GB/T 33752-2017Aldehyde slide for microarrays (English PDF)
微阵列芯片用醛基基片
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Issued by
SAMR; SAC
Level / Type
National · Recommended
Issue date
May 12, 2017
Implementation date
December 1, 2017
Scope
GB/T 33752-2017 is the English-translated version of 微阵列芯片用醛基基片.
GB/T 33752-2017 covers the aldehyde-coated glass slides used as substrates for microarray chips. It gives the terms and definitions, the requirements, the test methods, the marking, the label and the instructions for use, and the transport and storage conditions.
The requirements start from appearance and size: the effective spot range must be free of particles and scratches, and the slide may come in different sizes, for example rectangular with a length of 75.5 mm ± 0.2 mm.
Clause 3 defines microarray, probe and substrate. The standard applies to flat glass substrates whose surface has been chemically modified to carry active aldehyde groups, and it cites GB/T 191 and YY/T 0692 together with the medical device labelling rules issued by the State Food and Drug Administration. Issued on 12 May 2017, it has applied since 1 December 2017.
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Document preview — GB/T 33752-2017
National Standard of the People's Republic of China
- ICS
- 11.100
- Classification
- C 30
Issued by: State Administration for Market Regulation; Standardization Administration of the PRC
Contents
- Foreword
- 1 Scope
- 2 Normative reference documents
- 3 Terms and definitions YY/T 0692 Definitions and the following
- 4 Requirements
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
1 Scope
This standard specifies the terminology and definitions, requirements, test methods, signs, labels, and the like for the aldehyde base substrate (hereinafter referred to as "substrate") of microarray chips, Brochures and transport and storage.
This standard is applicable to the preparation of microarray chips by surface chemically modified, with active aldehyde groups of glass material plane substrate.
2 Normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this document. For undated references, the latest edition (including all modifications) applies to this document.
GB/T 191 packaging and storage icon
YY/T 0692 Biochip Basic Terminology
State Administration of Food and Drug Administration Order No. 6 Medical Device Manual and Labeling Regulations
3 Terms and definitions
YY/T 0692 Definitions and the following terms and definitions are used in this document.
3.1 Microarray chip
An array of microprocessors capable of arranging a plurality of pieces of information in a biological sample on a planar substrate carrier in an array manner.
3.2 Probe
A molecule that binds specifically to the target.
3.3 Substrate
The planar matrix used to immobilize biomolecules in microarray chips is characterized by flatness and modificability on its surface.
4 Requirements
4.1 Appearance and size
4.1.1 Appearance requirements
Effective spot range (see point A.1 in Appendix A) is free of particles, with no scratches.
4.1.2 Size requirements
Size should meet the product requirements, can have different sizes, such as.
a) shape. rectangular;
b) Length. 75.5 mm ± 0.2 mm;
......
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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Related Standards
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