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Directive 2010/45/EU of the European Parliament and of the CouncilShow full title
Directive 2010/45/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation
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- 2010 No. 53
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- Revised 06/08/20100.26 MB
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ANNEX ORGAN AND DONOR CHARACTERISATION
PART A Minimum data set
Minimum data – information for the characterisation of organs and donors, which has to be collected for each donation in accordance with second subparagraph of Article 7(1) and without prejudice to Article 7(2).
Minimum data set
The establishment where the procurement takes place and other general data
Type of donor
Blood group
Gender
Cause of death
Date of death
Date of birth or estimated age
Weight
Height
Past or present history of IV drug abuse
Past or present history of malignant neoplasia
Present history of other transmissible disease
HIV; HCV; HBV tests
Basic information to evaluate the function of the donated organ
PART B Complementary data set
Complementary data – information for the characterisation of organs and donors to be collected in addition to minimum data specified in Part A, based on the decision of the medical team, taking into account the availability of such information and the particular circumstances of the case, in accordance with the second subparagraph of Article 7(1).
Complementary data set
General data
Contact details of the procurement organisation/the establishment where the procurement takes place necessary for coordination, allocation and traceability of the organs from donors to recipients and vice versa.
Donor data
Demographic and anthropometrical data required in order to guarantee an appropriate matching between the donor/organ and the recipient.
Donor medical history
Medical history of the donor, in particular the conditions which might affect the suitability of the organs for transplantation and imply the risk of disease transmission.
Physical and clinical data
Data from clinical examination which are necessary for the evaluation of the physiological maintenance of the potential donor as well as any finding revealing conditions which remained undetected during the examination of the donor’s medical history and which might affect the suitability of organs for transplantation or might imply the risk of disease transmission.
Laboratory parameters
Data needed for the assessment of the functional characterisation of the organs and for the detection of potentially transmissible diseases and of possible contraindications with respect to organ donation.
Image tests
Image explorations necessary for the assessment of the anatomical status of the organs for transplantation.
Therapy
Treatments administered to the donor and relevant for the assessment of the functional status of the organs and the suitability for organ donation, in particular the use of antibiotics, inotropic support or transfusion therapy.
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