Document Details |
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| Name of Department/Committee : | MHD 06 |
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| Document Number : | MHD 06 ( 25002) |
| Document Title [English] : | Implants for surgery Active implantable medical devices Part 4: Implantable infusion pump systems |
| Document Title [Hindi] : | सर्जरी के लिए प्रत्यारोपण - सक्रिय प्रत्यारोपण योग्य चिकित्सा उपकरण - भाग 4: प्रत्यारोपण योग्य जलसेक पंप सिस्टम |
| 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| Standards to be Superseded : | |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 Registration |
| 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 14708-4:2022 |
| Organization Type: | ISO |
| Sl.No. | Synosis Points | |
| 1 | This document specifies particular requirements for active implantable medical devices intended to deliver a medicinal substance to site-specific locations within the human body, to provide basic assurance of safety for both patients and users. It amends and supplements ISO 14708-1:2014. The requirements of this document take priority over those of ISO 14708-1. This document is applicable to active implantable medical devices intended to deliver medicinal substances to site-specific locations within the human body. This document is also applicable to some non-implantable parts and accessories of the devices defined in Clause 3. The tests that are specified in this document are type tests intended to be carried out on a sample of a device to show compliance and are not intended to be used for the routine testing of manufactured products. | |
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, | ------- |