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Publisher: Peytchinski, Gospodin Iliev
ISSN: 1312 773X (Online)
Issue: 2015, vol. 21, issue 1
Subject Area: Medical Legal Regulations
Pages: 713-717
DOI: 10.5272/jimab.2015211.713
Published online:13 February 2015
J of IMAB 2015 Jan-Mar;21(1):713-717
EUROPEAN AND INTERNATIONAL STANDARDS ON MEDICAL DEVICES FOR DENTISTRY.
Jordan Deliversky1
, Mariela Yaneva-Deliverska2, Maya Lyapina3, Angelina Kisselova4.
1) Department of National Security, State University of Library Studies and Information Technologies, Sofia, Bulgaria
2) Legal Department, Military Medical Academy, Sofia, Bulgaria
3) Department of Hygiene, Medical Ecology and Nutrition, Medical University, Medical Faculty, Sofia, Bulgaria
4) Department of Oral and Image Diagnostic, Faculty of Dental Medicine, Medical University - Sofia, Bulgaria.
ABSTRACT:
Standards are produced for many different products and services, and may be created for company, national, regional or global application. In Europe there are three different categories of standard: International standard – a standard adopted by an international standardization organization; European standard – a standard adopted by a European standardization body; National standard – a standard adopted by a national standardization body and made available to the public. Harmonized standards play a special role in the EU. A harmonised standard is a European standard elaborated on the basis of a request from the European Commission to a recognised European Standards Organisation to develop a European standard that provides solutions for compliance with a legal provision. Most standards for dental materials have been harmonized through a so-called cumulative standard (EN 1641:2009 - Dentistry - Medical devices for dentistry - Materials). This European Standard specifies general requirements for materials used in the practice of dentistry for the restoration of the form and function of the dentition and which are medical devices. A multiplicity of laws, standards, and recommendations regulate the marketing of medical devices. The medical doctor and the dentist should be informed about the European and international standards concerning medical devices and use only those for which appropriate information is available. The manufacturer/importer is responsible for its products and is potentially liable for damages.
Key words: European standards, international standards, medical devices, dentistry,
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Please cite this article in PubMed Style or AMA (American Medical Association) Style:
Deliversky J, Yaneva-Deliverska M, Lyapina M, Kisselova A. EUROPEAN AND INTERNATIONAL STANDARDS ON MEDICAL DEVICES FOR DENTISTRY. J of IMAB. 2015 Jan-Mar;21(1):713-717. doi: http://dx.doi.org/10.5272/jimab.2015211.713
Correspondence to: Jordan Deliversky, Department of National Security, State University of Library Studies and Information Technologies, Sofia;119 Tzarigradsko shose blvd., 1784,Sofia, Bulgaria; E-mail: deliversky@yahoo.com
REFERENCES:
1. https://www.iso.org/obp/ui/#iso:std:iso:7405:ed-2:v1:en
2. http://www.iso.org/iso/home/standards_development.htm
3. Benefits of International Standards. http://www.iso.org/iso/home/standards/benefitsofstandards.htm
4. http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/index_en.htm
5. CSN EN 1641 - Dentistry - Medical devices for dentistry – Materials. European Committee for Standardization, Brussels 1996. http://www.en-standard.eu/csn-en-1641-dentistry-medical-devices-for-dentistry-materials/
6. ISO 7405:2008 Dentistry -- Evaluation of biocompatibility of medical devices used in dentistryл http://www.en-standard.eu/iso-7405-dentistry-evaluation-of-biocompatibility-of-medical-devices-used-in-dentistry/
7. International Organization for Standardization: ISO 10993: Biological evaluation of medical devices. International Organization for Standardization, Geneva. https://www.iso.org/obp/ui/#iso:std:iso:7405:ed-2:v1:en
8. BS EN ISO 14971:2012 Medical devices. Application of risk management to medical devices. http://shop.bsigroup.com/ProductDetail/?pid=000000000030268035
9. ISO 14155:2011 Clinical investigation of medical devices for human subjects -- Good clinical practice. http://www.iso.org/iso/catalogue_detail?csnumber=45557
10. http://standardsforum.com/new-bs-en-iso-14971-2012-edition-released-on-medical-devices-application-of-risk-management-to-medical-devices/.
Received: 05 December 2014
Published online: 13 February 2015