UNE-EN ISO 11608-7:2018

This part of ISO 11608 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 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.

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 part of ISO 11608 is written to address the needs of persons with all levels of visual limitations, including low, moderate, or severe visual impairment; legal, functional, or total blindness; and colour vision deficiencies.

Therefore, this part of ISO 11608 includes the requirement to provide information in visual formats that can be perceived and understood by people with moderate visual impairment and in non-visual formats (e.g. tactile or auditory) that can be perceived and understood by people with no useful vision.

For simplicity s sake, this range is described in this part of ISO 11608 as addressing the needs of individuals with moderate visual impairment or blindness.

NOTE NIS that are not claimed to be appropriate for use by persons with visual impairments need not meet these requirements, but manufacturers are encouraged to consider them.