YY/T 1854-2022 Active Industry standards-Medicine

YY/T 1854-2022 Test method for trioctyl triphthalate (TOTM) released from PVC medical devices

Publish Date: 2022-08-17 Implement Date: 2023-09-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1854-2022

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical hygiene products

ICS Name: Medical materials

Publish Date: 2022-08-17

Implement Date: 2023-09-01

Publisher: 国家药品监督管理局

Technical Committee: 全国医用输液器具标准化技术委员会(SAC/TC 106)

Pages: 12 pages

Scope

本文件规定了以偏苯三酸三辛酯(TOTM)增塑的聚氯乙烯(PVC)为原料制成的医疗器械，在模拟实际使用的条件下，与临床输注液体接触后，测定增塑剂TOTM溶出量的化学分析方法。
本文件适用于以TOTM增塑的PVC为原料制成的医疗器械。

Development Information

Drafting Units:

山东省医疗器械和药品包装检验研究院、成都市新津事丰医疗器械有限公司、山东中保康医疗器具有限公司、山东省药学科学院

Drafting Persons:

许凯、田兴龙、张敏、朱小敏、吴长岩、路志浩、凌霞、孙钰朋、孟建文

Word Count: 16 Thousand words Pages: 12 pages

Referenced Standards

GB/T 6682-1992 Water for analytical laboratory use—Specification and test methods GB/T 6682-2008 Water for analytical laboratory use—Specification and test methods

Related Standards

GB 2639-1990 Replaced

GB 2639-1990 Glass infusion bottles

Publish Date: 1990-07-17

GB 2641-1990 Abolished

GB 2641-1990 Tube vial for antibiotic use

Publish Date: 1990-07-17

GB/T 2640-1990 Replaced

GB/T 2640-1990 Injection vials for antibiotics

Publish Date: 1990-07-17

GB 2637-1995 Replaced

GB 2637-1995 Ampoule

Publish Date: 1995-12-26

GB/T 12414-1995 Replaced

GB/T 12414-1995 Pharmaceutical glass tube

Publish Date: 1995-12-26

GB 15980-1995 Abolished

GB 15980-1995 Hygienic standard of disinfection for single use medical products

Publish Date: 1996-01-23