| | SLO | ENG | Cookies and privacy

Bigger font | Smaller font

Show document Help

Title:UPORABA STANDARDA SIST EN ISO 13485:2012 PRI IZDELAVI INDIVIDUALNIH MEDICINSKIH VSADKOV
Authors:ID Valand, Tomaž (Author)
ID Drstvenšek, Igor (Mentor) More about this mentor... New window
ID Lutar-Skerbinjek, Andreja (Mentor) More about this mentor... New window
Files:.pdf UNI_Valand_Tomaz_2013.pdf (773,28 KB)
MD5: 8F2E930F98DA97B79A0A081F6BF617D0
PID: 20.500.12556/dkum/0e82f13e-447a-40e3-95a9-df536492a22b
 
Language:Slovenian
Work type:Undergraduate thesis
Typology:2.11 - Undergraduate Thesis
Organization:FS - Faculty of Mechanical Engineering
Abstract:Organizacija, ki izdeluje individualne medicinske vsadke mora imeti vzpostavljen standard nadzora kakovosti v procesu izdelave. Treba je definirati metode in postopke zagotavljanja kakovosti, ki bodo v skladu s standardom ISO 13485. V prvem delu diplomske naloge je predstavljen standard in izdelava individualnega medicinskega vsadka. V drugem delu pa je predstavljena tehnologija izdelave vsadka. Rezultat diplomskega dela je oblikovana in za uporabo pripravljena vsa potrebna dokumentacija, ki zajema obrazce od naročila do izdelanega vsadka. Poleg dokumentacije je izdelana tudi kalkulacija predvidenih stroškov posameznih procesov, ki nastanejo med izdelavo vsadka.
Keywords:tehnologija izdelave, standard, ISO 13485, medicinski vsadek, stroški, kalkulacija stroškov, dokumentacija
Place of publishing:Maribor
Publisher:[T. Valand]
Year of publishing:2013
PID:20.500.12556/DKUM-40583 New window
UDC:658.51+657.474.5(043.2)
COBISS.SI-ID:17140502 New window
NUK URN:URN:SI:UM:DK:QLWJWJTL
Publication date in DKUM:12.07.2013
Views:3145
Downloads:247
Metadata:XML DC-XML DC-RDF
Categories:KTFMB - FS
:
Copy citation
  
Average score:(0 votes)
Your score:Voting is allowed only for logged in users.
Share:Bookmark and Share



Hover the mouse pointer over a document title to show the abstract or click on the title to get all document metadata.

Secondary language

Language:English
Title:THE USE OF STANDARD SIST EN ISO 13485:2012 FOR THE MANUFACTURE OF INDIVIDUAL MEDICAL IMPLANTS
Abstract:In the organisation which produces individual medical implants a standard for quality management system in the manufacturing process must be established. The methods and procedures for quality management system must be defined to meet ISO 13485 requirements. In the first part of the thesis, the standard and the manufacturing of the individual medical implant are presented. In the second part, the technology for the medical implant manufacturing is described. The result of the thesis is the whole documentation needed, ready and prepared to be used including all forms from customer orders to the manufctured implants. Beside documentation also the calculation of estimated cost of individual processes ocurring during the implant manufacturing is included.
Keywords:manufactoring technology, standard, ISO 13485, medical implant, costs, calculation costs, documentation


Comments

Leave comment

You must log in to leave a comment.

Comments (0)
0 - 0 / 0
 
There are no comments!

Back
Logos of partners University of Maribor University of Ljubljana University of Primorska University of Nova Gorica