Document Details
Name of Department/Committee : MHD 11
Document Number : MHD 11 ( 25374)
Document Title [English] : Anaesthetic and respiratory equipment Heat and moisture exchangers HMEs for humidifying respired gases in humans Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml
Document Title [Hindi] : संवेदनाहारी और श्वसन उपकरण — मनुष्यों में श्वसन गैसों को नम करने के लिए ताप और नमी एक्सचेंजर्स (एचएमई) भाग 2: 250 मिलीलीटर की न्यूनतम ज्वारीय मात्रा वाले ट्रेकियोस्टोमाइज्ड रोगियों के साथ उपयोग के लिए एचएमई
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Standards to be Superseded :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 : Product Specification
Risk : Low
Certification : Voluntary Certification
Short Commom Man's Title : Heat and moisture exchangers (HMEs) for humidifying respired gases in humans Part 2: HMEs for use wi
ITCHS Code :
Ministry :
  • Ministry of Health and Family Welfare
Sustainable development Goals :
  • GOOD HEALTH AND WELL BEING
Degree of Equivalence : Modified/Technically Equivalent
Identical/Equivalent Standards : ISO 9360-2:2001
Organization Type: ISO

Sl.No. Synosis Points
1 SCOPE This part of ISO 9360 is based on ISO 9360-1:2000 and specifies certain requirements and test methods for heat and moisture exchangers (HMEs) without machine connector ports, including those incorporating breathing system filters. These devices are intended for the humidification of respired gases for tracheostomized patients having a tidal volume of 250 ml or greater.

Timeline Details


S.No. P-Draft
Completion Date
WC-Draft
Completion Date
Final-Draft
Completion Date
Project
Completion Date(Gazette)
Entered By Entered On
1 24-04-2024 24-09-2024 09-12-2024 24-04-2025 Mr. Satyam Rathore 24-04-2024
Stages
Sl.
No.
Stage Date of Occurence Remarks Circulated to Files
1 Generation of Document Number 24-04-2024 -------
2 P-Draft Waived 11-07-2024 -------
3 WC Draft 11-07-2024 Duration : 30 Days
Submitted for HOD approval
-------
4 WC Draft 11-07-2024 WC approved by HOD
MHDC   -------