EU RMap
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1 20 3
2 EU RMap
3 (1) (2)
4 2 (3) 1.3
5 3
6 4 2. R-Map 2.1 EU ISO/IEC 51 EU 2.2 EU (PL) EU
7 5 2.3 CPSC EU RAPEX R-Map R-Map
8 IEC61508 MIL-Std-882c CPSC R-Map IEC61508 ISO13949 ( ) RAPEX EU R-Map R-Map RAPEX RAPEX R-Map 3.2 EU EU EU RAPEX EU EU RAPEX
9 CPSC CPSC CPSC PROMPT CPSC CPSC PROMPT R-Map R-Map R-Map 0 ( )110 CPSC R-Map CPSC R-Map R-Map R-Map
10 ISOIEC JIS 4.3 R-Map
11 9 R-Map A R-Map B R-MapC ISOIEC
12 10
13 (1) R-Map R-Map (2) R-Map (3) R-Map A
14 12 B ALARP C A C C (4) R-Map 5.2 (1) R-Map (2) CPSC (3) R-Map
15 13 R-Map (4) R-Map A A A B B C C C (5)
16 14 (6) (7) R-MapJIS ISO14121 B
17
18 IEC MIL-Std-882.c System Safety Program Requirements 37 CPSC 38 RAPEX IEC
19 49 50 RMap RMap 52 RMap
20 18 ISO/IEC 51: ISO IEC ISO/IEC 51 ISO/IEC 51 ISO/IEC 51 ISO/IEC 51
21 19 1
22 20 ISO/IEC 51 EU ISO/IEC 51 CPSA2 1 CPSACFR1115 EU GPSDRAPEX CPSA2 CPSA 9(f)(3)
23 21 CPSA2 CFR Comparative safety CPSA2 ISO/IEC 51 EU CPSA9(f)(3) ISO/IEC 51
24 22 EU RAPEX ISO/IEC 51 CPSA15(a) ISO14121
25 1 CPSACFR1115 GPSDRAPEX Substantial product EU hazard Substantial risk of injury The hazard represents the intrinsic potential 15(a) CFR CPSAof the product to damage the health and safety of users under certain conditions. RAPEX ISO/IEC 51 ISO/IEC 51 EU ISO/IEC 51 CFR
26 24 1 CPSACFR1115 EU GPSDRAPEX Severity of the risk CFR Risk of injury CPSA3 Serious risk GPSD1(d) RAPEX ISO/IEC 51 ISO/IEC 51 ISO/IEC 51
27 25
28 26 EU Risk Estimation Risk Evaluation CFR CPSACFR1115 EU GPSDRAPEX CFR Safe product risks considered to be acceptable Risk Estimation Risk Evaluation
29 27
30 28
31 29 EU RAPEX RAPEX Substantial product hazard CPSA15CFR EU RAPEX
32 30 1 CPSACFR1115 EU GPSDRAPEX Substantial product hazard CPSA15CFR RAPEX RAPEX
33 EU CPSA GPSD GPSD (1.2) CPSA GPSD GPSD Federal Hazardous Substances Act Flammable Fabrics Act Poison Prevention Packaging Act Refrigerator Safety Act GPSD Guidance Document on the Relationship Between the General Product Safety Directive (GPSD) and Certain Sector Directives with Provisions on Product Safety2003,
34 EU (3.1) EU 20(1) 8.1(e) CPSA8 8.1(d) CPSA7,9 CPSA7 8.1(b) 8.1(c) CPSA9(f)(3) CPSA14 CPSC (3.2) CFR (3.4) CPSC rely 4 CPSA15 CPSC CPSA7 CPSC rely CPSC CPSC CFR (3.2) (3.3) 32
35 (5.1) CPSA PL 2 3 CPSA Substantial product hazard (8.1(f)) Substantial product hazard (5.1) CPSA15 EU 33
36 34 EU (5.1) (5.1) EU
37 IEC61508 IEC B ALARP ALARP 35
38 36 SIL SIL 10 10
39 MIL-Std-882.c System Safety Program Requirements A High 37
40 38 CPSC RECALL HANDBOOK CPSC Substantial product hazard A A A B C C CPSC
41 CFR CFR
42 40 RAPEX EU PRODUCT SAFETY IN EUROPE:A Guide to corrective action including recalls EU GPSD RAPEXRapid E change
43 41
44
45 RAPEX Low RAPEX
46 44 1 1
47 45 R-Map R-Map AC A B C
48 46 R-Map RAPEX B1 B2 RAPEX
49 47 IEC61508 IEC D SIL IEC61508 SIL ISO13849 SIL 1
50 48
51 EU EU Establishing a Comparative Inventory of Approaches and Methods Used by Enforcement Authorities for the Assessment of the Safety of Consumer Products Covered by Directive 2001/95/EC on General Product Safety and Identification of Best Practices(2006) Dariusz Lomowski, Risk assessment why it is so important?,
