When DDL purchased Citech in 2010, it took on the challenge of learning the methodology to perform electrosurgical accessory testing under the guidance of Citech’s founder and president, Robert Mosenkis. Citech’s primary area of expertise was in the performance testing of the insulation that protects patients and practitioners from the high voltage electrical signals used […]
DDL is pleased to announced its Eden Prairie, MN and Fountain Valley, CA facilities have received ISO/IEC 17025:2005 accreditation from the American Association for Laboratory Accreditation (A2LA).
ISO/IEC 17025:2005 is the international standard by which a laboratory’s commitment to quality and technical competence are evaluated. DDL achieved ISO/IEC 17025:2005 accreditation by demonstrating its laboratories are in […]
DDL is now able to provide testing for subcutaneous implanted ports in accordance with the newly added Part 6 of the ISO 10555 series of test standards. Part 6 standardizes the test methods for subcutaneous implanted ports. DDL’s capabilities include leakage, tensile and needle penetration as covered in Annex A, C, D and E of […]
The use of pre-filled glass syringes is becoming more and more prevalent as the preferred delivery device for drugs and vaccines. Pre-filled syringes are a more efficient, reliable and convenient method for drug administration helping to reduce drug waste and dosage errors while also improving safety.
A number of testing standards have been developed for the […]
Test method validation (TMV) is the documented process of ensuring a test method is suitable for its intended use. It involves establishing the performance characteristics and limitations of a method and the identification of influences which may change those characteristics. The experimental results are subjected to statistical analysis and a series of pre-defined acceptance criteria […]
ASTM F1929 “Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration” is a dye penetration integrity test used by package engineers that is designed to detect and locate leaks caused by channels formed between a transparent film and a porous material.
The ASTM F1929 standard was first written in 1998, was […]
At the heart of ASTM F1980 “Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices” are the Arrhenius equation and Accelerated Aging Factor (AAF) Determination (Sections 6 and 7). Practical use of the AAF involves choosing an aging factor (Q10) which is typically a value of two (2) for packaging testing, an […]
ASTM D4169-09 recently has been revised to D4169-14. ASTM D169 is the test method performed by subjecting shipping units to a test plan consisting of a sequence of hazard elements which would be encountered in various distribution environments.
ASTM D169 is the standard that has been used extensively in the medical device industry, as it is […]
Medical device packaging is almost as important as the device itself. Packaging for medical devices plays a key role in safely delivering specialized treatment to patients. Most single use, sterilized medical devices can be opened with a high degree of confidence that it has remained sterile throughout storage, handling, and transportation.
What makes medical device packaging […]
Many medical device manufacturers (MDMs) struggle with the development of a packaging system design qualification test plan for compliance to ISO 11607. ISO 11607 requires that sterile medical device package systems be capable of withstanding the transportation and distribution environment. This is typically accomplished by performing a package performance test protocol consisting of a series […]