DIN EN ISO 15798:2014
DIN · 2014-02

Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2013); German version EN ISO 15798:2013

Replaced ICS 11.040.70

1Key Takeaways

This International Standard applies to ophthalmic viscoelastic substances, a class of inactive surgical implants with viscous and/or viscoelastic properties intended for use in surgical procedures in the anterior segment of the human eye. Viscoelastic substances have been developed to create and maintain space, protect…

2Scope / Description

This International Standard applies to ophthalmic viscoelastic substances, a class of inactive surgical implants with viscous and/or viscoelastic properties intended for use in surgical procedures in the anterior segment of the human eye. Viscoelastic substances have been developed to create and maintain space, protect intraocular tissues, and manipulate tissue during surgical procedures. With regard to safety, this International Standard specifies requirements for intended function, design features, preclinical and clinical evaluations, sterilization, packaging, labeling, and the provision of information by the manufacturer of these products, as well as for testing procedures.

3Version History

DIN EN ISO 15798:2012 older
DIN EN ISO 15798:1970 older 1970-01
DIN EN ISO 15798:2001 older 2001-12-01
DIN EN ISO 15798:2001-12 older 2001-12-01
DIN EN ISO 15798 E:2008-08 Amd E/2008-08 older 2008-08-01
DIN EN ISO 15798:2010 older 2010-06
DIN EN ISO 15798:2010-06 older 2010-06-01
DIN EN ISO 15798 E:2012-07 Amd E/2012-07 older 2012-07
DIN EN ISO 15798:2014-02 newer 2014-02-01
DIN EN ISO 15798/A1 E:2016 Amd E/2016-01 newer 2016-04-01
DIN EN ISO 15798/A1 E:2016-04 Amd E/2016-04 newer 2016-04-01
DIN EN ISO 15798:2018 newer 2018-02-01
DIN EN ISO 15798:2018-02 newer 2018-02-01
DIN EN ISO 15798 E:2021 Amd E/2021-01 newer 2021-02-01
DIN EN ISO 15798:2021-02 newer 2021-02-01
DIN EN ISO 15798:2022 newer 2022-05-01
DIN EN ISO 15798:2022-05 newer 2022-05

5Citation Network

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Cite this standard
11
Referenced herein
DIN EN ISO 10993-16:2010 DIN EN ISO 10993-1:2010 DIN EN ISO 10993-2:2006 DIN EN ISO 10993-6:2009 DIN EN ISO 10993-9:2010 DIN EN ISO 11135-1:2007 DIN EN ISO 11137-1:2013 DIN EN ISO 11137-2:2013

6Frequently Asked Questions

What is DIN EN ISO 15798:2014?
DIN EN ISO 15798:2014 — Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2013); German version EN ISO 15798:2013 is an international standard developed by German Institute for Standardization. This International Standard applies to ophthalmic viscoelastic substances, a class of inactive surgical implants with viscous and/or viscoelastic properties intended for use in surgical procedures in the anterior segment of the human eye....
What does DIN EN ISO 15798:2014 cover?
This standard covers: This International Standard applies to ophthalmic viscoelastic substances, a class of inactive surgical implants with viscous and/or viscoelastic properties intended for use in surgical procedures in the anterior segment of the human eye. Viscoelastic substances have been developed to create and...
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 DIN EN ISO 15798:2014?
The current published version is DIN EN ISO 15798:2014, published on 2014-02. Always check for amendments or pending revisions.
How do I purchase DIN EN ISO 15798:2014?
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