definiens: means the current safety and performance specifications, guidelines, and regulations with which MILTENYI 's CliniMACS [ * * ], CliniMACS [ * * ] and CliniMACS [ * * ] currently comply . These specificatio ns, guidelines and regulations consist of the 1977 FDA document Points to Consider in the Manufacture and Testing of Monoclonal Antibodies Pr oducts for Human Use, the ICH harmonized tripartite guideline Q5A : Viral Safety E valuation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin, and the ISO standard 10993 - 1:1997 ( E ) Biological evaluation of medical d evices - Part 1 : Evaluation and testing . Additionally, the manufacture, testing and release of the CliniMACS [ * * ], ClinicMACS [ * * ] and CliniMACS [ * * ] are conduc ted under an ISO 13485 certified quality system and the manufacture, testi ng and release of CliniMACS [ * * ] and CliniMACS [ * * ] will also be conducted unde r the same quality system as the CliniMACS [ * * ], CliniMACS [ * * ] and CliniMACS [ * * ]