This International Standard specifies the information that the manufacturer of contact lenses and contact lens care products must provide to ensure the correct and safe use of these products and their accessories by both types of contact lens users - the contact lens fitter and the contact lens wearer. This International Standard does not specify the form in which this information is to be provided.
EN 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
EN ISO 11978:2014 history
2020EN ISO 11978:2017/A1:2020 Ophthalmic optics - Contact lenses and contact lens care products - Labelling - Amendment 1 (ISO 11978:2017/Amd 1:2020)
2017EN ISO 11978:2017 Ophthalmic optics - Contact lenses and contact lens care products - Labelling
2014EN ISO 11978:2014 Ophthalmic optics - Contact lenses and contact lens care products - Labelling (ISO 11978:2014)
2000EN ISO 11978:2000 Ophthalmic Optics - Contact Lenses and Contact Lens Care Products - Information Supplied by the Manufacturer