DIN EN ISO 15798:2018-02
DIN · 2018-02-01
Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2013 + Amd.1:2017) (includes Amendment :2017)
Replaced
1Key Takeaways
This standard specifies requirements for ophthalmic implants and visco-surgical devices intended to be used in eye surgery. It aims to ensure the quality, safety, and efficacy of these medical devices by providing detailed criteria for their design, production, testing, and labeling. The document includes provisions fo…
2Scope / Description
This standard specifies requirements for ophthalmic implants and visco-surgical devices intended to be used in eye surgery. It aims to ensure the quality, safety, and efficacy of these medical devices by providing detailed criteria for their design, production, testing, and labeling. The document includes provisions for risk management, material selection, sterilization methods, packaging, and instructions for use. It is based on ISO 15798:2013 with Amendment 1:2017.
3Version History
5Citation Network
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Referenced herein
6Frequently Asked Questions
What is DIN EN ISO 15798:2018-02?
DIN EN ISO 15798:2018-02 — 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 standard specifies requirements for ophthalmic implants and visco-surgical devices intended to be used in eye surgery. It aims to ensure the quality, safety, and efficacy of these medical devices by providing detailed criteria for their design,...
What does DIN EN ISO 15798:2018-02 cover?
This standard covers: This standard specifies requirements for ophthalmic implants and visco-surgical devices intended to be used in eye surgery. It aims to ensure the quality, safety, and efficacy of these medical devices by providing detailed criteria for their design, production, testing, and labeling. The document...
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 15798:2018-02?
The current published version is DIN EN ISO 15798:2018-02, published on 2018-02-01. Always check for amendments or pending revisions.
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