YY 1048-2007
Artificial heart-lung machine.Extracorporeal blood circuit (English Version)
- Standard No.
- YY 1048-2007
- Language
- Chinese, Available in English version
- Release Date
- 2007
- Published By
- Professional Standard - Medicine
- Status
- 2018-01
- Replace By
- YY 1048-2016
- Latest
- YY 1048-2016
- Replace
- YY 91048-1999
- Scope
- This standard specifies the classification and naming, requirements, test methods, inspection rules, marking, packaging, transportation and storage of artificial heart-lung machine extracorporeal circulation pipelines (hereinafter referred to as pipelines). This standard applies to extracorporeal circulation pipelines used in artificial heart-lung machines and the ancillary pipelines integrated with them. This product is used as a blood channel and channel connection for extracorporeal circulation in cardiovascular and related surgeries and is for one-time use.
YY 1048-2007 Referenced Document
- GB 9969.1 General principles for preparation of instructions for use of industrial products
- GB/T 14233.1-1998 Infusion, transfusion, injection equipment for medical use--Part 1: Chemical analysis 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 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process*， 2022-04-15 Update
- GB/T 191 Packaging.Pictorial marking for handling of goods*， 2008-04-01 Update
- GB/T 2828.1 Inspection procedure by count sampling part 1: Lot by lot inspection sampling plan retrieved by acceptance quality limit (AQL)*， 2013-02-15 Update
- YY/T 0313-1998 Package,lable,transport and storage for medical polymer products
YY 1048-2007 history
- 2018 YY 1048-2016 Cardiopulmonary bypass system extracorporeal circulation tubing
- 2007 YY 1048-2007 Artificial heart-lung machine.Extracorporeal blood circuit
- 1990 YY 91048-1999 Artificial heart-lung machine Roller pump
YY 1048-2007 Artificial heart-lung machine.Extracorporeal blood circuit has been changed from YY 91048-1999 Artificial heart-lung machine Roller pump.
