Home Cart Quotation Policy About-Us
www.ChineseStandard.net
Database: 221581 (27 Mar 2026)
SEARCH
Path: Home > YY/T > Page1 > YY/T 1908-2023

YY/T 1908-2023 PDF English

Price & Delivery

US$239.00 · In stock · Download in 9 seconds
YY/T 1908-2023: Nucleic acid extraction system
Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure
Status: Valid
Std IDVersionUSDBuyDeliver [PDF] inTitle (Description)
YY/T 1908-2023English239 Add to Cart 3 days [Need to translate] Nucleic acid extraction system

Click to Preview a similar PDF

Basic data

Standard ID YY/T 1908-2023 (YY/T1908-2023)
Description (Translated English) Nucleic acid extraction system
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C44
Classification of International Standard 11.100.10
Word Count Estimation 12,196
Date of Issue 2023-09-05
Date of Implementation 2024-09-15
Issuing agency(ies) State Drug Administration
Summary This standard specifies the requirements, test methods, labels, markings and instructions for use, packaging, transportation and storage of nucleic acid extraction instruments. This standard applies to instruments related to automated pre-processing such as extraction and purification of nucleic acids in clinical samples.

YY/T 1908-2023: Nucleic acid extraction system


---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 Nucleic acid extraction instrument Published on 2023-09-05 Implemented on 2024-09-15 Released by the State Drug Administration

Foreword

This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents" Drafting. Please note that some content in this document may be subject to patents. The publisher of this document assumes no responsibility for identifying patents. This document is proposed by the National Medical Products Administration. This document is under the jurisdiction of the National Standardization Technical Committee for Medical Clinical Laboratory and In Vitro Diagnostic Systems (SAC/TC136). This document was drafted by. Beijing Institute of Medical Device Inspection (Beijing Medical Biological Protective Equipment Inspection and Research Center), Shenzhen BGI Intelligent Technology Co., Ltd., China Institute for Food and Drug Control, Chinese Academy of Medical Sciences Peking Union Medical College Hospital, Capital Medical University Affiliated Beijing Tiantan Hospital, Hangzhou Bioer Technology Co., Ltd., Xi'an Tianlong Technology Co., Ltd., Shengxiang Biotechnology Co., Ltd., Shanghai Siludi Biomedical Technology Co., Ltd. and Kaijie Enterprise Management (Shanghai) Co., Ltd. The main drafters of this document. Li Da, Li Jing, Zhang Wenxin, Yi Jie, Zhang Guojun, Shang Xiaohui, Tian Zhen, Deng Zhongping, Liu Congzhi, Zhang Xi, Dai Leiying. Nucleic acid extraction instrument

1 Scope

This document specifies the requirements, test methods, labels, markings and instructions for use, packaging, transportation and storage of nucleic acid extraction instruments. This document is applicable to instruments related to automated pre-processing such as extraction and purification of nucleic acids in clinical samples.

2 Normative reference documents

The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, the dated quotations For undated referenced documents, only the version corresponding to that date applies to this document; for undated referenced documents, the latest version (including all amendments) applies to this document. GB/T 191 Packaging, storage and transportation pictorial mark 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 4793.9 Safety requirements for electrical equipment for measurement, control and laboratory use Part 9.Laboratory use for analysis and other purposes Special requirements for automatic and semi-automatic equipment 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 equipment GB/T 29791.3 Information provided by manufacturers 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

3 Terms and definitions

The following terms and definitions apply to this document. 3.1 surfacemagneticflux-densitysurfacemagneticflux-density The density of magnetic field lines perpendicularly passing through unit area. 3.2 Temperature consistency between corresponding sample wells of the module. [Source. YY/T 1173-2010,3.9] 3.3 average heating ratemeanheatingrate The average temperature rise of the module per unit time during the heating process. ...

Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY/T 1908-2023_English be delivered?


Answer: Upon your order, we will start to translate YY/T 1908-2023_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 1908-2023_English with my colleagues?


Answer: Yes. The purchased PDF of YY/T 1908-2023_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.
Refund Policy Privacy Policy Terms of Service