Frequently Asked Questions

What standards must be adhered to when implementing a biological evaluation program within a risk management plan?

• 1.1. EN ISO 10993-1:2009 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
• 1.2. EN ISO 10993-2:2006 Biological evaluation of medical devices – Part 2: Animal welfare requirements
• 1.3. EN ISO 10993-3:2009 Biological evaluation of medical devices – Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
• 1.4. EN ISO 10993-4:2009 Biological evaluation of medical devices – Part 4: Selection of tests for interactions with blood
• 1.5. EN ISO 10993-5:2009 Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity
• 1.6. EN/ISO 10993-6:2009 Biological evaluation of medical devices – Part 6: Tests for local effects after implantation
• 1.7. EN ISO 10993-7:2008 Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals
• 1.8. EN ISO 10993-9:2009 Biological evaluation of medical devices – Part 9: Framework for identification and quantification of potential degradation products
• 1.9. EN ISO 10993-10:2009 Biological evaluation of medical devices – Part 10: Tests for irritation and delayed-type hypersensitivity
• 1.10. EN ISO 10993-11:2009 Biological evaluation of medical devices – Part 11: Tests for systemic toxicity
• 1.11. EN ISO 10993-12:2009 Biological evaluation of medical devices – Part 12: Sample preparation and reference materials
• 1.12. EN ISO 10993-13:2009 Biological evaluation of medical devices – Part 13: Identification and quantification of degradation products from polymeric medical devices
• 1.13. EN ISO 10993-14:2009 Biological evaluation of medical devices – Part 14: Identification and quantification of degradation products from ceramics
• 1.14. EN ISO 10993-15:2009 Biological evaluation of medical devices – Part 15: Identification and quantification of degradation products from metals and alloys
• 1.15. EN ISO 10993-16:2010 Biological evaluation of medical devices – Part 16: Toxicokinetic study design for degradation products and leachables
• 1.16. EN ISO 10993-17:2009 Biological evaluation of medical devices – Part 17: Establishment of allowable limits for leachable substances
• 1.17. EN ISO 10993-18:2009 Biological evaluation of medical devices – Part 18: Chemical characterization of materials
• 1.18. ANSI/AAMI/ISO TIR10993-19:2006 Biological evaluation of medical devices – Part 19: Physico-chemical, morphological, and topographical characterization of materials
• 1.19. ANSI/AAMI/ISO TIR10993-20:2006 Biological evaluation of medical devices – Part 20: Principles and methods for immunotoxicology testing of medical devices

What Standards are associated with Cleanroom and Controlled Environments?

ISO 14644-1:1999 – Cleanrooms and associated controlled environments – Part 1: Classification of air cleanliness

ISO 14644-2:2000 - Cleanrooms and associated controlled environments – Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1

ISO 14644-3:2005 - Cleanrooms and associated controlled environments – Part 3: Test Methods

ISO 14644-4:2001 - Cleanrooms and associated controlled environments – Part 4: Design, Construction and start-up

ISO 14644-5:2004 - Cleanrooms and associated controlled environments – Part 5: Operations

ISO 14644-6:2007 - Cleanrooms and associated controlled environments – Part 6: Vocabulary

ISO 14644-7:2004 - Cleanrooms and associated controlled environments – Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)

ISO 14644-8:2006 - Cleanrooms and associated controlled environments – Part 8: Classification of airborne molecular contamination

ISO 14698-1:2003 - Cleanrooms and associated controlled environments – Biocontamination control – Part 1: General principles and methods

ISO 14698-2:2003 - Cleanrooms and associated controlled environments – Biocontamination control – Part 2: Evaluation and interpretation of biocontamination data