GB 9706.8-1995
Replaced
YY/T 0573.3-2019
Active
Industry standards-Medicine
YY/T 0573.3-2019 Sterile hypodermic syringes for single use—Part 3:Auto-disable syringes for fixed dose immunization
YY/T 0573.3-2019 Sterile hypodermic syringes for single use—Part 3:Auto-disable syringes for fixed dose immunization
Basic Information
Standard Code:
YY/T 0573.3-2019
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Generally, it refers to microsurgical instruments
ICS Name:
Medical equipment
Publish Date:
2019-05-31
Implement Date:
2020-06-01
Publisher:
国家药品监督管理局
Technical Committee:
全国医用注射器(针)标准化技术委员会(SAC/TC 95)
Pages:
22 pages
Scope
YY/T 0573的本部分规定了在输送至预设的疫苗剂量时，会自动失效的一次性使用无菌注射器（以下简称注射器）的术语和定义、命名、物理要求、化学要求、生物要求、包装和标志等。
本部分适用于由塑料材料和不锈钢材料制成的供抽吸疫苗或注入疫苗后立即注射用的带针或不带针的一次性使用无菌注射器。
本部分不适用于胰岛素注射器、玻璃注射器、带动力驱动注射泵的注射器、不固定剂量的自毁型注射器以及预装药液的注射器。
Development Information
Drafting Units:
上海市医疗器械检测所、浙江灵洋医疗器械有限公司、苏州碧迪医疗器械有限公司
Drafting Persons:
花松鹤、罗建兵、刘佩华、贾娜
Replace the following standards
Referenced Standards
GB/T 191-2008 Packaging—Pictorial marking for handling of goods
GB/T 6682-2008 Water for analytical laboratory use—Specification and test methods
GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods
GB 15811-2016 Sterile hypodermic needles for single use
GB/T 18457-2015 Stainless steel needle tubing for the manufacture of medical devices
GB/T 14233.2-1993 Infusion, transfusion, injction equipment for medical use—Part 2:Biological test methods
GB/T 14233.2-2005 Test methods for infusion,transfusion,injection equipment for medical use—Part 2:Biological test methods
GB 15810-2001 Sterile hypodermic syringes for single use
GB 15810-2019 Sterile syringes for single use
YY/T 0466.1-2009 Medical devices—Symbols to be used with medical device labels, labelling and information to be supplied—Part 1:General requirements
YY/T 0466.1-2016 Medical devices—Symbols to be used with medical device labels,labelling and information to be supplied—Part 1:General requirements
YY/T 0466.1-2023 Medical devices—Symbols to be used with information to be supplied by the manufacturer—Part 1:General requirements
GB/T 14233.2-2025 Test methods for infusion,transfusion,injection equipment for medical use—Part 2:Biological test methods
Adopt standards
ISO 7886-3:2005
Related Standards
GB 11235-1997
Replaced
GB 11235-1997 VCu intra-uterine device
GB/T 17257.1-1998
Replaced
GB/T 17257.1-1998 Urine collection bags—Part 1:Vocabulary
GB/T 17257.2-1998
Replaced
GB/T 17257.2-1998 Urine collection bags—Part 2:Determination of dimensions
GB/T 17257.3-1998
Replaced
GB/T 17257.3-1998 Urine collection bags—Part 3:Verification of rated volume
GB/T 17257.4-1998
Replaced