Abstract Preview

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.

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.

It covers requirements for NIS that are claimed to be appropriate for use by persons with visual impairments.

It 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, 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.

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.

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.

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.


General information

  • Status :  Published
    Publication date : 2016-08
  • Edition : 1
    Number of pages : 19
  • :
    ISO/TC 84
    Devices for administration of medicinal products and catheters
  • 11.040.25
    Syringes, needles and catheters

Buy this standard

Format Language
PDF
Paper
  • CHF118

Got a question?

Check out our FAQs

Customer care
+41 22 749 08 88

Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)

Keep up to date with ISO

Sign up to our newsletter for the latest news, views and product information