YY/T 1531-2017 English PDF

US$159.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 1531-2017: Biochemical identification systems for bacteria
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1531-2017	159	Add to Cart	3 days	Biochemical identification systems for bacteria	Valid

Similar standards

YY/T 1528   YY/T 1527   YY/T 1533   YY/T 1529   YY/T 1523   

Basic data

Standard ID: YY/T 1531-2017 (YY/T1531-2017)
Description (Translated English): Biochemical identification systems for bacteria
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C44
Classification of International Standard: 11.100
Word Count Estimation: 8,837
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 1531-2017: Biochemical identification systems for bacteria

---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.
Biochemical identification systems for bacteria ICS 11.100 C44 People's Republic of China pharmaceutical industry standards Bacterial biochemical identification system 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, Thermo Fisher Scientific (China) Co., Ltd., Changsha, Hunan, earth and animal Technology Co., Ltd., BD Medical Devices (Shanghai) Co., Ltd., Shandong Xin Branch Biological Technology Co., Ltd., Shanghai Star Bai Biotechnology Limited company. The main drafters of this standard. Bi Chunlei, Jiangdan Dan, Zhang Maolin, Yang Zhong, Zhang Rui, Pang Chao, Zhang Yuejian. Bacterial biochemical identification system

1 Scope

This standard specifies the requirements of bacterial biochemical identification system, test methods, labels and instructions for use, packaging, transportation and storage. This standard applies to the use of biochemical identification of bacteria on the clinical level of identification of instruments and identification reagents. Instruments include semi-self Moving, automatic bacterial identification equipment (hereinafter referred to as instruments), reagents include identification plate, identification card, identification of identification reagents (hereinafter referred to as Reagent).

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 191 Packaging - Pictorial signs GB 4793.1 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 1. General requirements GB 4793.9 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 9. Laboratory analysis and other purposes Special requirements for moving and semi-automatic equipment GB/T 14710 medical electrical environment requirements and test methods 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. Particular requirements for body External diagnostic (IVD) medical equipment GB/T 29791.2 Information provided by manufacturers of in vitro diagnostic medical devices (LABEL) SECTION 2. PROFESSIONAL IN VITRO DIAGNOSTIC AGENTS GB/T 29791.3 Information provided by manufacturers of in vitro diagnostic medical devices (LABEL) SECTION 3. PROFESSIONAL IN VITRO DIAGNOSIS INSTRUMENTS YY 0648 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101. In vitro diagnostic (IVD) medical equipment The special requirements

3 requirements

3.1 identification accuracy With known strains tested, the identification results should be consistent with the known bacteria name. 3.2 Identification of repeatability Quality control strains were tested repeatedly, the identification results obtained should be the same. 3.3 Repeatability between reagents With quality control strains of three batches of reagents for testing, the identification results obtained should be the same. 3.4 reagent stability Quality control strains of near-term detection of reagents, identification results should be consistent with the name of known bacteria. ......

Image