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YY/T 1245-2014 English PDF

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US$189.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 1245-2014: Automatic blood grouping analyzer
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1245-2014	189	Add to Cart	3 days	Automatic blood grouping analyzer	Valid

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YY/T 1247 YY/T 1249 YY/T 1244 YY/T 1240 YY/T 1253 YY/T 1252

Basic data

Standard ID: YY/T 1245-2014 (YY/T1245-2014)
Description (Translated English): Automatic blood grouping analyzer
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C44
Classification of International Standard: 11.100
Word Count Estimation: 8,869
Date of Issue: 6/17/2014
Date of Implementation: 7/1/2015
Quoted Standard: GB/T 191; GB 4793.1; GB/T 14710; YY/T 0466.1; YY 0648
Regulation (derived from): China Food and Drug Administration in 2014 Bulletin No. 30
Issuing agency(ies): State Food and Drug Administration
Summary: This Standard applies to the human red blood cell blood grouping, antibody screening tests, such as column agglutination, microplate method automatic blood analyzer. This Standard specifies requirements for automatic blood analyzer, test methods, labeling

YY/T 1245-2014: Automatic blood grouping 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.
Automatic blood grouping analyzer ICS 11.100 C44 People's Republic of China pharmaceutical industry standards Automatic blood analyzer Issued on. 2014-06-17 2015-07-01 implementation China Food and Drug Administration released

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules. Please note that some of the content of this document may involve patents. Distribution of this document Institutions do not assume the responsibility to identify these patents. This standard was proposed by the China Food and Drug Administration. This standard by the national medical clinical laboratory testing and in vitro diagnostic systems for Standardization Technical Committee (SAC/TC136) centralized. This standard was drafted. Beijing Medical Device Testing, Beckman Coulter Trading (China) Co., Ltd., Shenzhen Electronics Icahn has Limited, Johnson & Johnson (Shanghai) Medical Equipment Co., Ltd. The main drafters of this standard. Bi Chunlei, He Xueying, Zhang Jinwen, BIMONTHLY Nie Jing. Automatic blood analyzer

1 Scope

This standard specifies requirements for automatic blood analyzer, test methods, labeling and instructions for use, packaging, transportation and storage. This standard applies to the human red blood cell blood grouping, antibody screening test and other automatic blood analyzer (hereinafter referred to as the analyzer). This standard specifies only the column agglutination method, a method microplate blood analysis instrument technical requirements.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document. GB/T 191 Packaging - Pictorial signs GB 4793.1 measurement, control and laboratory safety requirements for electrical equipment - Part 1. General requirements GB/T 14710 medical electrical environmental requirements and test methods Symbols - Part 1 YY/T 0466.1 medical equipment used with medical device labels, labeling and information. General requirements YY 0648 measurement, control and laboratory safety requirements for electrical equipment - Part 2-101. In vitro diagnostic (IVD) medical equipment Special requirements

3 Requirements

3.1 blood typing accuracy 3.1.1 ABO blood group determination system Blood samples were seized, agglutination reaction with the corresponding private positive stereotypes and counter-stereotypes reagents, the analyzer shall automatically report the correct ABO typing results. 3.1.2 Rh blood group determination After blood samples were seized, with the corresponding dedicated reagent agglutinate, the analyzer shall automatically reports the correct Rh (D) negative and positive result. Stability Analyzer 3.2 After boot 30min, 8h, detected by the analyzer known blood sample, the test results should be consistent with the known results. 3.3 Temperature Control Incubation temperature should be set within ± 2.0 ℃ temperature range. 3.4 centrifuge speed Working speed conditions, the test speed deviation should be ± 2.5% within the range set value. NOTE. This applies to the use of centrifugal method analyzer. ......

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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY/T 1245-2014_English be delivered?

Answer: Upon your order, we will start to translate YY/T 1245-2014_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 1245-2014_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 1245-2014_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.