GB/T 16886.19-2011

Abolished

Biological evaluation of medical devices - Part 19: Physico-chemical,morphological and topographical characterization of materials

医疗器械生物学评价 第19部分:材料物理化学、形态学和表面特性表征

Standard Type
GBT
ICS
11.040.01
CCS
C30
Status
Abolished
Issue Date
2011-12-30
Implementation
2012-05-01
Centralized Committee
国家药监局
Issuing Authority
中华人民共和国国家质量监督检验检疫总局、中国国家标准化管理委员会

Application Summary AI generated

This standard specifies methods for characterizing the physical, chemical, morphological, and topographical properties of materials used in medical devices. It is applied during the biological evaluation process to assess how a material's surface and bulk characteristics may influence its biocompatibility and performance. The standard is primarily used by manufacturers and testing laboratories to ensure consistent material characterization for regulatory submissions and quality control in the healthcare industry.

Related Standards

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.