SIST EN ISO 16671:2015/A1:2018

Ophthalmic implants - Irrigating solutions for ophthalmic surgery - Amendment 1 (ISO 16671:2015/Amd 1:2017)

Ophthalmische Implantate - Spüllösungen für die ophthalmische Chirurgie - Änderung 1 (ISO 16671:2015/Amd 1:2017)

Implants ophtalmiques - Solutions d'irrigation pour la chirurgie ophtalmique - Amendement 1 (ISO 16671:2015/Amd 1:2017)

Očesni vsadki (implantati) - Raztopine za izpiranje za očesno kirurgijo - Dopolnilo A1 (ISO 16671:2015/Amd 1:2017)

General Information

• Status: Published
• Public Enquiry End Date: 04-Jun-2017
• Publication Date: 08-Jan-2018
• ICS: 11.040.70 - Ophthalmic equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 08-Dec-2017
• Due Date: 12-Feb-2018
• Completion Date: 09-Jan-2018
• 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: EN ISO 16671:2015/A1:2017 - Ophthalmic implants - Irrigating solutions for ophthalmic surgery - Amendment 1 (ISO 16671:2015/Amd 1:2017)

Relations

• Amends: SIST EN ISO 16671:2015 - Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2015)
• Effective Date: 01-Feb-2018

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 16671:2015/A1:2018
01-februar-2018
2þHVQLYVDGNLLPSODQWDWL5D]WRSLQH]DL]SLUDQMH]DRþHVQRNLUXUJLMR'RSROQLOR
$,62$PG
Ophthalmic implants - Irrigating solutions for ophthalmic surgery - Amendment 1 (ISO
16671:2015/Amd 1:2017)
Ophthalmische Implantate - Spüllösungen für die ophthalmische Chirurgie - Änderung 1
(ISO 16671:2015/Amd 1:2017)
Implants ophtalmiques - Solutions d'irrigation pour la chirurgie ophtalmique -
Amendement 1 (ISO 16671:2015/Amd 1:2017)
Ta slovenski standard je istoveten z: EN ISO 16671:2015/A1:2017
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 16671:2015/A1:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 16671:2015/A1:2018

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SIST EN ISO 16671:2015/A1:2018


EN ISO 16671:2015/A1
EUROPEAN STANDARD

NORME EUROPÉENNE

November 2017
EUROPÄISCHE NORM
ICS 11.040.70
English Version

Ophthalmic implants - Irrigating solutions for ophthalmic
surgery - Amendment 1 (ISO 16671:2015/Amd 1:2017)
Implants ophtalmiques - Solutions d'irrigation pour la Ophthalmische Implantate - Spüllösungen für die
chirurgie ophtalmique - Amendement 1 (ISO ophthalmische Chirurgie - Änderung 1 (ISO
16671:2015/Amd 1:2017) 16671:2015/Amd 1:2017)
This amendment A1 modifies the European Standard EN ISO 16671:2015; it was approved by CEN on 1 November 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 16671:2015/A1:2017 E
worldwide for CEN national Members.

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SIST EN ISO 16671:2015/A1:2018
EN ISO 16671:2015/A1:2017 (E)
Contents Page
European foreword . 3
2

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SIST EN ISO 16671:2015/A1:2018
EN ISO 16671:2015/A1:2017 (E)
European foreword
This document (EN ISO 16671:2015/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 16671:2015 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by May 2018, and
conflicting national standards shall be withdrawn at the latest by May 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(s).
For relationship with EU Directive(s), see informative Annex ZA, which is included in
EN ISO 16671:2015.
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
...