Document Details |
|
| Name of Department/Committee : | MHD 12 |
|---|---|
| Document Number : | MHD 12 ( 23591) |
| Document Title [English] : | In vitro diagnostic medical devices Single-use containers for the collection of specimens from humans other than blood |
| Document Title [Hindi] : | इन विट्रो डायग्नोस्टिक चिकित्सा उपकरण - रक्त के अलावा मनुष्यों से नमूनों के संग्रह के लिए एकल-उपयोग कंटेनर |
| Document Type : | New |
| Language : | English |
| Priority : | 2 |
| ICS Code : | 11.100.10 |
| Date of Project Approval : | 18-09-2023 |
| Standards to be Superseded : | |
Classification Details |
|
| Group : | Medical and Hospital Equipments |
| Sub Group : | Health care facilities |
| Sub Sub Group : | Surgical dressings and Disposable products |
| Aspects : | Product Specification |
| Risk : | Low |
| Certification : | Voluntary Certification |
| Short Commom Man's Title : | |
| ITCHS Code : | |
| Ministry : |
|
| Sustainable development Goals : | |
| Degree of Equivalence : | Identical under dual numbering |
| Identical/Equivalent Standards : | ISO 6717:2021 |
| Organization Type: | ISO |
::Cross Referenced Indian Standard:: |
|||
| Sl. No. | Is No & Year | IS Title | |
| 1 | IS 18105 : Part 1: 2023 | Medical devices Symbols to be used with information to be supplied by the manufacturer Part 1: General requirements | |
| Sl.No. | Synosis Points | |
| 1 | This document specifies requirements and test methods for specialized single-use evacuated and non-evacuated containers, intended by their manufacturers, for the primary containment and preservation of specimens, other than blood specimens, derived from the human body, for the purposes of in vitro diagnostic examination. It is not intended to cover specimen containers for forensic investigations. | |
| 2 | Examples of such specimens include, but are not limited to, cerebral spinal fluid (CSF), faeces, infected bodily fluids, saliva, ejaculate, sputum, urine, tissue samples. Specimens and types of devices specifically excluded are specialized containers for cryo-preservation, samples for nucleic acid testing and swabs. | |
Timeline Details |
|||||||
|
|
|||||||
|
|||||||
|
|||||||
Stages |
|||||
| Sl. No. |
Stage | Date of Occurence | Remarks | Circulated to | Files |
| 1 | Generation of Document Number | 18-09-2023 | ------- | ||
| 2 | P-Draft Waived | 18-09-2023 | ------- | ||
| 3 | WC Draft | 18-09-2023 | Duration : 30 Days Submitted for HOD approval |
------- | |
| 4 | WC Draft | 18-09-2023 | WC approved by HOD |
MHDC MHD 12, | ------- |
| 5 | WC-Draft | 25-09-2023 | WC-Draft Email Notifications Sent | MHDC, MHD 12, | ------- |
| 6 | Skipped to Finalization | 18-04-2024 | Stage-Changed | ------- | |
| 7 | Finalization | 18-04-2024 | ------ | ------- | |
| 8 | Final Draft | 18-04-2024 | Submited for HOD approval |
------- | |
| 9 | Final Draft draft accepted by HOD and sent to Publication | 19-04-2024 | Final Draft approved by HOD | ------- | |
| 10 | Accepted by Publication | 22-04-2024 | Final Draft accepted by Publication Remarks: Accepted by Publication |
------- | |
| 11 | Proof sent by OSA to Publication | 24-04-2024 | Proof to OSA Stage-Skipped | ------- | |
| 12 | Skipped to Pdf Stage | 24-04-2024 | Proof to Technial Department Stage-Skipped | ------- | |
| 13 | Stage-Skipped | 24-04-2024 | PDF to OSA Stage-Skipped | ------- | |
| 14 | Pdf sent by Publication to Technical Department | 24-04-2024 | डी सी चेयरपर्सन के अप्रूवल एवं गज़ेट डिटेल्स हेतु पी डी एफ फॉर्मैट संलग्न है । | ------- | |