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  • BSI
    BS EN ISO 11608-7:2017 Needle-based injection systems for medical use. Requirements and test methods - Accessibility for persons with visual impairment
    Edition: 2020
    $435.35
    / user per year

Description of BS EN ISO 11608-7:2017 2020

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.



Standard NumberBS EN ISO 11608-7:2017
TitleNeedle-based injection systems for medical use. Requirements and test methods - Accessibility for persons with visual impairment
StatusUnder Review
Publication Date2020-03-30
Identical National Standard OfISO 11608-7:2016, EN ISO 11608-7:2017
CorrectsBS EN ISO 11608-7:2017
DescriptorsContainers, Parenteral infusion equipment, Medical equipment, Performance, Surgical needles, Performance testing, Syringes, Drug administration, Specification (approval), Measuring cylinders, Injection instruments, Injection guns, Medical instruments
ICS11.040.25 Syringes, needles and catheters
CommitteeCH/84
ISBN978 0 539 13447 6
PublisherBSI
Pages30

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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