EN ISO 11608-7:2017
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 (ISO 11608-7:2016)
08-02-2017
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Test methods
6 Test report
7 Information supplied by the manufacturer
Annex A (informative) - Measuring vision and visual impairment:
Functional vision and visual acuity
Annex B (informative) - Guidance for developing instructions for
use for persons with visual impairment
Annex C (informative) - Process for establishing a specification,
test methods and verification related to 5.1
Bibliography
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.
| Committee |
CEN/TC 205
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Current
|
| Standards | Relationship |
| DIN EN ISO 11608-7:2017-10 | Identical |
| ISO 11608-7:2016 | Identical |
| PN EN ISO 11608-7 : 2017 | Identical |
| SN EN ISO 11608-7 : 2017 | Identical |
| NEN EN ISO 11608-7 : 2017 | Identical |
| UNE-EN ISO 11608-7:2018 | Identical |
| DIN EN ISO 11608-7:2015-08 (Draft) | Identical |
| NF EN ISO 11608-7 : 2017 | Identical |
| I.S. EN ISO 11608-7:2017 | Identical |
| UNI EN ISO 11608-7 : 2018 | Identical |
| NS EN ISO 11608-7 : 2017 | Identical |
| BS EN ISO 11608-7:2017 | Identical |
| 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 |
| EN ISO 11608-1:2015 | Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2014) |
| EN ISO 14971:2012 | Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
| 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 |
| EN 62366-1:2015/AC:2015 | MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366-1:2015) |
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