Medical Device Testing Industry Standards
DDL is experienced in performing tests that comply with the following medical device testing industry standards.
Do you have a question regarding medical device industry standards?
| ASTM Standards | |
| D3078 | Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission |
| D3079 | Standard Test Method for Water Vapor Transmission of Flexible Heat-Sealed Packages for Dry Products |
| D3330 | Standard Test Method for Peel Adhesion of Pressure-Sensitive Tape |
| D4169 | Standard Practice for Performance Testing of Shipping Containers and Systems |
| D4332 | Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing |
| D4991 | Standard Test Method for Leakage Testing of Empty Rigid Containers by Vacuum Method |
| F88 | Standard Test Method for Seal Strength of Flexible Barrier Materials |
| F1140 | Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages for Medical Applications |
| F1608 | Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method) |
| F1929 | Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration |
| F1980 | Standard Guide for Accelerated Aging of Sterile Medical Device Packaging |
| F2096 | Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test) |
| ISO Standards | |
| 10555-1 | Sterile, single-use intravascular catheters – general requirements |
| 11070 | Sterile Single-use Intravascular Catheter Introducers |
| ISTA Standards | |
| ISTA | Pre-Shipment Test Procedure |
For more information on industry standards and compliance requirements for medical device testing and package validation, please contact us today.
