EU RMap

Similar documents


技術流出防止指針公表用.PDF

0ミ0、0・タ

-2-

平成20年度内部評価実施結果報告書《本編》

untitled

untitled

untitled

01-11_20-22.indd

磐田市水道事業ビジョン

IEC :2014 (ed. 4) の概要 (ed. 2)

CONTENTS

1 1,200m ,482,620m 1 323,825m 1 205,988m 114,988m 60,000m 31,000m ,837m ,158,795m ,340m 1 48,006m 1 33,016m 1,125m

スライド 1

第1章フランチャイズビジネスの基礎知識

Japanese.PDF

73-5 大友

p...{..P01-48(TF)




Huawei G6-L22 QSG-V100R001_02

. 1 EBM Evidence-Based Medicine JCAHO 2


021017部会資料案.PDF

クイックスタートガイド [SC-03E]

VIRTUALLY INVISIBLE 300 WIRELESS SURROUND SPEAKERS

Domain Name System nisc.go.jp XXX -2-2

2. IEC61508 ISO WD IEC6150 SIL( Safety Integrity Level ) ISO WD2626 ASIL( Automotive Safety Integrity Level ) SIL/ASIL (tolerable risk) (Residu

ブック 1.indb

CSR報告書2005 (和文)


untitled

Taro12-認定-部門-ASG101-06

Tab 5, 11 Tab 4, 10, Tab 3, 9, 15Tab 2, 8, 14 Tab 1, 7, 13 2

Kumagai09-hi-2.indd


参考資料

Contents P. P. 1

< D906C95B639352D966B96EC8F48926A90E690B D5A CC8F898D5A816A2E706466>

JAB NF01 REV JIS Q 17025: /

平成15年度

機械指令 2006/42/EC への適合のためのガイド (第2版)

IBM BCS Blue

- 1 -

医療機器指令 93/42/EEC の概要(第2版)

m 3 /s

11夏特集号初校.indd

untitled

TOS7200 CD-ROM DUT PC 1.0X p.15 NEMA Vac/10 A [85-AA-0003] m : CEE7/7 : 250Vac/10 A [85-AA-0005] : GB1002 : 250Vac/10A [ ] 2016


300, , : 1

研究レポート表紙.PDF

<95DB8C9288E397C389C88A E696E6462>

untitled

() () () () () 175 () Tel Fax

C ONTENTS

BR indd

JAB GR300:2014 ISO 14065:2013 JAB GR300: /

P.3 P.4 P.9 P.11

P20 security senryaku.pdf 31 31

2 10 The Bulletin of Meiji University of Integrative Medicine 1,2 II 1 Web PubMed elbow pain baseball elbow little leaguer s elbow acupun

Contents 4 06 IP2 41 Thermo Scientific Nalgene Nalgene

橡災害.PDF

医学教育研究とは 2011_10_14 v1

The EMC Directives - Guide for 89/336/EEC and 2004/108/EC


01

170403_1_FABEX_2017会場案内マップ

Ł\”ƒ1PDFŠp

クイックスタートガイド [SC-06D]

<4D F736F F F696E74202D E7797DF82C597768B8182B382EA82E9838A E A B8CDD8AB B83685D>

untitled

Bull. of Nippon Sport Sci. Univ. 47 (1) Devising musical expression in teaching methods for elementary music An attempt at shared teaching

1. Database&Logic Word/Excel/PPT/PDF&Web Ultimate Dictionary 4. Jukkou&Rewrite 5. Convenience&Safety 6. Chinese&Korean 7. Support&Consultation 8

untitled

Motivation and Purpose There is no definition about whether seatbelt anchorage should be fixed or not. We tested the same test conditions except for t

untitled

(別添)環境表示ガイドライン(案)

医療事故の現状と課題-医療事故への対応策の整備を中心に-

RACK & INDUSTRIAL FURNITURE

No.7, (2006) A Survey of Legislation Regarding Environmental Information in Europe and Japan IWATA Motokazu Nihon University, Graduate School of

