YY/T 1530-2017 (YY/T1530-2017, YYT 1530-2017, YYT1530-2017)
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1530-2017 | English | 179 |
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Control materials for urine formed element analyzer
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YY/T 1530-2017
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Standards related to: YY/T 1530-2017
| Standard ID | YY/T 1530-2017 (YY/T1530-2017) | | Description (Translated English) | Control materials for urine formed element analyzer | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100 | | Word Count Estimation | 9,957 | | Date of Issue | 2017-03-28 | | Date of Implementation | 2018-04-01 | | Drafting Organization | Beijing Medical Device Inspection Institute, Love Granville Technology Co., Ltd., Changchun Di Rui Medical Technology Co., Ltd., Guilin excellent Lite Medical Electronics Co., Ltd., Chongqing Tianhai Medical Equipment Co., Ltd., Hangzhou Long Xin Technology Co., Ltd. | | Administrative Organization | National Medical Clinical Laboratory and in vitro diagnostic system standardization Technical Committee (SAC/TC 136) | | Regulation (derived from) | China Food & Drug Administration Announcement 2017 No. 38 | | Proposing organization | China Food and Drug Administration | | Issuing agency(ies) | State Food and Drug Administration | YY/T 1530-2017
Control materials for urine formed element analyzer
ICS 11.100
C44
People's Republic of China pharmaceutical industry standards
Urinary compositional analyzer with control substances
2017-03-28 Posted
2018-04-01 implementation
State Food and Drug Administration released
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of this document may be patentable. The release of this document
The agency does not assume responsibility for identifying these patents.
This standard proposed by the State Food and Drug Administration.
This standard by the National Medical Clinical Laboratory and in vitro diagnostic system standardization Technical Committee (SAC/TC136) centralized.
This standard was drafted. Beijing Medical Device Testing Institute, Love Granville Technology Co., Ltd., Changchun Di Rui Medical Technology Co., Ltd.
Secretary, Guilin excellent Lite Medical Electronics Co., Ltd., Chongqing Tianhai Medical Equipment Co., Ltd., Hangzhou Long Xin Technology Co., Ltd.
The main drafters of this standard. Yang Zongbing, Zhou Fengliang, Liu Chunping, Jiang Jun, Chen Wei, Han Weihua, Liu Guanghua.
Urinary compositional analyzer with control substances
1 Scope
This standard specifies the requirements of the control substance of urine visible components analyzer, test methods, labels and instructions for use, packaging, transportation and
Storage.
This standard applies to urine composition analyzer with red blood cells, white blood cells control substances.
This standard does not apply to urine composition analyzer with red blood cells, white blood cells to simulate particles.
This standard does not apply to flow-based analytical instruments with control substances.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version applies to this article
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 29791.2 Information provided by manufacturers of in vitro diagnostic medical devices (LABEL) SECTION 2. PROFESSIONAL IN VITRO DIAGNOSTIC AGENTS
3 requirements
3.1 traits
The state of the controlled substance and the normal appearance requirements shall be specified.
3.2 loading capacity
Loading should not be less than the indicated value.
3.3 source
RBC, WBC counts should be traceable to microscopy.
3.4 control material range settings
RBC, WBC should set at least two count levels.
3.5 control the material range
The counting results of RBC and WBC should be within ± 15% of the target value of the controlled substances.
3.6 Uniformity
3.6.1 bottle uniformity
Counting results Bottle uniformity (coefficient of variation) should meet the requirements of Table 1.
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