TC 194
Biological evaluation of medical devices
- Secretariat: DIN
- Secretary: Dipl.-Ing. Karl Wenzelewski
- Chairperson: Dr. Albrecht Poth (Germany) until end 2012
- Creation date: 1988
- Work programme
(drafts and new work items of TC 194)
Scope:
Standardization of the approach to biological evaluation of medical and dental materials and devices together with standardization of biological test methods applicable to those materials and devices.
| Total number of published ISO standards related to the TC and its SCs: | 28 |
| Number of published ISO standards under the direct responsibility of TC 194: | 25 |
| Participating countries: | 22 |
| Observing countries: | 26 |
ISO committees in liaison:
TC 76, TC 84, TC 106, TC 150, TC 150/SC 2, TC 150/SC 7, TC 172, TC 173, TC 198, TC 210, TC 215
Organizations in liaison:
Subcommittees/Working Groups:
| Subcommittee/Working Group | Title |
|---|---|
| TC 194/WG 1 |
Systematic approach to biological evaluation and terminology The convener can be reached through the secretariat |
| TC 194/WG 2 |
Degradation aspects related to biological testing The convener can be reached through the secretariat |
| TC 194/WG 3 |
Animal protection aspects The convener can be reached through the secretariat |
| TC 194/WG 4 |
Clinical investigations of medical devices in humans The convener can be reached through the secretariat |
| TC 194/WG 5 |
Cytotoxicity The convener can be reached through the secretariat |
| TC 194/WG 6 |
Mutagenicity, carcinogenicity and reproductive toxicity The convener can be reached through the secretariat |
| TC 194/WG 7 |
Systemic toxicity The convener can be reached through the secretariat |
| TC 194/WG 8 |
Irritation, sensitization The convener can be reached through the secretariat |
| TC 194/WG 9 |
Effects on blood The convener can be reached through the secretariat |
| TC 194/WG 10 |
Implantation The convener can be reached through the secretariat |
| TC 194/WG 11 |
Allowable limits for leachable substances The convener can be reached through the secretariat |
| TC 194/WG 12 |
Sample preparation and reference materials The convener can be reached through the secretariat |
| TC 194/WG 13 |
Toxicokinetic study The convener can be reached through the secretariat |
| TC 194/WG 14 |
Material characterization The convener can be reached through the secretariat |
| TC 194/WG 15 |
Strategic approach to biological assessment The convener can be reached through the secretariat |
| TC 194/WG 16 |
Pyrogenicity The convener can be reached through the secretariat |
| TC 194/SC 1 | Tissue product safety |
Meeting calendar
* Information definite but meeting not yet formally convened
** Provisional
| Month | Location | |||
|---|---|---|---|---|
| April 2010 | Bern (Switzerland) | ** | TC 194/SC 1 | |
| June 2010 | (Unknown) | ** | TC 194/SC 1 | |
| 2nd-3rd Quarter 2010 | Berlin (Germany) | ** | TC 194 |
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