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GB/T 42216.3-2022Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 3: Isolated DNA (English PDF)

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Issued by

State Administration for Market Regulation, China National Standardization Administration

Level / Type

National · Recommended

Issue date

December 30, 2022

Implementation date

July 1, 2023

Scope

GB/T 42216.3-2022 (Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 3: Isolated DNA) is available as an English-translated PDF.

GB/T 42216.3-2022 is the Chinese standard "Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 3: Isolated DNA".

Its scope clause reads: This document presents formalin-fixed and paraffin-embedded panels for DNA testing at the pretest stage prior to molecular analysis. Guidelines for the handling, recording, storage and collection of tissue (FFPE) specimens.

This document is applicable to molecular in vitro diagnostic tests, including laboratory self-created test items carried out by medical laboratories and molecular pathology laboratories Also applicable to laboratory customers, in vitro diagnostic developers and manufacturers, biobanks, institutions and commercial organizations engaged in biomedical research and regulators.

Note. International, national and regional regulatory requirements also apply to specific content covered in this document. Its clauses include terms and definitions.

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Document preview — GB/T 42216.3-2022

National Standard of the People's Republic of China

ICS: 11.100.10
Classification: C 30

Issued by: State Administration for Market Regulation, China National Standardization Administration

Preface
Introduction
1 Scope
2 Normative references
3 Terms and Definitions
4 General
5 Lab Exterior
5.1 Specimen collection
5.2 Shipping Requirements
6 Inside the laboratory
6.1 Information on Specimen Receipt
6.2 Formalin fixation of specimens/samples
6.3 Pathological evaluation of specimens and selection of samples
6.4 Fixation of frozen samples
6.5 Decalcification
6.6 Processing and paraffin embedding
6.7 Storage requirements
6.8 Isolation of DNA
6.9 Quantity and quality assessment of isolated DNA
6.10 Storage of DNA
Appendix A (informative) Effect of storage temperature on DNA integrity of FFPE tissue blocks

1 Scope

This document presents formalin-fixed and paraffin-embedded panels for DNA testing at the pretest stage prior to molecular analysis.

Guidelines for the handling, recording, storage and collection of tissue (FFPE) specimens.

This document is applicable to molecular in vitro diagnostic tests, including laboratory self-created test items carried out by medical laboratories and molecular pathology laboratories

Also applicable to laboratory customers, in vitro diagnostic developers and manufacturers, biobanks, institutions and commercial organizations engaged in biomedical research and regulators.

Note. International, national and regional regulatory requirements also apply to specific content covered in this document.

2 Normative references

The contents of the following documents constitute the essential provisions of this document through normative references in the text. Among them, dated references

For documents, only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to this document.

GB/T 22576.1-2018 Requirements for the quality and competence of medical laboratories Part 1.General requirements (ISO 15189.2012,

IDT)

GB/T 27020-2016 Operational requirements for various inspection agencies for conformity assessment (ISO /IEC 17020.2012, IDT) and competence)

Note. GB 19781-2005 Medical Laboratory Safety Requirements (ISO 15190.2003, IDT)

3 Terms and Definitions

The terms and definitions defined in ISO 15189 and the following apply to this document.

The ISO and IEC terminology databases for standardization are maintained at the following addresses.

3.1 aliquot of sample

Assuming that sampling errors are negligible, a portion of a mass of homogeneous substance.

Note 1.This term is usually applied to liquids. Tissues are heterogeneous and so cannot be equally divided.

Note 2.This definition comes from references [26], [27], [28].

3.2 Ambient temperature

The temperature of the unconditioned ambient air. […]

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 30 pages — is available in the English PDF.

Referenced standards

Normative references

ISO 15189.2012 · IEC 17020.2012 · ISO 15190.2003

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