Int. J. Metrol. Qual. Eng.
Volume 2, Number 2, 2011
|Page(s)||135 - 140|
|Published online||10 January 2012|
- R.C. Brownson, E.A. Baker, T.L. Leet, N. Gillespie, Evidence-Based Public Health (Oxford University Press, New York, 2002)
- Council directive 98/78/EEC of 27 October 1998 concerning in vitro diagnostic medical devices, Official Journal L 33, 7/12/1998
- S. Jonas, B. Michael, B. Reinhard, Balancing adoption and affordability of medical devices in Europe, Health Policy 92, 218–224 (2009) [CrossRef] [PubMed]
- Council directive 2007/47/EEC of 5 September 2007, Official Journal L 247, 21/09/2007, pp. 0021–0055
- World Health Organization, Medical Device Regulations (WHO, Geneva, 2003), ISBN 9241546182, http://www.who.int/medical_devices/en/
- http://www.eucomed.org/press/˜/media/A4261DDBBA854C7F852CA16F7AC3C716.ashx (accessed 2011-01-18)
- M.P. Keshia, D. Morhaimb, M.A. Williams, The public’s perspectives on advance directives: Implications for state legislative and regulatory policy, Health Policy 94, 57–63 (2010)
- V.P. Gundarov, G.I. Kavalerov, Standardization and Certification of Quality of Medical Devices, Biomed. Eng. 35, 123–126 (2001) [CrossRef]
- Chião et al., Metrology and Standards Needs for Some Categories of Medical Device, J. Res. Natl. Inst. Stand. Technol. 113, 121–129 (2008) [CrossRef] [PubMed]
- M.V. Lucatelli et al., Engenharia clínica e a metrologia em equipamentos eletromédicos, in metrologia para a Vida, Sociedade Brasileira de Metrologia (SBM) (Recife, Pernambuco, Brasil, 2003)
- G.M. Minyailik, Standardization and certification of medical devices: results and prospects, Biomed. Eng. 35, 121–122 (2001); Translated from Meditsinskaya Tekhnika 35, 3–4 (2001) [CrossRef]
- E.C. Monteiro, M.L. Lessa, A metrologia na área de saúde: garantia da segurança e da qualidade dos equipamentos electromédicos, Engevista 7, 51–60 (2005)
- R.D. Sriram, S.J. Fenves, Manufacturing Metrology and standards for the health care enterprise program summary (National Institute of Standards and Technology, 2008), NISTIR 7487
- M.J. Turner, P.C. Kam, A.B. Baker, Metrology in Medicine, Department of Anesthetics, University of Sydney, 2004, http://www.personal.usyd.edu.au/˜mjturn er/metrology_in_med_msa_2004.pdf
- Council directive 90/385/EEC of 20 June 1990 concerning the approximation of the laws of the member states relating to active implantable medical Devices, Official Journal L 189, 20.7.1990, p. 17
- R. Wilson et al., An analysis of the causes of adverse events from the quality in Australian health care study, Med. J. Aust. 170, 411–415 (1999) [PubMed]
- Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, Official Journal L 169, 12/07/1993, pp. 0001–004393/42/CE
- ISO 13485:2003, Medical devices-Quality management systems-requirements for regulatory purposes
- ISO/TR 14969:2004, Medical devices-Quality management systems- guidance on the application of ISO 13485:2003
- Report on the functioning of medical devices directive, http://www.bsigroup.com/upload/Standards–%"20–“&"–%"20Publications/Healthcare/MDDReport2002.pdf (accessed 2011-01-18)
Current usage metrics show cumulative count of Article Views (full-text article views including HTML views, PDF and ePub downloads, according to the available data) and Abstracts Views on Vision4Press platform.
Data correspond to usage on the plateform after 2015. The current usage metrics is available 48-96 hours after online publication and is updated daily on week days.
Initial download of the metrics may take a while.