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IS/ISO 11607 : Part 2 : 2019

IS/ISO 11607 : Part 2 : 2019 — Packing for Terminally Sterilized Medical Devices Part 2 Validation Requirements for Forming Sealing and Assembly Processes (First Revision)

IS/ISO 11607 : Part 2 : 2019 is an Indian Standard titled Packing for Terminally Sterilized Medical Devices Part 2 Validation Requirements for Forming Sealing and Assembly Processes (First Revision), classified under Medical and Hospital Equipments and administered by the Ministry of Health and Family Welfare. Certification is voluntary.

IS Number
IS/ISO 11607 : Part 2 : 2019
Status
0
Certification
Voluntary
Ministry
Ministry of Health and Family Welfare
Committee
Hospital Equipment and Surgical Disposable Products
Type
Code of Practice

Need ISI Mark certification for IS/ISO 11607 : Part 2 : 2019? Fixed-fee, 6–12 week timeline.

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What is IS/ISO 11607 : Part 2 : 2019?

IS/ISO 11607 : Part 2 : 2019 is an Indian Standard published by the Bureau of Indian Standards (BIS) under the title Packing for Terminally Sterilized Medical Devices Part 2 Validation Requirements for Forming Sealing and Assembly Processes (First Revision). 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 11607 : Part 2 : 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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