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IS/IEC/TS 10993 : Part 19 : 2006

IS/IEC/TS 10993 : Part 19 : 2006 — Biological Evaluation of Medical Devices Part 19 Physico-Chemical, Morphological and Topographical Characterization of Materials

IS/IEC/TS 10993 : Part 19 : 2006 is an Indian Standard titled Biological Evaluation of Medical Devices Part 19 Physico-Chemical, Morphological and Topographical Characterization of Materials, classified under Medical and Hospital Equipments. Certification is voluntary.

IS Number
IS/IEC/TS 10993 : Part 19 : 2006
Status
1
Certification
Voluntary
Committee
In-vitro Diagnostic Medical Devices and Biological Evaluation of Medical Devices
Type
Methods of tests

Need ISI Mark certification for IS/IEC/TS 10993 : Part 19 : 2006? Fixed-fee, 6–12 week timeline.

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What is IS/IEC/TS 10993 : Part 19 : 2006?

IS/IEC/TS 10993 : Part 19 : 2006 is an Indian Standard published by the Bureau of Indian Standards (BIS) under the title Biological Evaluation of Medical Devices Part 19 Physico-Chemical, Morphological and Topographical Characterization of Materials. It falls under the <strong>Medical and Hospital Equipments</strong> group. Certification under this standard is voluntary.

How to get certified for IS/IEC/TS 10993 : Part 19 : 2006

  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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