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 अपेक्षाएँ 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Standards to be Superseded :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

::Cross Referenced Indian Standard::
Sl. No. Is No & Year IS Title
1 IS 3933: 2021 Colour Identification of Gas Cylinders and Related Equipment Intended for Medical Use (First Revision)
2 IS/ISO 4871 : 1996 Acoustics - Declaration and Verification of Noise Emission Values of Machinery and Equipment
3 IS/ISO 5356 : Part 1: 2015 Anaesthetic and respiratory equipment - Conical connectors: Part 1 cones and sockets (First Revision)
4 IS/ISO 5367: 2000 Breathing tubes intended for use with anaesthetic apparatus and ventilators
5 IS/ISO 7396 : Part 1: 2007 Medical gas pipeline systems: Part 1 pipeline systems for compressed medical gases and vacuum
6 IS/ISO 14937 : 2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development validation and routine control of a sterilization process for medical devices
7 IS/ISO 16142 : Part 1: 2016 Medical Devices - Recognized Essential Principles of Safety and Performance of Medical Devices Part 1 General Essential Principles and Additional Specific Essential Principles for all Non-IVD Medical Devices and Guidance on the Selection of Standards
8 IS/ISO 17664 : 2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
9 IS/ISO 80369 : Part 1: 2018 Small-Bore Connectors for Liquids and Gases in Healthcare Applications Part 1 General Requirements
10 IS 13450 : Part 2 : Sec 84: 2023 Medical electrical equipment Part 2 - Particular requirements for basic safety and essential performance Section 84 Ventilators for emergency medical services environment
11 IS 9000 : Part 7 : Sec 1: 2018 Basic environmental testing procedures for electronic and electrical items: Part 7 impact test: Sec 1 shock (Test Ea) (Second Revision)
12 IS 9000 : Part 7 : Sec 3: 2019 Environmental testing: Part 7 tests :: Sec 3 test Ec: rough handling shocks, primarily for equipment - Types specimens (First Revision)
13 IS/IEC 60529: 2001 Degrees of protection provided by enclosures (IP Code)
14 IS 13450 : Part 1 : Sec 12: 2024 Medical electrical equipment : Part 1 General requirements for basic safety and essential performance, Section 12 Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
15 IS 17922 : Part 1: 2023 Medical Devices Part 1: Application of Usability Engineering

Sl. No. Document No Document Title
1 MHD/11 / 25205 Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 1: Evaluation and testing within a risk management process
2 MHD/14 / 23491 Medical devices Information to be supplied by the manufacturer
3 MHD/15 / 22648 Medical electrical equipment : Part 1 General requirements for basic safety and essential performance (Third Revision)
4 MHD/15 / 22656 Medical electrical equipment : Part 1 General requirements for basic safety and essential performance, Section 10 Requirements for the development of physiologic closed-loop controllers (First Revision)
5 MHD/15 / 22657 Medical electrical equipment : Part 1 General requirements for basic safety and essential performance , Section 11 Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (First Revison)
6 MHD/11 / 25226 Anaesthetic and Respiratory Equipment Low-Pressure Hose Assemblies for Use with Medical Gases
7 MHD/11 / 25381 Breathing system filters for anaesthetic and respiratory use Part 1: Salt test method to assess filtration performance
8 MHD/11 / 25383 Breathing system filters for anaesthetic and respiratory use Part 2: Non-filtration aspects
9 MHD/11 / 25372 Medical electrical equipment Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
10 MHD/11 / 25364 Medical electrical equipment Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment

::Cross Referenced International Standard(s) & Standard(s) Of National SDO(s) ::
Sl. No. Prefix Number Part Section Year
1 ISO 3744 - - 2010
2 IEC 60068 2 64 2008
3 IEC 62570 - - 2014

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
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4 WC Draft 10-04-2024 WC approved by HOD
MHDC  MHD 11, -------
5 Skipped to Finalization 10-06-2024 Stage-Changed -------
6 Finalization 10-06-2024 ------ -------
7 Final Draft 10-06-2024 Submited for HOD approval
-------
8 Final Draft draft accepted by HOD and sent to Publication 10-06-2024 Final Draft approved by HOD -------
9 Accepted by Publication 19-06-2024 Final Draft accepted by Publication
Remarks: Accepted by Publication
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10 Proof sent by OSA to Publication 25-06-2024 Proof to OSA Stage-Skipped -------
11 Skipped to Pdf Stage 25-06-2024 Proof to Technial Department Stage-Skipped -------
12 Stage-Skipped 25-06-2024 PDF to OSA Stage-Skipped -------
13 Pdf sent by Publication to Technical Department 25-06-2024 PDF attached some comments have been added in the document, kindly check and revert back along with their solution and also revert along with DC approval. -------
14 Pdf sent by Technical Department to Publication 12-07-2024 Dear Sir, Kindly refer to the attached comments and replies in given in the document. Kindly update the document accordingly and reshare it. -------
15 Stage-Skipped 15-07-2024 PDF to OSA Stage-Skipped -------
16 Pdf sent by Publication to Technical Department 15-07-2024 Correction done as marked in the document, kindly check and revert along with DC approval. -------
17 Pdf sent by Technical Department to Publication 16-07-2024 Dear Sir, Kindly refer to the attached comments and replies in given in the document. Kindly update the document accordingly and reshare it. -------
18 Pdf sent by Publication to Technical Department 25-07-2024 Correction done as marked in the document, kindly check and revert along with DC approval. -------
19 Pdf sent by Technical Department to Publication 03-09-2024 MHDC approval is attached -------
20 Stage-Skipped 09-09-2024 PDF to OSA Stage-Skipped -------
21 Ready for Gazette 09-09-2024 Stage-Changed -------