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ISO 11608-7:2016

Current
Current

The latest, up-to-date edition.

Needle-based injection systems for medical use Requirements and test methods Part 7: Accessibility for persons with visual impairment
Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English, French

Published date

07-29-2016

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.

DevelopmentNote
Supersedes ISO/DIS 11608-7. (08/2016)
DocumentType
Standard
Pages
19
PublisherName
International Organization for Standardization
Status
Current

ISO/IEC 18004:2015 Information technology Automatic identification and data capture techniques QR Code bar code symbology specification
ISO/TR 19244:2014 Guidance on transition periods for standards developed by ISO/TC 84 — Devices for administration of medicinal products and catheters
ISO 11608-5:2012 Needle-based injection systems for medical use Requirements and test methods Part 5: Automated functions
ISO 11608-1:2014 Needle-based injection systems for medical use Requirements and test methods Part 1: Needle-based injection systems
ISO 24502:2010 Ergonomics Accessible design Specification of age-related luminance contrast for coloured light
ISO 24500:2010 Ergonomics Accessible design Auditory signals for consumer products
ISO 11156:2011 Packaging — Accessible design — General requirements
ISO/TR 22411:2008 Ergonomics data and guidelines for the application of ISO/IEC Guide 71 to products and services to address the needs of older persons and persons with disabilities
ISO 14971:2007 Medical devices Application of risk management to medical devices

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