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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 049 Date of Entry 06/07/2018 
FR Recognition Number 10-110
Standard
ISO 15798 Third edition 2013-09-15
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.
Transition Period
FDA recognition of ISO 15798 Third edition 2013-09-15 [Rec# 10-110] will be superseded by recognition of ISO 15798 Fourth edition 2022-01 [Rec# 10-131]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 10-110] until July 9, 2023. After this transition period, declarations of conformity to [Rec# 10-110] will not be accepted.
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*
Guidance for Industry and Food and Drug Administration Staff: Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices, Issued August 2015.




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 Contacts
 Don Calogero
  FDA/OC/CDRH/OPEQ/OHTI/DHTIA/
  301-796-6483
  don.calogero@fda.hhs.gov
 Simona Bancos
  FDA/OC/CDRH/OPEQ/OHTI/DHTIA/
  301-796-6860
  simona.bancos@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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