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97年度醫療器材採認標準資料單
97年度醫療器材採認標準資料單
97年度醫療器材採認標準資料單
ABC.
CEI/IEC 61326-2-6:2005
Horizontal
Vertical
DOH-000480
ABC.
ISO 22870:2006
Horizontal
Vertical
DOH-000481
ABC.
POCT1-A2
Horizontal
Vertical
DOH-000482
ABC.
POCT2-P
Horizontal
Vertical
DOH-000483
ABC.
POCT4-A2
Horizontal
Vertical
DOH-000484
ABC.
CNS 15035:2006
95/10/31
Horizontal
()
()
Vertical
DOH-000485
ABC.
AST3-A
1999-02
Horizontal
Vertical
DOH-000486
ABC.
AST4-A2
Horizontal
Vertical
DOH-000487
ABC.
AUTO1-A
Horizontal
Vertical
DOH-000488
ABC.
AUTO2-A2
Horizontal
Vertical
DOH-000489
ABC.
AUTO5-A
Horizontal
Vertical
DOH-000490
AUTO7-A
AUTO7-A
Horizontal
Vertical
DOH-000491
ABC.
AUTO8-P
Horizontal
Vertical
DOH-000492
ABC.
AUTO9-P
Horizontal
Vertical
DOH-000493
ABC.
C37-A
Horizontal
Vertical
DOH-000494
ABC.
C40-A
Horizontal
Vertical
DOH-000495
ABC.
EP6-A
Horizontal
Vertical
DOH-000496
ABC.
EP17-A
Horizontal
Vertical
DOH-000497
ABC.
EP21-A
Horizontal
Vertical
DOH-000498
ABC.
GP10-A
Horizontal
Vertical
DOH-000499
ABC.
M6-A
Horizontal
Vertical
DOH-000500
ABC.
M7-A7
Horizontal
Vertical
DOH-000501
ABC.
M21-A
Horizontal
Vertical
DOH-000502
ABC.
M22-A3
Horizontal
IVDs
Vertical
DOH-000503
ABC.
M23-A2
Horizontal
IVDs
Vertical
DOH-000504
ABC.
M24-A
Horizontal
Vertical
DOH-000505
ABC.
M26-A
Horizontal
Vertical
DOH-000506
ABC.
M31-S1
Horizontal
Vertical
DOH-000507
ABC.
M31-A2
Horizontal
Vertical
DOH-000508
ABC.
M32-P
Horizontal
Vertical
DOH-000509
ABC.
M39-P
Horizontal
Vertical
DOH-000510
ABC.
M45-P
Horizontal
Vertical
DOH-000511
ABC.
MM13-A
Horizontal
Vertical
DOH-000512
3.
ISO 11140-1:2005
Horizontal
Vertical
DOH-000513
2.
ISO 10993-3:2003
Horizontal
Vertical
DOH-000514
2.
Horizontal
Vertical
DOH-000515
2.
ISO 10993-6:2007
Horizontal
Vertical
DOH-000516
2.
Horizontal
Vertical
DOH-000517
2.
ISO 10993-11:2006
Horizontal
Vertical
DOH-000518
3.
ISO 11138-1:2006
Horizontal
Vertical
DOH-000519
3.
ISO 11138-2:2006
Horizontal
Vertical
DOH-000520
3.
ISO 11138-3:2006
Horizontal
Vertical
DOH-000521
3.
ISO 11138-4:2006
Horizontal
Vertical
DOH-000522
2.
ISO 11138-5:2006
Horizontal
Vertical
DOH-000523
3.
ISO 11140-3:2007
Horizontal
Vertical
DOH-000524
3.
ISO 11140-4:2007
Horizontal
Vertical
DOH-000525
3.
ISO 11140-5:2007
Horizontal
Vertical
DOH-000526
3.
ISO 11737-1:2006
Horizontal
Vertical
DOH-000527
3.
ISO 11737-2:1998
Horizontal
Vertical
DOH-000528
3.
ISO 13408-3:2006
Horizontal
Vertical
DOH-000529
3.
ISO 13408-5:2006
Horizontal
Vertical
DOH-000530
3.
ISO 13408-6:2005
Horizontal
Vertical
DOH-000531
3.
ISO 14644-8:2006
Horizontal
Vertical
DOH-000532
2.
