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An evaluation of biocompatibility is one of the basic assessments needed for a medical device. As the use of medical devices should not exert harmful effect on human body, therefore, the safety of packaging materials that come in contact with the device should also be evaluated.
ASTM 2475-05 illustrates the appropriate testing for biocompatibility of packaging materials used to contain a medical device. The selection of biocompatibility testing depends on the degree of the packaging interacts with the device, while the testing is conducted according to the commonly recognized standard for biological evaluation of medical devices – ISO 10993.
A common regulatory position for solid medical devices is that the packaging material contacts the device only and is generally considered indirect contact to the patient and thus requires limited biocompatibility testing.
If blood, blood products, fluid products, biologicals and drugs have packaging materials that directly contact the patient product (for example, tissue, fluid, or blood), or if the packaging materials are considered an integral part of a device that directly contacts the patient, then this would require additional biocompatibility testing of the packaging materials.
The table below summarizes the suggested testing for different medical device packaging materials:
Packaging materials
classification
Suggested Testing
                                          
ABCDEFGHIDevice contact
materials
X
Possible patient
tissue/fluid contact
X
X
X
Direct patient
tissue/fluid contact
(External)
X
X
X
X
Direct patient/fluid
contact
(Internal)
X
X
X
X
X
X
X
Direct blood path/
Short term implants
X
X
X
X
X
X
X
X
X
Implants
X
X
X
X
X
X
X
X
14 A:CytotoxicityB:Acute Systemic ToxicityC:IrritationD:SensitizationE:MutagenicityF:PyrogenicityG:Implantation (muscle)H:HemocompatibilityI:Subchronic Toxicity If you concern about the safety of packaging materials of your medical device, SGS Hong Kong can help to provide you an answer. Contact us now.
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