1章


目 次

表紙 PDF

環境マネジメントシステムが抱える課題と対応策――ISO14001の取り組み現場から

Copyright

EC・GMO事件

公開講座09

untitled

Safety Tel Fax Tel Fax Tel Fax Tel

LHHBAA+ArialMT Adobe Identity 0

untitled

43 1 2

FreeSpace.book


untitled

環境報告書2003 

Transcription:

20 3

1. 1.1 1 1.2 1 1.3 2 2. 2.1 4 2.2 4 2.3 5 3. 3.1 6 3.2 EU 6 3.3 7 3.4 7 4. 4.1 8 4.2 8 4.3 8 5. 5.1 11 5.2 12 18 35 RMap 52 82 84

1 1.1. 1.2 (1) (2)

2 (3) 1.3

3

4 2. R-Map 2.1 EU ISO/IEC 51 EU 2.2 EU (PL) EU

5 2.3 CPSC EU RAPEX R-Map R-Map

6 3 3.1 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

7 3.3.2 CPSC CPSC CPSC PROMPT CPSC CPSC PROMPT R-Map R-Map R-Map 0 ( )110 CPSC 110 10 1 1001 R-Map CPSC 3.4.3 R-Map 0 110 R-Map R-Map

8 4. 4.1 ISOIEC 51 4.2 JIS 4.3 R-Map

9 R-Map A R-Map B R-MapC ISOIEC

10

11 5. 5.1 (1) R-Map R-Map (2) R-Map 0 110 1 (3) R-Map A

12 B ALARP C A C C (4) R-Map 5.2 (1) R-Map (2) CPSC (3) R-Map

13 R-Map (4) R-Map A A A B B C C C (5)

14 (6) (7) R-MapJIS ISO14121 B

18 20 20 21 23 24 26 31 31 32 33 34 35 IEC61508 35 MIL-Std-882.c System Safety Program Requirements 37 CPSC 38 RAPEX 40 44 45 47 IEC61508 48 49 49

49 50 RMap RMap 52 RMap 59 66 68 70 73 77 79 82 84 85 97

18 ISO/IEC 51:1999 1990 ISO IEC ISO/IEC 51 ISO/IEC 51 ISO/IEC 51 ISO/IEC 51

19 1

20 ISO/IEC 51 EU ISO/IEC 51 CPSA2 1 CPSACFR1115 EU GPSDRAPEX CPSA2 CPSA 9(f)(3)

21 CPSA2 CFR1115.6 Comparative safety CPSA2 ISO/IEC 51 EU CPSA9(f)(3) ISO/IEC 51

22 EU RAPEX ISO/IEC 51 CPSA15(a) ISO14121

1 CPSACFR1115 GPSDRAPEX Substantial product EU hazard Substantial risk of injury The hazard represents the intrinsic potential 15(a) CFR1115.4 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 1115.12 23

24 1 CPSACFR1115 EU GPSDRAPEX Severity of the risk CFR 1115.12 Risk of injury CPSA3 Serious risk GPSD1(d) RAPEX ISO/IEC 51 ISO/IEC 51 ISO/IEC 51

25

26 EU Risk Estimation Risk Evaluation CFR 1115.6 1 CPSACFR1115 EU GPSDRAPEX CFR1115.6 1 Safe product risks considered to be acceptable Risk Estimation Risk Evaluation

27

28

29 EU RAPEX 2 1 2 1 2 3 RAPEX Substantial product hazard CPSA15CFR1115.12 3 EU RAPEX

30 1 CPSACFR1115 EU GPSDRAPEX Substantial product hazard CPSA15CFR 1115.12 3 2 RAPEX 1 2 3 RAPEX

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, 2005 31

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) CFR1115.8 (3.4) CPSC rely 4 CPSA15 CPSC CPSA7 CPSC rely CPSC CPSC CFR1115.8 (3.2) (3.3) 32

