food and Drug Administration (2000) Guidance for industry and for the FDA staff: use of standards in substantial equivalence determinations. Rockville, Md: U. S. Department of Health and Human Services, FDA, Center for Devices and Radiological Health

    Google Scholar 

  20. 20. U. S. Food and Drug Administration, FDA recognized consensus standards. Rockville, Md.: U. S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, available at www.fda.gov/cdrh/modact/recstand.html

    Google Scholar 

  21. International Organization for Standardization (1995) Implants for surgery - Fundamental principles. Technical Report ISO/TR 14283

    Google Scholar 

  22. International Organization for Standardization (1997) Non-active surgical implants - General requirements. International Standard ISO 14630

    Google Scholar 

  23. European Committee for Standardisation (1997) Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer, European Standard EN 45502-1

    Google Scholar 

  24. International Organization for Standardization (1999) Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer. Final Draft International Standard ISO/FDIS 14708-1

    Google Scholar 

  25. International Organization for Standardization (1998) Non-active surgical implants - Implants for osteosynthesis - Particular requirements. International Standard ISO 14602

    Google Scholar 

  26. European Committee for Standardisation (1996) Dentistry - Medical devices for dentistry - Dental implants. European Standard EN 1642

    Google Scholar 

  27. International Organization for Standardization (1999) Implants for surgery - Metallic materials - Part 2: Unalloyed titanium. International Standard ISO 5832-2, 3rd ed.

    Google Scholar 

  28. American Society for Testing and Materials (1995) Standard specification for unalloyed titanium for surgical implant applications. ASTM Specification F67–95

    Google Scholar 

  29. International Organization for Standardization (1996) Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy. International Standard ISO 5832-3, 3rd ed.

    Google Scholar 

  30. American Society for Testing and Materials (1999) Standard specification for wrought titanium-6 aluminum-4 vanadium alloy for surgical implant applications (UNS R56400). ASTM Specification F1472-99

    Google Scholar 

  31. American Society for Testing and Materials (1998) Standard specification for wrought titanium-6 aluminum-4 vanadium ELI (extra low interstitial) alloy (UNS R56401) for surgical implant applications. ASTM Specification F136-98el

    Google Scholar 

  32. International Organization for Standardization (1996) Implants for surgery - Metallic materials - Part 10: Wrought titanium 5-aluminium 2.5-iron alloy. International Standard ISO 5832-10, 2nd ed.

    Google Scholar 

  33. International Organization for Standardization (1994) Implants for surgery - Metallic materials - Part 11: Wrought titanium 6-aluminium 7-niobium alloy. International Standard ISO 5832-11

    Google Scholar 

  34. American Society for Testing and Materials (1997) Standard specification for wrought titanium-6 aluminum-7 niobium alloy for surgical implant applications (UNS R56700). ASTM Specification F1295-97a

    Google Scholar 

  35. 35. Standard specification for wrought titanium-12 molybdenum-6 zirconium-2 iron alloy for surgical implant applications (1997). ASTM Specification F1813-97

    Google Scholar 

  36. American Society for Testing and Materials (1996) Standard specification for wrought titanium-13 niobium-13 zirconium alloy for surgical implant applications. ASTM Specification F1713-96

    Google Scholar 

  37. American Society for Testing and Materials (1995) Standard specification for titanium and titanium-6% aluminum-4% vanadium alloy powders for coatings of surgical implants. ASTM Specification F1580-95

    Google Scholar 

  38. American Society for Testing and Materials (1995) Standard specification for calcium phosphate coatings for implantable materials. ASTM Specification F1609-95

    Google Scholar 

  39. International Organization for Standardization (2000) Implants for surgery - Hydroxyapatite - Part 2: Coatings of hydroxyapatite. Final Draft International Standard ISO/FDIS 13779-2

    Google Scholar 

  40. International Organization for Standardization (1997) Dentistry - Preclinical evaluation of biocompatibility of medical devices used in dentistry - Test methods for dental materials. International Standard ISO 7405

    Google Scholar 

  41. International Organization for Standardization (1997) Biological evaluation of medical devices - Part 1: Evaluation and testing. International Standard ISO 10993-1,2nd ed.

    Google Scholar 

  42. International Organization for Standardization (1992) Biological evaluation of medical devices - Part 2: Animal welfare requirements. International Standard ISO 10993-2

    Google Scholar 

  43. International Organization for Standardization (1992) Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity. International Standard ISO 10993-3; under revision (2000) Draft International Standard ISO/DIS 10993-2, 2nd ed.

