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YY/T 0653-2017/XG1-2022   Hematology analyzer|| inlucdes Amendment 1 (English Version)
Standard No.: YY/T 0653-2017/XG1-2022 Status:valid remind me the status change

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Language:English File Format:PDF
Word Count: 7500 words Price(USD):230.0 remind me the price change

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Implemented on:2022-10-17 Delivery: via email in 1 business day
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Standard No.: YY/T 0653-2017/XG1-2022
English Name: Hematology analyzer|| inlucdes Amendment 1
Chinese Name: 《血液分析仪》行业标准第1号修改单
Chinese Classification: C44    Medical laboratory equipment
Professional Classification: YY    Professional Standard - Pharmaceutics
Issued by: China Food and Drug Adminstration
Issued on: 2022-10-17
Implemented on: 2022-10-17
Status: valid
Superseding:YY/T 0653-2017 Hematology analyzer
Language: English
File Format: PDF
Word Count: 7500 words
Price(USD): 230.0
Delivery: via email in 1 business day
Hematology analyzer 1 Scope This standard specifies the terms and definitions, product classification, technical requirements, test methods, labeling, marking and instructions as well as packaging, transportation and storage of hematology analyzers. This standard is applicable to hematology analyzers (hereinafter referred to as analyzer) used for analyzing visible components in human blood and providing relevant information. This standard is not applicable to reticulocyte detection. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. GB/T 191 Packaging - Pictorial marking for handling of goods GB 4793.1 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 1: General requirements GB 4793.9 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 9: Particular requirements for automatic and semi-automatic laboratory equipment for analysis and other purposes GB/T 14710 Environmental requirement and test methods for medical electrical equipment GB/T 18268.1 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements GB/T 18268.26 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 26: Particular requirements - In vitro diagnostic (IVD) medical equipment GB/T 29791.1 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements GB/T 29791.3 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use YY 0648 Safety requirements for electrical equipment for measurement control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 hematology analyzer instrument used to detect human blood samples, being able to quantitatively analyze the visible components in blood and provide relevant information 3.2 semi-automatic device for blood cell analysis that requires off-machine dilution function. It means that some analysis steps of an instrument or test system are mechanized, while other steps still require operator involvement
Foreword i 1 Scope 2 Normative references 3 Terms and definitions 4 Product classification 5 Technical requirements 6 Test method 7 Labeling, marking and instructions 8 Packaging, transportation and storage Annex A (Normative) Test method for five-part analyzer Bibliography
Referred in YY/T 0653-2017/XG1-2022:
*GB/T 191-2008 Packaging - Pictorial Marking for Handling of Goods
*GB 4793.1-2007 Safety requirements for electrical equipment for measurement,control,andlaboratory use-Part 1:General requirements
*GB 4793.9-2013 Safety requirements for electrical equipment for measurement,control and laboratory use—Part 9:Particular requirements for automatic and semi-automatic laboratory equipment for analysis and other purposes
*GB/T 14710-2009 Environmental requirement and test methods for medical electrical equipment
*GB/T 18268.1-2010 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 1:General requirements
*GB/T 18268.26-2010 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 26:Particular requirements—In vitro diagnostic (IVD) medical equipment
*GB/T 29791.1-2013 In vitro diagnostic medical devices―Information supplied by the manufacturer(labelling)―Part 1:Terms,definitions and general requirements
*GB/T 29791.3-2013 In vitro diagnostic medical devices—Information supplied by the manufacturer(labelling)—Part 3:In vitro diagnostic instruments for professional use
*YY 0648-2008 Safety requirements for electrical equipment for measurement control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
Code of China
Standard
YY/T 0653-2017/XG1-2022  Hematology analyzer|| inlucdes Amendment 1 (English Version)
Standard No.YY/T 0653-2017/XG1-2022
Statusvalid
LanguageEnglish
File FormatPDF
Word Count7500 words
Price(USD)230.0
Implemented on2022-10-17
Deliveryvia email in 1 business day
Detail of YY/T 0653-2017/XG1-2022
Standard No.
YY/T 0653-2017/XG1-2022
English Name
Hematology analyzer|| inlucdes Amendment 1
Chinese Name
《血液分析仪》行业标准第1号修改单
Chinese Classification
C44
Professional Classification
YY
ICS Classification
Issued by
China Food and Drug Adminstration
Issued on
2022-10-17
Implemented on
2022-10-17
Status
valid
Superseded by
Superseded on
Abolished on
Superseding
YY/T 0653-2017 Hematology analyzer
Language
English
File Format
PDF
Word Count
7500 words
Price(USD)
230.0
Keywords
YY/T 0653-2017/XG1-2022, YY 0653-2017/XG1-2022, YY 0653-2017XG1-2022, YY/T0653-2017/XG1-2022, YY/T 0653, YY/T0653, YY0653-2017/XG1-2022, YY 0653, YY0653, YY0653-2017XG1-2022, YY 0653, YY0653
Introduction of YY/T 0653-2017/XG1-2022
Hematology analyzer 1 Scope This standard specifies the terms and definitions, product classification, technical requirements, test methods, labeling, marking and instructions as well as packaging, transportation and storage of hematology analyzers. This standard is applicable to hematology analyzers (hereinafter referred to as analyzer) used for analyzing visible components in human blood and providing relevant information. This standard is not applicable to reticulocyte detection. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. GB/T 191 Packaging - Pictorial marking for handling of goods GB 4793.1 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 1: General requirements GB 4793.9 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 9: Particular requirements for automatic and semi-automatic laboratory equipment for analysis and other purposes GB/T 14710 Environmental requirement and test methods for medical electrical equipment GB/T 18268.1 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements GB/T 18268.26 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 26: Particular requirements - In vitro diagnostic (IVD) medical equipment GB/T 29791.1 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements GB/T 29791.3 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use YY 0648 Safety requirements for electrical equipment for measurement control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 hematology analyzer instrument used to detect human blood samples, being able to quantitatively analyze the visible components in blood and provide relevant information 3.2 semi-automatic device for blood cell analysis that requires off-machine dilution function. It means that some analysis steps of an instrument or test system are mechanized, while other steps still require operator involvement
Contents of YY/T 0653-2017/XG1-2022
Foreword i 1 Scope 2 Normative references 3 Terms and definitions 4 Product classification 5 Technical requirements 6 Test method 7 Labeling, marking and instructions 8 Packaging, transportation and storage Annex A (Normative) Test method for five-part analyzer Bibliography
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