EN ISO 10943:2011
Ophthalmic instruments - Indirect ophthalmoscopes (ISO 10943:2011)

Standard No.

EN ISO 10943:2011

Release Date

2011

Published By

European Committee for Standardization (CEN)

Status

Be replaced 2023-04

Replace By

EN ISO 10943:2023

Latest

EN ISO 10943:2023

Replace

EN ISO 10943:2006

Scope

This International Standard, together with ISO 15004-1 and ISO 15004-2, specifies minimum requirementsand test methods for hand-held, spectacle-type, and head-worn indirect ophthalmoscopes for observingindirect images of the eye fundus.

EN ISO 10943:2011 Referenced Document

• IEC 60601-1:2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
• ISO 15004-1 Ophthalmic instruments — Fundamental requirements and test methods — Part 1: General requirements applicable to all ophthalmic instruments*， 2020-06-04 Update
• ISO 15004-2 Ophthalmic instruments - Fundamental requirements and test methods - Part 2: Light hazard protection

EN ISO 10943:2011 history

• 2023 EN ISO 10943:2023 Ophthalmic instruments - Indirect ophthalmoscopes (ISO 10943:2023)
• 2011 EN ISO 10943:2011 Ophthalmic instruments - Indirect ophthalmoscopes (ISO 10943:2011)
• 2006 EN ISO 10943:2006 Ophthalmic Instruments - Indirect Ophthalmoscopes
• 1998 EN ISO 10943:1998 Ophthalmic Instruments - Indirect Ophthalmoscopes ISO 10943:1998