BE - Biological Evaluation Committee (U.S. TAG to ISO/TC 194)
AAMI Staff Contact
Rose Kodzwa RKodzwa@aami.org
Description
The AAMI BE Biological Evaluation Committee provides input into international standards by acting as the mirror committee and U.S. TAG to ISO/TC 194 - Biological and clinical evaluation of medical devices which develops standards for the approach to the biological and clinical evaluation of medical and dental materials and devices and the biological test methods applicable to those materials and devices as well as good clinical practice principles to clinical investigations in humans of those devices.
Related Groups
- BE/WG 01 - Systematic Approach to Biological Evaluation and Terminology Working Group
- BE/WG 02 - Degradation Aspects Related to Biological Testing Working Group
- BE/WG 03 - Animal Protection Aspects Working Group
- BE/WG 04 - Clinical Investigations Working Group
- BE/WG 05 - Cytotoxicity Working Group
- BE/WG 06 - Mutagen, Carcinogen, Reproduction toxicity Working Group
- BE/WG 07 - Systemic Toxicity Working Group
- BE/WG 08 - Irritation and Sensitization Working Group
- BE/WG 09 - Effects on Blood Working Group
- BE/WG 10 - Implantation Working Group
- BE/WG 11 - Allowable Limits for Leachable Substances Working Group
- BE/WG 12 - Sample preparation and reference materials Working Group
- BE/WG 13 - Toxicokinetics Study Design Working Group
- BE/WG 14 - Material Characterization Working Group
- BE/WG 15 - Strategic Approach to Biological Assessment
- BE/WG 17 - Nanomaterials Working Group
Related Documents
- AAMI/ISO TIR10993-19: 2006, Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials
- AAMI/ISO TIR10993-20:2006,Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices