YY 0584-2005Blood component separation sets for single use - Centrifuge bowl type (English PDF)
一次性使用离心杯式血液成分分离器
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
December 7, 2005
Implementation date
December 1, 2006
Scope
YY 0584-2005 is the English-translated version of 一次性使用离心杯式血液成分分离器.
YY 0584-2005 is a mandatory Chinese medical device and pharmaceutical industry standard for single use blood component separation sets of the centrifuge bowl type.
It describes sets whose main structural feature is the separation bowl and which are made up of three parts, the bowl itself, the tubing system and the collection system.
The sets it covers are used with blood component collection machines for collecting, separating, transfusing, exchanging and storing blood components. Among the standards cited with it are GB 8368, GB 8369, GB 14232.1-2004, GB/T 14233.1-1998, GB 15593, GB/T 16886.1, GB 18457, YY 0326.1-2002 and YY 0328-2002.
It was issued by the State Food and Drug Administration under ICS 11.040.20. Issued on 7 December 2005, it has applied since 1 December 2006.
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Document preview — YY 0584-2005
National Standard of the People's Republic of China
- ICS
- 11.040.20
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- 2 Normative references
2 Normative references
YY 0584-2005 cites the following standards, which apply in full or in part through the references made to them in its clauses.
GB/T 1962.2-2001
GB 8368
GB 8369
GB 14232.1-2004
GB/T 14233.1-1998
GB/T 14233.2
GB 15593
GB/T 16886.1
GB 18457
GB 19335-2003
YY/T 0313-1998
YY 0326.1-2002
YY 0326.2-2002
YY 0326.3-2005
YY 0328-2002
YY 0466
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 16 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 1962.2-2001Conical fittings with a 6 %(Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
- GB 8368Infusion sets for single use -- Gravity feed
- GB 14232.1-2004Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers
- GB/T 14233.1-1998Test methods for infusion, transfusion, injection equipments for medical use - Part 1: Chemical analysis methods
- GB/T 14233.2Test methods for infusion, transfusion, injection equipment for medical use - Part 2: Biological test methods
- GB/T 16886.1Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
GB 8369 · GB 15593 · GB 18457 · GB 19335-2003
Similar standards
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Related Standards
GB 8368-2018 — Infusion sets for single use -- Gravity feed
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
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YY 0584-2005
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