<p>ISO 11608-7:2016 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.</p>
<p>It 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.</p>
<p>It covers requirements for NIS that are claimed to be appropriate for use by persons with visual impairments.</p>
<p>It does not address requirements for use of sharps containers by persons with visual impairments.</p>
<p>Although specifically intended to apply to needle-based injection systems within the ISO 11608 series, ISO 11608-7:2016 can be applied to NIS outside the ISO 11608 series as well, if they might be used by persons with visual impairments.</p>
<p>It 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.</p>
<p>Therefore, ISO 11608-7:2016 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.</p>
<p>For simplicity's sake, this range is described in ISO 11608-7:2016 as addressing the needs of individuals with moderate visual impairment or blindness.</p>
Registration number (WIID)
62507
Scope
<p>ISO 11608-7:2016 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.</p>
<p>It 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.</p>
<p>It covers requirements for NIS that are claimed to be appropriate for use by persons with visual impairments.</p>
<p>It does not address requirements for use of sharps containers by persons with visual impairments.</p>
<p>Although specifically intended to apply to needle-based injection systems within the ISO 11608 series, ISO 11608-7:2016 can be applied to NIS outside the ISO 11608 series as well, if they might be used by persons with visual impairments.</p>
<p>It 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.</p>
<p>Therefore, ISO 11608-7:2016 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.</p>
<p>For simplicity's sake, this range is described in ISO 11608-7:2016 as addressing the needs of individuals with moderate visual impairment or blindness.</p>
