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YY/T 1530-2017 English PDF

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US$179.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 1530-2017: Control materials for urine formed element analyzer
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1530-2017	179	Add to Cart	3 days	Control materials for urine formed element analyzer	Valid

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Basic data

Standard ID: YY/T 1530-2017 (YY/T1530-2017)
Description (Translated English): Control materials for urine formed element analyzer
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C44
Classification of International Standard: 11.100
Word Count Estimation: 9,924
Date of Issue: 2017-03-28
Date of Implementation: 2018-04-01
Regulation (derived from): China Food & Drug Administration Announcement 2017 No. 38
Issuing agency(ies): State Food and Drug Administration

YY/T 1530-2017: Control materials for urine formed element 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.
Control materials for urine formed element analyzer ICS 11.100 C44 People's Republic of China pharmaceutical industry standards Urinary compositional analyzer with control substances 2017-03-28 Posted 2018-04-01 implementation State Food and Drug Administration released

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of this document may be patentable. The release of this document The agency does not assume responsibility for identifying these patents. This standard proposed by the State Food and Drug Administration. This standard by the National Medical Clinical Laboratory and in vitro diagnostic system standardization Technical Committee (SAC/TC136) centralized. This standard was drafted. Beijing Medical Device Testing Institute, Love Granville Technology Co., Ltd., Changchun Di Rui Medical Technology Co., Ltd. Secretary, Guilin excellent Lite Medical Electronics Co., Ltd., Chongqing Tianhai Medical Equipment Co., Ltd., Hangzhou Long Xin Technology Co., Ltd. The main drafters of this standard. Yang Zongbing, Zhou Fengliang, Liu Chunping, Jiang Jun, Chen Wei, Han Weihua, Liu Guanghua. Urinary compositional analyzer with control substances

1 Scope

This standard specifies the requirements of the control substance of urine visible components analyzer, test methods, labels and instructions for use, packaging, transportation and Storage. This standard applies to urine composition analyzer with red blood cells, white blood cells control substances. This standard does not apply to urine composition analyzer with red blood cells, white blood cells to simulate particles. This standard does not apply to flow-based analytical instruments with control substances.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version applies to this article Pieces. For undated references, the latest edition (including all amendments) applies to this document. GB/T 29791.2 Information provided by manufacturers of in vitro diagnostic medical devices (LABEL) SECTION 2. PROFESSIONAL IN VITRO DIAGNOSTIC AGENTS

3 requirements

3.1 traits The state of the controlled substance and the normal appearance requirements shall be specified. 3.2 loading capacity Loading should not be less than the indicated value. 3.3 source RBC, WBC counts should be traceable to microscopy. 3.4 control material range settings RBC, WBC should set at least two count levels. 3.5 control the material range The counting results of RBC and WBC should be within ± 15% of the target value of the controlled substances. 3.6 Uniformity 3.6.1 bottle uniformity Counting results Bottle uniformity (coefficient of variation) should meet the requirements of Table 1. ......

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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY/T 1530-2017_English be delivered?

Answer: Upon your order, we will start to translate YY/T 1530-2017_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 1530-2017_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 1530-2017_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.