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IS/ISO 13022 : 2012

IS/ISO 13022 : 2012 — Medical products containing viable human cells - Application of risk management and requirements for processing practices

IS/ISO 13022 : 2012 is an Indian Standard titled Medical products containing viable human cells - Application of risk management and requirements for processing practices, classified under Medical and Hospital Equipments and administered by the Ministry of Health and Family Welfare. Certification is voluntary.

IS Number
IS/ISO 13022 : 2012
Status
0
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

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What is IS/ISO 13022 : 2012?

IS/ISO 13022 : 2012 is an Indian Standard published by the Bureau of Indian Standards (BIS) under the title Medical products containing viable human cells - Application of risk management and requirements for processing practices. 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 13022 : 2012

  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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