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)

Publication date:   Dec 14, 2017

General information

60.60 Standard published   Aug 2, 2017

CEN

CEN/TC 205 Non-active medical devices

European Norm

11.040.25   Syringes, needles and catheters

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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.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Harmonized/Supporting

Life cycle

NOW

PUBLISHED
EN ISO 11608-7:2017
60.60 Standard published
Aug 2, 2017

Relations

Adopted from ISO 11608-7:2016 IDENTICAL