YY 0645-2008 Replaced Industry standards-Medicine

YY 0645-2008 Continuous blood purification equipment

YY 0645-2008 Continuous blood purification equipment

Publish Date: 2008-04-25 Implement Date: 2009-12-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY 0645-2008

Standard Type: Industry standards

Standard Status: Replaced

is_force_gb: no

CCS Name: Extracorporeal circulation, artificial organs, and prosthetic devices

ICS Name: Surgical instruments and materials

Publish Date: 2008-04-25

Implement Date: 2009-12-01

Pages: 8 pages

Scope

This standard specifies the terms and definitions, classification and marking, requirements, test methods, labels, user manuals, and packaging, transportation, and storage of continuous blood purification equipment. This standard applies to continuous blood purification equipment (hereinafter referred to as the equipment). The equipment does not include replacement fluid or dialysis fluid preparation systems and can be used for continuous blood purification treatments such as blood filtration for more than 24 hours.

Development Information

Word Count: 13 Thousand words Pages: 8 pages

Superseded by the following standards

YY 0645-2018 Continuous blood purification equipment

Referenced Standards

GB/T 14710-1993 The environmental requirements and test methods for medical electrical equipment 医疗器械说明书、标签和包装标识管理规定　国家食品药品监督管理局10号令 GB/T 191-2000 Packaging—Pictorial marking for handling of goods GB/T 191-2008 Packaging—Pictorial marking for handling of goods GB 9706.1-1995 Medical electrical equipment—Part 1:General requirements for safety GB 9706.1-2007 Medical electrical equipment—Part 1:General requirements for safety GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance GB 9706.2-2003 Medical electrical equipment—Part 2-16:Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment GB 9969.1-1998 General principles for preparation of instructions for use of industrial products GB/T 13074-1991 Terms of blood purification—Hemodialysis and hemofiltration GB/T 13074-2009 Terms of blood purification YY 0466-2003 Medical devices—Symbols to be used with medical device labels,labelling and information to be supplied 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 0466.2-2015 Medical devices—Symbols to be used with medical device labels, labelling,and information to be supplied—Part 2:Symbol development,selection and validation GB/T 13074-2024 Blood purification terminology GB/T 191-2025 Graphical symbols marking for handling and storage of packages

Related Standards

GB 8662-1988 Replaced

GB 8662-1988 Fitting dimension between knife blades and knife handles

Publish Date: 1988-02-13

GB 2766-1995 Replaced

GB 2766-1995 Haemostatic forceps with box joint—General specifications

Publish Date: 1995-06-02

GB/T 10160-1995 Abolished

GB/T 10160-1995 Test methods of locking force and opening force for medical use forceps

Publish Date: 1995-06-02

GB 9706.4-1999 Replaced

GB 9706.4-1999 Medical electrical equipment—Part 2:Particular requirements for the safety of high frequency surgical equipment

Publish Date: 1999-08-02

YY 0464-2003 Replaced

YY 0464-2003 Single use hemoperfutor

Publish Date: 2002-06-20

YY 0054-2003 Replaced

YY 0054-2003 Haemodialysis、haemodiafiltration and haemofiltration equipment

Publish Date: 2003-06-20