52 50 General C. Possible Probable EU 0 4
53 51
54 RMap 1. RMap RMapRisk-Map, PSProduct Safety, 1974 Product Liability, 1990 ISO/IEC Guide R-Map R-Map R-Map Acceptable Level R-Map R-Map R-Map 1 R-Map 52
55 2 Unacceptable Risk 1990 ISO/IEC Guide51 PL R-Map R-Map R-Map A1, B3, C 53
56 54 5B3 4B3 3B3 2B3 B3 5B3 5 1/10 4, 3, 2 4 1:29:300 80
57 55 5 R-Map IEC IEC R-Map R-Map FDA
58 R-Map A,B,C IEC R-Map A Intolerable region: B ALARP region: ALARP, as low as reasonably practicable: C Broadly acceptable region: = Safety A 56
59 57 6 R-Map ,
60 58 8 AC 3 5: 1/10 1/1,000 accept A ISO ,-2
61 ISO B ISO ISO IEC IEC IEC ISO/IEC Guide51 IEC IEC EU ISO IEC ISO IEC R-Map R-Map 1995 R-Map PS R-Map 2. R-Map 912 R-Map
62 60
63 A B3
64 62 14 R-Map 15 CO B A1 11/21 A2 11/29
65 16 CO A1 A 63
66 64 17 B A1
67 20 H16 9 B1 1 B3 B2 C B / or 1 state of the art 21 2 T 1/ T ppmT 10 6ppm T 10 65
68 66 3. EU EC 36 state of the art
69 67 PL EU PDCA Plan-Do-Check-Action : 1990 PS R-Map
70 4. 10Fit1 Fit=10-9 /H 1,000 1/ / 1 1 1,000H 1/10 1 1/ /
71 / /101/1, Fail Safe Fool Proof 69
72 R-Map protective device ISO/IEC Guide51
73 71 R-Map ppm
74 72 2 R-Map R-Map
75 6. 52 R-Map CPSCConsumer Product Safety Commission,
76 74 GFCIGround Fault Circuit Interrupter ON OFF OFF R-Map 2: Remote GFCI A B : -2-B3 GFCI 2
77 75 GFCI GFCI 5556 R-Map C I -4-A1
78 76 A1 R-Map 3
79
80 A2 61
81 8. 62 ISO/IEC GUIDE 51 tolerable risk R-Map 79
82 80 63 GUIDE 51 3 IEC R-Map a lost-time work
83 81
84 82 IEC61508MIL-Std-882cCPSC R-Map IEC61508 ISO13949 ( )
85 83
86 RAPEX EU R-Map EU RAPEX RAPEX WEEK DVD DEHP DBP / DBP DINP 84
87 DEHP CPSC R-Map CPSC Consumer Product Safety Commission R-Map CPSC CPSC R-Map CPSC CPSC incident 85
88 R-Map CPSC AC R-Map CPSC CPSC prompt CPSC AC No CPSC / 4 86
89 / ATV ( ) 19 87
90 AC AC DVD 蠟 蠟 OFF PIROT
91 prompt CPSC CPSC 2 prompt CPSC prompt R-Map 13 3 prompt 2 prompt prompt prompt R-Map 89
92 R-Map R-Map 90
93 1 11, , ,0008X ,0005X10-4 R-Map B Recall 1 3 B3 2 Recall 2 9 A1 Prompt prompt 91
94 R-Map A1 Prompt
95 prompt R-Map 1 B2 B3 2 A1 prompt CPSC Most Wanted 93
96 R-Map R-Map AB2 B3 B
97 5 3 B1 CPSC R-Map B3 R-Map
98 CPSC CPSC CPSC 6 M M 1, R-Map B1 C 5 CPSC R-Map
99 R-Map R-Map 1. 1 M 2 P 2. 3 I 4 T 5 S R-Map R-Map 97
100 1 M CO M R-Map B3 2. ( ) 1 A A2 A R-Map /
101 2 P CO P 2 R-Map 1. CO A A A1 A R-Map / / /
102 3 I R-Map A1 2 9 A2 3mm R-Map 2006/3/10 :32,000 : ?
103 4 T 84%( 16 ) R-Map : ( ) : : : 0 : R-Map 1990 B A1 34, /101988/2 1990/5 2007/ B3 A
104 5 S 30 R-Map ,000 7,000 B3 2. B2B3 ALARP ( ) ,000 7,
105 IEC R-Map 1. B1 ALARP
10 9 10 12 13 13 14 21 21 24 26 26 28 31 33 36 38 35 38 40 41 41 41 45 51 53 62 64 68 68 70 71 78 83 84 84 85 96 96 101 101 102 104 104 106 67 95 107 108 109 112 112 113 120 120 120 121 123 123 125 125
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10 11 12 13 14 15 16 17 Plan Do Check Action 1 2 3 4 146 13 20 43 44 45 62 104 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47
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