Biomedical Engineering Reference
In-Depth Information
17.8.2
Standards Related to the Development of Medical Devices
• ISO 10993 standard on “biological evaluation of medical devices”
• ISO 13485 standard on “sanitary products, quality management and regulatory
affairs”
• ISO 13488 standard on “quality systems, medical devices, sanitary products and
especial requirements for applying ISO 9002 standard”
• ISO 14971 standard on “application of risk management to medical devices and
sanitary products”
• ISO 15223 standard on “symbols used for labelling and information provided
together with medical devices”
17.8.3
Standards and Associations Related to Medical Imaging
• DICOM standard - Digital Imaging and Communications in Medicine: Strategic
Document (
http://medical.nema.org
)
• Medical Imaging and Technology Alliance (
www.medicalimaging.org
)
• NEMA - The Association of Electrical and Medical Imaging Equipment
Manufacturers (
www.nema.org
)
17.8.4
Additional Documents of Interest
• Council of Europe “Convention for the protection of Human Rights and dignity
of the human being with regard to the application of biology and medicine:
Convention on Human Rights and Biomedicine” (1994)
• UNESCO “Universal Declaration on the Human Genome and Human Rights”
(1997) and “Guidelines for Implementation” (1999)
•
World Medical Association “Declaration of Helsinki. Ethical principles for med-
ical research involving human subjects” (current revised edition 2008)
References
Díaz Lantada, A.: Handbook on Active Materials for Medical Devices: Advances and Applications.
PAN Stanford, Singapore (2012)
Díaz Lantada, A., Lorenzo Yustos, H., Lafont, P., Munoz-Guijosa, J.M., Echavarri Otero, J.,
Muñoz Sanz, J.L.: Teaching applications for rapid prototyping technologies. Int. J. Eng. Educ.
23
(2), 411-418 (2007)
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