MEDICAL PACKAGE TESTING
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Standards
Life Science Outsourcing has deep expertise in providing packaging testing that complies with all relevant industry standards and guidelines.
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
ISTA Standards
ISO Standards
