Greg LeBlanc Dir. Regulatory Affairs and Quality Systems Cook (Canada) Inc.

Transcription

1 Greg LeBlanc Dir. Regulatory Affairs and Quality Systems Cook (Canada) Inc.

2 ISO/TC 194 OVERVIEW Biological and clinical evaluation of medical devices Secretariat: DIN Secretary: Mr. Karl Wenzelewski Chairperson: Mr. Albrecht Poth until end 2017 ISO Technical Programme Manager: Dr. Mary Lou Pelaprat ISO Editorial Programme Manager: Mrs. Laura Mathew Creation date: 1988

3 ISO/TC 194 OVERVIEW Scope Structure Work program Disclaimers: All information in this presentation is from publicly available sources as of Sept. 8, The information given does not represent the views of my employer or any particular industry association.

4 ISO/TC 194 SCOPE Standardization of the approach to biological and clinical evaluation of medical and dental materials and devices together with standardization of biological test methods applicable to those materials and devices as well as good clinical practice principles to clinical investigations in humans of those devices. Total number of published ISO standards related to the TC and its SCs (number includes updates): Number of published ISO standards under the direct responsibility of ISO/TC 194 (number includes updates): Participating countries: 25 Observing countries:

5 ISO/TC 194 STRUCTURE ISO/TC 194 Working groups: WG 1 Systemic approach to biological evaluation and terminology WG 2 Degradation aspects related to biological testing WG 3 Animal protection aspects WG 4 Clinical investigations of medical devices in humans WG 5 Cytotoxicity WG 6 Mutagenicity, carcinogenicity and reproductive toxicity WG 7 Systemic toxicity WG 8 Irritation, sensitization WG 9 Effects on blood WG 10 Implantation WG 11 Allowable limits on leachable substances

6 ISO/TC 194 STRUCTURE ISO/TC 194 Working groups: WG 12 Sample preparation and reference materials WG 13 Toxicokinetics WG 14 Material characterization WG 15 Strategic approach to biological assessment WG 16 Pyrogenicity WG 17 Nanomaterials TC 194/SC 1, Tissue Product Safety, Working groups: WG 1 Risk assessment, terminology and global aspects WG 2 Sourcing controls, collection and handling WG 3 Elimination and /or inactivation of viruses and TSE agents WG 4 TSE Elimination

7 ISO/TC 194 Work programme ISO/CD Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process ISO/DIS Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood ISO/CD Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity ISO/FDIS Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation ISO/AWI Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals ISO/NP Biological evaluation of medical devices -- Part 9: Framework for identification and quantification of potential degradation products ISO/DIS Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity ISO/NP Biological evaluation of medical devices -- Part 15: Identification and quantification of degradation products from metals and alloys ISO/DIS Biological evaluation of medical devices -- Part 16: Toxicokinetic study design for degradation products and leachables ISO/NP Biological evaluation of medical devices -- Part 18: Chemical characterization of materials ISO/NP TS Biological evaluation of medical devices -- Part 19: Physico-chemical, morphological and topographical characterization of materials

8 ISO/TC 194 Work programme ISO/NP TS Biological evaluation of medical devices -- Part 20: Principles and methods for immunotoxicology testing of medical devices ISO/DTR Biological evaluation of medical devices -- Part 22: Guidance on nanomaterials ISO/AWI Clinical investigation of medical devices for human subjects -- Good clinical practice ISO/NP TR Biological evaluation of medical devices -- Guidance on the conduct of biological evaluation within a risk management process ISO/DTR Pyrogenicity -- Principle and method for pyrogen testing of medical devices ISO/NP TS Biological evaluation of medical devices -- Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of extractable substances from medical devices ISO/AWI TS Biological evaluation of medical devices -- Development of tolerable intake values for Di(2-ethylhexyl)phthalate (DEHP) ISO/DTR Cardiovascular biological evaluation of medical devices -- Guidance for absorbable implants -- Part 2: Standard guide for absorbable metals

9 ISO/TC 194 FOCUS Bioloigical evaluation includes: Biocompatibility testing Materials, additives and leachable substances Design and application of the right tests and their interpretation Bioactive materials and tissue response Assessment of bioactivity and associated risk Toxicity testing

10 ISO/TC 194 SPECIFIC DOMAINS BIOLOGICAL EVALUATION OF MEDICAL DEVICES ISO Series Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process Describes a procedure to generate a systematic approach to the biological evaluation, including the minimum requirements for an evaluation Other parts : Provide tests (in vitro and in vivo methods), or other provisions necessary for the application of the tests (such as sample preparations and reference materials, toxicokinetic studies and animal welfare requirements)

11 ISO/TC 194 SPECIFIC DOMAINS CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice This International Standard specifies general requirements intended to: Protect the rights, safety and well-being of human subjects Ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results Define the responsibilities of the sponsor and principal investigator Assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.

12 ISO/TC 194 in Summary Focuses on new and innovative directions in medical device regulations, biomaterial development, medical device design. Works towards satisfying the growing public demand for standardised test methods for biological testing and evaluation of medical devices especially for the thousands of new and innovative medical devices and materials entering the healthcare field every year. Ensure your organizations are well informed! Thank you!