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BS EN ISO 11979-10 : 2006

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 10: PHAKIC INTRAOCULAR LENSES
Amended by

BS EN ISO 11979-10:2006+A1:2014

Available format(s)

Hardcopy , PDF

Superseded date

05-15-2018

Language(s)

English

Published date

01-01-2006

Publisher

British Standards Institution

Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Optical requirements
5 Mechanical requirements
6 Clinical investigation
7 Information supplied by the manufacturer
Annex A (informative) - Clinical investigation
Annex B (informative) - Statistical sample size
                        considerations
Bibliography

Pertains to any intraocular lens (IOL) whose primary indication is the modification of the refractive power of a phakic eye.

Committee
CH/172/7
DevelopmentNote
Supersedes 05/30114984 DC. (10/2006) 2006 Edition Re-issued in September 2014 & incorporates AMD 1 2014. Supersedes 13/30280913 DC. (09/2014)
DocumentType
Standard
Pages
28
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

ISO 11979-7:2014 Ophthalmic implants Intraocular lenses Part 7: Clinical investigations
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
ISO 11979-3:2012 Ophthalmic implants — Intraocular lenses — Part 3: Mechanical properties and test methods
ISO 11979-1:2006 Ophthalmic implants Intraocular lenses Part 1: Vocabulary
ISO 11979-4:2008 Ophthalmic implants — Intraocular lenses — Part 4: Labelling and information
ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
ISO 11979-2:2014 Ophthalmic implants — Intraocular lenses — Part 2: Optical properties and test methods
EN 980:2008 Symbols for use in the labelling of medical devices
ISO 15223:2000 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied

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PDF - English
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