GB 8662-1988
Replaced
YY/T 1550.3-2024
Active
Industry standards-Medicine
YY/T 1550.3-2024 Guidance of study on the compatibility of infusion equipments and pharmaceutical products—Part 3:Leachable study—Unknown substance
YY/T 1550.3-2024 Guidance of study on the compatibility of infusion equipments and pharmaceutical products—Part 3:Leachable study—Unknown substance
Basic Information
Standard Code:
YY/T 1550.3-2024
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Generally, it refers to microsurgical instruments
ICS Name:
Surgical instruments and materials
Publish Date:
2024-07-08
Implement Date:
2025-07-20
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:
16 pages
Scope
本文件描述了在模拟临床输液条件下或临床输液条件下，一次性使用输液器具与药物接触过程中可沥滤物中未知物的研究方法。
本文件适用于需要开展未知可沥滤物研究的特定输液器具，需要时，与经论证的药物替代溶剂或拟输液的药物，开展未知可沥滤物研究。其他输注器具如需评价时，参考使用。
Development Information
Drafting Units:
山东省医疗器械和药品包装检验研究院、苏州百特医疗用品有限公司、山东中保康医疗器具有限公司
Drafting Persons:
张敏、骆红宇、沈永、刘洪英、吕沙沙、刘敏、陈方、刘莉莉
Related Standards
GB 2766-1995
Replaced
GB 2766-1995 Haemostatic forceps with box joint—General specifications
GB/T 10160-1995
Abolished
GB/T 10160-1995 Test methods of locking force and opening force for medical use forceps
GB 9706.4-1999
Replaced
GB 9706.4-1999 Medical electrical equipment—Part 2:Particular requirements for the safety of high frequency surgical equipment
YY 0464-2003
Replaced
YY 0464-2003 Single use hemoperfutor
YY 0054-2003
Replaced