Need help?

EN ISO 15004-1:2009 Standard

wave
Save  

  Keywords:

#part #eye #laser #instruments #active

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 5th of January 2022

  Description:

Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2006)

  Purpose

This part of ISO 15004 specifies fundamental requirements for non-invasive, active and non-active ophthalmic instruments. This part of ISO 15004 is also applicable to low-vision aids and tonometers, but not to other ophthalmic instruments which are used in contact with the globe of the eye. This part of ISO 15004 is not applicable to operation microscopes, endoscopes and devices intended for laser investigation or laser treatment of the eye.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN ISO 15004-1:2006"

Anyway is still possible use the "EN ISO 15004-1:2006" until March 21st, 2010

  Related Standards

EN ISO 14607:2018

Medical devices Directive (93/42/EEC)

Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2018, Corrected version 2018-08)

EN ISO 10524-4:2008

Medical devices Directive (93/42/EEC)

Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (ISO 10524-4:2008)

EN 60645-1:2001

Medical devices Directive (93/42/EEC)

Electroacoustics - Audiological equipment - Part 1: Pure-tone audiometersIEC 60645-1:2001

EN 60645-2:1997

Medical devices Directive (93/42/EEC)

Audiometers - Part 2: Equipment for speech audiometryIEC 60645-2:1993

EN ISO 10993-23:2021

Medical devices Directive (93/42/EEC)

Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)

EN 60645-3:2007

Medical devices Directive (93/42/EEC)

Electroacoustics - Audiometric equipment - Part 3: Test signals of short durationIEC 60645-3:2007

  Stay up to date

CELAB is Notified Body No.2037 for the EMC Directive and Italian office of a Notified Body for the RED Directive.

CELAB performs voluntary inspection activities on technical construction files to check their contents.

CELAB can accomplish all the required tests in order to affix the CE-marking related to EMC, LVD, RED, MDD, machines and many others.

CLICK HERE TO GET TESTS AND INFO ON THE EN ISO 15004-1:2009 STANDARD

  ACCESS

Search for a standard
GO

Register

Already a member?
Login

  OTHER APPLICATIONS

If you are interested in DO160 tests, you can give a try to our other free of charge software:
CE-Marking assistant, Version: 1.3.0