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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 028 Date of Recognition 03/16/2012 
FR Recognition Number 9-53
Standard
ASTM F1992 -99 (Reapproved 2007)
Standard Practice for Reprocessing of Reusable, Heat-Stable Endoscopic Accessory Instruments (EAI) Used with Flexible Endoscopes
Scope/Abstract
This practice covers reusable, heat-stable endoscopic accessory instruments (EAI) designed to be inserted into flexible endoscopes and clearly defined in the user instructions as devices intended for reuse among patients. The EAIs covered by this practice may or may not have lumens or loosely joined surfaces, may or may not have access ports for flushing, and may or may not be capable of being completely disassembled prior to reprocessing.

This practice is intended to complement, not replace, the instructions provided by product manufacturers. EAI manufacturers should provide properly validated instruction and labeling necessary for users to understand the basic design, specifications, nomenclature, and components of specific accessories and to properly inspect, prepare, use, reprocess, and store these instruments.

Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§878.4400 Electrosurgical, Cutting & Coagulation & Accessories Class 2 GEI
§876.5365 Dilator, Esophageal Class 2 KNQ
§876.4730 Snare, Non-Electrical Class 1 FGX
§876.4680 Dislodger, Stone, Basket, Ureteral, Metal Class 2 FFL
§876.4680 Dislodger, Stone, Flexible Class 2 FGO
§876.4300 Electrode, Flexible Suction Coagulator Class 2 FEH
§876.4300 Forceps, Biopsy, Electric Class 2 KGE
§876.4300 Snare, Flexible Class 2 FDI
§876.4300 Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Class 2 KNS
§876.1500 Accessories, Cleaning Brushes, For Endoscope Class 1 MNL
§876.1500 Apparatus, Pneumoperitoneum, Automatic Class 2 FDP
§876.1500 Carrier, Sponge, Endoscopic Class 2 FGS
§876.1500 Device, Measuring, For Panendoscope Class 1 FDY
§876.1500 Endoscope Holder Class 2 OCV
§876.1500 Endoscopic Grasping/Cutting Instrument, Non-Powered Class 2 OCZ
§876.1500 Endoscopic Guidewire, Gastroenterology-Urology Class 2 OCY
§876.1500 Endoscopic Injection Needle, Gastroenterology-Urology Class 2 FBK
§876.1500 Endoscopic Irrigation/Suction System Class 2 OCX
§876.1500 Mini Endoscope, Gastroenterology-Urology Class 2 ODF
§876.1500 Needle, Pneumoperitoneum, Simple Class 2 FHP
§876.1500 Obturator, For Endoscope Class 2 FEC
§876.1500 Pneumoperitoneum Needle Class 2 FHO
§876.1075 Biopsy Needle Class 2 FCG
§876.1075 Forceps, Biopsy, Non-Electric Class 1 FCL
Relevant FDA Guidance and/or Supportive Publications
Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile: Guidance for Industry and Food and Drug Administration Staff, Issued January 2016.
FDA Technical Contact
 Shanil Haugen
  FDA/OMPT/CDRH/ODE/DRGUD/ULDB/
  301-796-0301
  shanil.haugen@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
ObGyn/Gastroenterology/Urology
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