Loren Data Corp.

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COMMERCE BUSINESS DAILY ISSUE OF JULY 10,1997 PSA#1884

SWITZERLAND: ORDINANCE OF RADIATION PROTECTION OF MEDICAL USE OF X-RAY EQUIPMENT The following notification is being circulated in accordance with Article 10.6. G/TBT/Notif.97.285. 1. Member to Agreement notifying: SWITZERLAND. If applicable, name of local government involved (Articles 3.2 and 7.2). 2. Agency responsible: Federal Office of Public Health. Agency or authority designated to handle comments regarding the notification can be indicated if different from above. 3. Notified under Article 2.9.2. 4. Products covered (HS or CCCN where applicable, otherwise national tariff heading. ICS numbers may be provided in addition, where applicable): Medical X-ray equipment for diagnosis and therapy on humans and animals. 5. Title, number of pages and language(s) of the notified document: Ordinance on Radiation Protection for Medical Use of X-Ray Equipment. 6. Description of content: Issue of the necessary regulations delegated by the Radiological Protection Ordinance. The topics are: -- Protection of the patient and the personnel: Measures relative to behavior, applied examination techniques and protective means. -- Structural shielding design: Objectives of protection and measures to achieve them, shielding calculations for X-ray rooms. -- -- Requirements for the use of X-ray equipment: Some few definitions of the properties of X-ray equipment which are important for the safety of persons, especially for the patients. -- Quality assurance: Regulations concerning quality assurance procedures, scope and periodicity of tests and maintenance. 7. Objective and rationale: Total revision as a consequence of the total revision of the superior Radiological Protection Ordinance. 8. Relevant documents: Radiological Protection Ordinance from 22 June 1994; Radiological Protection Act from 22 March 1991. 9. Proposed date of adoption: 1 October 1997; Proposed date of entry into force: 1 October 1997. 10. Final date for comments: 26 August 1997. 11. Text available from: National enquiry point. (0189)

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