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EN ISO 13485
(AIMD)
(MDD)
(IVDD),
E-mail
HP
MED_F_03.06J.docx
Rev.9
2009-09-01
Page 1/8
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EN ISO 13485
(AIMD)
(MDD)
(IVDD),
ISO9000
AIDM MDD
IVDD
*
*
OEM
1
EN ISO13485 / ISO9001
1
2
AIMDD (90/385/EEC)
1
3
MDD (93/42/EEC)
2
4
IVDD (98/79/EEC)
1
5
(2000/70/EEC)
1
(2003/32/EEC)
MED_F_03.06J.docx
Rev.9
2009-09-01
Page 2/8
Telephone: +81 3 3372 4821
Telefax: +81 3 3372 4163
http://www.tuv-sud.jp
160-0023
4-33-4
TÜV®
EN ISO 13485
(AIMD)
(MDD)
(IVDD),
1
US QSR’s
[
[
]
]
[
[
]
]
1
1
EN ISO 13485
ISO13485/CMDCAS
ISO9001 : 2008
EN ISO 13485
ISO13485/CMDCAS
ISO9001 : 2008
EN ISO 13485
ISO13485/CMDCAS
ISO9001 : 2008
MED_F_03.06J.docx
Rev.9
2009-09-01
Page 3/8
Telephone: +81 3 3372 4821
Telefax: +81 3 3372 4163
http://www.tuv-sud.jp
160-0023
4-33-4
TÜV®
EN ISO 13485
(AIMD)
(MDD)
(IVDD),
2
a)
b)
c) UMDNS
d) UMDNS
AIMDD
(GMDN
)
(GMDN
)
UMDNS/Universal Medical Device Nomenclature System
GMDN/Global Medical Device Nomenclature (http://gmdn.org)
TÜV Product Service
AIMDD Annex 3 (
)
AIMDD Annex 2.4 (
)
TÜV Product Service
AIMDD Annex 2.4
Annex 2.3
AIMDD Annex 3
Annex 5
AIMDD Annex 3
Annex 4
AIMDD Annex 3 + 5
EC
3+4
Annex 3
AIMDD Annex 3
E-mail
MED_F_03.06J.docx
Rev.9
2009-09-01
Page 4/8
Telephone: +81 3 3372 4821
Telefax: +81 3 3372 4163
http://www.tuv-sud.jp
160-0023
4-33-4
TÜV®
EN ISO 13485
(AIMD)
(MDD)
(IVDD),
3
MDD
a)
b)
c) UMDNS
d) UMDNS
(GMDN
)
(GMDN
)
UMDNS/Universal Medical Device Nomenclature System
GMDN/Global Medical Device Nomenclature (http://gmdn.org)
MDD *
MDD a
MDD
MDD Annex
MDD **
MDD b
TÜV Product Service
1
MDD1 Annex
(
MDD2 Annex
.4 (
)
)
2
b
TÜV Product Service
MDD3 Annex
MDD3 Annex
EC
MDD3 Annex
MDD3 Annex
3
*
MDD Annex
Annex
Annex
+
*
Annex
+
Annex
MED_F_03.06J.docx
Rev.9
2009-09-01
Page 5/8
Telephone: +81 3 3372 4821
Telefax: +81 3 3372 4163
http://www.tuv-sud.jp
160-0023
4-33-4
TÜV®
EN ISO 13485
(AIMD)
(MDD)
(IVDD),
E-mail
MED_F_03.06J.docx
Rev.9
2009-09-01
Page 6/8
Telephone: +81 3 3372 4821
Telefax: +81 3 3372 4163
http://www.tuv-sud.jp
160-0023
4-33-4
TÜV®
EN ISO 13485
(AIMD)
(MDD)
(IVDD),
4
IVDD
a)
b)
c) EMDS
d) EMDS
EMDS/European Diagnostic Market Statistics Nomenclature
(http://www.edma-ivd.be)
IVDD,
A
IVDD,
B
IVDD,
TÜV Product Service
IVDD1Annex
(
IVDD2 Annex
.4 (
)
IVDD3Annex
.6 (
)
)
1
IVDD Annex
Annex
A
2
IVDD Annex
Annex
A
B
3
TÜV Product Service
IVDD Annex
IVDD Annex
E-mail
MED_F_03.06J.docx
Rev.9
2009-09-01
Page 7/8
Telephone: +81 3 3372 4821
Telefax: +81 3 3372 4163
http://www.tuv-sud.jp
160-0023
4-33-4
TÜV®
EN ISO 13485
(AIMD)
(MDD)
(IVDD),
5
EMEA European Agency for the Evaluation of Medical Products
MDD Annex
MED_F_03.06J.docx
Rev.9
2009-09-01
Page 8/8
4.3
Telephone: +81 3 3372 4821
Telefax: +81 3 3372 4163
http://www.tuv-sud.jp
160-0023
4-33-4
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