滅菌バリデーション基準の制定について [PDFファイル／346KB]
Contents
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3. 8 1 2 9 1 ee 7 oe Hite RODE
4. QMS 2 QMS OT 6 oestiieioats bua 2 fis TER ie 2 WT Spell IS Ce ee ae 3 1 JIS T 0801 1 2010 ISO 11135 1 2007 1 11s T 0806 1 2010 ISO 11137 1 2006 RE REN JIS T 0806 2 2014 ISO 11137 2 201 0 13004 2013 2 3 MPA JIS T 0816 1 2010 SO 17665 1 200
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6. 5 6 0Q Operational Qualification 7 PQ Performance Qualification 8 p yas Gy 7s tet 9 10 CMBR pA Lis A gt
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13. 6 WATS Bina Ox tPA 1 1 2 PP Se 3 SAL Sterility Assurance Leve1 UR IC ER RAE 1 10 4 MR 10 oo ot 5 10 Installation Qualification
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