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RS ISO 11608-7: 2016
Needle-based injection systems for medical use — Requirements and test methods — Part 7: Accessibility for persons with visual impairment

Abstract

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.

General Information

Code	Classification	Theme	Pages	Publisher	Availability
RS ISO 11608-7: 2016	ADOPTED AFSEC STANDARDS	Health care technology	27	First Edition Jul 2026	Available