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GB/T 34324-2017Technical requirement of microarray biochip spotter (English PDF)

微阵列生物芯片点样仪技术要求

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Issued by

SAMR; SAC

Level / Type

National · Recommended

Issue date

September 7, 2017

Implementation date

April 1, 2018

Scope

GB/T 34324-2017 is the English-translated version of 微阵列生物芯片点样仪技术要求.

GB/T 34324-2017 is the Chinese standard "Technical requirement of microarray biochip spotter".

Its scope clause reads: This standard specifies the microarray biological chip spotting instrument (hereinafter referred to as the spotter) terms and definitions, requirements, test methods, inspection rules, Logo, label and instruction manual, packaging, shipping and storage.

This standard applies to microarray biological chip spotting instrument. Its clauses include terms and definitions.

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Document preview — GB/T 34324-2017

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

  • 1 Scope
  • 2 Normative references
  • 3 Terms and definitions
  • 3.1 Spotter arrayer
  • 3.2 Microarray Biochip microarray
  • 3.3 Flux throughput
  • 3.4 Array regularity regularity
  • 3.5 Dot size consistency regularity
  • 3.6 Missing points

1 Scope

This standard specifies the microarray biological chip spotting instrument (hereinafter referred to as the spotter) terms and definitions, requirements, test methods, inspection rules,

Logo, label and instruction manual, packaging, shipping and storage.

This standard applies to microarray biological chip spotting 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 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/T 25000.51 software engineering software product quality requirements and evaluation (SQuaRE) commercial spot (COTS) software products

The quality requirements and test rules

YY/T 0466.1 Medical Devices Labeling, Marking and Notification of Use for Medical Devices Part 1. General Requirements

3 Terms and definitions

The following terms and definitions apply to this document.

3.1 Spotter arrayer

Through the liquid dispensing head, a trace amount of liquid is drawn from the source sample plate and carried by precision moving parts to the micro

Array of biochip substrate, the distribution of a trace amount of liquid in each chip substrate set position of the instrument.

3.2 Microarray Biochip microarray

A collection of multiple micro-processing units capable of processing information in a biological sample in parallel.

3.3 Flux throughput

The maximum number of microarray biochips that can be prepared once with a spotter.

3.4 Array regularity regularity

The degree of alignment of the rows and columns on the microarray, the regularity is usually measured by the difference between the sample center distance.

3.5 Dot size consistency regularity

The consistency of the sample point diameter size.

3.6 Missing points

Sample preparation at some point during microarray preparation was not dispensed, as measured by the leak rate.

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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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