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168. Regulation of the Federal Minister for health, modifies the tissue extraction facility regulation
On the basis of § 7 of the tissue safety law - GSG, Federal Law Gazette I no. 49/2008, as last amended by the Federal Act Federal Law Gazette I no. 162/2013, is prescribed:
The tissue collection device regulation - GEEVO, Federal Law Gazette II No. 191/2008 in the version of regulation BGBl. II, no. 87/2014, is amended as follows:
1. at the end of § 1 para. 3 Z 5 the point is replaced by a semi-colon and following Nos. 6 and 7 are added:
"6 quarantine: the status of removed tissues or cells or physically or by other effective means isolated tissue in anticipation of a decision concerning the adoption or rejection;"
"7 critical: coming with any impact on quality or safety or with the cells and tissues in contact."
2. after section 3 para 3 be inserted following paragraph 3a and 3B:
(3a) deceased children, whose mothers with HIV, hepatitis B, hepatitis C or HTLV are infected or where there is a risk of such infection, should be excluded from donation if they were breastfed during the previous twelve months from the mother.
(3B) deceased are children, whose mothers are infected with HIV, to exclude from the donation, when the risk of transmission of infection can be excluded not completely. "
3. in article 11, paragraph 10, 6 is attached following Z:
"To exclude from the donation are 6 persons with a transmission risk for hereditary diseases known in the family."
4. paragraph 12:
"Referring to acts of the European Union
§ 12. The following guidelines are implemented by this Regulation:
1. Directive 2004/23/EC laying down standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells OJ No. L 102 of the 07.04.2004 p. 48, 2. the directive 2006/17/EC implementing Directive 2004/23/EC of the European Parliament and of the Council as regards technical requirements for the donation, procurement and testing of human tissues and cells OJ No. L 38 of the 09.02.2006 p. 40, 3. Directive 2006/86/EC on the implementation of Directive 2004/23/EC of the European Parliament and of the Council as regards requirements for the traceability, the notification of serious adverse events and adverse reactions, as well as certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells, OJ No. L 294 of the 25.10.2006, p. 32, and 4. the 2012/39/CE directive amending Directive 2006/17/EC as regards certain technical provisions for the testing of human tissues and cells OJ "No. L 327 from the 26.11.2012 S. 24."
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