    Google Scholar 

  44. International Organization for Standardization (1992) Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood. International Standard ISO 10993-4; under revision (2000) Draft International Standard ISO/DIS 10993-4, 2nd ed.

    Google Scholar 

  45. International Organization for Standardization (1999) Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity. International Standard ISO 10993-5,2nd ed.

    Google Scholar 

  46. International Organization for Standardization (1994) Biological evaluation of medical devices - Part 6: Tests for local effects after implantation. International Standard ISO 10993-6

    Google Scholar 

  47. International Organization for Standardization (2000) Biological evaluation of medical devices - Part 8: Selection and qualification of reference materials for biological tests. Final Draft International Standard ISO 10993-8

    Google Scholar 

  48. International Organization for Standardization (1998) Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products. International Standard ISO 10993-9

    Google Scholar 

  49. International Organization for Standardization (1995) Biological evaluation of medical devices - Part 10: Tests for irritation and sensitization. International Standard ISO 10993-10; under revision (2000) as Tests for irritation and delayed-type hypersensitivity. Draft International Standard ISO/DIS 10993-10, 2nd ed

    Google Scholar 

  50. International Organization for Standardization (1993) Biological evaluation of medical devices - Part 11: Tests for systemic toxicity. International Standard ISO 10993-11

    Google Scholar 

  51. International Organization for Standardization (1996) Biological evaluation of medical devices - Part 12: Sample preparation and reference materials. International Standard ISO 10993-12

    Google Scholar 

  52. International Organization for Standardization (1999) Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys. Final Draft International Standard ISO/FDIS 10993-15

    Google Scholar 

  53. International Organization for Standardization (1997) Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables. International Standard ISO 10993-16

    Google Scholar 

  54. International Organization for Standardization (2000) Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances using health-based risk assessment. Draft International Standard ISO/DIS 10993-17.2

    Google Scholar 

  55. International Organization for Standardization (1998) Biological evaluation of medical devices - Part 18: Chemical characterization of materials. ISO Committee Draft ISO/CD 10993-18

    Google Scholar 

  56. Organization for Economic Co-operation and Development (1998) OECD principles on good laboratory practice (as revised in 1997). OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring, No. 1, ENV/MC/CHEM(98)17, Paris: Organization for Economic Co-operation and Development

    Google Scholar 

  57. U.S. Food and Drug Administration (1995) Guidance for the biological evaluation of materials, draft, December 22,1995, Rockville, Md.: Center for Devices and Radiological Health

    Google Scholar 

  58. European Committee for Standardisation (1997) Medical devices - Risk analysis. European Standard EN 1441

    Google Scholar 

  59. International Organization for Standardization (1998) Medical devices - Risk management - Part 1: Application of risk analysis. International Standard ISO 14971-1

    Google Scholar 

  60. European Committee for Standardisation (1993) Clinical investigation of medical devices for human subjects. European Standard EN 540

    Google Scholar 

  61. International Organization for Standardization (1996) Clinical investigation of medical devices. International Standard ISO 14155

    Google Scholar 

  62. World Medical Association (2000) Recommendations guiding physicians in biomedical research involving human subjects. Declaration of Helsinki, 1964, as amended by the 52nd World Medical Assembly, Ferney-Voltaire, France: World Medical Association

    Google Scholar 

  63. American Society for Testing and Materials (1994) Practice for retrieval and analysis of implanted medical devices and associated tissues. ASTM Specification F561–87

    Google Scholar 

  64. International Organization for Standardization (1998) Retrieval and analysis of surgical implants - Part 1: Retrieval and handling. International Standard ISO 12891-1

    Google Scholar 

  65. International Organization for Standardization (2000) Retrieval and analysis of surgical implants - Part 2: Analysis of retrieved metallic surgical implants. International Standard ISO 12891-2

    Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Rights and permissions

Reprints and permissions

Copyright information

© 2001 Springer-Verlag Berlin Heidelberg

About this chapter

Cite this chapter

Strid, KG. (2001). Regulatory Aspects in the Use of Titanium-based Materials for Medical Applications. In: Titanium in Medicine. Engineering Materials. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-56486-4_28

Download citation

  • DOI: https://doi.org/10.1007/978-3-642-56486-4_28

  • Publisher Name: Springer, Berlin, Heidelberg

  • Print ISBN: 978-3-642-63119-1

  • Online ISBN: 978-3-642-56486-4

  • eBook Packages: Springer Book Archive

Publish with us

Policies and ethics