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IS/ISO 10993 : Part 12 : 2021

IS/ISO 10993 : Part 12 : 2021 — Biological Evaluation of Medical Devices Part 12 Sample Preparation and Reference Materials

IS/ISO 10993 : Part 12 : 2021 is an Indian Standard titled Biological Evaluation of Medical Devices Part 12 Sample Preparation and Reference Materials, classified under Medical and Hospital Equipments and administered by the Ministry of Consumer Affairs. Certification is voluntary.

IS Number
IS/ISO 10993 : Part 12 : 2021
Status
0
Certification
Voluntary
Ministry
Ministry of Consumer Affairs
Committee
In-vitro Diagnostic Medical Devices and Biological Evaluation of Medical Devices
Type
Methods of tests

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What is IS/ISO 10993 : Part 12 : 2021?

IS/ISO 10993 : Part 12 : 2021 is an Indian Standard published by the Bureau of Indian Standards (BIS) under the title Biological Evaluation of Medical Devices Part 12 Sample Preparation and Reference Materials. It falls under the <strong>Medical and Hospital Equipments</strong> group and is administered by the Ministry of Consumer Affairs. Certification under this standard is voluntary.

How to get certified for IS/ISO 10993 : Part 12 : 2021

  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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