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IS/ISO/TR 24971 : 2020

IS/ISO/TR 24971 : 2020 — Medical Devices Guidance on the Application of ISO 14971 (First Revision)

IS/ISO/TR 24971 : 2020 is an Indian Standard titled Medical Devices Guidance on the Application of ISO 14971 (First Revision), classified under Health, Sports and Fitness Services and administered by the Ministry of Health and Family Welfare. Certification is voluntary.

IS Number
IS/ISO/TR 24971 : 2020
Status
0
Certification
Voluntary
Ministry
Ministry of Health and Family Welfare
Committee
Hospital Planning
Type
Code of Practice

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What is IS/ISO/TR 24971 : 2020?

IS/ISO/TR 24971 : 2020 is an Indian Standard published by the Bureau of Indian Standards (BIS) under the title Medical Devices Guidance on the Application of ISO 14971 (First Revision). It falls under the <strong>Health, Sports and Fitness Services</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/TR 24971 : 2020

  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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