Document Details |
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| Name of Department/Committee : | MHD 06 |
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| Document Number : | MHD 06 ( 24992) |
| Document Title [English] : | Sizing parameters of surgical valve prostheses: Requirements regarding the application of ISO 5840-2 |
| Document Title [Hindi] : | शल्य चिकित्सा द्वारा कपाटिका प्रत्यारोपण के लिए परिमाण मापदण्ड : आईएसओ 5840-2 के आवेदन सन्दर्भ में अपेक्ष्याएं |
| Document Type : | New |
| Language : | English |
| Priority : | 3 |
| ICS Code : | 11.040.40 |
| Date of Project Approval : | 22-02-2024 |
| Standards to be Superseded : | |
Classification Details |
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| Group : | Medical and Hospital Equipments |
| Sub Group : | Implants |
| Sub Sub Group : | Cardiovascular surgery instrument and implants |
| Aspects : | Dimensions |
| Risk : | High |
| 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 : | Identical under dual numbering |
| Identical/Equivalent Standards : | ISO/PAS 7020:2023 |
| Organization Type: | ISO |
| Sl.No. | Synosis Points | |
| 1 | The document is devised to cater the inconsistencies with the labeling and instruction for use associated with sizing procedures for heart valve replacement. For aortic valve replacements, severe mismatch may lead to significant risk of mortality and morbidity. The best approach to avoid prosthesis-patient mismatch is prevention. This requires the surgeon to have clear and accurate information about the sizing parameters and effective orifice area of valve being substituted. The document recommends additional valve sizing parameters to be added on the device labeling. The document also present suitable methods to obtain these parameters and the degree of accuracy required. | |
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 | 22-02-2024 | ------- | ||
| 2 | P-Draft Waived | 07-03-2024 | As decided by the sectional committee in 16th SC meeting. | ------- | |
| 3 | WC Draft | 28-03-2024 | Duration : 30 Days Submitted for HOD approval Remarks : As decided by sectional committee circulated for the period of one month |
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| 4 | WC Draft | 28-03-2024 | WC approved by HOD |
MHDC MHD 06, | ------- |