. /.WORLD TRADE
ORGANIZATIONG/TBT/N/CAN/83
27 November 2003
(03-6317)
Committee on Technical Barriers to Trade Original: English/
French
NOTIFICATION
The following notification is being circulated in accordance with Article 10.6.
1. Member to Agreement notifying:   CANADA
If applicable, name of local government involved (Articles 3.2 and 7.2):           
2. Agency responsible:   Department of Health
Name and address (including telephone and fax numbers, e-mail and web-site
addresses, if available) of  agency or authority designated to handle comments
regarding the notification shall be indicated if different from above:   Canadian Enquiry
Point, 200-270 Albert Street, Ottawa, Ontario, Canada, K1P 6N7 Tel.:  +1 613 238 3222,
Fax:  +1 613 569 7808, E-mail:  info@scc.ca
3. Notified under Article 2.9.2 [  X ], 2.10.1 [    ], 5.6.2 [    ], 5.7.1 [    ], other:           
4. Products covered (HS or CCCN where applicable, otherwise national tariff heading.
ICS numbers may be provided in addition, where applicable):   Dental X-ray Equipment
(ICS: 11.060.20)
5. Title, number of pages and language(s) of the notified document:   Proposed Amendment
to the Radiation Emitting Devices Regulations (Dental X-ray Equipment)
(pages 3690-3701;  English and French)
6. Description of content:
The Radiation Emitting Devices Regulations serve to protect Canadians from injury due to
exposure to radiation by prescribing standards that regulate the construction and functioning
of certain classes of radiation emitting devices.
This amendment will replace the present standard for dental X-ray equipment with a new
standard that is compatible with internationally accepted standards and which reflects the
current state of dental X-Ray equipment design and technology.
The existing Canadian standard on dental X-ray equipment has been in force since 1979 and
was amended in 1993.  In its present form, it does not represent the current state ofequipment design and technology that is reflected in the U.S. performance standards
(CFR 1020.30) or the International Electrot echnical Commission standards (IEC 60601-1
series).
The major changes to the Regulations are the harmonization of equipment safety
performance, the addition of the universally recognised radiation symbol, the inclusion of
performance limits for factors influencing the amount of radiation delivered by the
equipment such as tube voltage and exposure time, and a reduction by a factor of 4 in theG/TBT/N/CAN/83
Page 2
permissible amount of leakage radiation from the equipment and its harmonization with
international standards from the IEC.  This reduction in leakage radiation will benefit both
patients and workers.
7. Objective and rationale, including the na ture of urgent problems where applicable:
Protection of human health
8. Relevant documents:   Canada Gazette, Part I, 22 November 2003
9. Proposed date of adoption:
Proposed date of entry into force: }Not stated
10. Final date for comments:   5 February 2004
11. Texts available from:  National enquiry point [ X ] or address, telephone and fax
numbers, e-mail and web-site addresses, if available of the other body:  The electronic
version of the regulatory text can be downloaded at:
http://canadagazette.gc.ca/partI/2003/20031122/pdf/g1-13747.pdf