ISO/TS 20993:2006
Horizontal
Vertical
DOH-000533
3.
ANSI/AAMI ST24:1999
Horizontal
Vertical
DOH-000534
3.
ANSI/AAMI ST55:2003
2004/06/02/
Horizontal
Vertical
DOH-000535
3.
ANSI/AAMI ST66:1999
Horizontal
Vertical
DOH-000536
3.
ANSI/AAMI ST77:2006
Horizontal
Vertical
DOH-000537
3.
ISO 15882:2003
Horizontal
Vertical
DOH-000538
5.
CNS 13382-1:2004
93/09/27
Horizontal
Vertical
DOH-000539
5.
CNS 13382-2:2004
93/09/27
Horizontal
---
---(
)
Vertical
DOH-000540
5.
CNS 13382-3:2004
93/09/27
Horizontal
-----
-----
()
Vertical
DOH-000541
5.
CNS 13382-4:2004
93/09/27
Horizontal
---
---(
)
Vertical
DOH-000542
5.
CNS 13382-5:2004
93/09/27
Horizontal
(
)
(2)
Vertical
DOH-000543
5.
CNS 13382-6:2004
--
93/09/27
Horizontal
--
--(
)
Vertical
DOH-000544
5.
CNS 13382-7:2004
93/09/27
Horizontal
-6 -4
-6-4
()
Vertical
DOH-000545
5.
CNS 13382-8:2004
93/09/27
Horizontal
----
---()
Vertical
DOH-000546
N.
CNS 13382-9:1995
84/01/04
Horizontal
Vertical
DOH-000547
N.
CNS 13382-10 :1995
84/01/04
Horizontal
ab
cde
fgh
Vertical
DOH-000548
N.
CNS 13382-11:1995
84/01/04
Horizontal
Vertical
DOH-000549
N.
CNS 13382-12:1995
84/01/04
Horizontal
1. CNS
2.
B
Vertical
DOH-000550
N.
CNS 13382-13:1995
84/01/04
Horizontal
Vertical
DOH-000551
N.
CNS 13382-14:1995
84/01/04
Horizontal
Vertical
DOH-000552
N.
CNS 13382-15:1995
84/07/29
Horizontal
1.
2.
A
Vertical
DOH-000553
N.
CNS 13382-16:1995
84/07/29
Horizontal
CNS 13382-13
Vertical
DOH-000554
N.
CNS 13382-17:1995
84/07/29
Horizontal
guide wires
Vertical
DOH-000555
5.
CNS 13382-18:1995
84/07/29
Horizontal
Vertical
DOH-000556
N.
CNS 13382-19:1995
84/07/29
Horizontal
per-load
50mm
Vertical
DOH-000557
N.
CNS 13382-20:1995
84/07/29
Horizontal
Vertical
DOH-000558
N.
CNS 13382-21:1995
84/07/29
Horizontal
(2)CNS 13382-205(2)
(3)CNS 13382-205(3)
Vertical
DOH-000559
N.
CNS 13382-22:1995
84/07/29
Horizontal
Vertical
DOH-000560
N.
CNS 13382-23:1995
84/07/29
Horizontal
Vertical
DOH-000561
5.
CNS 13382-24:1996
85/07/24
Horizontal
UHMWPE
UHMWPE
Vertical
DOH-000562
5.
CNS 13382-25:1996
85/07/24
Horizontal
Vertical
DOH-000563
N.
CNS 13382-26:1996
85/07/24
Horizontal
Vertical
DOH-000564
N.
CNS 13382-27:1996
Steinmann
85/07/24
Horizontal
Steinmann
Vertical
DOH-000565
N.
CNS 13382-28:1996
85/07/24
Horizontal
U
U
Vertical
DOH-000566
N.
CNS 13382-29:1996
85/07/24
Horizontal
1
1. CNS 13382-12
CNS 13382-1[-
]/
2.
2
Vertical
DOH-000567
N.
CNS 13382-30:1996
85/07/24
Horizontal
Vertical
DOH-000568
D.
CNS 14961:2005
94/12/05
Horizontal
200 bar15
(5L)
Vertical
DOH-000569
D.
CNS 14962:2005
94/12/05
Horizontal
5LLPG
Vertical
DOH-000570
D.
CNS 14963:2005
94/12/05
Horizontal
B(1)
(2)
(3)
Vertical
DOH-000571
D.
