Document Details |
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| Name of Department/Committee : | MHD 11 |
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| Document Number : | MHD 11 ( 25205) |
| Document Title [English] : | Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 1: Evaluation and testing within a risk management process |
| Document Title [Hindi] : | स्वास्थ्य देखभाल अनुप्रयोगों में श्वास गैस मार्गों की जैव अनुकूलता मूल्यांकन भाग 1: जोखिम प्रबंधन प्रक्रिया के भीतर मूल्यांकन और परीक्षण |
| Document Type : | New |
| Language : | English |
| Priority : | 3 |
| ICS Code : | 11.040.10 |
| Date of Project Approval : | 09-04-2024 |
| Standards to be Superseded : | |
Classification Details |
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| Group : | Medical and Hospital Equipments |
| Sub Group : | Clinical, pathological, anaesthetic and respiratory equipments and systems |
| Sub Sub Group : | Biological tests |
| Aspects : | Methods of tests |
| Risk : | Low |
| Certification : | Voluntary Certification |
| Short Commom Man's Title : | |
| ITCHS Code : | |
| Ministry : |
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| Sustainable development Goals : |
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| Degree of Equivalence : | Modified/Technically Equivalent |
| Identical/Equivalent Standards : | ISO 18562-1: 2024 |
| Organization Type: | ISO |
| Sl.No. | Synosis Points | |
| 1 | This Indian Standard represents the application of the best-known science, in order to improve patient safety, by addressing the risk of potentially hazardous substances being conveyed to the patient by the gas stream. This Indian Standard is intended to cover the biological evaluation of gas pathways of medical devices within a risk management process, as part of the overall medical device evaluation and development. This approach combines the review and evaluation of existing data from all sources with, where necessary, the selection and application of additional tests. | |
Timeline Details |
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Stages |
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| Sl. No. |
Stage | Date of Occurence | Remarks | Circulated to | Files |
| 1 | Generation of Document Number | 09-04-2024 | ------- | ||
| 2 | P-Draft Waived | 09-04-2024 | This Indian standard is an ISO adoption | ------- | |
| 3 | WC Draft | 09-04-2024 | Duration : 30 Days Submitted for HOD approval |
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| 4 | WC Draft | 09-04-2024 | WC rejected by HOD Remarks: as requested |
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| 5 | WC Draft | 09-04-2024 | Duration : 30 Days Submitted for HOD approval |
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| 6 | WC Draft | 09-04-2024 | WC approved by HOD |
MHDC MHD 11, | ------- |