I.S. 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)
Hardcopy , PDF
English
01-01-2017
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National Foreword
European foreword
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
Annex ZA (informative) - Relationship between this
European standard and the essential
requirements of Directive 93/42/EEC [OJ L 169]
aimed to be covered
Defines particular requirements to make needle-based drug delivery systems or NIS (needle-based injection system) accessible for persons with visual impairments.
| DocumentType |
Standard
|
| Pages |
38
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Standards | Relationship |
| EN ISO 11608-7:2017 | Identical |
| ISO 11608-7:2016 | 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 |
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