Document Details |
|
| Name of Department/Committee : | MHD 06 |
|---|---|
| Document Number : | MHD 06 ( 24999) |
| Document Title [English] : | Cardiovascular implants and artificial organs Cannulae for extracorporeal circulation |
| Document Title [Hindi] : | ह्रदयवाहिनी प्रत्यारोपण एवं कृत्रिम अंग - बाह्य परिसंचरण के लिए प्रवेशनी |
| 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| Standards to be Superseded : | |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 : | Medium |
| 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 18193:2021 |
| Organization Type: | ISO |
| Sl.No. | Synosis Points | |
| 1 | This document specifies requirements for sterile, single-use cannulae for removal and delivery of patients’ blood during cardiopulmonary bypass (CPB) up to 6 h duration, extracorporeal lung assist (ECLA with VV, VAV, or AV cannulation strategies), left or right heart bypass (LHB, RHB), cardiopulmonary support (CPS), extracorporeal life support (ECLS with VA cannulation strategy), extracorporeal carbon dioxide removal (ECCO2R), and other extracorporeal circulation techniques. | |
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, | ------- |