Tissue Extraction Facility Regulation

Original Language Title: Änderung der Gewebeentnahmeeinrichtungsverordnung

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24 regulation of the Federal Minister for health, modifies the tissue collection device regulation

On the basis of § 7 of the tissue safety law - GSG, Gazette I no. 49/2008, as last amended by Federal Law Gazette I no. 162/2013, is prescribed:

The tissue collection device regulation - GEEVO, Federal Law Gazette II No. 191/2008, as last amended by the regulation BGBl. II No 168/2014, is amended as follows:

1 in §§ 6 para 2, no. of 6 and 11 paragraph 4 the phrase "Donors/donors" is replaced by the word "Donors".

2. § 11 paragraph 10 be added following no. 7:

"7 sperm donations are to be kept at least 180 days under quarantine conditions. The donor is to test again. The testing of a repeat blood sample can be omitted is a donor blood sample also tested using nucleic acid amplification technique (NAT) for HIV, HBV and HCV. Also the repeat test may be omitted, if the processing includes an inactivation step, which has been validated for the particular viruses."

3. the previous section 12 is paragraph labeled "§ 13.". § 12 (new) is as follows:

"§ 12. All personal names used in this regulation the chosen form applies to both sexes, unless these come as addressees of the provision in question."

4. § 13 14 the following section is added:

"§ 14. No. 24/2016 II sections 6, 11, 12 and 13 as amended the regulation BGBl. with the on the day of the publication of this regulation in the Gazette the following day into force."


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