Transcription of Bulletin200903号 認証申請チェックリスト 修正
1 1 3 Bulletin 2016 11 8 2016 11 17 28 11 8 28 11 17 17 122 13 5 6 24 3 28 0328 JIST0601-1-2:2012 - JIS T0601-1-2 2012 IEC 60601 -1-2:2001/ Amendment1:2004 IDT IEC 60601 -1-2 JIS T 0601-1-2 IEC IEC 60601 -1-2 13 JIS T 0601-1-2:2012 IEC 60601 -1-2 2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests IEC 60601 -1-2 2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard.
2 Electromagnetic compatibility - Requirements and tests IEC 60601 -1-2 2001 Amendment1 2004 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests 2 3 Bulletin IEC 60601 -1-2 2014 IEC 60601 -1-2 2014 IEC Bulletin JIS T 0601-1-2 28 11 17 28 11 8 Bulletin201604 IEC 60601 -1-2:2012 IEC 60601 -1-2.
3 2014 28 11 17 ( RF MRI ME ( ) ( ) ( ) ( ) ME ( MRI ME RF ) ( ) ( ) 3 3 IEC 60601 -2-44:2009 + AMD2:2016 Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography JIS Z 4751-2-44 IEC 60601 -1:2005 +AMD1:2012 Amendment 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance JIS T 0601-1 IEC 60601 -1-2: 2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests JIS T 0601-1-2 IEC 60601 -1-3:2008 +AMD1:2013 Medical electrical equipment - Part 1-3.)
4 General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment JIS T 0601-1-3: 2012 IEC 60601 -2-44:2009 + AMD2:2016 IEC 60601 -2-44 JIS T 4751-2-44 JIS T 4751-2-44 AMD2 2016 CT IEC 60601 -1:2005+AMD1:2012 IEC 60601 -2-44 IEC 60601 -1-2: 2014 JIS T 0601-1-2 2012 IDT IEC 60601 -1-2 2001, 2004 Bulletin 201604 IEC 60601 -1-3:2008+AMD1:2013 JIS T 0601-1-3 2012 IDT IEC 60601 -1-3 2008 AMD 2013 X-CT
