Document Details |
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| Name of Department/Committee : | MHD 05 |
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| Document Number : | MHD 05 ( 23547) |
| Document Title [English] : | Ophthalmic instruments Optical coherence tomograph for the posterior segment of the human eye |
| Document Title [Hindi] : | नेत्र संबंधी उपकरण - मानव आँख के पिछले भाग के लिए प्रकाशीय सुसंगतता टोमोग्राफ |
| 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| Standards to be Superseded : | |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 16971:2015 |
| Organization Type: | ISO |
Division Council Chairperson Approval Details |
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| Sl. No. | Document No | Document Title | |
| 1 | MHD/05 / 23851 | Ophthalmic instruments Fundamental requirements and test methods Part 1: General requirements applicable to all ophthalmic instruments | |
| 2 | MHD/05 / 23852 | Ophthalmic instruments Fundamental requirements and test methods Part 2: Light hazard protection | |
| 3 | MHD/15 / 22648 | Medical electrical equipment : Part 1 General requirements for basic safety and essential performance (Third Revision) | |
::Cross Referenced International Standard(s) & Standard(s) Of National SDO(s) :: |
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| Sl. No. | Prefix | Number | Part | Section | Year | |
| 1 | IEC | 60825 | 1 | - | - | |
| Sl.No. | Synosis Points | |
| 1 | This International Standard is applicable to optical coherence tomography (OCT) instruments, systems, and methods that are intended to image and measure the biological tissue of the posterior segment of the human eye. This International Standard defines certain terms that are specific to this diagnostic procedure. This International Standard specifies minimum requirements for OCT instruments and systems. It specifies tests and procedures that will verify that a system or instrument complies with this International Standard and so qualifies as an OCT in the meaning of this International Standard. It specifies type test methods and procedures that will allow the verification of capabilities of systems that are beyond the minimum required for OCTs. | |
Timeline Details |
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