kSIST FprEN ISO 12870:2024

Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO/FDIS 12870:2024)

Augenoptik - Brillenfassungen - Anforderungen und Prüfverfahren (ISO/FDIS 12870:2024)

Dieses Dokument legt grundlegende Anforderungen und deren Prüfverfahren für unverglaste Brillenfassungen fest, die zur Verwendung mit Korrektionsgläsern bestimmt sind. Es ist zum Zeitpunkt des Verkaufs der Brillenfassung durch den Hersteller oder Lieferant an den Wiederverkäufer gültig.
Dieses Dokument ist anwendbar für:
   alle serienmäßig hergestellten Brillenfassungsarten, einschließlich randloser, halb-randloser und faltbarer Brillenfassungen;
   Brillenfassungen, die durch additive Fertigung, z. B. 3-D-Druck, hergestellt werden;
   Brillenfassungen aus natürlichen organischen Materialien;
   die Fassung oder die Halterung von Aufsteckscheiben, die speziell für die Befestigung an bestimmten Modellen von Brillenfassungen ausgelegt sind, nicht jedoch an deren Brillengläser oder Filter, für die ISO 16034 oder ISO 12312 1 gilt;
   Korrektionseinsätze, die für die Befestigung an bestimmten Modellen von z. B. Augenschutz, Sonnenbrillen oder Tauchmasken ausgelegt sind.
Teile dieses Dokuments sind anwendbar für als Sonderanfertigung angefertigte Brillenfassungen – siehe 3.1.3 und Tabelle 1.
ANMERKUNG   Siehe Anhang A für Empfehlungen zur Konstruktion von Brillenfassungen und zur Beschreibung von Metallfassungen zu verwendende Benennungen.
Dieses Dokument ist nicht anwendbar für Brillenfassungen für den Augenschutz, für die ISO 16321 1 gilt, oder für Sonnenbrillen mit afokalen Filtern, für die ISO 12312 1 gilt.

Optique ophtalmique - Montures de lunettes - Exigences et méthodes d'essai (ISO/FDIS 12870:2024)

Očesna optika - Okviri očal - Zahteve in preskusne metode (ISO/FDIS 12870:2024)

General Information

• Status: Not Published
• Public Enquiry End Date: 25-Apr-2022
• ICS: 11.040.70 - Ophthalmic equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 5020 - Formal vote (FV) (Adopted Project)
• Start Date: 02-Sep-2024
• Due Date: 21-Oct-2024
• Completion Date: 02-Sep-2024
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Ref Project: FprEN ISO 12870 - Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO/FDIS 12870:2024)

Relations

• Revised: SIST EN ISO 12870:2018 - Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO 12870:2016)
• Effective Date: 19-Jan-2023
• Revised: SIST EN ISO 12870:2018 - Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO 12870:2016)
• Effective Date: 18-Jan-2023
• Revised: SIST EN ISO 12870:2018 - Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO 12870:2016)
• Effective Date: 04-Dec-2019

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN ISO 12870:2022
01-april-2022
Očesna optika - Okviri očal - Zahteve in preskusne metode (ISO/DIS 12870:2022)
Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO/DIS
12870:2022)
Augenoptik - Brillenfassungen - Anforderungen und Prüfverfahren (ISO/DIS 12870:2022)
Optique ophtalmique - Montures de lunettes - Exigences et méthodes d'essai (ISO/DIS
12870:2022)
Ta slovenski standard je istoveten z: prEN ISO 12870
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
oSIST prEN ISO 12870:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

oSIST prEN ISO 12870:2022
oSIST prEN ISO 12870:2022
DRAFT INTERNATIONAL STANDARD
ISO/DIS 12870
ISO/TC 172/SC 7 Secretariat: DIN
Voting begins on: Voting terminates on:
2022-01-24 2022-04-18
Ophthalmic optics — Spectacle frames — Requirements
and test methods
Optique ophtalmique — Montures de lunettes — Exigences et méthodes d'essai
ICS: 11.040.70
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 12870:2022(E)
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 SUPPORTING DOCUMENTATION. © ISO 2022

oSIST prEN ISO 12870:2022
ISO/DIS 12870:2022(E)
© ISO 2022
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.
ISO copyright office
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Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
oSIST prEN ISO 12870:2022
ISO/DIS 12870:2022(E)
Contents Page
Foreword .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
3.1 General terms . 2
3.2 Types of frame . . . 3
3.3 Terms describing frame materials and frames made from specific metals . 4
4 Requirements . 5
4.1 General . 5
4.2 Physiological compatibility . 7
4.2.1 Construction. 7
4.2.2 General physiological compatibility. 7
4.2.3 Nickel release . 8
4.2.4 Clinical evaluation. 8
4.3 Measurement system . 8
4.4 Dimensional tolerances on nominal size . 8
4.5 Tolerance on screw threads (optional) . 9
4.6 Dimensional stability at elevated temperature . 9
4.7 Resistance to perspiration . 9
4.8 Mechanical stability . 9
4.8.1 Bridge deformation . 9
4.8.2 Lens retention characteristics . 10
4.8.3 Endurance . 10
4.9 Resistance to ignition . 11
4.10 Resistance to optical radiation (optional) . 11
5 Selection of test samples .11
5.1 General . 11
5.2 Testing for nickel release . 11
5.3 Change in spectacle frame model . 11
6 Preparation and conditioning of test samples .11
6.1 Test lenses . 11
6.2 Sample conditioning and test conditions .12
7 Testing, inspection and compliance .12
7.1 Testing .12
7.2 Inspection and examination .12
7.3 Compliance .12
8 Test methods .13
8.1 General .13
8.2 Test for dimensional stability. 14
8.2.1 Apparatus . 14
8.2.2 Procedure . 14
8.3 Test for resistance to perspiration . 14
8.3.1 Apparatus and reagents . . 14
8.3.2 Procedure .15
8.4 Bridge deformation and lens retention . 15
8.4.1 Apparatus . 15
8.4.2 Procedure . 16
8.5 Endurance test . 17
8.5.1 Apparatus . 17
8.5.2 Procedure . 18
8.6 Test for resistance to ignition . 19
8.6.1 Apparatus . 19
iii
oSIST prEN ISO 12870:2022
ISO/DIS 12870:2022(E)
8.6.2 Procedure . 19
8.7 Test for resistance to optical radiation . 20
8.7.1 Apparatus . 20
8.7.2 Procedure . 20
9 Marking . .21
10 Additional information to be supplied by the manufacturer or other person placing
the product on the market .22
11 Reference to this document.22
Annex A (informative) Recommendations for the design of spectacle frames .23
Annex B (informative) Examples of layout of test equipment .25
Annex C (informative) European requirements and legislation on nickel release .28
Annex D (normative) Long wavelength pass filter .29
Annex E (inform
...