IS 18131 : 2023/ISO 17822 : 2020 In Vitro Diagnostic Test Systems - Nucleic Acid Amplification-Based Examination Procedures for Detection and Identification of Microbial Pathogens - Laboratory Quality Practice Guide

ICS 11.100.01

MHD 14

New Standard from Last Update.

NATIONAL FOREWORD

This Indian Standard which is identical with ISO 17822 : 2020 ‘In vitro diagnostic test systems - Nucleic acid amplification-based examination procedures for detection and identification of microbial pathogens - Laboratory quality practice guide’ issued by the International Organization for Standardization was adopted by the Bureau of Indian Standards on the recommendation of the Hospital Planning Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council.

This standard supersedes IS/ISO/TS 17822-1 : 2014 which was first published in 2018 as an identical adoption of ISO/TS 17822-1 : 2014 ‘In vitro diagnostic test systems - Qualitative nucleic acid-based in vitro examination procedures for detection and identification of microbial pathogens - Part 1: General requirements, terms and definitions’.