GB/T 35895-2018Technical requirement of microarray hybridizer (English PDF)
微阵列生物芯片反应仪技术要求
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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 35895-2018 is the English-translated version of 微阵列生物芯片反应仪技术要求.
GB/T 35895-2018 sets the technical requirements for microarray hybridizers, the instruments that control the temperature, time and movement needed for the biochemical reactions on microarray biochips.
It defines the key terms, such as reaction temperature, reaction time and warm-up time, and specifies the requirements, starting from the normal working conditions, together with the test methods, the inspection rules, the marking, labels and operating instructions, and packaging, transport and storage.
Electrical safety is referred to GB 4793.1 and environmental testing to GB/T 14710. It applies to microarray biochip reactors and is used by manufacturers and by the laboratories that test and buy them.
GB/T 35895-2018 was issued on 6 February 2018 and has applied since 1 September 2018.
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Document preview — GB/T 35895-2018
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 biochip reactor (hereinafter referred to as the reactor) terms and definitions, requirements, test methods, inspection rules, Logo, label and instruction manual, packaging, shipping and storage.
This standard applies to microarray biochip reactor.
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 reactor (hybridizer)
In order to ensure the quality and efficiency of biochemical reactions of microarray biochips, based on the immobilization of probes on biological samples and microarray biochips Biochemical reactions required for the environment, the reaction process required temperature, time, movement can be precisely controlled instruments.
3.2 Microarray biochip (microarray)
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 Reaction temperature
The temperature of the reaction zone during chip reaction.
3.4 Reaction time
Chip reaction time required for the process.
3.5 Warm-up time (heating-up time)
The time from the ambient temperature to the reaction temperature.
4 Requirements
4.1 Normal working conditions
Normal working conditions are as follows.
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.
Referenced standards
Normative references
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Related Standards
GB 4793.1-2007 — Safety requirements for electrical equipment for measurement,control,andlaboratory use-Part 1:General requirements
GB/T 14710-2009 — The environmental requirement and test methods for medical electrical equipment
GB/T 191-2025 — Graphical symbols marking for handling and storage of packages
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GB/T 35895-2018
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