OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 7: CLINICAL INVESTIGATIONS (ISO 11979-7:2014)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2014

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

National foreword
National Annex NA (informative) - Bibliography
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Justification for a clinical investigation
5 Ethical considerations
6 General requirements
Annex A (informative) - Elements of a clinical
        investigation
Annex B (informative) - Evaluation of post-operative
        adverse event and visual acuity rates
Annex C (informative) - Additional elements for
        toric IOLs
Annex D (informative) - Additional elements for
        accommodating IOLs
Annex E (informative) - Clinical tests
Bibliography

Defines particular requirements for clinical investigations for posterior and anterior chamber intraocular lenses (IOLs).

DocumentType	Standard
Pages	48
PublisherName	German Institute for Standardisation (Deutsches Institut für Normung)
Status	Current

Standards	Relationship
NF EN ISO 11979-7 : 2014	Identical
ISO 11979-7:2014	Identical
NBN EN ISO 11979-7 : 2014	Identical
NEN EN ISO 11979-7 : 2014	Identical
NS EN ISO 11979-7 : 2014	Identical
I.S. EN ISO 11979-7:2014	Identical
ONORM EN ISO 11979-7 : 2015	Identical
SN EN ISO 11979-7 : 2014	Identical
UNI EN ISO 11979-7 : 2015	Identical
BS EN ISO 11979-7:2014	Identical
UNE-EN ISO 11979-7:2015	Identical
EN ISO 11979-7:2018	Identical

DIN EN ISO 11979-8 E : 2015	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS (ISO 11979-8:2017)
DIN EN ISO 11979-9 E : 2014	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 9: MULTIFOCAL INTRAOCULAR LENSES (ISO 11979-9:2006 + AMD.1:2014)
DIN EN ISO 11979-6 E : 2015	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY TESTING (ISO 11979-6:2014)
DIN EN ISO 11979-4 E : 2013	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 4: LABELLING AND INFORMATION (ISO 11979-4:2008 + AMD.1:2012)
DIN EN ISO 11979-5 E : 2010	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 5: BIOCOMPATIBILITY
DIN EN ISO 11979-3 E : 2013	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 3: MECHANICAL PROPERTIES AND TEST METHODS (ISO 11979-3:2012)
DIN EN ISO 11979-1 E : 2013	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 1: VOCABULARY (ISO 11979-1:2012)

ISO 11979-10:2006	Ophthalmic implants Intraocular lenses Part 10: Phakic intraocular lenses
ISO/TR 22979:2017	Ophthalmic implants — Intraocular lenses — Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
ISO 11979-1:2006	Ophthalmic implants Intraocular lenses Part 1: Vocabulary
ISO 14155:2011	Clinical investigation of medical devices for human subjects Good clinical practice
ISO 14971:2007	Medical devices Application of risk management to medical devices
DIN EN ISO 11979-1 E : 2013	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 1: VOCABULARY (ISO 11979-1:2012)

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DIN EN ISO 11979-7 E : 2014

Current

Table of Contents

Abstract

General Product Information

International Equivalents

Standards Referenced By This Book

Standards Referencing This Book

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