Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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062
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Date of Entry 05/29/2024
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FR Recognition Number
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10-134
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Standard | |
ISO 10943 Fourth edition 2023-01 Ophthalmic instruments - Indirect ophthalmoscopes |
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Scope/AbstractThis document, together with ISO 15004-1 and ISO 15004-2, specifies minimum requirements and test methods for hand-held, spectacle-type, and head-worn indirect ophthalmoscopes for observing indirect images of the eye fundus.
This document takes precedence over ISO 15004-1 and ISO 15004-, if differences exist.
This document is not applicable to condensing lenses used for indirect ophthalmoscopy or to accessories.
This document is not applicable to table-mounted instruments such as Gullstrand ophthalmoscopes and their derivatives, nor to ophthalmoscopes primarily intended for image capture and/or processing such as those based on scanning laser techniques. |
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Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized: |
Any reference to ISO 15004-2 in the standard. |
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Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
This standard is recognized in part because: Reference to ISO 15004-2 for light hazard protection is in conflict with another FDA-recognized standard, see ANSI Z80.36-2021 listed below. FDA has replaced ISO 15004-2 with ANSI Z80.36 as the recognized standard for light hazard protection in ophthalmic instruments. |
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Transition Period
FDA recognition of ISO 10943 Third edition 2011-08-15 [Rec# 10-70] will be superseded by recognition of ISO 10943 Fourth edition 2023-01 [Rec# 10-134]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 10-70] until July 05, 2026. After this transition period, declarations of conformity to [Rec# 10-70] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§886.1570 |
Ophthalmoscope, Ac-Powered
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Class 2
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HLI
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§886.1570 |
Ophthalmoscope, Battery-Powered
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Class 2
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HLJ
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§886.1570 |
Ophthalmoscope, Laser, Scanning
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Class 2
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MYC
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Relevant FDA Guidance and/or Supportive Publications*
ANSI Z80.36-2021 Ophthalmics - Light Hazard Protection for Ophthalmic Instruments.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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FDA Technical Contact
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Standards Development Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |