DIN EN ISO 15798:2014
Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2013); German version EN ISO 15798:2013

Standard No.

DIN EN ISO 15798:2014

Release Date

2014

Published By

German Institute for Standardization

Status

Be replaced

Replace By

DIN EN ISO 15798 A1 E:2016-04

Latest

DIN EN ISO 15798:2022-05

Replace

DIN EN ISO 15798:2010 DIN EN ISO 15798:2012

DIN EN ISO 15798:2014 Referenced Document

• DIN EN ISO 10993-16:2010 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010); German version EN ISO 10993-16:2010
• DIN EN ISO 10993-1:2010 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system (ISO 10993-1:2009); German version EN ISO 10993-1:2009
• DIN EN ISO 10993-2:2006 Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2006); English version of DIN EN ISO 10993-2:2006-10
• DIN EN ISO 10993-6:2009 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007); English version of DIN EN ISO 10993-6:2009-08
• DIN EN ISO 10993-9:2010 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)
• DIN EN ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007); English version of DIN EN ISO 11135-1:2007-08
• DIN EN ISO 11137-1:2013 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006 + Amd 1:2013); German version EN ISO 11137-1:2006 + A1:2013
• DIN EN ISO 11137-2:2013 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013); German version EN ISO 11137-2:2013
• DIN EN ISO 11137-3:2006 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects (ISO 11137-3:2006) English version of DIN EN ISO 11137-3:2006-07
• DIN EN ISO 11607-1:2009 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006); English version of DIN EN ISO 11607-1:2009-09

DIN EN ISO 15798:2014 history

• 2022 DIN EN ISO 15798:2022-05 Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2022); German version EN ISO 15798:2022
• 1970 DIN EN ISO 15798 E:2021-02
• 2018 DIN EN ISO 15798:2018 Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2013 + Amd.1:2017) (includes Amendment :2017)
• 1970 DIN EN ISO 15798 A1 E:2016-04
• 2014 DIN EN ISO 15798:2014 Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2013); German version EN ISO 15798:2013
• 2010 DIN EN ISO 15798:2010 Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2010); German version EN ISO 15798:2010