EU基準認証制度のののの現状現状ととと問題点と …

1 17 18181818 .. 1 .. 1 .. 1 .. 2 .. 4 .. 5 .. 5 .. 9 .. 10 .. 10 NBs .. 12 .. 16 .. 19 .. 19 .. 20 .. 21 .. 26 .. 26 .. 26 .. 28 2003 .. 28 .. 31.

2 31 .. 32 .. 33 ..41 UNICE .. 41 It's the Internal Market, Stupid! .. 41 IMFMG WG .. 51 .. 53 CECIMO .. 53 ORGALIME .. 54 CECED .. 55 EUCOMED .. 55 ANEC .. 56 .. 58 .. 58 .. 61 .. 63 .. 64 .. 67 .. 70 .. 72 EEA EFTA .. 72 .. 73 .. 76 1 .. 12 2 .. 16 3 ..17 4 EMC .. 18 5.

3 40 1 .. 6 2 .. 8 3 .. 8 4 .. 9 5 .. 13 6 .. 14 7 2003 .. 28 1 1985 1985 i 1985 1 ii 1989 2 iii 1993 3 1985

4 1985 1 Council Resolution of 7 May 1985 on a new approach to technical harmonization and standards (85/C 136/01) Official Journal C136, 04/06/1985 2 Council Resolution of 21 December 1989 on a global approach to conformity assessment (90/C 10/01) Official Journal C010, 16/01/1990 3 93/465/EEC: Council Decision of 22 July 1993 concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the CE conformity marking, which are intended to be used in the technical harmonization directives Official Journal L220.

5 30/08/1993 2 Harmonised Standards CEN CENELEC ETSI a b 3 c d 1993

6 E f 4 General Guidelines i ii CEN CENELEC ETSI iii iv v vi vii

7 5 25 1993 1993 93/68/EEC4 21 21 1 EMC 2 3 4 a 50 1000V 75 1500V 4 Council Directive 93/68/EEC of 22 July 1993 amending Directives 87/404/EEC (simple pressure vessels), 88/378/EEC (safety of toys), 89/106/EEC (construction products), 89/336/EEC (electromagnetic compatibility), 89/392/EEC (machinery), 89/686/EEC (personal protective equipment), 90/384/EEC (non-automatic weighing instruments), 90/385/EEC (active implantable medicinal devices), 90/396/EEC (appliances burning gaseous fuels)

8 , 91/263/EEC (telecommunications terminal equipment), 92/42/EEC (new hot-water boilers fired with liquid or gaseous fuels) and 73/23/EEC (electrical equipment designed for use within certain voltage limits) Official Journal L220, 30/08/1993 6 b EMC DIY EMI EMS c 1

9 1 (Low voltage equipment) 73/23/EEC 93/68/EEC 1974 8 19 1995 1 1 1997 1 1 2 (Simple pressure vessels) 50bar 87/404/EEC 90/488/EEC 93/68/EEC 1990 7 1 1991 7 1 1995 1 1 1992 7 1 1997 1 1 3 (Safety of toys) 14 88/378/EEC 93/68/EEC 1990 1 1 1995 1 1 1997 1 1 4 (Construction products) 89/106/EEC 93/68/EEC 1991 6 27 1995 1 1 1997 1 1 5 (EMC/Electromagnetic compatibility) 89/336/EEC 92/31/EEC 93/68/EEC 2004/108/EC 1992 1 1 1992 10 28 1995 1 1 2005 20 1995 12 31 1997 1 1 2007 1 20 6 (Machinery) 89/392/EEC 91/368/EEC 93/44/EEC 98/37/EC 98/79/EC 1993 1 1 1995 1 1 1998 8 12 1998 12 7 1994 12 31 1997 1 1 2000 6 7 7 7 (Personal protective equipment) 89/686/EEC 93/68/EEC 93/95/EEC 96/58/EC 1992 7 1 1995 1 1 1994 1 29 1997 1 1 1995 6 30 1997 1 1 8 (Non-automatic weighing instruments) 90/384/EEC 93/68/EEC 1993 1 1 1995 1 1 2002 12 31 1997 1 1 9 (Active implantable medical devices)

10 90/385/EEC 93/42/EEC 93/68/EEC 1993 1 1 1995 1 1 1997 1 1 1994 12 31 1998 6 14 10 (Appliances burning gaseous fuels) 90/396/EEC 93/68/EEC 2004/8/EC 2005/32/EC 1992 1 1 1995 1 1 2004 2 21 2005 8 11 1995 12 31 1997 1 1 2006 2 21 2007 8 10 11 (New hot-water boilers) 4kW 400kW 92/42/EC 93/68/EEC 1994 1 1 1995 1 1 1997 12 31 1997 1 1 12 (Explosives for civil uses) 93/15/EEC 1995 1 1 2002 12 31 13 (Medical devices) 93/42/EEC 98/79/EC 2000/70/EC 2001/104/EC 1995 1 1 2000 6 7 2001 12 13 2002 1 10 1998 6 14 2001 6 30