GB/T 19335-2022 Active National standards

GB/T 19335-2022 Blood flow products for single use—General specification

GB/T 19335-2022 Blood flow products for single use—General specification

Publish Date: 2022-04-15 Implement Date: 2023-05-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB/T 19335-2022
Standard Type: National standards
Standard Status: Active
is_force_gb: no
CCS Name: Generally, it refers to microsurgical instruments
ICS Name: Blood transfusion, infusion, and injection equipment
Publish Date: 2022-04-15
Implement Date: 2023-05-01
Publisher: 国家市场监督管理总局、国家标准化管理委员会
Technical Committee: 全国医用输液器具标准化技术委员会(SAC/TC 106)
Pages: 13 pages

Scope

本文件规定了一次性使用血路产品的通用技术条件。
本文件适用于一次性使用血路以及与其连为一体的附属管路,包括液路和压力监测管路等组成的产品(以下简称“血路”)。

Development Information

Drafting Units:

山东省医疗器械产品质量检验中心、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、费森尤斯卡比(中国)投资有限公司、山东威高集团医用高分子制品股份有限公司、山东新华安得医疗用品有限公司

Drafting Persons:

张博、许凯、吴淼、巩家富、洪梅、余克龙、李未扬、李松华、郝树彬、赵增琳

Word Count: 27 Thousand words Pages: 13 pages

Replace the following standards

Referenced Standards

GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods YY/T 1288-2015 Nylon blood filter nets for transfusion equipments for single use ISO 18250-8:2018 ISO 80369-7 GB 8369-1998 Transfusion sets for single use GB 8369-2005 Transfusion sets for single use GB 8369.1-2019 Transfusion sets for single use—Part 1:Gravity feed GB 8369.2-2020 Transfusion sets for single use—Part 2:With pressure infusion apparatus use 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/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 GB/T 19633.1-2015 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials, sterile barrier systems and packaging systems GB/T 19633.1-2024 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials,sterile barrier systems and packaging systems YY/T 0316-2003 Medical devices—Application of risk management to medical devices YY/T 0316-2008 Medical devices—Application of risk management to medical devices YY/T 0316-2016 Medical devices—Application of risk management to medical devices YY/T 0581.1-2011 Infusion access adapters—Part 1:Needle access adapters(Heparin plugs) YY/T 0581.2-2011 Infusion access adapter—Part 2:Needleless access adapters YY/T 0615.1-2007 Requirements for medical devices to be designated "STERILE"—Part 1:Requirements for terminally sterilized medical devices YY/T 0923-2014 Needleless access ports for fluid lines and blood lines—Test method for microbial ingress YY/T 0923-2024 Test method for microbial ingress on infusion access adapters for fluid lines and blood lines YY/T 1556-2017 Test methods for particle contamination of infusion,transfusion and injection equipments for medical use YY/T 0316-2000 YY/T 0316-2000 Medical devices - Risk analysis - Part 1: Application of risk analysis YY/T 0581.2-2024 Infusion access adapter—Part 2:Needleless access adapters GB/T 14233.2-2025 Test methods for infusion,transfusion,injection equipment for medical use—Part 2:Biological test methods

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