Packaging Standards for Medical Device Safety
Learn about packaging standards and their importance in ensuring the safety and performance of medical devices over time.
Both the FDA and international regulatory bodies emphasize on compliance with ISO 11607; Packaging for Terminally Sterilized Medical Devices. This standard defines the test requirements necessary to ensure that the terminally sterilized package/device will maintain its design performance over the intended life of the product and will not degrade as a result of sterilization, shelf life, transport, or storage.
- ANSI
American National Standards Institute - AAMI
Association for the Advancement of Medical Instrumentation - ASTM
American Society for Testing & Materials - ISO
International Organization for Standardization - ISTA
International Safe Transit Association
- ASTM-D3078
- ASTM-D4169
- ASTM-D642
- ASTM-F1140
- ASTM-F1980
- ASTM-D4728
- ASTM-D999
- ASTM-D6344
- ASTM-D6653
- ASTM-F1886
- ASTM-F2096
- ASTM-D5276
- ASTM-D4332
- ASTM-F1929
- ASTM-F88
Standards Expertise
Package Testing Standards Organizations
Life Science Outsourcing is experienced in package testing that must comply with the following standards:
ASTM Standards
ISTA Standards
• ISTA 1A • ISTA 2A • ISTA 3A • ISTA 1G Learn More
ISO Standards
• ISO 11607 • ISO 17665 Learn More
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