EMC China Lab

Medical Device Packaging Biocompatibility

Views :
Update time : 2025-03-18

For medical devices that come into direct contact with patients, packaging is particularly crucial. In particular, the biocompatibility of medical device packaging materials directly affects patient health and safety. Therefore, testing various indicators of medical device packaging materials is essential, especially biocompatibility testing.

 

Medical Device Packaging Biocompatibility(图1)


Biocompatibility Requirements for Medical Packaging Materials

The latest ISO 10993-1 standard mentions that packaging materials in contact with the product must be included in the evaluation process. This requirement arises because medical devices are often in prolonged contact with packaging materials, raising concerns about potential extractables and leachables transferring to the device. As a result, chemical analysis of packaging materials is necessary for evaluation.

 

Additionally, packaging materials that directly contact medical devices must undergo a biological safety assessment. Relevant guidelines can be found in ASTM F2475-20. Furthermore, if the medical device is used for pharmaceutical packaging, compliance with USP <87> Biological Reactivity Tests, in vitro and USP <88> Biological Reactivity Tests, in vivo is required. These tests classify materials into Class I–IV based on invasiveness or implantability, ensuring material safety and reducing overall product risk. Moreover, the cleanliness of packaging materials is closely related to product cleanliness, making particulate residue a critical factor for consideration.

 

Potential Risks of Non-Compliant Packaging Materials

If non-compliant medical device packaging materials come into short-term contact with the human body, they may cause toxicity, irritation, teratogenicity, and localized inflammation at both the cellular and systemic levels. Long-term exposure may lead to genetic mutations, teratogenic effects, or even carcinogenicity. When in contact with blood, such materials could cause coagulation abnormalities and hemolysis.

 

Therefore, all materials used in medical device packaging must undergo biocompatibility testing. China JJR Laboratory is certified to conduct biocompatibility testing and biological evaluations for medical device packaging materials, including toxicological assessments. We welcome inquiries regarding our services.


Email:hello@jjrlab.com


Leave Your Message


Write your message here and send it to us


Related News
Read More >>
FCC ID Certification Compliance Certificate FCC ID Certification Compliance Certificate
04 .30.2025
FCC ID certifies RF products meet U.S. standards for safety and interference. JJR Lab provides testi...
How many types of FCC certifications are there? How many types of FCC certifications are there?
04 .30.2025
FCC certification includes SDoC and FCC ID for electronic and wireless devices. JJR Lab provides tes...
Australia RCM LOGO Certification Australia RCM LOGO Certification
04 .30.2025
RCM certification combines safety & EMC for AU/NZ market access. JJR Lab provides testing to hel...
ANATEL Certification Process in Brazil ANATEL Certification Process in Brazil
04 .30.2025
ANATEL certification is required for telecom products entering Brazil. JJR Lab provides testing to e...
Faucet European Standard EN 817 Testing Faucet European Standard EN 817 Testing
04 .30.2025
JJR Lab provides faucet testing and certification according to European standards EN 817, EN 200, EN...
ISO 17025 Laboratory Test Report ISO 17025 Laboratory Test Report
04 .30.2025
Amazon product removals may occur due to missing ILAC ISO17025 reports or label issues. JJR Lab prov...
Temu Requires UN 38.3 Certification Temu Requires UN 38.3 Certification
04 .30.2025
TEMU requires UN 38.3 certification for battery transport. JJR Testing Laboratory offers professiona...
What is the Amazon ASTM F2057 Test Report? What is the Amazon ASTM F2057 Test Report?
04 .30.2025
The ASTM F2057-23 standard ensures safety for clothing storage units, focusing on stability, flammab...

Leave Your Message