Standard No.:	T/CSBM 0061-2025
English Name:	Ectoin for medical device
Chinese Name:	医疗器械用四氢甲基嘧啶羧酸
Chinese Classification:	C35    Orthopedic devices
Professional Classification:	T/    Social Organization Standard
ICS Classification:	11.040.40 11.040.40    Implants for surgery, prosthetics and orthotics 11.040.40
Source Content Issued by:	Chinese Society for Biomaterials
Issued on:	2025-09-16
Implemented on:	2026-3-1
Status:	to be valid
Target Language:	English
File Format:	PDF

本文件规定了医疗器械级原料四氢甲基嘧啶羧酸的要求、检验规则、标志、包装、运输、贮存、有效期，描述了相应的试验方法。
本文件适用于微生物发酵制得的用作医疗器械的四氢甲基嘧啶羧酸。