来源：人民网-人民日报 作者：史自强/
贺林平/王昊男
Congratulations! You want to sterile package your medical device. Now what?
Here are four issues to keep in mind to make your packaging project a success.
Concern #1—Specifications and Design
Since budget is always a concern, the first question you should ask yourself is, “How many products or product lines do I want to package?” A package that fits multiple product lines or product sizes will drop your costs significantly by reducing the number of validations you need to perform. You can also consider a package scheme that fits two or three sizes and covers all product lines.
Concern #2—Sterilization Method
What’s the most effective sterilization method? It depends. First, ensure that the sterilization method you choose is compatible with your product and your packaging materials. The two most common sterilization methods are gamma sterilization and ethylene oxide gas. If you choose gamma sterilization, check that your materials do not change color after sterilization since some materials such as Acrylonitrile-Butadiene-Styrene (ABS) and polyvinyl chloride (PVC) tend to turn yellow. With ethylene oxide gas, you need to make sure that there isn't residual gas left on your product. A good rule of thumb is if you need surface sterilization, choose gamma. If your product has intricate surfaces, go with ethylene oxide. Gamma can also penetrate through most materials, but it’s dependent on the density of your product’s component materials.
