Document Details |
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| Name of Department/Committee : | MHD 06 |
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| Document Number : | MHD 06 ( 25000) |
| Document Title [English] : | Cardiovascular implants Transcatheter cardiac occluders |
| Document Title [Hindi] : | हृदय प्रत्यारोपण - ट्रांसकैथेटर कार्डियक ऑक्लुडर |
| 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| Standards to be Superseded : | |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 : | Product Specification |
| Risk : | High |
| Certification : | Voluntary Certification |
| Short Commom Man's Title : | |
| ITCHS Code : | |
| Ministry : |
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| Sustainable development Goals : | |
| Degree of Equivalence : | Identical under dual numbering |
| Identical/Equivalent Standards : | ISO 22679:2021 |
| Organization Type: | ISO |
| Sl.No. | Synosis Points | |
| 1 | This document specifies important in vitro tests including functional and durability characteristics of transcatheter cardiac occluders, and their delivery systems and accessories. This document does not specify exact test methods for functional and durability testing, but it offers requirements and recommendations for performance tests of the cardiac occluder system. Surgical occluders have been omitted from the scope of this document given their significant differences in device geometry, materials, implantation methods, and test methods as compared to transcatheter cardiac occluders. This document is applicable to all intracardiac occluders intended for transcatheter implantation in humans (e.g. atrial septal occluder, ventricular septal occluder, patent foramen ovale occluder, left atrial appendage occluder, and paravalvular leak occluders). This document does not cover non-cardiac occluders, but elements of this document can be applicable to patent ductus arteriosus occluders. | |
| 2 | The following devices and components are outside the scope of this document: surgical devices, cardiac shunt devices, atrial flow regulators, active components (such as sensors), or degradable or animal tissue components. This document is applicable to both newly developed and modified cardiac occluders, their accessory devices, packaging, and labelling. This document defines operational conditions and performance requirements for cardiac occluders where either adequate scientific or clinical evidence, or both, exists for their justification. | |
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 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 | 31-03-2024 | WC approved by HOD |
MHDC MHD 06, | ------- |