Document Details |
|
Name of Department/Committee : | MHD 06 |
---|---|
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Standards to be Superseded : |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 |
|
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 : |
|
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 |
|||||||
|
|||||||
|
|||||||
|
|||||||
Stages |
|||||
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 |
------- | |
4 | WC Draft | 31-03-2024 | WC approved by HOD |
MHDC MHD 06, | ------- |