CNS 15003-1:2006
95/04/19
Horizontal
()
()
, , ,
, , /,
, ,
CNS 15004
Vertical
DOH-000572
D.
CNS 15003-2:2006
95/04/19
Horizontal
(1)
(2) (3)
(4)
Vertical
DOH-000573
D.
CNS 15004:2006
95/04/19
Horizontal
Vertical
DOH-000574
D.
CNS 15005-1:2006
95/04/19
Horizontal
/[50%50% ()]
(NIST)ISO
5359
(AGSS)
CNS 15005-2 ( ISO 9170-2 )
Vertical
DOH-000575
D.
CNS 15005-2:2006
95/04/19
Horizontal
CNS
15003-2ISO 7396-2
Vertical
DOH-000576
D.
CNS 15006:2006
95/04/19
Horizontal
1.2
/
50/50 (%)1.3
Vertical
DOH-000577
4.
ISO/IEC 25000-1:2007
Horizontal
Vertical
DOH-000578
1.
Horizontal
Vertical
DOH-000579
1.
IEC 60601-1-6:2006
Horizontal
Vertical
DOH-000580
P.
CEI/IEC 60601-2-22:1995
Horizontal
Radiographic equipment
Vertical
DOH-000581
P.
Horizontal
Radiographic equipment
Vertical
DOH-000582
1.
IEC 61326-1:2005
Horizontal
Vertical
DOH-000583
P.
IEC/TR 60825-8:2006
Horizontal
Vertical
DOH-000584
1.
IEC/TR 62354:2005
2005-12-15
Horizontal
Vertical
DOH-000585
1.
ISO 12052:2006
Horizontal
Health informatics
Vertical
DOH-000586
4.
ISO/IEC 25051:2006
Horizontal
Vertical
DOH-000587
4.
ISO/IEC 25062:2006
Horizontal
Vertical
DOH-000588
J.
CNS 15036-1:2006
95/10/31
Horizontal
(
)
/
Vertical
DOH-000589
J.
CNS 13460:1994
83/12/01
Horizontal
0.3 ~ 5MHz
50W
Vertical
DOH-000590
J.
CNS 14624-1 :2002
91/03/07
Horizontal
Vertical
DOH-000591
J.
CNS 14624-2 :2002
91/03/07
Horizontal
CNS l4624-l-
Vertical
DOH-000592
J.
CNS 14624-3:2002
91/03/07
Horizontal
CNS l4624-l
Vertical
DOH-000593
J.
CNS 14624-4:2002
91/03/07
Horizontal
Vertical
DOH-000594
J.
CNS 14624-5:2002
91/03/07
Horizontal
50 mll00 ml l50 ml
Vertical
DOH-000595
J.
CNS 14624-6 :2002
91/03/07
Horizontal
CNS l4624-l-
Vertical
DOH-000596
J.
CNS 14624-7:2002
91/03/07
Horizontal
CNS l4624-1-
Vertical
DOH-000597
J.
ISO 15883-1:2006
Horizontal
Sterilizing equipment
Vertical
DOH-000598
J.
ISO 15883-2:2006
Horizontal
Sterilizing equipment
Vertical
DOH-000599
J.
ISO 15883-3:2006
Horizontal
Sterilizing equipment
Vertical
DOH-000600
J.
ISO/TS 15883-5:2005
Horizontal
Sterilizing equipment
Vertical
DOH-000601
J.
D6499-03
ASTM International
Horizontal
Vertical
1.2 For the purpose of this test method, the range of protein
will be measured in terms of microgram to milligram
quantities.
1.3 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish
appropriate safety and health practices and determine the
applicability of regulatory limitations prior to use.
DOH-000602
J.
E1104-98(R2003)
ASTM International
Horizontal
Vertical
DOH-000603
J.
E196598 (R2003)
ASTM International
Horizontal
Vertical
DOH-000604
E.
F2081-01
ASTM International
Horizontal
Vertical
DOH-000605
K.
F64794 (R2000)
ASTM International
Horizontal
Vertical
1.2 Devices to which this practice is applicable include, but are not
limited to, those that are temporarily implanted to effect external
drainage; or permanently implanted to effect shunting of fluid from a
cerebral ventricle, a cyst, the subarachnoid space to the peritoneal
cavity, the venous circulation, or some other suitable internal delivery
site, and intracranial bypass.
