Document Details |
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| Name of Department/Committee : | MHD 11 |
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| 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| Standards to be Superseded : | |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 |
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| 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 : |
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| Sustainable development Goals : |
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| Degree of Equivalence : | Modified/Technically Equivalent |
| Identical/Equivalent Standards : | ISO 80601-2-87: 2021 |
| Organization Type: | ISO |
::Cross Referenced Indian Standard:: |
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| 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) :: |
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| 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 |
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Stages |
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| 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 |
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| 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 | ------- | |