ISO 16578:2022
This document specifies verification and validation parameters and processes for microarray detection and identification of specific nucleic acid sequences.
This document provides recommendations and protocols for:
— microarray design and manufacture;
— validation of hybridization specificity;
— interlaboratory validation of qualitative methods;
— determination of limits of detection for a microarray;
— determination of range of reliable signals;
— criteria for assessing technical performance of the microarray platform:
This document is applicable to all methods that use microarrays for detection of nucleic acids.
It does not apply to the following protocols:
— quantitative measurement;
— requirements for sample preparation prior to DNA microarray experiments.
SDO:
ISO
Language:
English
ICS Codes:
67.050
Status:
Published
Publish date:
2022-09-27
Standard Number:
ISO 16578:2022