1.3 Limitations-- Although this practice includes a standard test
method for the evaluation of pressure/flow characteristics of shunts or
shunt components, it does not include specific pressure/flow
requirements.
1.4 The following components, that individually or in combination
comprise shunt assemblies, are considered to be within the scope of
this practice: catheters (such as atrial, peritoneal, ventricular),
connectors, implantable accessory devices (such as antisiphon devices
and reservoirs), valved catheters and valves.
1.5 This standard does not purport to address all of the safety
concerns, if any, associated with its use. It is the responsibility of the
user of this standard to establish appropriate safety and health
practices and determine the applicability of regulatory limitations
prior to use.
DOH-000606
J.
F88194 (R2000)
ASTM International
Horizontal
Facial Implants
Vertical
DOH-000607
K.
F154294 (R2000)
ASTM International
Horizontal
Vertical
DOH-000608
J.
F167003
ASTM International
Horizontal
Vertical
DOH-000609
J.
F167103
ASTM International
Horizontal
Vertical
DOH-000610
J.
BF7:1989/(R)2002
2002-1-31
Horizontal
Vertical
DOH-000611
J.
BP22:1994/(R)2001
1994-08-30
Horizontal
Vertical
DOH-000612
E.
DF80:2003
Horizontal
Cardiac defibrillators
Vertical
DOH-000613
E.
EC11:1991/(R)2001
2001-05-04
Horizontal
Vertical
DOH-000614
E.
EC12:2000/(R)2005
2005-01-06
Horizontal
Vertical
DOH-000615
E.
EC53:1995/(R)2001
2001-05-11
Horizontal
Vertical
DOH-000616
E.
EC57:1998/(R)2003
Horizontal
Vertical
DOH-000617
K.
60601-2-23:1999
Horizontal
Vertical
DOH-000618
E.
60601-2-27:1994
Horizontal
Electrocardiographs
Vertical
DOH-000619
E.
60601-2-30:1999
Horizontal
Vertical
DOH-000620
E.
60601-2-34:2000
Horizontal
Vertical
DOH-000621
J.
60601-2-38:1996/Amd.1, 1999
Horizontal
Vertical
DOH-000622
J.
594-1:1986
Horizontal
Vertical
DOH-000623
J.
594-2:1998
Horizontal
Vertical
DOH-000624
E.
5841-1:1989
1989-11-15
Horizontal
Vertical
DOH-000625
E.
5841-2:2000
Horizontal
Vertical
DOH-000626
E.
5841-3:2000
Horizontal
Vertical
DOH-000627
K.
7197:1997
Horizontal
Vertical
DOH-000628
J.
8537:1991/Amd.1, 2000
Horizontal
Vertical
DOH-000629
K.
NS28:1988/(R)2001
2001-07-23
Horizontal
Vertical
DOH-000630
J.
PB70:2003
Horizontal
Vertical
DOH-000631
E.
SP10:2002/A1:2003
2002-10-28
Horizontal
Vertical
DOH-000632
J.
ANSI/AAMI II:36:1997
Infant incubators
1997/09/15
Horizontal
Vertical
DOH-000633
H. -
ANSI/AAMI RD5:2003
Hemodialysis systems
2007/11/08
Horizontal
Dialysis equipment
Vertical
DOH-000634
H. -
ANSI/AAMI RD16:2007
Horizontal
Vertical
DOH-000635
H. -
ANSI/AAMI RD17:2007
Cardiovascular implants and artificial organs Extracorporeal blood circuit for hemodialyzers,
hemodiafilters and hemofilters
2007/07/19
Horizontal
Vertical
DOH-000636
H. -
Reuse of hemodialyzers
2003/04/25
Horizontal
Vertical
DOH-000637
H. -
ANSI/AAMI RD52:2004
2004/09/16
Horizontal
Vertical
DOH-000638
H. -
ANSI/AAMI RD61:2006
2007/05/04
Horizontal
Vertical
DOH-000639
H. -
ANSI/AAMI RD62:2006
2007/01/06
Horizontal
Vertical
DOH-000640
J.
ISO 7886-2:1996
Horizontal
Vertical
DOH-000641
J.
Horizontal
Vertical
DOH-000642
J.
Horizontal
Vertical
DOH-000643
ABC.
CNS 13075:2007
96/01/19
Horizontal
()
Vertical