Document Details |
|
| Name of Department/Committee : | MHD 11 |
|---|---|
| Document Number : | MHD 11 ( 25389) |
| Document Title [English] : | Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 3: Tests for emissions of volatile organic substances |
| Document Title [Hindi] : | स्वास्थ्य देखभाल अनुप्रयोगों में श्वास गैस मार्गों की जैव अनुकूलता मूल्यांकन भाग 3: वाष्पशील कार्बनिक पदार्थों के उत्सर्जन 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| Standards to be Superseded : | |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 3: Tests for emissions of volatile organic substances |
| ITCHS Code : | |
| Ministry : |
|
| Sustainable development Goals : |
|
| Degree of Equivalence : | Identical under dual numbering |
| Identical/Equivalent Standards : | ISO 18562-3:2024 |
| Organization Type: | ISO |
| Sl.No. | Synosis Points | |
| 1 | Scope - This Indian standard specifies tests for the emissions of volatile organic substances from the 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 tests of this document are intended to quantify emissions of volatile organic substances that are added to the respirable gas stream by the materials of the gas pathway. This document establishes acceptance criteria for these tests. | |
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 | 26-07-2024 | ISO adoption. | ------- | |
| 3 | WC Draft | 26-07-2024 | Duration : 30 Days Submitted for HOD approval |
------- | |
| 4 | WC Draft | 26-07-2024 | WC approved by HOD |
MHDC | ------- |