(5.1) CPSA15 5.3 PL 2 3 CPSA37 1.75 102 Substantial product hazard (8.1(f)) Substantial product hazard (5.1) CPSA15 EU 33

34 EU (5.1) (5.1) EU

IEC61508 IEC61508-5 B ALARP ALARP 35

36 SIL SIL 10 10

MIL-Std-882.c System Safety Program Requirements A 10 10 High 37

38 CPSC RECALL HANDBOOK CPSC Substantial product hazard A A A B C C CPSC

CFR1115.12 CFR1115.12 39

40 RAPEX EU PRODUCT SAFETY IN EUROPE:A Guide to corrective action including recalls EU GPSD RAPEXRapid E change

41

100 100 42

RAPEX Low RAPEX 20076 2007 11 43

44 1 1

45 R-Map R-Map AC A B C

46 R-Map 10 10 RAPEX B1 B2 RAPEX

47 IEC61508 IEC61508-5 D SIL IEC61508 SIL ISO13849 SIL 1

48

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?, 2007101 49

50 General C. Possible Probable EU 0 4

51

RMap 1. RMap RMapRisk-Map, PSProduct Safety, 1974 Product Liability, 1990 ISO/IEC Guide51 2005 R-Map R-Map R-Map Acceptable Level R-Map R-Map R-Map 1 R-Map 52

2 Unacceptable Risk 1990 ISO/IEC Guide51 PL R-Map R-Map R-Map 56 30 A1, B3, C 53

54 5B3 4B3 3B3 2B3 B3 5B3 5 1/10 4, 3, 2 4 1:29:300 80

55 5 R-Map IEC 60601-1-4 IEC 61508 0 R-Map R-Map FDA 2005.4 2007.10

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

57 6 R-Map 1 100 3 1,000 6 0 7 0

58 8 AC 3 5: 1/10 1/1,000 accept A ISO 12100-1,-2

ISO 14121 B ISO 13849-1 ISO IEC 2006.4.1 IEC 61508 IEC ISO/IEC Guide51 IEC 60513 IEC60601-1-4 EU 1998 10 ISO 14971 IEC60601-1-4 ISO IEC R-Map R-Map 1995 R-Map PS R-Map 2. R-Map 912 R-Map 10 10 59

60

61 13 0 10-6 2004 859 A B3

62 14 R-Map 15 CO 2005.11.29 82 1985 B3 2005.4 1 A1 11/21 A2 11/29

16 CO 2 1985.1 20 A1 A 63

64 17 B3 20 18 17 A1

20 H16 9 B1 1 B3 B2 C B1 21 1 / or 1 state of the art 21 2 T 1/10 0.2 T 10 1 0.6ppmT 10 6ppm T 10 65

66 3. EU EC 36 state of the art

67 PL EU PDCA Plan-Do-Check-Action : 1990 PS 3738 39 R-Map

4. 10Fit1 Fit=10-9 /H 1,000 1/10 10-5 / 1 1 1,000H 1/10 1 1/1010-1 / 10 1 40 68

7 10-6 10-8 / 1 10-5 1/101/1,000 41 Fail Safe Fool Proof 69

70 5. 43 5 R-Map protective device ISO/IEC Guide51

71 R-Map 44 3 3 ppm 2 45 46 1996 18 64 16

72 2 R-Map 4751 44 R-Map

6. 52 R-Map CPSCConsumer Product Safety Commission, 1991 73

74 GFCIGround Fault Circuit Interrupter ON OFF OFF R-Map 2: Remote GFCI A B3 0 10-8 10-8 5354 : -2-B3 GFCI 2

75 GFCI GFCI 5556 R-Map C I -4-A1

76 A1 R-Map 3

77 57 7. 58 5960 34 59

78 8 5 60-5-A2 61

8. 62 ISO/IEC GUIDE 51 tolerable risk R-Map 79

80 63 GUIDE 51 3 IEC 61508 R-Map 1930 5 64 1 a lost-time work 29 300

81

82 IEC61508MIL-Std-882cCPSC R-Map IEC61508 ISO13949 ( )

83

RAPEX EU R-Map EU RAPEX RAPEX WEEK45 2007 DVD DEHP DBP / DBP DINP 84

DEHP CPSC R-Map CPSC Consumer Product Safety Commission R-Map 1. 2007 10 2. 2006 1 2007 12 2 3. CPSC CPSC 0 1 10-8 R-Map CPSC 2007 10 67 29 38 CPSC incident 85

R-Map CPSC AC R-Map CPSC 26 13 CPSC 12 10 2 2 prompt CPSC AC No. 1 2 3 4 5 CPSC 2007 10 18 35 4 10 328 / 4 86

6 0 5 185 830 7 80 2 8 0 1 9 1250 1 0 5 10 4700 4 0 3 11 / 11 7 1 2 12 800 3 13 ATV 011 14 6000 2 323 68 15 11000 3 16 2 6000 2 17 1 5 9 3 18 ( ) 19 87

20 0 2 247 6 21 2 45 1 1 2 22 22 4 23 0 6 5700 2 24 25 0 1 1800 6 26 27 9000 4 28 29 0 7 25 4 30 31 0 2 AC AC 14 15 DVD 32 0 4 蠟 9600 12 蠟 33 325 2 17 34 010 8 3.5 35 OFF PIROT 1 4000 3 36 88

37 310 5200 4 38 prompt CPSC CPSC 2 prompt CPSC prompt 20062007 2 23 R-Map 13 3 prompt 2 prompt 13 2 2 prompt 4 10 3 4 3 2005 prompt R-Map 89

R-Map R-Map 90

1 11,0001 3 38,000 3 338,0008X10-5 20 2038,0005X10-4 R-Map B3 10-8 1 Recall 1 3 B3 2 Recall 2 9 A1 Prompt 1 10-8 2 2 prompt 91

2 1 14 2 1 R-Map A1 Prompt 1 10-8 2 92

3 1 5 14 2 prompt 1 2 10-8 R-Map 1 B2 B3 2 A1 prompt CPSC Most Wanted 93

4 10 10 R-Map R-Map AB2 B3 B2 10-8 94

5 3 B1 CPSC R-Map B3 R-Map 10-8 95

CPSC CPSC CPSC 6 M M 1,410 2 1 7 23 30 R-Map B1 C 5 CPSC R-Map 10-8 96

R-Map R-Map 1. 1 M 2 P 2. 3 I 4 T 5 S 3. 6 1 10-8 R-Map R-Map 97

1 M CO 2005 11 29 M R-Map 1. 2005 4 B3 2. ( ) 1 A1 3. 7 A2 A R-Map 6.6 10-6 4.0 10-7 11/21 2005.4.21 2005.11.21 2004.62005.4 1 1985 2005.4 6-1 98

2 P CO 2006 8 P 2 R-Map 1. CO 1985 1 1982 4 28 4 3 1020 A1 2. 1989 7 6 A1 3. 21 2006 8 21 A1 A R-Map 2006 8 21 19801989 26 06/8 21 6 10-6 89/7 6 4 10-6 85/1 26 10-6 6-2 99

3 I R-Map 1. 2 9 2. A1 2 9 A2 3mm R-Map 2006/3/10 :32,000 :2005.12006.4? 4.8 10-5 6-3 100

4 T 84%( 16 ) R-Map 2007 10 : ( ) : : : 0 : R-Map 1990 B A1 34,359 1986/101988/2 1990/5 2007/4 100 2 5.7 10-6 B3 A1 6-4 94 2.7 10-4 8 2.3 10-5 101

5 S 30 R-Map 1. 3050 6,000 7,000 B3 2. B2B3 ALARP 2007 8 2 1970 ( ) 1956 77 670 6,000 7,000 2000 24 19 6-5 102

103 6 10 1 IEC R-Map 1. B1 ALARP 2006 7 10 70 10 7 4700 6-6