Toshiba ALEXION SERİSİ TÜM VÜCUT BİLGİSAYARLI TOMOGRAFİ CİHAZI CDR 8471.70.30.90.00 Tomografi Cihazı

No. 2B201-467TR 7.1.7 Standartlara uyum • "Medical X-ray device criteria" stipulated in Article 42, Paragraph 2 of the Pharmaceutical Affairs Law: Announcement of the Ministry of Health, Labour and Welfare No. 75 (Japan) • Criteria for medical devices stipulated by the Minister of Health, Labour and Welfare in Article 41, Paragraph 3 of the Pharmaceutical Affairs Law: Announcement of the Ministry of Health, Labour and Welfare No. 122 (Japan) • Medical devices designated by the Minister of Health, Labour and Welfare based on the criteria stipulated by the Minister of Health, Labour and Welfare in Article 23, Paragraph 2 (1) of the Pharmaceutical Affairs Law: Announcement of the Ministry of Health, Labour and Welfare No. 112 (Japan) • Ministerial ordinance concerning the criteria for medical device and in vitro diagnostic manufacturing control and quality control: Ordinance of the Ministry of Health, Labour and Welfare No. 169 (Japan) • IEC 60601-1:1988+Amd.1:1991+Amd.2:1995 • IEC 60601-1-1:2000 • IEC 60601-1-2:2001+Amd.1:2004 • IEC 60601-1-3:1994 • IEC 60601-1-4:1996+Amd.1:1999 • IEC 60601-1-6:2006 • IEC 60601-2-28:1993 • IEC 60601-2-32:1994 ~ ~ ~ ~ ~ ❑ ❑ ❑ ❑ ❑ ❑ ❑ • IEC 60601-2-44:2001+Amd.1:2002 • IEC 62366:2007 • IEC 62304:2006 * Yukaridaki standartlar CT sisteminin satin alindiği tarih itibari ile geçerlidir. Sistem konfigürasyonu birtakim isteğe bağli cihazlar ile değiştirildiğinde, yukaridaki standartlar sistemin değiştirilmeden önceki konfigürasyonu için geçerlidir. Sistemin Özellikleri ve Performansi 208