Standard No.:	GB/T 16886.19-2011
English Name:	Biological evaluation of medical devices—Part 19:Physico-chemical,morphological and topographical characterization of materials
Chinese Name:	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
Chinese Classification:	C30    Medical apparatus and devices in general
Professional Classification:	GB    National Standard
ICS Classification:	11.040.01 11.040.01    Medical equipment in general 11.040.01
Source Content Issued by:	AQSIQ;SAC
Issued on:	2011-12-30
Implemented on:	2012-5-1
Status:	superseded
Superseded by:	GB/T 16886.19-2022 Biological evaluation of medical devices—Part 19: Physico-chemical, morphological and topographical characterization of materials
Superseded on:	2024-1-1
Target Language:	English
File Format:	PDF
Word Count:	9000 words
Translation Price(USD):	190.0
Delivery:	via email in 1~3 business day

GB/T16886的本部分给出了适用于成品医疗器械材料物理化学、形态学和表面特性(PMT)判定与评价的各种参数和试验方法。这种评定仅限于与生物学评价和医疗器械的预期用途(临床应用和使用时间)相关的性能,即使这类性能与临床有效性重合。GB/T16886的本部分不描述降解产物的表征或定量测定,这部分内容已在GB/T16886的第9部分、第13部分、第14部分和第15部分中规定,材料化学表征见GB/T16886.18。
GB/T16886标准不适用于与人体无直接或间接接触的医疗器械和材料(见ISO10993-1)。