医疗器材之生物相容性

療

Host Response to Biomaterials

(Biological safety)

1. 理

料 (Biological response to biomedical materials)

1. (cellular reactions)

(cytotoxicity)

2. (tissue reactions)

( local response)

3. (systematic response)

若 料 ( ) ( : thrombus formation thrombosis)

*clot thrombus 不

(biocompatibility) 料

* (blood compatibility) 不易 (thromboresistant; nonthrombogenic; antithrombogenic)

IMPLANTATION 料

Acute Inflammation

Immune Response

Chronic inflammation

Healing and Repair ? Calcification “Foreign Body

Reactions”

料

降

exudate 料swelling 料 (functionality)降

exudate 料 量 降 來

*

injurious agent mononulcear leukoctyes foreign body giant cells ( macrophages 來) biomaterials foreign body granuloma Granuloma 類 狀 來 foreign body granuloma

不 料 不 不 foreign body reaction 料不 異

*

料

fibrin crosslinked polymer entrap (platelets) (red blood cells; erythrocytes) 來

理

clotting cascade activation

platelet activation

連串 coagulation proteins intrinsic extrinsic pathways fibrin clot platelet aggregation

* 料 料

降

Leachables( )

ISO 10993

Part 13~18 料

料 降

2.

Biocompatibility Testing

Effectiveness ( )

Safety( )

療 concepts

療 料

料 ( ) 見 ASTM (F748 ) USP

ISO 10993

ANSI

Generic names!!

regulation (or不 )

tests 不

could be proprietary!

The test lab should follow GLP.

若不 行 說

(regulatory authority) Regulation: science-based A partner rather than merely a judge. (Guidance documents)

Extremely controversial

ASTM F748 (test types with recommended tests*)

TBG-ISO TC 194

ISO 10993

CNS ISO 10993

ISO 10993

Part 1: ( ) Part 2:

Part 3:

Part 4:

Part 5:

Part 6:

ISO 10993

Part 7: EO 留

Part 8: 料

Part 9: 降

Part 10: 刺

Part 11:

Part 12:

ISO 10993

Part 13: 降

Part 14: 降

Part 15: 金 金降 Part 16: 降

力

Part 17:

Part 18: 料

ISO 10993

ISO 10993-1: 2003

ISO 10993-4: 2002

ISO 10993-5: 1999

ISO 10993-10: 2002

ISO 10993-12: 1996

SELECTION MATRIX

ASTM F748

ISO 10993-1

SELECTION MATRIX 利

兩參數來

(ISO)

Non-contact devices (not included) Surface-contacting devices

External communicating devices

Implant devices

(ISO)

Surface-contacting devices

Skin (

)

Mucosal membranes ( 尿 ) Beached or compromised surface (

料 )