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DIN EN ISO 16671

Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2015 + Amd 1:2017) (includes Amendment :2017)

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Organization: DIN
Publication Date: 1 March 2018
Status: active
Page Count: 35
ICS Code (Ophthalmic equipment): 11.040.70
scope:

This International Standard defines requirements with regards to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling, and the information supplied by the manufacturer.

This International Standard applies to ophthalmic irrigating solutions (OIS), used during ophthalmic surgery. These solutions do not provide any primary immunological, pharmacological, or metabolic function.

Document History

DIN EN ISO 16671
January 1, 2024
Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO/DIS 16671:2023); German and English version prEN ISO 16671:2023
A description is not available for this item.
DIN EN ISO 16671
March 1, 2018
Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2015 + Amd 1:2017) (includes Amendment :2017)
This International Standard defines requirements with regards to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product...
DIN EN ISO 16671/A1
April 1, 2017
Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2015/DAM 1:2017); German and English version EN ISO 16671:2015/prA1:2017
A description is not available for this item.
DIN EN ISO 16671
December 1, 2015
Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2015)
This International Standard defines requirements with regards to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product...
DIN EN ISO 16671
July 1, 2004
Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2003)
A description is not available for this item.

References

This document references:
TIR19 AMD 1 - Guidance for ANSI/AAMI/ISO 10993-7:1995, Biological evaluation of medical deices—Part 7: Ethylene oxide sterilization residuals Amendment
Published by AAMI on January 1, 1999
A description is not available for this item.
This document references:
DIN EN 1041 - Information supplied by the manufacturer of medical devices (includes Amendment A1:2013)
Published by DIN on December 1, 2013
This European Standard specifies requirements for information to be supplied by a manufacturer for medical devices regulated by Council Directive 90/385/EEC relating to active implantable medical...
This document references:
DIN EN ISO 10993-1 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)
Published by DIN on May 1, 2021
A description is not available for this item.
This document references:
DIN EN ISO 10993-2 - Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2006)
Published by DIN on October 1, 2006
A description is not available for this item.
This document references:
DIN EN ISO 10993-6 - Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)
Published by DIN on September 1, 2017
A description is not available for this item.
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