Ver dec 2003 - Abilia

Appendix 1 - Declaration of Conformity
Tillägg 1 - Declaration of Conformity
EC DECLARATION OF CONFORMITY
Toby Churchill Ltd. Augmentative Communication Devices
Toby Churchill Limited, 20 Panton Street, Cambridge, CB2 1HP, United Kingdom, declares that:
the AdVocate range of devices and their associated accessories, as described
within the technical documentation files referenced AdVocate, conform to Class I
requirements of Council Directive 93/42/EEC of 14 June 1993 concerning medical
devices;
• are in conformity with the provisions of that Directive and, where such is the
case, with the applicable sections of national standards transposing harmonized
standards as noted:
EN 12182: 1999, EN 60601-1: 1990 + A1 A11 A12 A13: 1996,
EN 60601-1-1: 2001, EN 60601-1-2 2002
• the requirements of Annex I, Annex VII and Annex IX have been followed for
Class I devices and registration requirements of Article 14 have been notified to the
UK Competent Authority. In support of these requirements the company have had
an independent testing of samples of their device to:
EN 50081-1: 1992, EN 60601-1-2 2002
• the Declaration covers devices manufactured from the period commencing
January 2003 and until such time as a renewed conformity declaration is raised;.
• this declaration covers the device family range listed below and includes the
software embedded within the hardware.
AdVocate
This declaration is signed on behalf of Toby Churchill Limited by:
Signed
Name:
Authority:
Toby Churchill
Managing Director
Date: 01/02/2003
AdVocate 65