Medical Package Testing Standards
Standards Expertise
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.
Package Testing Standards Organizations
Life Science Outsourcing is experienced in package testing that must comply with the following standards:
- 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 Standards
ISTA Standards
ISO Standards
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