Biological Evaluation of medical devices ISO 10993-1 – 2 day course

Who should attend

This introductory course is of value to employees at all levels within the organisation of Medical Device manufacturers, and suppliers to the Medical Devices industry including:

  • Design engineers
  • Development engineers
  • Regulatory Affairs managers
  • Regulatory Affairs officers
  • Quality Assurance managers
  • Quality Assurance officers
  • Members of the senior management team

Book onto this course

Course Outline

Credible training courses on this hugely important subject are rare. Biological Evaluation of Medical Devices is often not well understood and typically falls upon Regulatory Affairs staff to write reasoned justifications to avoid testing. Join us on this 2-day course, led by our toxicology expert  to learn and understand Biological Evaluation of medical Devices, particularly in the context of your Risk Management   Process, as we take you through the entire ISO 10993 series of standards in a this training course punctuated with practical workshops to really enhance the learning experience.

In this 2-day training course we will describe the big-picture concepts of Biological evaluation of medical devices within a risk management process. We begin with the parent standard  ISO 10993-1:2009 and introduce Human Factors before digging into deeper detail with parts -2 through -10 on day 1 before leaving you  with a little light ‘homework’ for day 2.

On day 2 we illustrate many key points using real life case studies from examples we have seen in the field, this takes us outside of just theory and deals with the practical issues which we know medical device manufacturers face. There is also the opportunity for you to bring your specific questions along to the course for group discussion and to help to determine a resolution using our toxicology expert. Further group discussions and workshops on day 2 prelude completing going through sub parts of ISO 10993 parts -11 through -20. We conclude the course with a hands on exercise to draft a plan to undertake a biological evaluation of a medical device.

Topics covered

  • Big picture concepts of Biological evaluation of medical devices
  • Most confusing issue(s) about ISO 10993
  • Case Studies & Group Discussions
  • Product failures
  • Gap analyses
  • Draft plan to undertake a biological evaluation of a medical device
  • ISO 10993-1 Part 1: Evaluation and testing within a risk management process
  • ISO 10993-2 Part 2: Animal welfare requirements
  • ISO 10993-3 Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • ISO 10993-4 Part 4: Selection of tests for interactions with blood
  • ISO 10993-5 Part 5: Tests for in vitro cytotoxicit
  • ISO 10993-6 Part 6: Tests for local effects after implantation
  • ISO 10993-7 Part 7: Ethylene oxide sterilization residuals
  • NOTE: ISO 10993-8 is Withdrawn
  • ISO 10993-9 Part 9: Framework for identification and quantification of potential degradation products
  • ISO 10993-10 Part 10: Tests for irritation and delayed-type hypersensitivity
  • ISO 10993-11 Part 11: Tests for systemic toxicity
  • ISO 10993-12 Part 12: Sample preparation and reference materials (available in English only)
  • ISO 10993-13 Part 13: Identification and quantification of degradation products from polymeric medical devices
  • ISO 10993-14 Part 14: Identification and quantification of degradation products from ceramics
  • ISO 10993-15 Part 15: Identification and quantification of degradation products from metals and alloys
  • ISO 10993-16 Part 16: Toxicokinetic study design for degradation products and leachables
  • ISO 10993-17 Part 17: Establishment of allowable limits for leachable substances
  • ISO 10993-18 Part 18: Chemical characterization of materials
  • ISO/TS 10993-19 Part 19: Physico-chemical, morphological and topographical characterization of materials
  • ISO/TS 10993-20 Part 20: Principles and methods for immunotoxicology testing of medical devices

Course outcomes

At the end of the course, delegates will gain a detailed knowledge of :

  • Biological evaluation of medical devices within a Risk Management Process
  • Key points of each sub-section of the ISO 10993 series of standards
  • Appreciation of testing required
  • When to test, and when not to test
  • How to deal with process failures
  • How to plan and undertake a biological evaluation of a medical device

Venue

  • Holiday Inn, Birmingham, UK
  • Close to Birmingham International Airport & International train station (with free shuttle bus)
  • 1 minute from junction 6 of the M42  

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