Medical Device Packaging Requirements

Test aims to validate the integrity of the material bubble leak the integrity of the seal resistance of the seal the distribution tests and the aging of the package. Ensuring your material. Labeling regulations pertaining to medical devices are found in the following parts of title 21 of the code of federal regulations cfr.

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Package validation testing for medical devices are described in iso 11607.

Medical device packaging requirements.

In short the medical device development is not limited to the devices themselves but. The package of a medical device will play a fundamental role in the safe delivery of treatment to patients. General device labeling 21 cfr part 801 use of symbols. It needs to ensure the integrity of the product from the manufacturer to its final point of use and in some cases the packaging could function in the treatment application.

Keystone works closely with kentwood mich based packaging compliance labs pcl which validates sterile medical device packaging according to fda recognized standard iso 11607. The general labeling requirements for medical devices are contained in 21 cfr part 801. Where a control number is required by 820 65 that control number shall be on or shall accompany the device through distribution. Industry experts at a recent medical device packaging seminar gave many good reasons why companies should think about it earlier.

Here is a breakdown of the design sterilization testing requirements and validation processes medical device companies need to consider when tackling a packaging project. Medical device packaging requirements. Packaging design is often last on the to do list of medical device manufacturers despite complex regulatory requirements. These regulations specify the minimum requirements for all devices.

The standard has three main pillars according to ryan erickson a packaging engineer at pcl. The resilient packaging must also meet rigorous labeling standards which let the fda trace devices in use. Selection criteria for medical device packaging. Most medical devices are packaged either in a pouch or a tray.

The label and labeling used for each production unit lot or batch shall be documented in the dhr. Each manufacturer shall control labeling and packaging operations to prevent labeling mixups. Packaging for terminally sterilized medical devices published in 2006 is the principal reference guide for medical device packaging and includes information on testing requirements. If not properly planned for upfront packaging can significantly delay timelines.

Astm and ista series distribution testing offer a set of specific test methods for compliance with iso 11607.

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