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YY/T 0655-2024 English PDF

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Q: Should I purchase the latest version YY/T 0655-2024?

Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY/T 0655-2024 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically.

US$199.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 0655-2024: Dry chemistry analyzer
Status: Valid

YY/T 0655: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 0655-2024	199	Add to Cart	3 days	Dry chemistry analyzer	Valid
YY/T 0655-2008	209	Add to Cart	3 days	Dry Chemistry Analyzer	Valid

Similar standards

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Older Standard (superseded by this standard): YY/T 0655-2008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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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY/T 0655-2024_English be delivered?

Answer: Upon your order, we will start to translate YY/T 0655-2024_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of YY/T 0655-2024_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 0655-2024_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.

Question 3: Does the price include tax/VAT?

Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countries

Question 4: Do you accept my currency other than USD?

Answer: Yes. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.

Question 5: Should I purchase the latest version YY/T 0655-2024?

Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY/T 0655-2024 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically.