SIST EN ISO 18369-2:2006/oprA1:2010
(Amendment)Ophthalmic optics - Contact lenses - Part 2: Tolerances - Amendment 1 (ISO 18369-2:2006/DAM 1:2009)
Ophthalmic optics - Contact lenses - Part 2: Tolerances - Amendment 1 (ISO 18369-2:2006/DAM 1:2009)
D version delivered by DIN on 2008-01-30 for 40.20
Augenoptik - Kontaktlinsen - Teil 2: Grenzabweichungen - Änderung 1 (ISO 18369-2:2006/DAM 1:2009)
Optique ophtalmique - Lentilles de contact - Partie 2: Tolérances - Amendement 1 (ISO 18369-2:2006/DAM 1:2009)
Očesna optika - Kontaktne leče - 2. del: Tolerance - Dopolnilo A1 (ISO 18369-2:2006/DAM 1:2009)
General Information
- Status
- Not Published
- Public Enquiry End Date
- 09-Mar-2010
- Technical Committee
- VAZ - Healthcare
- Current Stage
- 98 - Abandoned project (Adopted Project)
- Start Date
- 03-Aug-2012
- Due Date
- 08-Aug-2012
- Completion Date
- 03-Aug-2012
Relations
- Effective Date
- 01-Mar-2010
Overview
SIST EN ISO 18369-2:2006/oprA1:2010 is an important standard amendment that addresses tolerances for contact lenses within the field of ophthalmic optics. This amendment, developed by ISO Technical Committee 172 and CEN/TC 170, refines and clarifies requirements and procedures related to manufacturing tolerances, referencing risk management and clinical investigation practices. As part of the EN ISO 18369 standards series, it plays a crucial role in ensuring the safety, quality, and performance of contact lenses on both European and international markets.
Key Topics
- Contact Lens Tolerances: Establishes requirements for acceptable deviations in parameters such as power, diameter, and thickness of contact lenses.
- Amendment Provisions: Updates normative references and introduces new clauses to enhance clarity and compliance around manufacturing deviations.
- Risk Assessment: Incorporates ISO 14971 for medical device risk management, requiring a systematic analysis if specified tolerances cannot be universally met.
- Clinical Investigations: References ISO 11980 for clinical procedures to ensure product safety and effectiveness when deviations from standard tolerances are necessary.
- Regulatory Compliance: Supports legal and regulatory frameworks by providing internationally recognized standards to guide manufacturers and authorities.
Applications
The practical implications and uses of SIST EN ISO 18369-2:2006/oprA1:2010 are significant for stakeholders in the ophthalmic industry and for health professionals:
- Manufacturers of Contact Lenses: The amendment allows for justified deviations from tolerance specifications, provided a thorough risk assessment and supporting clinical data are available. This flexibility benefits the introduction of innovative lens designs or advanced manufacturing technologies.
- Ensures safer products by requiring risk evaluations and clinical evidence in cases of non-standard manufacturing.
- Facilitates compliance with European and international regulatory requirements.
- Quality Assurance and Regulatory Teams: Enables application of internationally harmonized safety and quality benchmarks. Tolerances and listed deviations serve as reliable criteria during product development, conformity assessment, and market surveillance.
- Clinical Researchers: By referencing ISO 11980, the amendment encourages well-documented clinical investigations before introducing any product that deviates from typical tolerances. This helps in demonstrating the performance and safety of novel contact lens solutions.
- Healthcare Professionals and Patients: Assurance that lenses available in the market, even with manufacturing deviations, maintain high safety and performance standards, supported by documented risk management and clinical research.
Related Standards
SIST EN ISO 18369-2:2006/oprA1:2010 is closely related to a set of international standards that form the foundation for contact lens safety and performance:
- ISO 18369 Series: Comprehensive standards for contact lenses, including definitions, test methods, and overall requirements.
- ISO 14971 - Medical Devices: Application of Risk Management: Key reference for evaluating and controlling risks associated with medical devices, now explicitly required for tolerance deviations.
- ISO 11980 - Clinical Investigation of Contact Lenses and Care Products: Provides guidance for the clinical validation of products with non-standard parameters.
- European and National Standards: Harmonized through the CEN/CENELEC framework, ensuring widespread acceptance across European markets.
