ISO 8600-5 First edition 2005-03-15

Standard Organization:

ISO 8600-5 First edition 2005-03-15 Optics and photonics - Medical endoscopes and endotherapy devices - Part 5: Determination of optical resolution of rigid endoscopes with optics

Rationale:

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Scope:

This part of ISO 8600 specifies a test method for determining the optical resolution of endoscopes for type testing. It is applicable to rigid endoscopes with optics designed for use in the practice of medicine for type testing. It is not applicable to endoscopes having a fibre-optic or opto-electronic imaging system.

Code of Federal Regulations:

FDA Guidance:

Hysteroscopes and Gynecologic Laparoscopes: Submission Guidance for a 510(k), Issued March 1996.