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Comments on the Terms of References About Laboratory Products and Services

Author(s): Hasan Bağcı | Musa Ardoğan

Journal: Türk Biyokimya Dergisi
ISSN 0250-4685

Volume: 31;
Issue: 1;
Start page: 41;
Date: 2006;
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Keywords: Medical device purchase | public bids | technical terms of reference | invitro diagnostic device | EC certificate | declaration of conformity.

In this paper in the concept of public bids some subjects about terms of references which defines the compulsive rules when aimed to purchase laboratory products (in-vitro diagnostic devices) and services for hospitals are taking into account. Althoughthe rules are written in the legislation and directives, the integrated interpretations of the regulations and the sharing of the complementary statements for perfect implementations are more important. At the beginning some of the terms have been defined. Next the general principles about terms of references related to in-vitro diagnostic devices are discussed. The purchase of the clinical laboratory service in the form of test demands, medicaldevice acquiring by means of reactive substances and purchasing principles of the medicinal products have been considered in an order. The collection of ideas about the terms of references are significantly important for avoiding the problems in the legal base following the bids. Documents that might have been wanted for, thesubjects especially about the audit and inspection, guaranty, assistance and training are also taking into consideration in the purchase.
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