DZ/T 0101.12-1994
Active
GB/T 16886.10-2024
Active
National standards
GB/T 16886.10-2024 Biological evaluation of medical devices—Part 10:Tests for skin sensitization
GB/T 16886.10-2024 Biological evaluation of medical devices—Part 10:Tests for skin sensitization
Price:
$ 140
Basic Information
Standard Code:
GB/T 16886.10-2024
Standard Type:
National standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
-
Publish Date:
2024-08-23
Implement Date:
2025-09-01
Pages:
48 pages
Scope
This document specifies the evaluation steps for potential skin sensitization reactions induced by medical devices and their constituent materials.
This document is applicable to:
—— Detailed in vivo skin sensitization test steps;
—— Key factors for interpreting the results.
Note: Preparation instructions for specific materials related to the aforementioned tests are provided in Appendix A.
Development Information
Replace the following standards
Referenced Standards
ISO 10993-1
ISO 10993-2
ISO 10993-12
ISO 10993-18
Adopt standards
ISO 10993-10:2021
Related Standards
JJG 204-1980
Active
JJG 204-1980 Meteorological Ventilation Psychrometer
SC 53-1980
Active
SC 53-1980 Transfer blade hydraulic steering gear repair quality standard
DZ 4-1981
Replaced
\nDZ 4-1981 Method for Compiling Product Models of Geological Instrumentation Equipment
SC 69-1982
Active
SC 69-1982 ZSS-12 Flash-type seawater desalination production device technical specifications
SC 72-1982
Active