GB/T 16886.10-2005
AbolishedBiological evaluation of medical devices-Part 10:Tests for irritation and delayed-type hypersensitivity
医疗器械生物学评价 第10部分:刺激与迟发型超敏反应试验
Application Summary AI generated
This standard specifies test methods for evaluating the potential of medical devices to cause skin irritation and delayed-type hypersensitivity (allergic contact dermatitis). It is applied during the biological safety assessment of medical devices, materials, and their extracts, particularly for devices that come into direct or indirect contact with human skin or mucosal surfaces. The standard is used by manufacturers and testing laboratories to ensure compliance with regulatory requirements for preclinical biocompatibility testing.
Related Standards
GB/T 19381-2003
General methods of test for medical closures of butyl rubber
GB/T 14214-2003
Spectacle frames--General requirements and test methods
GB/T 18375.7-2004
Prosthetics--Structural testing of lower-limb prostheses--Part 7:Test submission document
GB/T 18375.6-2004
Prosthetics--Structural testing of lower-limb prostheses--Part 6:Loading parameters of supplementary structural tests
GB/T 18375.5-2004
Prosthetics--Structural testing of lower-limb prostheses--Part 5:Supplementary structural tests
GB/T 18375.8-2004
Prosthetics--Structural testing of lower-limb prostheses--Part 8:Test report
GB/T 19543-2004
Prostheses--Structural testing of hip units
GB/T 19629-2005
Medical Electrical Equipment-Dosimeters with ionization chambers and/or semi-conductors as used in X-ray diagnostic imaging
Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.