British Standards Institution

Source:: ISO
Committee:: CH/172/7 - Eye implants
Categories:: Medical equipment. Ophthalmic
Number of comments:: 1

Scope

This document defines requirements with regards to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling, and the information supplied by the manufacturer.

This document applies to ophthalmic irrigating solutions (OIS), used during ophthalmic surgery. These solutions do not provide any primary immunological, pharmacological, or metabolic function.

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Please email further comments to: debbie.stead@bsigroup.com

Standard timeline

1. Proposal (Complete)

Proposal start date:

2. Draft (Complete)

Draft start date:

12/06/2023

3. Public Comments

Public Comments start date:

21/12/2023

Public Comments end date:

13/02/2024

Learn more about the standards development process

Standards Development

BS EN ISO 16671 ISO 16671 Ophthalmic implants. Irrigating solutions for ophthalmic surgery

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