YY 0613-2007
Blood components separation sets for single use,centrifuge bag type (English Version)

Standard No.

YY 0613-2007

Language

Chinese, Available in English version

Release Date

2007

Published By

Professional Standard - Medicine

Latest

YY 0613-2007

Scope

This standard specifies the requirements for disposable centrifugal bag blood component separators (hereinafter referred to as separators) with the separator shown in Appendix A as the main structural feature. These separators are used in conjunction with blood component separators for human body Collection, separation, reinfusion and storage of blood components. The separator specified in this standard generally consists of a pipeline system and a bag system.

YY 0613-2007 Referenced Document

• GB 14232.1-2004 Plastics collapsible containers for human blood and blood components-Part 1:Conventional containers
• GB 19335-2003 Blood flow products for single use-General specification
• GB 8369 Transfusion sets for single use
• 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 16886.4 Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood*， 2022-04-15 Update
• GB/T 1962.2 Conical fittings with a 6%(Luer)taper for syringes,needles and certain other medical equipment Part 2: Lock fittings
• GB/T 6682 Water for analytical laboratory use.Specification and test methods*， 2008-05-15 Update
• YY 0326.1-2002 Plasmapheresis centrifuge apparatus for single use----Part 1: Centrifuge bowl
• YY 0326.2-2002 Plasmapheresis centrifuge apparatus for single use----Part 2: Plasma tubing
• YY 0326.3-2005 Plasmapheresis centrifuge apparatus for single use - Part 3: Containers for plasma
• YY 0328-2002 Single use blood-taking set for blood processing equipment
• YY 0466 Medical devices-Symbols to be used with medical device labels,labelling and information to be supplied
• YY 0584 Blood components separation sets for single use, centrifuge bowl type
• YY/T 0313 Medical polymer products.Requirement for package and information supplied by manufacturer*， 2014-06-17 Update

YY 0613-2007 history

• 2007 YY 0613-2007 Blood components separation sets for single use,centrifuge bag type