ISO 11978:2017 pdf download

ISO 11978:2017 pdf download.Ophthalmic optics — Contact lenses and contact lens care products — Labelling
1 Scope
This document specifies the information to be provided by the manufacturer of contact lenses and contact lens care products to ensure the correct and safe use of these devices and their accessories by both types of user of contact lenses: the eye care professional and the contact lens wearer.
This document does not specify the format in which such information shall be provided.
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 15223–1:2012, Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements
ISO 18369–1, Ophthalmic optics — Contact lenses — Part 1: Vocabulary, classification system and recommendations for labelling specifications
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 18369–1 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
4 Labelling requirements
4.1 General
Where practicable and possible, the information supplied by the manufacturer shall be provided in the language of the country in which the device is distributed. Where appropriate, this information should take the form of symbols. Symbols used shall conform to ISO 15223–1. Where a symbol is not described in ISO 15223–1, it shall be described in the documentation supplied with the device. Provided the minimum essential requirements are fulfilled, the manufacturer may use his discretion as to the format in which the information is provided, e.g. product-specific information either on the packaging for each unit or on the sales packaging, or in separated leaflets, brochures, booklets, or generic handling guides. These may be supplied as hard copy, electronic format, video, etc. All symbols and written information shall be a minimum of 0,7 mm in height and be legible at a reading distance of 30 cm under the illumination of 215 lx, except for Trademarks and any manufacturing part numbers.