GB 18278-2000
Replaced
YY 0451-2023
Pending
Industry standards-Medicine
YY 0451-2023 Portable infusion devices for single use—Non electrically driven
YY 0451-2023 Portable infusion devices for single use—Non electrically driven
Basic Information
Standard Code:
YY 0451-2023
Standard Type:
Industry standards
Standard Status:
Pending
is_force_gb:
no
CCS Name:
Public medical equipment
ICS Name:
Integrated disinfection and sterilization
Publish Date:
2023-09-05
Implement Date:
2026-09-15
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:
17 pages
Scope
本文件规定了一次性使用便携式输注泵非电驱动(以下简称输注泵)的基本要求和相应的试验方法。
本文件适用于神经、血管内或皮下应用的可持续(固定的或可调节)给液和/或自控给液的输注泵。
注: 神经应用的部位包括脊柱、鞘内或蛛网膜下腔、脑室、硬脑膜上隙、硬脑膜外隙或硬脑膜间隙。神经应用麻醉剂可被局部输注从而影响人体的大部分(如肢体)以及包括神经丛阻断(如臂丛神经阻断或单根神经阻断)。神经应用过程包括对创面持续输注局部麻醉剂。
Development Information
Replace the following standards
Referenced Standards
GB/T 14233.1-2022 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods
YY 0286.1-2019 Infusion sets for special purpose—Part 1:Infusion sets for single use with micropore filters
ISO 80369-7
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
GB 8368-1998 Infusion sets for single use
GB 8368-2005 Infusion sets for single use, gravity feed
GB 8368-2018 Infusion sets for single use—Gravity feed
GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing
GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
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
YY/T 0916.1-2014 Small-bore connectors for liquids and gases in healthcare applications—Part 1:General requirements
YY/T 0916.1-2021 Small-bore connectors for liquids and gases in healthcare applications—Part 1:General requirements
YY/T 0916.6-2022 Small-bore connectors for liquids and gases in healthcare applications—Part 6:Connectors for neuraxial applications
Adopt standards
ISO 28620:2020
Related Standards
GB 18281.1-2000
Replaced
GB 18281.1-2000 Sterilization of health care products—Biological indicators—Part 1:General
GB 18281.2-2000
Replaced
GB 18281.2-2000 Sterilization of health care products—Biological indicators—Part 2:Biological indicators for ethylene oxide sterilization
GB 18281.3-2000
Replaced
GB 18281.3-2000 Sterilization of health care products—Biological indicators—Part 3:Biological indicators for moist heat sterilization
GB 18282.1-2000
Replaced
GB 18282.1-2000 Sterilization of health care products—Chemical indicators—Part 1:General requirements
YY/T 0567.2-2005
Replaced