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YY/T 1531-2017Biochemical identification systems for bacteria (English PDF)

细菌生化鉴定系统

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

March 28, 2017

Implementation date

April 1, 2018

Scope

YY/T 1531-2017 is the English-translated version of 细菌生化鉴定系统.

YY/T 1531-2017 is the Chinese pharmaceutical industry standard for biochemical identification systems for bacteria, that is the semi-automatic and automatic identification instruments together with the identification panels, cards and reagents they use.

It sets the requirements, the test methods, the labels and instructions for use and the rules for packaging, transport and storage, covering the agreement of the identification with reference strains, the repeatability, the reading of the reactions by the instrument, the carry-over, the database and its updating, and the stability of the reagents. Issued on 28 March 2017, it has applied since 1 April 2018.

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Document preview — YY/T 1531-2017

National Standard of the People's Republic of China

ICS: 11.100
Classification: C 44

Issued by: National Medical Products Administration of the People's Republic of China

Foreword
1 Scope
2 Normative references
3 Requirements

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009.

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 document. 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.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 17 pages — is available in the English PDF.

Referenced standards

Normative references

GB 4793.9

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