Document Details |
|
| Name of Department/Committee : | MHD 11 |
|---|---|
| Document Number : | MHD 11 ( 25390) |
| Document Title [English] : | Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 4: Tests for leachables in condensate |
| Document Title [Hindi] : | स्वास्थ्य देखभाल अनुप्रयोगों में श्वास गैस मार्गों की जैव अनुकूलता मूल्यांकन भाग 4: कंडेनसेट में लीचेबल्स के लिए परीक्षण |
| Document Type : | New |
| Language : | English |
| Priority : | 3 |
| ICS Code : | 11.040.10 |
| Date of Project Approval : | 24-04-2024 |
| Standards to be Superseded : | |
Classification Details |
|
| Group : | Medical and Hospital Equipments |
| Sub Group : | Clinical, pathological, anaesthetic and respiratory equipments and systems |
| Sub Sub Group : | Diagnostic , anaesthetic and respiratory equipment |
| Aspects : | Code of Practice |
| Risk : | Low |
| Certification : | Voluntary Certification |
| Short Commom Man's Title : | Part 4: Tests for leachables in condensate |
| ITCHS Code : | |
| Ministry : |
|
| Sustainable development Goals : |
|
| Degree of Equivalence : | Modified/Technically Equivalent |
| Identical/Equivalent Standards : | ISO 18562-4:2024 |
| Organization Type: | ISO |
| Sl.No. | Synosis Points | |
| 1 | SCOPE - This Indian standard specifies tests for substances leached by liquid water condensing in gas pathways of a medical device, its parts or accessories, which are intended to provide respiratory care or supply substances via the respiratory tract to a patient in all environments. The chemical characterization methods described in this document apply to chemical substances that could leach from the medical device, its parts or accessories into the condensate. This document establishes verifiable acceptance criteria for these tests. The identity and quantity of each chemical released is intended for toxicological risk assessment as described in ISO 18562-1:2024. | |
Timeline Details |
|||||||
|
|
|||||||
|
|||||||
|
|||||||
Stages |
|||||
| Sl. No. |
Stage | Date of Occurence | Remarks | Circulated to | Files |
| 1 | Generation of Document Number | 24-04-2024 | ------- | ||
| 2 | P-Draft Waived | 29-07-2024 | This is ISO standard. | ------- | |
| 3 | WC Draft | 29-07-2024 | Duration : 30 Days Submitted for HOD approval |
------- | |
| 4 | WC Draft | 29-07-2024 | WC approved by HOD |
MHDC | ------- |