Document Details |
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| Name of Department/Committee : | MHD 12 |
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| Document Number : | MHD 12 ( 28657) |
| Document Title [English] : | Sterilization of health care products — Low temperature vaporized hydrogen peroxide — Requirements for the development, validation and routine control of a sterilization process for medical devices |
| Document Title [Hindi] : | स्वास्थ्य देखभाल उत्पादों का विसंक्रमण — निम्न तापमान पर वाष्पीकृत हाइड्रोजन पेरॉक्साइड — चिकित्सा उपकरणों के लिए विसंक्रमण प्रक्रिया के विकास, सत्यापन और नियमित नियंत्रण के लिए अपेक्षाएँ |
| Document Type : | New |
| Language : | English |
| Priority : | 3 |
| ICS Code : | 11.080.01 |
| Date of Project Approval : | 02-09-2025 |
| Standards to be Superseded : | |
Classification Details |
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| Group : | Medical and Hospital Equipments |
| Sub Group : | Health care facilities |
| Sub Sub Group : | Sterilizers & incubators |
| Aspects : | Process Specification |
| Risk : | Low |
| Certification : | None |
| Short Commom Man's Title : | |
| ITCHS Code : | |
| Ministry : |
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| Sustainable development Goals : |
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| Degree of Equivalence : | Identical under dual numbering |
| Identical/Equivalent Standards : | ISO 22441:2022 |
| Organization Type: | ISO |
| Sl.No. | Synosis Points | |
| 1 | This document provides requirements for the development, validation and routine monitoring and control of a low temperature sterilization process for medical devices using vaporized hydrogen peroxide (VH2O2) as the sterilizing agent. This document is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized, organizations performing process validation of VH2O2 sterilization, and organizations responsible for sterilizing medical devices. | |
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