DIN EN ISO 11608-7:2017-10

This International Standard specifies particular requirements to make needle-based drug delivery systems or NIS (needle-based injection system) accessible for persons with visual impairments. It applies to devices intended for patient or caregiver administration of medicinal products to humans. This part of the ISO 11608 series of standards covers requirements to allow for safe and correct handling of the NIS, including labelling, packaging, and instructions for use. It also includes requirements for training programs, if applicable. This part of ISO 11608 covers requirements for NIS that are claimed to be appropriate for use by persons with visual impairments. This part of ISO 11608 does not address requirements for use of sharps containers by persons with visual impairments. Although specifically intended to apply to needle-based injection systems within the ISO 11608 series, this part of ISO 11608 can be applied to NIS outside the ISO 11608 series as well, if they might be used by persons with visual impairments. This document has been prepared by Technical Committee ISO/TC 84 (secretariat: DS, Denmark) in collaboration with Technical Committee CEN/TC 205 "Non-active medical devices", the secretariat of which is held by DIN. DIN Standards Committee Medicine (NAMed), Working Committee NA 063-02-01 AA "Injektionssysteme" ("Injection systems") is responsible for this standard. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). The informative Annex ZA is attached to this version.