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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 049 Date of Recognition 06/07/2018 
FR Recognition Number 9-114
Standard
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
§874.4770 Otoscope Class 1 ERA
§874.4760 Nasopharyngoscope (Flexible Or Rigid) Class 2 EOB
§874.4750 Laryngostroboscope Class 1 EQL
§874.4720 Mediastinoscope, Surgical Class 2 EWY
§874.4710 Esophagoscope (Flexible Or Rigid) Class 2 EOX
§874.4680 Bronchoscope (Flexible Or Rigid) Class 2 EOQ
§874.4350 Source, Carrier, Fiberoptic Light Class 1 EQH
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance developed at this time.
FDA Technical Contacts
 Tuan Nguyen
  FDA/OMPT/CDRH/ODE/DRGUD/ULDB/
  301-796-5174
  tuan.nguyen2@fda.hhs.gov
 Sunny Park
  FDA/OMPT/CDRH/ODE/DOED/ENTB/
  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
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