Conclusion
SIST EN ISO 18369-2:2006/oprA1:2010 enhances the existing framework for contact lens tolerances by integrating risk management and clinical validation requirements. This amendment supports innovation, quality assurance, and regulatory compliance in the manufacture and approval of contact lenses, ensuring enduring safety and performance for end users in the field of ophthalmic optics.
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Frequently Asked Questions
SIST EN ISO 18369-2:2006/oprA1:2010 is a draft published by the Slovenian Institute for Standardization (SIST). Its full title is "Ophthalmic optics - Contact lenses - Part 2: Tolerances - Amendment 1 (ISO 18369-2:2006/DAM 1:2009)". This standard covers: D version delivered by DIN on 2008-01-30 for 40.20
D version delivered by DIN on 2008-01-30 for 40.20
SIST EN ISO 18369-2:2006/oprA1:2010 is classified under the following ICS (International Classification for Standards) categories: 11.040.70 - Ophthalmic equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN ISO 18369-2:2006/oprA1:2010 has the following relationships with other standards: It is inter standard links to SIST EN ISO 18369-2:2006. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN ISO 18369-2:2006/oprA1:2010 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
01-marec-2010
2þHVQDRSWLND.RQWDNWQHOHþHGHO 7ROHUDQFH'RSROQLOR$ ,62
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Ophthalmic optics - Contact lenses - Part 2: Tolerances - Amendment 1 (ISO 18369-
2:2006/DAM 1:2009)
Augenoptik - Kontaktlinsen - Teil 2: Grenzabweichungen - Änderung 1 (ISO 18369-
2:2006/DAM 1:2009)
Optique ophtalmique - Lentilles de contact - Partie 2: Tolérances - Amendement 1 (ISO
18369-2:2006/DAM 1:2009)
Ta slovenski standard je istoveten z: EN ISO 18369-2:2006/prA1
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
DRAFT
EN ISO 18369-2:2006
NORME EUROPÉENNE
EUROPÄISCHE NORM
prA1
December 2009
ICS 11.040.70
English Version
Ophthalmic optics - Contact lenses - Part 2: Tolerances -
Amendment 1 (ISO 18369-2:2006/DAM 1:2009)
Optique ophtalmique - Lentilles de contact - Partie 2: Augenoptik - Kontaktlinsen - Teil 2: Grenzabweichungen -
Tolérances - Amendement 1 (ISO 18369-2:2006/DAM Änderung 1 (ISO 18369-2:2006/DAM 1:2009)
1:2009)
This draft amendment is submitted to CEN members for third parallel enquiry. It has been drawn up by the Technical Committee CEN/TC
170.
This draft amendment A1, if approved, will modify the European Standard EN ISO 18369-2:2006. If this draft becomes an amendment,
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.
This draft amendment was established by CEN 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 Management Centre has the same
status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
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.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 18369-2:2006/prA1:2009: E
worldwide for CEN national Members.
Contents Page
Foreword .3
Foreword
This Amendment (EN ISO 18369-2:2006/prA1:2009) 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 document is currently submitted to the third parallel CEN Enquiry.
Endorsement notice
The text of ISO 18369-2:2006/DAM 1:2009 has been approved by CEN as a EN ISO 18369-2:2006/prA1:2009
without any modification.
DRAFT AMENDMENT ISO 18369-2:2006/DAmd 1.3
ISO/TC 172/SC 7 Secretariat: DIN
Voting begins on: Voting terminates on:
2009-12-03 2010-02-03
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION • МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ • ORGANISATION INTERNATIONALE DE NORMALISATION
Ophthalmic optics — Contact lenses —
Part 2:
Tolerances
AMENDMENT 1
Optique ophtalmique — Lentilles de contact —
Partie 2: Tolérances
AMENDEMENT 1
ICS 11.040.70
ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for Standardization (ISO), and
processed under the ISO-lead mode of collaboration as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member bodies for a parallel
five-month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments received, will be
submitted to a parallel two-month approval vote in ISO and formal vote in CEN.
In accordance with the provisions of Council Resolution 15/1993 this document is circulated in
the English language only.
Conformément aux dispositions de la Résolution du Conseil 15/1993, ce document est distribué
en version anglaise seulement.
To expedite distribution, this document is circulated as received from the committee secretariat.
ISO Central Secretariat work of editing and text composition
...