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IS/ISO 14937 : 2009

IS/ISO 14937 : 2009 — Sterilization of health care products General requirements for characterization of a sterilizing agent and the development validation and routine control of a sterilization process for medical devices

IS/ISO 14937 : 2009 is an Indian Standard titled Sterilization of health care products General requirements for characterization of a sterilizing agent and the development validation and routine control of a sterilization process for medical devices, classified under Medical and Hospital Equipments and administered by the Ministry of Health and Family Welfare, Ministry of Heavy Industries. Certification is voluntary.

IS Number
IS/ISO 14937 : 2009
Status
0
Certification
Voluntary
Ministry
Ministry of Health and Family Welfare, Ministry of Heavy Industries
Committee
Hospital Equipment and Surgical Disposable Products
Type
Code of Practice

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What is IS/ISO 14937 : 2009?

IS/ISO 14937 : 2009 is an Indian Standard published by the Bureau of Indian Standards (BIS) under the title Sterilization of health care products General requirements for characterization of a sterilizing agent and the development validation and routine control of a sterilization process for medical devices. It falls under the <strong>Medical and Hospital Equipments</strong> group and is administered by the Ministry of Health and Family Welfare, Ministry of Heavy Industries. Certification under this standard is voluntary.

How to get certified for IS/ISO 14937 : 2009

  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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