Standard Swedish standard · SS-EN ISO 11608-7:2017

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

Status: Valid

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Standard Swedish standard · SS-EN ISO 11608-7:2017

Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment (ISO 11608-7:2016)
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Scope
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.

Subjects

Syringes, needles and catheters (11.040.25)


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Standard Swedish standard · SS-EN ISO 11608-7:2017

Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment (ISO 11608-7:2016)
Subscribe on standards - Read more Dölj
Price: 1 152 SEK
standard ikon pdf

PDF

Price: 1 152 SEK
standard ikon

Paper

Price: 1 843,20 SEK
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Product information

Language: English

Written by: Svenska institutet för standarder

International title:

Article no: STD-8027876

Edition: 1

Approved: 8/8/2017

No of pages: 36