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GB/T 35891-2018Technical requirement of microarray washer (English PDF)

微阵列生物芯片清洗仪技术要求

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Issued by

SAMR; SAC

Level / Type

National · Recommended

Issue date

February 6, 2018

Implementation date

September 1, 2018

Scope

GB/T 35891-2018 is the English-translated version of 微阵列生物芯片清洗仪技术要求.

GB/T 35891-2018 sets the Chinese national technical requirements for microarray biochip washers. It covers terms and definitions, requirements, test methods, inspection rules, marking and instructions for use, and packaging, transport and storage.

The washer is defined as equipment that removes non-specifically adsorbed material and buffer impurities from the chip, with functions for supplying the wash solution and controlling its temperature, incubating and washing the chip, draining the solution and drying the chip.

The document also defines chip drying and the wash residue measured on the probe area after drying, and fixes the normal working conditions for testing, including an AC 220 V, 50 Hz supply.

It refers to GB 4793.1 for electrical safety and GB/T 14710 for environmental tests. It was issued on 6 February 2018 and has applied since 1 September 2018.

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Document preview — GB/T 35891-2018

National Standard of the People's Republic of China

ICS
71.040.20
Classification
N 60

Issued by: State Administration for Market Regulation; Standardization Administration of the PRC

Contents

  • Preface
  • 1 Scope
  • 2 Normative references
  • 3 Terms and definitions
  • 4 Requirements
  • 5 Test methods
  • 6 Inspection rules
  • 7 Logos, labels and operating instructions
  • 8 Packaging, transportation and storage

Foreword

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

1 Scope

This standard specifies the microarray biological chip cleaning equipment (hereinafter referred to as cleaning instrument) terms and definitions, requirements, test methods, test rules Then, signs, labels and instructions for use, packaging, transportation and storage.

This standard applies to microarray biochip cleaning instrument.

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/T 14710 medical appliances environmental requirements and test methods

3 Terms and definitions

The following terms and definitions apply to this document.

3.1 Chip washer

Used to remove non-specific adsorption material on the microarray chip and impurities in the buffer to eliminate interference, facilitate the adsorption of specific substances Quality identification.

Note: with lotion supply, lotion temperature control, chip incubation cleaning, lotion discharge and chip drying and other functions.

3.2 Microarray biochip

An array of multiple micro-processing units capable of processing information in a biological sample in parallel on a planar matrix support is set in an array.

3.3 Chip drying

The method of removing the residual lotion on the cleaned microarray chip by a specific way prevents the salt dissolved in the lotion after it is dissolved Even non-specifically adsorbed fluorescent substances remain on the surface of the chip.

3.4 Wash residue

After the chip drying step is completed, the degree of wash residue on the surface of the chip active area (probe-immobilized microarray area) is measured.

4 Requirements

4.1 Normal working conditions

Test under the following conditions.

a) Power. AC220V; 50Hz; […]

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

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