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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 049 Date of Entry 06/07/2018 
FR Recognition Number 10-110
Standard
ISO 15798 Third edition 2013-09-15 15
Ophthalmic implants - Ophthalmic viscosurgical devices [Including: Amendment 1 (2017)]
Scope/Abstract
This International Standard is applicable to ophthalmic viscosurgical devices (OVDs), a class of non-active surgical implants with viscous and/or viscoelastic properties, intended for use during surgery in the anterior segment of the human eye. OVDs are designed to create and maintain space, to protect intraocular tissues and to manipulate tissues during surgery.

This International Standard specifies requirements with regard to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling and information supplied by the manufacturer of these devices.
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
§886.4275 Aid, Surgical, Viscoelastic Class 3 LZP
Relevant FDA Guidance and/or Supportive Publications*
Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices: Guidance for Industry and Food and Drug Administration Staff, Issued August 2015.


FDA Technical Contact
 Don Calogero
  FDA/OC/CDRH/OPEQ/OHTI/DHTIA/
  301-796-6483
  don.calogero@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Ophthalmic
*These are provided as examples and others may be applicable.
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