Document Details |
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| Name of Department/Committee : | MHD 05 |
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| Document Number : | MHD 05 ( 23548) |
| Document Title [English] : | Ophthalmic instruments Corneal topographers |
| Document Title [Hindi] : | नेत्र उपकरण - कॉर्नियल टोपोग्राफर |
| Document Type : | New |
| Language : | English |
| Priority : | 3 |
| ICS Code : | 11.040.70 |
| Date of Project Approval : | 17-08-2023 |
| Standards to be Superseded : | |
Classification Details |
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| Group : | Medical and Hospital Equipments |
| Sub Group : | Diagnostic Instruments |
| Sub Sub Group : | Equipment/Instruments used for diagnostic and clinical purpose |
| 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 19980:2021 |
| Organization Type: | ISO |
Division Council Chairperson Approval Details |
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| Sl. No. | Document No | Document Title | |
| 1 | MHD/15 / 22648 | Medical electrical equipment : Part 1 General requirements for basic safety and essential performance (Third Revision) | |
| Sl.No. | Synosis Points | |
| 1 | This document specifies minimum requirements for instruments and systems that fall into the class of corneal topographers (CTs). It also specifies tests and procedures to verify that a system or instrument complies with this document and thus qualifies as a CT according to this document. It also specifies tests and procedures that allow the verification of capabilities of systems that are beyond the minimum requirements for CTs. This document defines terms that are specific to the characterization of the corneal shape so that they may be standardized throughout the field of vision care. This document is applicable to instruments, systems and methods that are intended to measure the surface shape of the cornea of the human eye. NOTE The measurements can be of the curvature of the surface in local areas, three-dimensional topographical measurements of the surface or other more global parameters used to characterize the surface. This document is not applicable to ophthalmic instrum | |
Timeline Details |
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