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NSAI
I.S. EN ISO 11608-7:2017

I.S. EN ISO 11608-7:2017

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 (ISO 11608-7:2016)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2017

Publisher

National Standards Authority of Ireland

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.


Dates of withdrawal of national standards are available from NSAI.

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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