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IS/ISO 16142 : Part 1 : 2016

IS/ISO 16142 : Part 1 : 2016 — Medical Devices - Recognized Essential Principles of Safety and Performance of Medical Devices Part 1 General Essential Principles and Additional Specific Essential Principles for all Non-IVD Medical Devices and Guidance on the Selection of Standards

IS/ISO 16142 : Part 1 : 2016 is an Indian Standard titled Medical Devices - Recognized Essential Principles of Safety and Performance of Medical Devices Part 1 General Essential Principles and Additional Specific Essential Principles for all Non-IVD Medical Devices and Guidance on the Selection of Standards, classified under Medical and Hospital Equipments and administered by the Ministry of Health and Family Welfare. Certification is voluntary.

IS Number
IS/ISO 16142 : Part 1 : 2016
Status
0
Certification
Voluntary
Ministry
Ministry of Health and Family Welfare
Committee
Hospital Planning
Type
Safety Standard

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What is IS/ISO 16142 : Part 1 : 2016?

IS/ISO 16142 : Part 1 : 2016 is an Indian Standard published by the Bureau of Indian Standards (BIS) under the title Medical Devices - Recognized Essential Principles of Safety and Performance of Medical Devices Part 1 General Essential Principles and Additional Specific Essential Principles for all Non-IVD Medical Devices and Guidance on the Selection of Standards. 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 16142 : Part 1 : 2016

  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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