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IS/ISO 11137 : Part 1 : 2006

IS/ISO 11137 : Part 1 : 2006 — Sterilization of health care products - Radiation: Part 1 requirements for development, validation and routine control of a sterilization process for medical devices

IS/ISO 11137 : Part 1 : 2006 is an Indian Standard titled Sterilization of health care products - Radiation: Part 1 requirements for 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. Certification is voluntary.

IS Number
IS/ISO 11137 : Part 1 : 2006
Status
0
Certification
Voluntary
Ministry
Ministry of Health and Family Welfare
Committee
Hospital Equipment and Surgical Disposable Products
Type
Others

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What is IS/ISO 11137 : Part 1 : 2006?

IS/ISO 11137 : Part 1 : 2006 is an Indian Standard published by the Bureau of Indian Standards (BIS) under the title Sterilization of health care products - Radiation: Part 1 requirements for 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. Certification under this standard is voluntary.

How to get certified for IS/ISO 11137 : Part 1 : 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.

Amendments to IS/ISO 11137 : Part 1 : 2006

AmendmentYear
First Amendment2006
Second Amendment2024
View official document on bis.gov.in →

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