ISO/TR 22979:2017 pdf download – Ophthalmic implants — Intraocular lenses — Guidance on assessment of the need for clinical investigation of intraocular lens design modifications.
1 Scope This document provides guidance on the application of all parts of the ISO 11979 series of International Standards for intraocular lenses (IOLs). [1–9] It addresses factors to be considered in the risk management process of modifications to anterior and posterior chamber IOLs in accordance with ISO 14971. [11] It also suggests methods of data analysis and interpretation that can be used to determine the need for a clinical investigation and its design. 2 Normative references The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 11979-1, Ophthalmic implants — Intraocular lenses — Part 1: Vocabulary 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 11979-1 and the following apply. ISO and IEC maintain terminological databases for use in standardization at the following addresses: — IEC Electropedia: available at http:// www .electropedia .org/ — ISO Online browsing platform: available at http:// www .iso .org/ obp NOTE The terms listed are related to Annex B. 3.1 open-loop IOL IOL model which contains two loops, each loop having one end attached to the body of the IOL and the other end free 3.2 closed-loop IOL IOL model, which contains two loops, each loop having both ends attached to the body of the optic 3.3 hybrid open-loop/closed-loop IOL IOL model which contains two loops, with one loop having one end attached to the body of the IOL and the other end free, and the other loop having both ends attached to the body of the IOL
ISO 13485 [10] provides requirements for the design and development of medical devices, which are applicable to intraocular lenses including modifications of existing models. The risk assessment and design evaluation are part of the risk management in the design control process in accordance with ISO 14971, and can be used as input for the clinical evaluation. ISO 14971 describes sources for data and information for estimating risks. To determine and evaluate the hazards associated with the modification of IOL models, the manufacturer can additionally use the following sources: a) clinical data; b) literature study of equivalent features of similar IOL models. The literature can be general published and unpublished reports, proprietary evaluations and post-market surveillance reports; c) physical model-eyes, laboratory bench testing or numerical/computational models, which have been verified and validated for evaluation of optical and mechanical behaviour; d) usability and human factor engineering data resulting from the application of IEC 62366-1 [12] or ANSI/AAMI HE75 [13] such as the use of error risk analysis, formative and summative evaluation results, including studies to evaluate surgical manipulation and delivery of the IOL in the eye. Modifications to the delivery system are subject to the design control process in accordance with ISO 13485 and factors that pertain to the interaction of IOL and delivery system, as described in ISO 11979-3, and user interaction during surgery are to be considered in a risk assessment. 4.2 Modification levels 4.2.1 General Design modifications to parent model IOLs are classified as Level A, B or C. The classification depends on the safety and performance risks that are identified. Examples of risks associated with design modifications are provided in Annex A. 4.2.2 Level A modifications Level A modifications of a parent model are those for which all safety and performance questions can be adequately addressed without clinical investigation.