scope:

This part of ISO 11608 specifies particular requirements to make needle-based drug delivery systems or NIS (Needle 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 ISO 11608 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. NIS that are claimed appropriate for use by persons with visual impairments shall meet the applicable requirements of this part of ISO 11608. 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, this part of ISO 11608 may be applied to NIS outside the ISO 11608 series as well, if they might be used by persons with visual impairments.