YY 0485-2020 Active Industry standards-Medicine

YY 0485-2020 Single-use cardioplegia delivery system

YY 0485-2020 Single-use cardioplegia delivery system

Publish Date: 2020-06-30 Implement Date: 2021-12-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY 0485-2020
Standard Type: Industry standards
Standard Status: Active
is_force_gb: no
CCS Name: Extracorporeal circulation, artificial organs, and prosthetic devices
ICS Name: Blood transfusion, infusion, and injection equipment
Publish Date: 2020-06-30
Implement Date: 2021-12-01
Publisher: 国家药品监督管理局
Technical Committee: 全国医用体外循环设备标准化技术委员会(SAC/TC 158)
Pages: 8 pages

Scope

本标准规定了一次性使用心脏停跳液灌注器的结构与分类、要求、试验方法。
本标准适用于一次性使用心脏停跳液灌注器(以下简称灌注器)。灌注器供体外循环心脏直视手术作心脏停跳液灌注用。

Development Information

Drafting Units:

广东省医疗器械质量监督检验所、山东威高新生医疗器械有限公司、宁波菲拉尔医疗用品有限公司

Drafting Persons:

何晓帆、许朝生、徐苏华、梁泽鑫、熊伟、王毅、孔建明

Word Count: 14 Thousand words Pages: 8 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 GB 19335-2003 Blood flow products for single use—General specification YY/T 0149-2006 Medical instruments of stainless steel—Test methods of corrosion resistance 中华人民共和国药典 GB/T 1962.1-2001 Conical fittings with a6%(Luer)taper for syringes, needles and certain other medical equipment Part 1:General requirement GB/T 1962.1-2015 Conical fittings with a 6%(Luer)taper for syringes,needles and certain other medical equipment—Part 1:General requirement GB/T 1962.2-2001 Conical fittings with a 6%(Luer) taper for syringes, needles and certain other medical equipment—Part 2:Lock fittings 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 18278.1-2015 Sterilization of health care products—Moist heat—Part 1:Requirements for the development, validation and routine control of a sterilization process for medical devices GB 18279.1-2015 Sterilization of health care products—Ethylene oxide—Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices GB 18280.1-2015 Sterilization of health care products—Radiation—Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices YY/T 0681.1-2009 Test methods for sterile medical device package—Part 1:Test guide for accelerated aging YY/T 0681.1-2018 Test methods for sterile medical device package—Part 1:Test guide for accelerated aging GB 18280.1-2025 Sterilization of health care products—Radiation—Part 1:Requirements for the development,validation and routine control of a sterilization process for medical devices

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