ISO/TC 194
Biological evaluation of medical devices
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.
Standards of the Committee Projects of the CommitteeSubordinate Committees ISO/TC 194
| Committee ID | Name | Plat- form |
Mirror Committee |
|---|---|---|---|
|
ISO/TC 194/AG
Secretariat : DIN |
Chairman's advisory group | NA 027 BR | |
|
ISO/TC 194/WG 1
Secretariat : ANSI |
Systematic approach to biological evaluation and terminology |
URL |
NA 027-02-12 AA |
|
ISO/TC 194/WG 2
Secretariat : ANSI |
Degradation aspects related to biological testing |
URL |
NA 027-02-12 AA |
|
ISO/TC 194/WG 3
Secretariat : BSI |
Animal protection aspects |
URL |
NA 027-02-12 AA |
|
ISO/TC 194/WG 4
Secretariat : SNV |
Clinical investigations of medical devices in humans |
URL |
NA 027-02-20 AA |
|
ISO/TC 194/WG 5
Secretariat : DIN |
Cytotoxicity |
URL |
NA 027-02-12 AA |
|
ISO/TC 194/WG 6
Secretariat : DIN |
Mutagenicity, carcinogenicity and reproductive toxicity |
URL |
NA 027-02-12 AA |
|
ISO/TC 194/WG 7
Secretariat : ANSI |
Systemic toxicity |
URL |
NA 027-02-12 AA |
|
ISO/TC 194/WG 8
Secretariat : NEN |
Irritation, sensitization |
URL |
NA 027-02-12 AA |
|
ISO/TC 194/WG 9
Secretariat : ANSI |
Effects on blood |
URL |
NA 027-02-12 AA |
|
ISO/TC 194/WG 10
Secretariat : SN |
Implantation |
URL |
NA 027-02-12 AA |
|
ISO/TC 194/WG 11
Secretariat : ANSI |
Allowable limits for leachable substances |
URL |
NA 027-02-12 AA |
|
ISO/TC 194/WG 12
Secretariat : ANSI |
Sample preparation and reference materials |
URL |
NA 027-02-12 AA |
|
ISO/TC 194/WG 13
Secretariat : SN |
Toxicokinetic study |
URL |
NA 027-02-12 AA |
|
ISO/TC 194/WG 14
Secretariat : BSI |
Material characterization |
URL |
NA 027-02-12 AA |
|
ISO/TC 194/WG 15
Secretariat : ANSI |
Strategic approach to biological assessment |
URL |
NA 027-02-12 AA |
|
ISO/TC 194/WG 16
Secretariat : DIN |
Pyrogenicity |
URL |
NA 027-02-12 AA |
|
ISO/TC 194/WG 17
Secretariat : NEN |
Nanomaterials | NA 027-02-12 AA | |
|
ISO/TC 194/SC 1
Secretariat : DIN |
Tissue product safety |
URL |
NA 027-02-21 AA |
|
ISO/TC 194/SC 1/WG 1
Secretariat : DIN |
Risk assessment, terminology and global aspects |
URL |
NA 027-02-21 AA |
|
ISO/TC 194/SC 1/WG 2
Secretariat : BSI |
Sourcing controls, collection and handling |
URL |
NA 027-02-21 AA |
|
ISO/TC 194/SC 1/WG 3
Secretariat : NEN |
Elimination and /or inactivation of viruses and TSE agents |
URL |
NA 027-02-21 AA |
|
ISO/TC 194/SC 1/WG 4
Secretariat : ANSI |
TSE Elimination |
URL |
NA 027-02-21 AA |
National mirror committee of ISO/TC 194
| Committee ID | Name |
|---|---|
| NA 027-02-12 AA | Biological evaluation of medical devices |