Document Details
Name of Department/Committee : MHD 11
Document Number : MHD 11 ( 25230)
Document Title [English] : Medical electrical equipment Part 2 Particular Requirements for Basic Safety and Essential Performance Section 87 High Frequency Ventilators
Document Title [Hindi] : चिकित्सा विद्युत उपकरण भाग 2 बुनियादी सुरक्षा और आवश्यक प्रदर्शन के लिए विशेष आवश्यकताएं अनुभाग 87 हाई फ्रीक्वेंसी वेंटिलेटर
Document Type : New
Language : English
Priority : 3
ICS Code : 11.040.10
Date of Project Approval : 10-04-2024
Standards to be Superseded :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 :
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 80601-2-87: 2021
Organization Type: ISO

Sl.No. Synosis Points
1 This Indian Standard specifies the basic safety and essential performance of a high-frequency ventilator (HFV) in combination with its accessories, hereafter referred to as ME equipment which is Intended for use in an environment that provides specialized care for patients whose conditions can be life-threatening and who can require comprehensive care and constant monitoring in a professional healthcare facility;

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 10-04-2024 10-09-2024 25-11-2024 09-04-2025 Mr. Satyam Rathore 10-04-2024
Stages
Sl.
No.
Stage Date of Occurence Remarks Circulated to Files
1 Generation of Document Number 10-04-2024 -------
2 P-Draft Waived 10-04-2024 This Indian Standard is an ISO adoption -------
3 WC Draft 10-04-2024 Duration : 30 Days
Submitted for HOD approval
-------
4 WC Draft 10-04-2024 WC approved by HOD
MHDC  MHD 11, -------