EN ISO 15798:2013/A1:2017

Ophthalmic implants - Ophthalmic viscosurgical devices - Amendment 1 (ISO 15798:2013/Amd 1:2017)

2017-09-13 - CEN/BT C127/2017 - BT approved new Annex ZA and European Foreword - CCMC to publish

Ophthalmische Implantate - Viskoelastische Substanzen - Änderung 1 (ISO 15798:2013/Amd 1:2017)

Implants ophtalmiques - Dispositifs ophtalmiques viscoélastiques - Amendement 1 (ISO 15798:2013/Amd 1:2017)

Očesni vsadki (implantati) - Očesni kirurški pripomočki - Dopolnilo A1 (ISO 15798:2013/Amd 1:2017)

General Information

• Status: Withdrawn
• Publication Date: 10-Oct-2017
• Withdrawal Date: 08-Feb-2022
• ICS: 11.040.70 - Ophthalmic equipment
• Technical Committee: CEN/TC 170 - Ophthalmic optics
• Drafting Committee: CEN/TC 170 - Ophthalmic optics
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 09-Feb-2022
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 15798:2013/A1:2017 - Ophthalmic implants - Ophthalmic viscosurgical devices - Amendment 1 (ISO 15798:2013/Amd 1:2017)

Relations

• Replaced By: EN ISO 15798:2022 - Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2022)
• Effective Date: 08-Jun-2022
• Amends: EN ISO 15798:2013 - Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2013)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
01-december-2017
2þHVQLYVDGNLLPSODQWDWL2þHVQLNLUXUãNLSULSRPRþNL'RSROQLOR$,62
$PG
Ophthalmic implants - Ophthalmic viscosurgical devices - Amendment 1 (ISO
15798:2013/Amd 1:2017)
Ophthalmische Implantate - Viskoelastische Substanzen - Änderung 1 (ISO
15798:2013/Amd 1:2017)
Implants ophtalmiques - Dispositifs ophtalmiques viscoélastiques - Amendement 1 (ISO
15798:2013/Amd 1:2017)
Ta slovenski standard je istoveten z: EN ISO 15798:2013/A1:2017
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 15798:2013/A1
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2017
EUROPÄISCHE NORM
ICS 11.040.70
English Version
Ophthalmic implants - Ophthalmic viscosurgical devices -
Amendment 1 (ISO 15798:2013/Amd 1:2017)
Implants ophtalmiques - Dispositifs ophtalmiques Ophthalmische Implantate - Viskoelastische
viscoélastiques - Amendement 1 (ISO Substanzen - Änderung 1 (ISO 15798:2013/Amd
15798:2013/Amd 1:2017) 1:2017)
This amendment A1 modifies the European Standard EN ISO 15798:2013; it was approved by CEN on 10 October 2017.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This amendment exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15798:2013/A1:2017 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered . 5

European foreword
This document (EN ISO 15798:2013/A1:2017) has been prepared by Technical Committee ISO/TC 172
“Optics and photonics” in collaboration with Technical Committee CEN/TC 170 “Ophthalmic optics” the
secretariat of which is held by DIN.
This Amendment to the European Standard EN ISO 15798:2013 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by April 2018, and
conflicting national standards shall be withdrawn at the latest by April 2018.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive.
For relationship with EU Directive, see informative Annex ZA, which is an integral part of this
document.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 15798:2013/Amd 1:2017 has been approved by CEN as EN ISO 15798:2013/A1:2017
without any modification.
The following referenced documents are indispensable for the application of this document. For
undated references, the latest edition of the referenced document (including any amendments) applies.
For dated references, only the edition cited applies. However, for any use of this standard ‘within the
meaning of Annex ZA’, the user should always check that any referenced document has not been
superseded and that its relevant contents can still be considered the generally acknowledged state-of-
art.
When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a
normative reference to the corresponding EN standard, if available, and otherwise to the dated version
of the ISO or IEC standard, as listed below.
NOTE The way in which these referenced documents are cited in normative requirements determines the
extent (in whole or in part) to which they apply.
Table — Correlation between normative references and dated EN and ISO standards
Normative references Equivalent dated standard
as listed in Clause 2 of the
EN ISO
ISO standard
ISO 10993-1 EN ISO 10993-1:2009 ISO 10993-1:2009
ISO 10993-2 EN ISO 10993-2:2006 ISO 10993-2:2006
ISO 10993-6 EN ISO 10993-6:2009 ISO 10993-6:2007
ISO 10993-9 EN ISO 10993-9:2009 ISO 10993-9:2009
ISO 10993-16 EN ISO 10993-16:2010 ISO 10993-16:2010
a a a
ISO 11135-1 EN ISO 11135-1:2007 ISO 11135-1:2007
ISO 11137-1 EN ISO 11137-1:2015 ISO 11137-1:2006 +
ISO 11137-1:2006/Amd 1:2013
ISO 11137-2 EN ISO 11137-2:2015 ISO 11137-2:2013
ISO 11137-3 EN ISO 11137-3:2006 ISO 11137-3:2006
ISO 11607-1 EN ISO 11607-1:2009 + ISO 11607-1:2006 +
EN ISO 11607-1:2009/A1:2014 ISO 11607-1:2006/Amd 1:2014
ISO 13408-1 EN ISO 13408-1:2015 ISO 13408-1:2008 +
ISO 13408-1:2008/Amd 1:2013
ISO 14155 EN ISO 14155:2011 + ISO 14155:2011 +
EN ISO 14155:2011/AC:2011 ISO 14155:2011/Cor 1:2011
ISO 14630 EN ISO 14630:2012 ISO 14630:2012
ISO 14971 EN ISO 14971:2012 ISO 14971:2007
ISO 15223-1 EN ISO 15223-1:2012 ISO 15223-1:2012
ISO 15223-2 — ISO 15223-2:2010
ISO 17665-1 EN ISO 17665-1:2006 ISO 17665-1:2006
ISO 22442-1 EN ISO 22442-1:2015 ISO 22442-1:2015
ISO 22442-2 EN ISO 22442-2:2015 ISO 22442-2:2015
ISO 22442-3 EN ISO 22442-3:2007 ISO 22442-3:2007
b b —
EN 980 EN 980:2008
EN 1041 EN 1041:2008+A1:2013 —
a
Withdrawn. The version available at the time of publication of the present document is EN ISO 11135:2014
(ISO 11135:2014).
b
Withdrawn. The version available at the time of publication of the present document is EN ISO 15223-1:2012
(ISO 15223-1:2012, Corrected version 2017-03).
Annex ZA
(informative)
Relationship between this European Standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered
This European Standard has been prepared under a Commission’s standardization request [M/023
concerning the development of European Standards related to medical devices] to provide one
voluntary means of conforming to essential requirements of Council Directive 93/42/EEC of 14 June
1993 concerning medical devices [OJ L 169].
Once this standard is cited in the Official J
...