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IS 17647

IS 17647 — Biotechnology - Ancillary materials present during the production of cellular therapeutic products Part 2: Best practice guidance for ancillary material suppliers

IS 17647 is an Indian Standard titled Biotechnology - Ancillary materials present during the production of cellular therapeutic products Part 2: Best practice guidance for ancillary material suppliers, classified under Medical and Hospital Equipments and administered by the Ministry of Health and Family Welfare. Certification is voluntary.

IS Number
IS 17647
Status
1
Certification
Voluntary
Ministry
Ministry of Health and Family Welfare
Committee
Medical Biotechnology and Medical Nanotechnology
Type
Code of Practice

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What is IS 17647?

IS 17647 is an Indian Standard published by the Bureau of Indian Standards (BIS) under the title Biotechnology - Ancillary materials present during the production of cellular therapeutic products Part 2: Best practice guidance for ancillary material suppliers. 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 17647

  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.

Amendments to IS 17647

AmendmentYear
First Amendment2023
View official document on bis.gov.in →

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