UNLIMITED FREE
ACCESS TO THE WORLD'S BEST IDEAS

SUBMIT
Already a GlobalSpec user? Log in.

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

Customize Your GlobalSpec Experience

Select Your Free Newsletters

Industry Newsletters

Select Your Free Product Alerts

Finish!
Privacy Policy

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

DIN EN ISO 11980

Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations (ISO 11980:2012); German version EN ISO 11980:2012

active, Most Current
Buy Now
Organization: DIN
Publication Date: 1 March 2013
Status: active
Page Count: 33
ICS Code (Ophthalmic equipment): 11.040.70
scope:

Diese Internationale Norm legt Leitlinien für die klinische Prüfung (CI; en: clinical investigation) der Sicherheit und Leistungsfähigkeit von Kontaktlinsen und Kontaktlinsenpflegemitteln fest

ANMERKUNG Diese Internationale Norm versucht, die gültigen Reglementierungen für die Durchführung einer klinischen Prüfung zu harmonisieren, die zur Erfüllung der Marktzulassungsvoraussetzungen und Kennzeichnungspflichten von Kontaktlinsen und Kontaktlinsenpflegemitteln weltweit erforderlich sind. Allerdings variieren die nationalen Anforderungen erheblich. Wo immer die national übliche Praxis oder Reglementierung gesetzlich verankert ist, hat die Rechtsvorschrift Vorrang vor dieser Internationalen Norm.

Document History

DIN EN ISO 11980
March 1, 2013
Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations (ISO 11980:2012); German version EN ISO 11980:2012
Diese Internationale Norm legt Leitlinien für die klinische Prüfung (CI; en: clinical investigation) der Sicherheit und Leistungsfähigkeit von Kontaktlinsen und Kontaktlinsenpflegemitteln fest...
DIN EN ISO 11980
July 1, 2012
Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations (ISO/FDIS 11980:2012); German version FprEN ISO 11980:2012
A description is not available for this item.
DIN EN ISO 11980
March 1, 2010
Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations (ISO 11980:2009); German version EN ISO 11980:2009
A description is not available for this item.
DIN EN ISO 11980
April 1, 2008
Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations (ISO/DIS 11980:2008); German version prEN ISO 11980:2008
A description is not available for this item.
DIN EN ISO 11980
February 1, 1998
Opthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations (ISO 11980:1997); German version EN ISO 11980:1997
A description is not available for this item.

References

This document references:
DIN EN ISO 14155 - Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020); German version EN ISO 14155:2020
Published by DIN on December 1, 2020
A description is not available for this item.
This document references:
DIN EN ISO 14534 - Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011); German version EN ISO 14534:2015
Published by DIN on August 1, 2015
Diese Internationale Norm legt Anforderungen an die Sicherheit und Funktion von Kontaktlinsen, Kontakt-linsenpflegemitteln und anderem Zubehör für Kontaktlinsen fest. Diese Internationale Norm legt...
This document references:
DIN EN ISO 18369-1 - Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification system and recommendations for labelling specifications (ISO 18369-1:2017, Corrected version 2017-10-01); German version EN ISO 18369-1:2017
Published by DIN on April 1, 2018
Dieses Dokument legt Begriffe für die physikalischen, chemischen und optischen Eigenschaften von Kontaktlinsen sowie deren Herstellung und Gebrauch fest. Es gibt hierzu die Begriffe sowie, wo...
This document references:
ISO 14534 - Ophthalmic optics — Contact lenses and contact lens care products — Fundamental requirements
Published by ISO on April 1, 2011
This International Standard specifies safety and performance requirements for contact lenses, contact lens care products, and other accessories for contact lenses. This International Standard does...
This document references:
ISO 13485 - Medical devices - Quality management systems - Requirements for regulatory purposes
Published by ISO on March 1, 2016
This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that...
This document references:
ISO 14155 - Clinical investigation of medical devices for human subjects — Good clinical practice
Published by ISO on July 1, 2020
This document addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the clinical performance or...
This document references:
ISO 18369-1 - Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification system and recommendations for labelling specifications
Published by ISO on August 1, 2017
This document identifies and defines the terms applicable to the physical, chemical and optical properties of contact lenses, their manufacture and uses. It provides a vocabulary of terms and, when...
This document references:
ISO 9001 - Quality management systems — Requirements
Published by ISO on September 15, 2015
This International Standard specifies requirements for a quality management system when an organization: a) needs to demonstrate its ability to consistently provide products and services that meet...
This document is referenced by:
DIN EN ISO 18369-2 - Ophthalmic optics - Contact lenses - Part 2: Tolerances (ISO 18369-2:2017); German version EN ISO 18369-2:2017
Published by DIN on April 1, 2018
Dieses Dokument legt die Grenzabweichungen für die wesentlichen optischen und physikalischen Eigenschaften von formstabilen Korneal-, formstabilen Skleral- und weichen Kontaktlinsen zum Zeitpunkt der...
View Less
View All
Advertisement