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2017.3.28
2017
National Taipei University of Technology
2
Safety
National Taipei University of Technology
3
(biocompatibility) : The quality of not having toxic or injurious effects on biological systems
(systematic response)
(cellular response)
(tissue response)
(local response)
National Taipei University of Technology
4
- ISO 10993 http://www.iso.org/iso/iso_catalogue.htm- ASTM F748-95 http://www.astm.org
- FDA Guidance documents (G95-1) http://www.fda.gov/cdrh/g951.html
- CNS 14393:2004 http://www.cnsonline.com.tw/
CNS 14393FDA (G95-1)ISO 10993
National Taipei University of Technology
ISO 10993
5
ISO 10993 Biological evaluation of medical devices
()
National Taipei University of Technology
ISO 10993
6
ISO 10993 :
National Taipei University of Technology
ISO 10993
7
National Taipei University of Technology
ISO 10993
8
/
ISO 10993-8 ISO 10993-12
ISO 10993-1
ISO 10993-2
///ISO 10993-9 ISO 10993-13 ISO 10993-14 ISO 10993-15 /ISO 10993-16 ISO 10993-17 ISO 10993-18
ISO 10993-7
ISO 10993-3 ISO 10993-4 ISO 10993-5 ISO 10993-6 ISO 10993-10 ISO 10993-11
National Taipei University of Technology
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:
National Taipei University of Technology
:
10
ISO 10993
()
//
National Taipei University of Technology
:
11
A. (Limited)24
B. (Prolonged)24~30
C. (Permanent)30
National Taipei University of Technology
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(ISO 10993-5 ) (ISO 10993-11) (ISO 10993-11) (ISO 10993-10) (ISO 10993-10) (ISO 10993-10) (ISO 10993-4) (ISO 10993-6)
(ISO 10993-11) (ISO 10993-3) (ISO 10993-3) (ISO 10993-9)
? ?
National Taipei University of Technology
ISO 10993
13
FDA + ISO additional test for FDA
National Taipei University of Technology
14
ISO 10993-1
()
CytotoxicityISO10993-5
National Taipei University of Technology
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ISO 10993-5 Test for in vitro Cytotoxicity
(L929 3T3)
? ?
>24
/
(Cytotoxicity)
National Taipei University of Technology
17
(Filter diffusion test)
(Direct contact test)
(Elution test)
: ()
/
0123
(Agar diffusion test)
(0.45m)
()
IrritationISO10993-10
National Taipei University of Technology
19
ISO 10993-10 Test for Irritation and Delayed-type Hyperseneitivity
(2Kg)
(
()
(Irritation)
National Taipei University of Technology
20
12345
12345
12345
12345
0.2ml
4
()
()
25mm2
25mm2
25mm2
25mm2
(Skin irritation)
(Intracutance reactivity)
()
SensitizationISO10993-10
National Taipei University of Technology
(1/2)
22
ISO 10993-10 Test for Irritation and Delayed-type Hyperseneitivity
(300~500g)
-: (48h)(24h)
-: 33
/
(Hyperseneitivity)
National Taipei University of Technology
23
10SLS
+
8cm2 ()
1
2
3
7 day
48h
14 day
24h
ABC
+
+
0.1ml
6h
24h
6h
24h
6h
24h 14day
6h6h
24h
6h
24h
6h
24h
6h
24h
6h
24h
6h
(Bueher test) (maximization)
Implant EffectsISO10993-6
1. ()24h
2. ()24h
ISO 10993-6 Tests for local effects after implantation
(Subcutaneous)
(Muscle)
(Bone)
(12)
(12)
Muscle tissue from negative and positive reacting implants.
Minimal response
Severe response
http://www.devicelink.com/mddi/archive/98/08/013.html
():
() :
Systemic EffectsISO10993-11
1.
2. 30d30d()
3. 30d30d
()
ISO 10993-11 Tests for systemic toxicity
(acute toxicity) : < 24 hours (subacute) : 14-28 days (subacute/subchronictoxicity) : up to 90 days (chronic toxicity) : > 90 days
(oral) (dermal) (inhalation) (intravenous) (intraperitoneal)
:
/
Hemocompatibility
ISO10993-4
()(
)(thrombogenicity)(
)
ASTM F75616((NIH)
Autian)()
(
ELISA)C3aSC5b-9
ASTM F206519ASTM F1984
GenotoxicityISO10993-3
In vitro Ames test In vitro Chromosomal aberration TKIn vitro Mouse lymphoma In vivo micronucleus
DNA
ISO 10993-3 Tests for genotoxicity, carcinogenicity and reproductive toxicity
(mutagenicsubstancemutagen)(carcinogenicity)
(ISO 10993OEDC )
OECD : Organisation for Economic Co-operation and Development)
Ames
Salmonella typhimuriumhis
DNA DNA
CarcinogenicityISO10993-3
In vivo bioassay
Species: rat, mouse
Two year duration
Multiple dose groups
Histological tissue examination
Statistical analysis
Risk assessment
Re p r o d u c t i v e a n d d e v e l o p m e n t a l t o x i c i t y
ISO10993-3
1
2 ()
3
ISO10993-
ISO 10993-1
- MEM elution method
ISO10993-5 L929
-
ISO10993-4ASTM
- -
ISO10993-10
- -
ISO10993-10()
-
ISO10993-10
-
ISO10993-11
/- /
ISO10993-11(14~90)
-
ISO10993-11(>6)
- - LAL Test
USPLAL test
- - - - TK
ISO10993-3DNA
- - -
ISO10993-6
National Taipei University of Technology
52
ISO 10993-1 6 :
Equivalent
ISO 10993
National Taipei University of Technology
53
ISO 10993-1
?
?
1. 2.
/
/
ISO 10993
()
?
1.2.3.
?
National Taipei University of Technology
54
2
2
-
-
-
/
A.
B.
C.
D.
E.
F.
~Thankyou~