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YY/T 0655-2024: Dry chemistry analyzer
Status: Valid YY/T 0655: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0655-2024 | English | 199 |
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Dry chemistry analyzer
| Valid |
YY/T 0655-2024
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| YY/T 0655-2008 | English | 209 |
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3 days [Need to translate]
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Dry Chemistry Analyzer
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YY/T 0655-2008
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PDF similar to YY/T 0655-2024
Standard similar to YY/T 0655-2024 YY/T 0653 YY/T 0659 YY/T 0657 Basic data | Standard ID | YY/T 0655-2024 (YY/T0655-2024) | | Description (Translated English) | Dry chemistry analyzer | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100.10 | | Word Count Estimation | 9,938 | | Date of Issue | 2024-02-07 | | Date of Implementation | 2025-03-01 | | Older Standard (superseded by this standard) | YY/T 0655-2008 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the requirements, markings, labels, instructions for use and packaging, transportation and storage of dry chemical analyzers (hereinafter referred to as analyzers), and describes the corresponding test methods. This document is applicable to analyzers that use solid-phase carrier reagents to perform chemical testing on patient blood, urine, cerebrospinal fluid and other samples in medical clinical settings. This document does not apply to glucose analyzers, urine analyzers, blood gas analyzers, or other dry analyzers. | YY/T 0655-2024: Dry chemistry analyzer---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
ICS 11.100.10
CCSC44
Pharmaceutical Industry Standards of the People's Republic of China
Replaces YY/T 0655-2008
Dry Chemical Analyzer
Released on 2024-02-07
2025-03-01 Implementation
The State Drug Administration issued
Foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents"
Drafting.
This document replaces YY/T 0655-2008 Dry Chemical Analyzer. Compared with YY/T 0655-2008, except for structural adjustment and editing,
In addition to the changes in performance, the main technical changes are as follows.
--- Changed "Normal working conditions of the instrument" (see 5.1, 4.1 of the.2008 edition);
--- Changed the "accuracy" requirement (see 4.3, 4.3 of the.2008 edition);
--- Changed the "precision" requirement (see 4.4, 4.4 of the.2008 edition);
--- Changed the "linear correlation coefficient" requirements (see 4.5, 4.5 of the.2008 edition);
--- Added "electrical safety" related requirements (see 4.10, 4.10 of the.2008 edition);
--- Added "Electromagnetic compatibility requirements" (see 4.11);
--- Changed the "Accuracy" test method (see 5.3, 5.3 of the.2008 edition);
--- Changed the requirements for “marking, labeling and instruction manual” (see Chapter 6, Chapter 6 of the.2008 edition).
Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents.
This document is proposed by the State Food and Drug Administration.
This document is under the jurisdiction of the National Technical Committee for Standardization of Medical Clinical Testing Laboratories and In Vitro Diagnostic Systems (SAC/TC136).
This document was drafted by. Beijing Medical Device Inspection Institute (Beijing Medical Biological Protection Equipment Inspection and Research Center), Jiangsu Provincial Planning
Energy Measurement Science Research Institute (Jiangsu Energy Measurement Data Center), Ortho Medical Equipment Trading (China) Co., Ltd., Fujifilm (China) Investment
Ltd.
The main drafters of this document are. Zhao Bingfeng, Cui Hongen, Su Jie, Shen Haitao and Li Shengmin.
The previous versions of this document and the documents it replaces are as follows.
---First published in.2008 as YY/T 0655-2008;
---This is the first revision.
Dry Chemical Analyzer
1 Scope
This document specifies the requirements, marking, labeling, instruction manual, packaging, transportation, storage, and other aspects of dry chemical analyzers (hereinafter referred to as analyzers).
The corresponding test methods are described.
This document is applicable to the use of solid phase carrier reagents in clinical medical research on patients' blood, urine, cerebrospinal fluid and other samples.
Analyzer for inspection.
This document does not apply to blood glucose analyzers, urine analyzers, blood gas analyzers, or other dry analyzers.
2 Normative references
The contents of the following documents constitute the essential clauses of this document through normative references in this document.
For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to
This document.
GB/T 191 Pictorial markings for packaging, storage and transportation
GB 4793.1 Safety requirements for electrical equipment for measurement, control and laboratory use Part 1.General requirements
GB 4793.6 Safety requirements for electrical equipment for measurement, control and laboratory use Part 6.Characteristics of laboratory material heating equipment
Special requirements
GB/T 14710 Environmental requirements and test methods for medical electrical appliances
GB/T 18268.1 Electromagnetic compatibility requirements for electrical equipment for measurement, control and laboratory use Part 1.General requirements
GB/T 18268.26 Electromagnetic compatibility requirements for electrical equipment for measurement, control and laboratory use Part 26.Special requirements
In vitro diagnostic (IVD) medical devices
GB/T 29791.3 Information provided by the manufacturer of in vitro diagnostic medical devices (labeling) Part 3.Professional in vitro diagnostic instruments
YY 0648 Safety requirements for electrical equipment for measurement, control and laboratory use Part 2-101.In vitro diagnostic (IVD) medical equipment
Special requirements for
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Dry chemistry
The liquid sample is placed on a solid phase carrier containing reagents to react, and the concentration of specific components in the sample is quantitatively determined according to the reaction results.
or activity detection methods.
3.2
Dry biochemical analyzer
An analyzer designed specifically for clinical chemistry tests using solid phase carrier reagents.
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