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

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 older 2014-02
DIN EN ISO 15798:2014-02 older 2014-02-01
DIN EN ISO 15798/A1 E:2016 Amd E/2016-01 older 2016-04-01
DIN EN ISO 15798/A1 E:2016-04 Amd E/2016-04 older 2016-04-01
DIN EN ISO 15798:2018 older 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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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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