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DIN EN ISO 15798

Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2013 + Amd.1:2017) (includes Amendment :2017)

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Organization: DIN
Publication Date: 1 February 2018
Status: active
Page Count: 29
ICS Code (Ophthalmic equipment): 11.040.70
scope:

This International Standard is applicable to ophthalmic viscosurgical devices (OVDs), a class of nonactive surgical implants with viscous and/or viscoelastic properties, intended for use during surgery in the anterior segment of the human eye. OVDs are designed to create and maintain space, to protect intraocular tissues and to manipulate tissues during surgery.

This International Standard specifies requirements with regard to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling and information supplied by the manufacturer of these devices.

Document History

May 1, 2022
Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2022)
A description is not available for this item.
February 1, 2021
Ophthalmic implants - Ophthalmic viscosurgical devices (ISO/DIS 15798:2020); German and English version prEN ISO 15798:2020
A description is not available for this item.
DIN EN ISO 15798
February 1, 2018
Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2013 + Amd.1:2017) (includes Amendment :2017)
This International Standard is applicable to ophthalmic viscosurgical devices (OVDs), a class of nonactive surgical implants with viscous and/or viscoelastic properties, intended for use during...
April 1, 2016
Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2013/DAM 1:2016), German and English version EN ISO 15798:2013/prA1:2016
A description is not available for this item.
February 1, 2014
Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2013)
This International Standard is applicable to ophthalmic viscosurgical devices (OVDs), a class of nonactive surgical implants with viscous and/or viscoelastic properties, intended for use during...
June 1, 2010
Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2010)
A description is not available for this item.
July 1, 2005
Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2001); Corrigenda to DIN EN ISO 15798:2001-12
A description is not available for this item.
December 1, 2001
Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2001); English version of DIN EN ISO 15798
A description is not available for this item.

References

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