Document Details |
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| Name of Department/Committee : | MHD 11 |
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| Document Number : | MHD 11 ( 25372) |
| Document Title [English] : | Medical electrical equipment Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors |
| Document Title [Hindi] : | चिकित्सा विद्युत उपकरण भाग 2-55: श्वसन गैस मॉनिटर की बुनियादी सुरक्षा और आवश्यक प्रदर्शन के लिए विशेष आवश्यकताएं |
| 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| Standards to be Superseded : | |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 |
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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 : | Medical electrical equipment Part 2-55: Particular requirements for the basic safety and essential p |
| ITCHS Code : | |
| Ministry : |
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| Sustainable development Goals : |
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| Degree of Equivalence : | Identical under dual numbering |
| Identical/Equivalent Standards : | ISO 80601-2-55:2018 |
| Organization Type: | ISO |
| Sl.No. | Synosis Points | |
| 1 | SCOPE This Standards specifies particular requirements for the BASIC SAFETY and ESSENTIAL PERFORMANCE of a RESPIRATORY GAS MONITOR (RGM), hereafter referred to as ME EQUIPMENT, intended for CONTINUOUS OPERATION for use with a PATIENT. This document specifies requirements for — anaesthetic gas monitoring, — carbon dioxide monitoring, and — oxygen monitoring. NOTE 1 An RGM can be either stand‐alone ME EQUIPMENT or integrated into other equipment, e.g. an anaesthetic workstation or a ventilator. | |
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 | 24-04-2024 | ------- | ||
| 2 | P-Draft Waived | 15-07-2024 | ------- | ||
| 3 | WC Draft | 15-07-2024 | Duration : 30 Days Submitted for HOD approval |
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| 4 | WC Draft | 15-07-2024 | WC approved by HOD |
MHDC | ------- |