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YY/T 1870-2023 English PDF

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US$169.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 1870-2023: (General requirements for liquid chromatography-mass spectrometry kits)
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1870-2023	169	Add to Cart	3 days	(General requirements for liquid chromatography-mass spectrometry kits)	Valid

Basic data

Standard ID: YY/T 1870-2023 (YY/T1870-2023)
Description (Translated English): (General requirements for liquid chromatography-mass spectrometry kits)
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of International Standard: 11.100.10
Word Count Estimation: 8,842
Date of Issue: 2023-01-13
Date of Implementation: 2024-01-15
Issuing agency(ies): State Drug Administration
Summary: This standard specifies the requirements, test methods, labels and instructions for use, packaging, transportation and storage of liquid chromatography-mass spectrometry detection kits. This standard applies to kits for quantitative detection of human samples (whole blood, serum, plasma, urine, etc.) by liquid chromatography-mass spectrometry.

YY/T 1870-2023: (General requirements for liquid chromatography-mass spectrometry kits)

---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 Standard of the People's Republic of China General requirements for liquid chromatography-mass spectrometry kits Released on 2023-01-13 2024-01-15 Implementation Released by the State Drug Administration

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" to be drafted. Please note that some contents of this document may refer to patents. Publishing of this document The Agency assumes no responsibility for identifying patents. This document is proposed by the State Drug Administration. This document is under the jurisdiction of the National Medical Clinical Laboratory and In Vitro Diagnostic System Standardization Technical Committee (SAC/TC136). This document was drafted by. Beijing Institute of Medical Device Testing, Shanghai Xuhui District Central Hospital, Food and Drug Evaluation and Inspection of Shandong Province Center, Shanghai Clinical Laboratory Center, Meikang Biotechnology Co., Ltd., Shenzhen Huada Gene Co., Ltd. The main drafters of this document. Sun Xueqing, Li Shuijun, Guo Jinshuang, Ju Yi, Shen Min, Zhang Shenyan. General requirements for liquid chromatography-mass spectrometry kits

1 Scope

This document specifies the requirements, test methods, labels and instructions for use of liquid chromatography-mass spectrometry detection kits, packaging, transportation and storage. This document is applicable to kits for quantitative detection of human samples (whole blood, serum, plasma, urine, etc.) by liquid chromatography-mass spectrometry (hereinafter referred to as the kit). Note. The kit generally includes pretreatment solution, internal standard solution, calibrator, quality control product and other related components.

2 Normative references

The contents of the following documents constitute the essential provisions of this document through normative references in the text. Among them, dated references For documents, only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to this document. GB/T 21415 Metrology traceability of measuring calibrators and control substances in biological samples of in vitro diagnostic medical devices origin GB/T 29791.2 Information provided by manufacturers of in vitro diagnostic medical devices (labelling) Part 2.In vitro diagnostic reagents for professional use YY/T 1789.5 In vitro diagnostic test system performance evaluation method - Part 5.Analytical specificity

3 Terms and Definitions

This document does not have terms and definitions that need to be defined.

4 requirements

4.1 Appearance Manufacturers should specify appropriate appearance requirements according to the packaging characteristics of their own products. Generally, there should be the composition and properties of each component of the kit; Requirements for packaging, clear labels, etc. 4.2 Net content The net content should not be less than the marked value. 4.3 Traceability The manufacturer shall provide the source, assignment process and measurement uncertainty of the calibration products used in accordance with GB/T 21415 and relevant regulations content. 4.4 Linearity The following requirements shall be met within the linear interval given by the manufacturer. a) The correlation coefficient (r) should not be less than 0.9900; ......

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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY/T 1870-2023_English be delivered?

Answer: Upon your order, we will start to translate YY/T 1870-2023_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 1870-2023_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 1870-2023_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.