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Position: Chinese Standard in English/YY/T 1155-2019
YY/T 1155-2019   Automatic luminescence immunoassay analyzer (English Version)
Standard No.: YY/T 1155-2019 Status:valid remind me the status change
Language:English File Format:PDF
Word Count: 10500 words Price(USD):240.00 remind me the price change
Implemented on:2020-6-1 Delivery: immediately
Standard No.: YY/T 1155-2019
English Name: Automatic luminescence immunoassay analyzer
Chinese Name: 全自动发光免疫分析仪
Chinese Classification: C44    Medical laboratory equipment
Professional Classification: YY    Professional Standard - Pharmaceutics
Issued by: National Medical Products Adminstration
Issued on: 2019-05-31
Implemented on: 2020-6-1
Status: valid
Superseding:YY/T 1155-2009 Automatic Luminescence Immunoassay Analyzer
Language: English
File Format: PDF
Word Count: 10500 words
Price(USD): 240.00
Delivery: via email in 1 business day
Referred in YY/T 1155-2019:
*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 4793.6-2008 Safety requirements for electrical for measurement control and laboratory use - Part 6: Particular requirements for laboratory equipment for the heating of materials
*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 29791.3-2013 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
*GB/T 29791.1-2013 In vitro diagnostic medical devices―Information supplied by the manufacturer(labelling)―Part 1:Terms,definitions and general requirements
*YY/T 0316-2016 Medical devices-Application of risk management to medical devices
*YY/T 0654-2017 Automatic chemistry analyzer
*YY/T 1174-2010 Semi-automatic chemiluminescence immunoassay analyzer
*YY/T 1175-2010 Quantitative detection reagent(kit) for tumor markers—Chemiluminescent immunoassay
*YY/T 1441-2016 General requirements of performance evaluation of in vitro diagnostic medical devices
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