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 15798:1970
older
1970-01
5Citation Network
Referenced by DIN EN ISO 15798:2018
EN 1041
EN 980
ISO 10993-1
ISO 10993-16
ISO 10993-2
ISO 10993-6
ISO 10993-9
ISO 11135-1
6Frequently Asked Questions
What is DIN EN ISO 15798:2018?
DIN EN ISO 15798:2018 — Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2013 + Amd.1:2017) (includes Amendment :2017) 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 15798:2018 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 15798:2018?
The current published version is DIN EN ISO 15798:2018, published on 2018-02-01. Always check for amendments or pending revisions.
How do I purchase DIN EN ISO 15798:2018?
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