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
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