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

German Institute for Standardisation (Deutsches Institut für Normung)

National foreword
National Annex NA (informative) - Bibliography
European foreword
Annex ZA (informative) - Relationship between this
         European standard and the essential requirements
         of Directive 93/42/EEC [OJ L 169] aimed to be
         covered
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

Describes particular requirements to make needle-based drug delivery systems or NIS (needle-based injection system) accessible for persons with visual impairments.

DocumentType	Standard
Pages	28
PublisherName	German Institute for Standardisation (Deutsches Institut für Normung)
Status	Current

Standards	Relationship
EN ISO 11608-7:2017	Identical
ISO 11608-7:2016	Identical

DIN EN ISO 11608-1 E : 2015	NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 1: NEEDLE-BASED INJECTION SYSTEMS (ISO 11608-1:2014)
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
DIN EN 62366-1 : 2017	MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366-1:2015 + COR1:2016)
DIN CEN ISO/TR 22411;DIN SPEC 33421:2014-12	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/TR 22411:2008)
VDE 0750-241-1 : 2017	MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366-1:2015 + COR1:2016)
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
DIN CEN ISO/TR 22411;DIN SPEC 33421:2014-12	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/TR 22411:2008)

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DIN EN ISO 11608-7 E : 2017

NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 7: ACCESSIBILITY FOR PERSONS WITH VISUAL IMPAIRMENT (ISO 11608-7:2016)

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Abstract

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