ASTM D4332 Testing

ISO 11607: Sterile Barrier

The Applied Technical Services Family of Companies (FoC) provides package testing for sterilized medical devices in compliance with ISO 11607: Sterile Barrier. Medical device packaging must adhere to relevant standards and regulations, and ATS’ package testing lab offers the resources needed to ensure the sterility, quality and durability of medical device packaging systems.

The Importance of Medical Device Sterilization

The term “medical device” refers to a wide range of medical instruments, tools, and equipment used to diagnose, treat, and prevent illness and disease. Medical devices encounter various environments and conditions throughout the supply chain process, and its essential that these devices remain sterilized until the moment patients and medical professionals use them. Failure to properly sterilize medical devices and their packaging could result in compromised equipment that can spread harmful germs and diseases.

What is ISO 11607?
The International Organization for Standardization (ISO) developed ISO 11607 as a guideline for what qualifies a medical device as “terminally sterilized.” Terminal sterilization is the sterilization of a product in its final packaging or container. Packaging engineers implement a sterile barrier system or the minimum layer of protection necessary to ensure the contents of the package remain sterile until they reach the end user. ISO 110607 has two parts, ISO 11607-1 and 11607-2.
ISO 11067-1
The standard’s first half addresses the requirements and approved methods used to test the sterile barriers and packing systems needed to sustain the terminal sterilization of products before use.

ISO 11067-2

The second half of the standard establishes the requirements that manufacturers must follow to ensure the terminal sterilization of their medical devices.
About Our Package Testing Lab
Our package testing labs offer an extensive list of package testing services, including:
Our package engineers have decades of collective experience in related sciences and disciplines. We work closely with our clients to develop unique procedures that address the needs of our clients while also complying with relevant regulatory standards.
Our Commitment to Quality
Applied Technical Services provides professional consulting engineering, inspection, and testing services. As an ISO 9001 quality management system, we’ve remained committed to continually improving and expanding our capabilities and customer service. Please call +1 (888) 287-5227 or submit an online request to inquire about our ISO 11607: Sterile Barrier services.

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