IS/ISO 11135 : 2014
IS/ISO 11135 : 2014 — Sterilization of health - Care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
IS/ISO 11135 : 2014 is an Indian Standard titled Sterilization of health - Care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices.
- IS Number
- IS/ISO 11135 : 2014
- Status
- 0
- Certification
- —
- Committee
- Hospital Equipment and Surgical Disposable Products
- Type
- Process Specification
Need ISI Mark certification for IS/ISO 11135 : 2014? Fixed-fee, 6–12 week timeline.
Get a quoteWhat is IS/ISO 11135 : 2014?
IS/ISO 11135 : 2014 is an Indian Standard published by the Bureau of Indian Standards (BIS) under the title Sterilization of health - Care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices.. Certification under this standard is voluntary.
How to get certified for IS/ISO 11135 : 2014
- 1Apply online — Submit the BIS portal application with product details, factory information, and test reports.
- 2Lab testing — Submit product samples to a BIS-recognised testing laboratory for evaluation against the standard.
- 3Factory inspection — A BIS officer visits your manufacturing facility to verify quality control systems.
- 4Licence grant — On approval, BIS issues the licence. You may then affix the ISI Mark on compliant products.
Amendments to IS/ISO 11135 : 2014
| Amendment | Year |
|---|---|
| First Amendment | 2023 |
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Fixed fee. End-to-end handling. We manage the entire BIS certification process.