This International Standard 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 users of contact lenses: the eye care professional and the contact lens wearer.
This International Standard does not specify the format in which such information shall be provided.
ISO 11978:2014 Referenced Document
ISO 14534:2011 Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements
ISO 14729:2001 Ophthalmic optics - Contact lens care products - Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses
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 18369-1:2006 Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification system and recommendations for labelling specifications
ISO 11978:2014 history
2020ISO 11978:2017/Amd 1:2020 Ophthalmic optics — Contact lenses and contact lens care products — Labelling — Amendment 1
2017ISO 11978:2017 Ophthalmic optics — Contact lenses and contact lens care products — Labelling
2014ISO 11978:2014 Ophthalmic optics - Contact lenses and contact lens care products - Labelling
2000ISO 11978:2000 Ophthalmic optics - Contact lenses and contact lens care products - Information supplied by the manufacturer