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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 049 Date of Entry 06/07/2018 
FR Recognition Number 9-114
Standard(Included in ASCA)
IEC  60601-2-18: Edition 3.0 2009-08
Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
Scope/Abstract
IEC 60601-2-18:2009 establishes particular basic safety and essential performance requirements for endoscopic equipment. The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of endoscopic equipment. IEC 60601-2-18:2009 amends and supplements IEC 60601-1:2005. This third edition cancels and replaces the second edition, published in 1996, and its Amendment 1 (2000). This edition constitutes a technical revision and has been aligned or harmonized with IEC 60601-1:2005. The main changes with respect to the previous edition include:
- alignment of requirements with IEC 60601-1:2005;
- inclusion of essential performance requirements;
- the inclusion of energized endoscopes and energized endotherapy devices used through second and subsequent punctures within the scope of the standard;
- reference to IEC 60601-2-2 for the dielectric strength testing of HF energized endotherapy devices, rather than defining different tests.
Extent of Recognition
Complete standard
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.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§874.4350 Source, Carrier, Fiberoptic Light Class 1 EQH
§874.4680 Bronchoscope (Flexible Or Rigid) Class 2 EOQ
§874.4710 Esophagoscope (Flexible Or Rigid) Class 2 EOX
§874.4720 Mediastinoscope, Surgical Class 2 EWY
§874.4750 Laryngostroboscope Class 1 EQL
§874.4760 Nasopharyngoscope (Flexible Or Rigid) Class 2 EOB
§874.4770 Otoscope Class 1 ERA
Relevant FDA Guidance and/or Supportive Publications*
AAMI CR500:2019 Basic Introduction to the IEC 60601 Series.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Sunny Park
  FDA/OC/CDRH/OPEQ/OHTI/DHTIC/
  301-796-7059
  sunny.park@fda.hhs.gov
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
ObGyn/Gastroenterology/Urology
*These are provided as examples and others may be applicable.
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