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YY/T 1585-2024 English PDF

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Q: Should I purchase the latest version YY/T 1585-2024?

Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY/T 1585-2024 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$279.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 1585-2024: 25-Hydroxyl vitamin D testing kit
Status: Valid

YY/T 1585: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1585-2024	279	Add to Cart	3 days	25-Hydroxyl vitamin D testing kit	Valid
YY/T 1585-2017	199	Add to Cart	3 days	Total 25-hydroxyl vitamin D testing kit(labelling immunoassay)	Valid

Similar standards

YY/T 1579 YY/T 1578 YY/T 1581

Basic data

Standard ID: YY/T 1585-2024 (YY/T1585-2024)
Description (Translated English): 25-Hydroxyl vitamin D testing kit
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C44
Classification of International Standard: 11.100.10
Word Count Estimation: 14,138
Date of Issue: 2024-09-29
Date of Implementation: 2025-10-15
Older Standard (superseded by this standard): YY/T 1585-2017
Issuing agency(ies): State Drug Administration
Summary: This standard specifies the requirements, identification, labeling, instructions for use, packaging, transportation and storage of 25-hydroxyvitamin D assay kits, and specifies the corresponding test methods. This standard is applicable to kits for quantitative detection of total 25-hydroxyvitamin D, 25-hydroxyvitamin D2, and 25-hydroxyvitamin D3 in human serum or plasma, including labeled immunoassay (such as enzyme labeling, luminescent labeling, etc.), immunochromatography, immunoturbidimetry, and liquid chromatography-tandem mass spectrometry.

YY/T 1585-2024: 25-Hydroxyl vitamin D testing kit

---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.
Pharmaceutical Industry Standards of the People's Republic of China ICS 11.100.10CCS C 44 25-Hydroxyvitamin D Assay Kit 25⁃Hydroxyl vitamin D testing kit 2024-09-29 Release 2025-10-15 Implementation The State Drug Administration issued Replaces YY/T 1585-2017

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 is required. This document replaces YY/T 1585-2017 "Total 25-hydroxyvitamin D Assay Kit (Labeled Immunoassay)" and is compatible with YY/T 1585- Compared with.2017, in addition to structural adjustments and editorial changes, the main technical changes are as follows. -- The scope adds the methodologies applicable to this document and deletes the inapplicable contents of this document (see Chapter 1,.2017 edition). Chapter 1); -- The classification method has been deleted (see Chapter 4 of the.2017 edition); --The main changes in technical indicators are as follows. l Changed the appearance requirements (see 4.1.1 and 4.2.1, 4.1 of the.2017 edition), l Changed the linearity requirements (see 4.1.3 and 4.2.3, 4.5 of the.2017 edition), l Changed the repeatability requirements (see 4.1.4 and 4.2.4, 4.6 of the.2017 edition), l Changed the accuracy requirements (see 4.1.6 and 4.2.6, 4.3 of the.2017 edition), l Changed the detection limit requirements (see 4.1.7 and 4.2.7, 4.4 of the.2017 edition), l Added the limit of quantification requirements (see 4.1.8 and 4.2.8), l Added analytical specificity requirements (see 4.1.9 and 4.2.9); --The test method has been changed to be compatible with the requirements of Chapter 4 (see Chapter 5, Chapter 5 of the.2017 edition); --Changes have been made to packaging, transportation and storage (see Chapter 7, Chapter 7 of the.2017 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/TC 136). This document was drafted by. Beijing Institute of Medical Device Inspection (Beijing Medical Bioprotection Equipment Inspection and Research Center), National Health Commission of China National Health Commission Clinical Laboratory Center, Zhejiang Medical Device Evaluation Center, Zhengzhou Antu Bioengineering Co., Ltd., Beijing Shuimu Jihengsheng Biotechnology Co., Ltd., Beijing Hospital, Comed Diagnostics Technology Co., Ltd., and Abbott Trading (Shanghai) Co., Ltd. The main drafters of this document are. Sun Xueqing, Zhou Weiyan, Ye Chaofu, Zhang Lihong, Yang Zongbing, Qiang Zhonghua, Wu Xiaojun, Wu Kechun, and Zhang Chuanbao. The previous versions of this document and the documents it replaces are as follows. --First published in.2017 as YY/T 1585-2017; --This is the first revision. 25-Hydroxyvitamin D Assay Kit

1 Scope

This document specifies the requirements, identification, labeling and instructions for use, packaging, transportation and storage of 25-hydroxyvitamin D assay kits. The corresponding test methods are described. This document is applicable to the quantitative detection of total 25-hydroxyvitamin D, 25-hydroxyvitamin D2, 25-hydroxyvitamin D3 kits include labeled immunoassays (such as enzyme labeling, luminescent labeling, etc.), immunochromatography, immunoturbidimetry, and liquid chromatography-tandem Mass spectrometry, etc.

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/T 21415 Metrological traceability of values assigned to calibrators and control materials for the measurement of quantities in biological samples of in vitro diagnostic medical devices Origin GB/T 29791.2 Information provided by the manufacturer of in vitro diagnostic medical devices (labeling) Part 2.Professional in vitro diagnostic reagents

3 Terms and definitions

There are no terms or definitions that require definition in this document.

4 Requirements

4.1 Liquid chromatography-tandem mass spectrometry kit 4.1.1 Appearance Manufacturers should specify appropriate appearance requirements based on the packaging characteristics of their products. Generally, the components and properties of the kit should be Requirements for outer packaging, labeling, etc. 4.1.2 Traceability If calibrators are included, the manufacturer shall provide the source, value assignment process and Measurement uncertainty etc. 4.1.3 Linearity The linear range of 25-hydroxyvitamin D2 should cover [4.0, 100.0] ng/mL. Within the linear range specified by the manufacturer, the correlation coefficient (r) should not be less than 0.990 0.In the interval [4.0, 15.0] ng/mL, the absolute deviation should not exceed ±2.25 ng/mL, (15.0, 100.0] ng/mL Within the range, the relative deviation should not exceed ±15.0%. ......

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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY/T 1585-2024_English be delivered?

Answer: Upon your order, we will start to translate YY/T 1585-2024_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 1585-2024_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 1585-2024_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 1585-2024?

Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY/T 1585-2024 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.