新EU指令で要求されるリスクアセスメント

1 2016/6. EU . RA .. 1. Copyright (c) FSS Corp. (INDEX). (1) NLF EU CE . (2) (2014/35/EU) Risk Assessment (RA) . - LV RA : ANNEX . - LV . (3) EMC (2014/30/EU) RA . - EMC RA: ANNEX . (4) EU RA . (5) RA (ISO/ R-Map etc.) . (6) RA . - RA . - . (7) . / / / . Copyright (c) FSS Corp. 2. (1) NLF EU CE .. CE (NLF New Legislative Framework 2008 8 EU . NLF . 2011 11 9 EMC(Electromagnetic Compatibility ) .. EU (NLF). EMC 2014/30/EU). LV (2014/35/EU). RE (2014/53/EU) etc. Copyright (c) FSS Corp. 3. EU (New EU Directives). EU . 1) EMC - 2014/30/EU- *OJ:2016/5/13 *EMC: Electric-Magnetic Compatibility :52016XC0513(10)&qid=1465156996479&from= EN.

2 2016 4 20 2004/108/EC). 2) (LV) - 2014/35/EU - *OJ:2016/5/13 *LV: Low Voltage :52016XC0408(04)R(01)&qid=1465156996479. 2016 4 20 ( 2006/95/EC). 3) (RE) - 2014/53/EU - *OJ:2014/5/22 *RE: Radio Equipment :L:2014:153:TOC. 2016 6 13 1995/5/EC ). CE . EMC RoHS (2011/65/EU) . (Machinery Directive -2006/42/EC *OJ:2016/5/13). :C:2016:173:TOC. Copyright (c) FSS Corp. 4. (2) (2014/35/EU) RA .. ( A: ).. shall establish the technical documentation . shall make it possible to assess the electrical equipment's conformity to the relevant requirements.

3 Shall include an adequate analysis and assessment of the *risk(s). Guidance Document @ EU). *CENELEC Guide 32 / ISO IEC Guide 51. *ISO 13849-1 / FMEA (Failure Mode and Effect Analysis) etc. *ISO 12100 / R-Map etc. *risk(s) . Copyright (c) FSS Corp. 5. (3) EMC (2014/30EU) RA .. ( A: ). EMC (an EMC Assessment) . (the relevant phenomena) (Annex ) . EMC an normal intended operating conditions) taking different configurations) epresentative of its intended use .. shall include an adequate analysis and assessment of the *risk(s). EMC 2016/5/13:OJ EU) * :2016.

4 :C:2016:173:TOC.. EMC . EMC : Key-W: Intended use, Ref. MDD with IEC60601-1-2:2014). Copyright (c) FSS Corp. 6. (4) EU RA . Risk Assessment (TD) . The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the electrical equipment's conformity to the relevant requirements, and shall include an adequate analysis and assessment of the risk(s). CE - ( ) RA . RA . RA Report) * : RA Report . ) * TD .. Copyright (c) FSS Corp. 7. (5) RA (ISO/R-Map etc.).. ISO 13849-1:2006 *New: 2015.

5 ISO 13849-1:2006 JIS B 9705-1:2011 B .. PL PLr . ISO 12100:2010. (3 Step Method). Step 1 . Step 2 . Step 3 . R-Map R-Map ( ) R-Map . R-Map R-Map 1 . #01. Copyright (c) FSS Corp. 8. (6) RA . - (LV) - - CE - (2015 3 ) - .. CENELEC Guide 32:2014. 9 ( ): . IEC .. ( . RA .. LV 21 (Article 21:Compliant electrical equipment which presents a risk .. RA CE (PL) . 9. Copyright (c) FSS Corp. (6) RA . - (EMC) - EMC . (See EMCD ANNEX Item 2 3 . EMC . EMC . (See EMCD Guide Cl. : Worst Case Approach .. EMC . TD . EMC IEC 60601-1-12:2014 . ME.))))

6 K .. EMC EMC .. Copyright (c) FSS Corp. 10.. Copyright (c) FSS Corp. 11. (7) . RA .. (RA) .. RA . RA . Copyright (c) FSS Corp. 12.