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IS/ISO 10993 : Part 10 : 2010

IS/ISO 10993 : Part 10 : 2010 — Biological evaluation of medical devices Part 10 Tests for irritation and skin sensitization

IS/ISO 10993 : Part 10 : 2010 is an Indian Standard titled Biological evaluation of medical devices Part 10 Tests for irritation and skin sensitization, classified under Medical and Hospital Equipments and administered by the Ministry of Health and Family Welfare. Certification is voluntary.

IS Number
IS/ISO 10993 : Part 10 : 2010
Status
1
Certification
Voluntary
Ministry
Ministry of Health and Family Welfare
Committee
In-vitro Diagnostic Medical Devices and Biological Evaluation of Medical Devices
Type
Methods of tests

Need ISI Mark certification for IS/ISO 10993 : Part 10 : 2010? Fixed-fee, 6–12 week timeline.

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What is IS/ISO 10993 : Part 10 : 2010?

IS/ISO 10993 : Part 10 : 2010 is an Indian Standard published by the Bureau of Indian Standards (BIS) under the title Biological evaluation of medical devices Part 10 Tests for irritation and skin sensitization. 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 10993 : Part 10 : 2010

  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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