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IS/ISO 20395 : 2019

IS/ISO 20395 : 2019 — Biotechnology Requirements for evaluating the performance of quantification methods for nucleic acid target sequences qPCR and dPCR

IS/ISO 20395 : 2019 is an Indian Standard titled Biotechnology Requirements for evaluating the performance of quantification methods for nucleic acid target sequences qPCR and dPCR, classified under Medical and Hospital Equipments and administered by the Ministry of Health and Family Welfare. Certification is voluntary.

IS Number
IS/ISO 20395 : 2019
Status
0
Certification
Voluntary
Ministry
Ministry of Health and Family Welfare
Committee
Medical Biotechnology and Medical Nanotechnology
Type
Methods of tests

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What is IS/ISO 20395 : 2019?

IS/ISO 20395 : 2019 is an Indian Standard published by the Bureau of Indian Standards (BIS) under the title Biotechnology Requirements for evaluating the performance of quantification methods for nucleic acid target sequences qPCR and dPCR. It falls under the <strong>Medical and Hospital Equipments</strong> group and is administered by the Ministry of Health and Family Welfare. Certification under this standard is voluntary.

How to get certified for IS/ISO 20395 : 2019

  1. 1
    Apply online — Submit the BIS portal application with product details, factory information, and test reports.
  2. 2
    Lab testing — Submit product samples to a BIS-recognised testing laboratory for evaluation against the standard.
  3. 3
    Factory inspection — A BIS officer visits your manufacturing facility to verify quality control systems.
  4. 4
    Licence grant — On approval, BIS issues the licence. You may then affix the ISI Mark on compliant products.
View official document on bis.gov.in →

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