ISO 16672:2003
ISO · 2003-02

Ophthalmic implants - Ocular endotamponades

Replaced ICS 11.040.70

1Key Takeaways

This International Standard applies to ocular endotamponades (OEs), a group of non-solid implants used in ophthalmology to flatten and position a detached retina onto the choroid, or to tamponade the retina. With regard to the safety and efficacy of OEs, this International Standard specifies requirements for their inte…

2Scope / Description

This International Standard applies to ocular endotamponades (OEs), a group of non-solid implants used in ophthalmology to flatten and position a detached retina onto the choroid, or to tamponade the retina.
With regard to the safety and efficacy of OEs, this International Standard specifies requirements for their intended performance, design attributes, pre-clinical and clinical evaluation, sterilization, product packaging, product labelling and the information supplied by the manufacturer.

3Version History

ISO 16672:2003 2003-02
ISO 16672:2015 newer 2015-08
ISO 16672:2020 newer 2020-06-26

5Citation Network

0
Cite this standard
11
Referenced herein
EN 1041:1998 EN 868-1:1997 ISO 10993-1:1997 ISO 10993-2:1992 ISO 10993-6:1994 ISO 11607:1997 ISO 13408-1:1998 ISO 14155-1

6Frequently Asked Questions

What is ISO 16672:2003?
ISO 16672:2003 — Ophthalmic implants - Ocular endotamponades is an international standard developed by International Organization for Standardization (ISO). This International Standard applies to ocular endotamponades (OEs), a group of non-solid implants used in ophthalmology to flatten and position a detached retina onto the choroid, or to tamponade the retina. With regard to the safety and efficacy of...
What does ISO 16672:2003 cover?
This standard covers: This International Standard applies to ocular endotamponades (OEs), a group of non-solid implants used in ophthalmology to flatten and position a detached retina onto the choroid, or to tamponade the retina. With regard to the safety and efficacy of OEs, this International Standard specifies...
Who should use this standard?
This standard is intended for organizations, professionals, and stakeholders involved in various industries and sectors. It is applicable to manufacturers, service providers, regulatory bodies, and certification organizations.
What is the latest version of ISO 16672:2003?
The current published version is ISO 16672:2003, published on 2003-02. Always check for amendments or pending revisions.
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