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YY/T 0657-2008

Search Result of Chinese Standard: 'YY/T 0657-2008'
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Detail Information of YY/T 0657-2008; YY/T0657-2008
Description (Translated English): Medical centrifuge
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C44
Classification of International Standard: 11.100
Word Count Estimation: 8,899
Date of Issue: 2008-04-25
Date of Implementation: 2009-06-01
Older Standard (superseded by this standard): YY 91046-1999; YY 91100-1999
Quoted Standard: GB/T 191; GB 4793.1; GB 4793.7; GB/T 14710
Drafting Organization: Beijing Medical Device Testing
Administrative Organization: National Standardization Technical Committee of Medical clinical testing laboratories and in vitro diagnostic systems
Regulation (derived from): SFDA [2008] No. 192
Proposing organization: State Food and Drug Administration
Issuing agency(ies): China Food and Drug Administration
Summary: This standard specifies the Medical Centrifuge (hereinafter referred to as centrifuges) product classification, requirements, test methods, marking, labeling, instructions, packaging, transportation and storage requirements. This standard applies to medical centrifuge design, production and testing. This standard does not apply to ultracentrifuge (speed above 30000r/min),

YY/T 0657-2008
Medical centrifuge
ICS 11.100
C44
People's Republic of China pharmaceutical industry standards
Replacing YY 91046-1999, YY 91100-1999
Medical Centrifuge
Posted 2008-04-25
2009-06-01 implementation
State Food and Drug Administration issued
Foreword
This standard is YY 91046-1999 "medical centrifuge low speed" and YY 91100-1999 "high-speed refrigerated centrifuge," the revision of the
Amendment in the above two criteria is incorporated to prepare.
This standard compared with the original standard main changes are as follows:
--- Information about the content of the low-speed large-capacity centrifuge frozen;
--- General requirements for electrical safety, the original standards GB 9706.1, was replaced by the Executive GB 4793.1;
--- Increase the special security requirements, the implementation of GB 4793.7.
From the date of implementation of this standard, instead YY 91046-1999, YY 91100-1999.
This standard was proposed by the State Food and Drug Administration.
This standard by the national medical clinical testing laboratory and diagnostic systems in vitro Standardization Technical Committee.
This standard was drafted: Beijing Medical Device Testing, Shanghai Anting Scientific Instrument Factory.
The main drafters of this standard: Man Liao Shen Benjamin, chapter trillion Park.
This standard replaces the standards previously issued as follows:
--- GB 12258-90, YY 91046-1999;
--- ZBC44002-84, YY 91100-1999.
Medical Centrifuge
1 Scope
This standard specifies the medical centrifuge (hereinafter referred to as centrifuges) product classification, requirements, test methods, sign, label, manual,
Packaging, transportation and storage requirements.
This standard applies to medical centrifuge design, production and testing.
This standard does not apply to an ultracentrifuge (speed is higher than 30000r/min).
2 Normative references
The following documents contain provisions which, through this standard reference and become the standard terms. For dated references, all subsequent
Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to study under this agreement is standard
Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard.
GB/T 191 Packaging - Pictorial signs
GB 4793.1 measurement, control and laboratory safety requirements for
Related standard:   YY/T 0657-2017  YY/T 0653-2017
   
 
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