ISO 11979-7:2024
(Main)Ophthalmic implants — Intraocular lenses — Part 7: Clinical investigations of intraocular lenses for the correction of aphakia
Ophthalmic implants — Intraocular lenses — Part 7: Clinical investigations of intraocular lenses for the correction of aphakia
This document specifies the particular requirements for the clinical investigations of intraocular lenses that are implanted in the eye in order to correct aphakia.
Implants ophtalmiques — Lentilles intraoculaires — Partie 7: Investigations cliniques de lentilles intraoculaires pour la correction de l'aphakie
Le présent document spécifie les exigences particulières applicables aux investigations cliniques de lentilles intraoculaires destinées à être implantées dans l’œil pour corriger l’aphakie.
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FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 11979-7
ISO/TC 172/SC 7
Ophthalmic implants — Intraocular
Secretariat: DIN
lenses —
Voting begins on:
2023-10-23
Part 7:
Voting terminates on:
Clinical investigations of intraocular
2023-12-18
lenses for the correction of aphakia
Implants ophtalmiques — Lentilles intraoculaires —
Partie 7: Investigations cliniques de lentilles intraoculaires pour la
correction de l'aphakie
ISO/CEN PARALLEL PROCESSING
RECIPIENTS OF THIS DRAFT ARE INVITED TO
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/FDIS 11979-7:2023(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. © ISO 2023
---------------------- Page: 1 ----------------------
ISO/FDIS 11979-7:2023(E)
FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 11979-7
ISO/TC 172/SC 7
Ophthalmic implants — Intraocular
Secretariat: DIN
lenses —
Voting begins on:
Part 7:
Voting terminates on:
Clinical investigations of intraocular
lenses for the correction of aphakia
Implants ophtalmiques — Lentilles intraoculaires —
Partie 7: Investigations cliniques de lentilles intraoculaires pour la
correction de l'aphakie
COPYRIGHT PROTECTED DOCUMENT
© ISO 2023
ISO/CEN PARALLEL PROCESSING
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
RECIPIENTS OF THIS DRAFT ARE INVITED TO
ISO copyright office
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
CP 401 • Ch. de Blandonnet 8
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
CH-1214 Vernier, Geneva
DOCUMENTATION.
Phone: +41 22 749 01 11
IN ADDITION TO THEIR EVALUATION AS
Reference number
Email: copyright@iso.org
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/FDIS 11979-7:2023(E)
Website: www.iso.org
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
Published in Switzerland
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
ii
© ISO 2023 – All rights reserved
NATIONAL REGULATIONS. © ISO 2023
---------------------- Page: 2 ----------------------
ISO/FDIS 11979-7:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions and abbreviated terms . 1
3.1 Terms and definitions . 1
3.2 Abbreviated terms . 1
4 Justification for a clinical investigation . 2
5 Ethical considerations . 2
6 General requirements . 2
6.1 General .
...
ISO/FDIS 11979-7:2023(E) Style Definition: Heading 1: Indent: Left: 0 pt, First
line: 0 pt, Tab stops: Not at 21.6 pt
ISO TC 172/SC 7/WG 7
Style Definition: Heading 2: Font: Bold, Tab stops: Not
at 18 pt
Secretariat: DIN
Style Definition: Heading 3: Font: Bold
Style Definition: Heading 4: Font: Bold
Date: 2023-09-22xx
Style Definition: Heading 5: Font: Bold
Ophthalmic implants — Intraocular lenses — Part 7: Clinical investigations of
Style Definition: Heading 6: Font: Bold
intraocular lenses for the correction of aphakia
Style Definition: ANNEX
Style Definition: AMEND Terms Heading: Font: Bold
Implants ophtalmiques — Lentilles intraoculaires — Partie 7: Investigations cliniques de
lentilles intraoculaires pour la correction de l'aphakie Style Definition: AMEND Heading 1 Unnumbered:
Font: Bold
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ISO/FDIS 11979-7:2023(E)
© ISO 2023
Commented [eXtyles1]: The reference is to a withdrawn
standard which has been replaced
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no
ISO 20344, Personal protective equipment — Test methods
part of this publication may be reproduced or utilized otherwise in any form or by any means,
for footwear
electronic or mechanical, including photocopying, or posting on the internet or an intranet, without
Formatted: Pattern: Clear
prior written permission. Permission can be requested from either ISO at the address below or
ISO’s member body in the country of the requester. Formatted: Pattern: Clear
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.orgwww.iso.org
Published in Switzerland
ii © ISO 2023 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/FDIS 11979-7:2023(E)
Contents
Foreword . vii
Introduction . viii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions and abbreviated terms . 1
3.1 Terms and definitions . 1
3.2 Abbreviated terms . 1
4 Justification for a clinical investigation . 2
5 Ethical considerations . 2
6 General requirements . 2
6.1 General . 2
6.2 Design of a clinical investigation . 3
6.2.1 Requirements for all types of IOL . 3
6.2.2 Additional requirements for toric IOLs (TIOL) . 3
6.2.5 Additional requirements for anterior chamber IOLs . 5
6.3 Characteristics of clinical investigations . 5
6.3.1 General . 5
6.3.2 Characteristics to be studied for all types of IOL . 6
6.3.3 Additional characteristics to be studied for toric IOL . 6
6.3.4 Additional characteristics to be studied for SVIOLs . 7
6.3.5 Additional characteristics to be studied for accommodating IOL . 7
6.3.6 Additional characteristics applying to anterior chamber IOLs . 7
6.3.7 Addit
...
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