Product Compliance NDIS

 

Compliance with AT Australian Standards

(Ref 3.7.4 on Assessment Template – General Assistive Technology)

The NDIS requires you to state the relevant assistive technology standards. Please find information below on Link Assistive products and refer to your purchase quote.

Link Assistive is a registered NDIS supplier of Assistive Technology throughout Australia.

Tobii Dynavox Products

Product Standards
TD I-110 AS/NZS 4268:2012

ISO14971:2019

ISO 13485:2016

Declaration of Conformity: https://www.linkassistive.com/wp-content/uploads/2022/07/DoC-TDI110revA.docx.pdf

Indi 10 AS/NZS 60950.1:2015

Declaration of Conformity: http://download.mytobiidynavox.com/Indi/documents/TobiiDynavox_Indi_DeclarationOfConformity.pdf

I-13 ISO14971:2007

Declaration of Conformity: http://download.mytobiidynavox.com/I-Series/documents/I-Series_Declarations_and_certification/Tobii_Dynavox_I-13_Declaration_of_Conformity_revB.pdf

I-16 ISO14971:2007

This product is compliant with a range of IEC and EN standards which are recognised and accepted in Australia. Declaration of Conformity: http://download.mytobiidynavox.com/I-Series/documents/I-Series_Declarations_and_certification/Tobii_Dynavox_I-16_Declaration_of_Conformity_revB.pdf

Speech Case ISO14971:2019

Declaration of Conformity: http://download.mytobiidynavox.com/Speech%20Case/Documents/Speech%20Case%202.0/DoC_Speech_Case_2revA-Signed.pdf

Indi 7 ISO14971:2007+2012

Declaration of Conformity: http://tdvox.web-downloads.s3.amazonaws.com/Indi/documents/TobiiDynavox_Indi7_DeclarationOfConformity.pdf

TD Pilot ISO 14971:2019

Declaration of Conformity: https://downloads.tobiidynavox.com/Devices/TD_Pilot/Documentation/DoC_TDPilot.docx.pdf

 

EyeMobile Plus

 

ISO 14971:2019

Radio-communications (Electromagnetic Compatibility) Standard 2008. AS/NZS CISPR 32:2013

PC Eye 5 ISO14971:2007+2012

Declaration of Conformity: https://www.linkassistive.com/wp-content/uploads/2022/07/Declaration_of_Conformity_PCEye5.pdf

iPad and Surface Pro Tablet Are mainstream technologies and therefore not considered in assistive technology standards

 

Full documentation can be found on the Tobii Dynavox website under the specific device: https://www.tobiidynavox.com/support-training/ “Manuals and other documentation”

Rehadapt Mounts

All Rehadapt products are compliant with the ISO 14971:2019 Standard.

Declarations of Conformity are in place for all products. Rehadapt is ISO certified (23 March 2021). ISO Norm: DIN EN ISO 13485.

You can find further information here: https://rehadapt.com/regulatory-compliance/

AbleNet

AbleNet follows regulations outlined by different regulatory bodies worldwide. You can find further information here: https://www.ablenetinc.com/resources/regulatory-guiding-prinicples

To find the declaration of conformity for individual products see: https://www.ablenetinc.com/technology and click on downloads.

Emego

The Emego is an approved Class 1 medical device. You can find further information here: http://emego.co.uk/wp-content/uploads/2018/03/Emego-Instructions-for-Use.pdf

Other

For any products not listed please contact us at office@linkassistive.com