Blog

Aug6, 2015

DDL Now Offering Test Method Validation Services

Aug 6, 2015|Test Method Validation, Testing Services|

DDL is now offering test method validation (TMV) services to medical device manufacturers and developers.

Test method validation 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.
“TMV is a […]

Jul22, 2015

DDL Expands Its Medical Device Package Testing Capacity

Jul 22, 2015|Medical Device Package Testing, Medical Device Packaging, Packaging Validation|

DDL has expanded capacity for medical device package testing at its laboratories in Fountain Valley, CA and Eden Prairie, MN.

The expansion includes the addition of more chambers at its recently opened facility at the Fountain Valley laboratory to provide increased capacity for environmental conditioning, real time aging and accelerated aging testing. Additional chamber capacity has […]

Jun29, 2015

FAQ’s About Electrosurgical Accessory Testing IEC 60601-2-2

Jun 29, 2015|Medical Device Testing|

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 […]

Jun25, 2015

DDL Receives ISO/IEC 17025 Accreditation

Jun 25, 2015|DDL News, Medical Device Package Testing, Medical Device Testing|

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 […]

Jun16, 2015

DDL Offers Testing Capabilities to Support ISO 10555 Part 6 for Subcutaneous Implanted Ports

Jun 16, 2015|Medical Device Testing|

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 […]

May13, 2015

Testing Guidelines for Pre-Filled Syringes

May 13, 2015|Medical Device Testing, Testing Services|

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 […]

Apr23, 2015

DDL Offers New White Paper: “What is test method validation (TMV) and what can it do for me?”

Apr 23, 2015|Medical Device Testing, Testing Services|

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 […]

Mar18, 2015

Overview of ASTM F1929 Dye Penetration Integrity Test

Mar 18, 2015|ASTM, Medical Device Package Testing, Package Integrity|

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 […]

Feb18, 2015

Accelerated Aging: Abusing the Time Machine

Feb 18, 2015|Medical Device Package Testing, Packaging Validation|

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 […]

Feb3, 2015

Revisions to ASTM D4169 and Impact on Medical Device Package Testing

Feb 3, 2015|ASTM, Medical Device Package Testing, Packaging Validation|

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 […]

DDL's Testing Locations

DDL's testing laboratories are located in Eden Prairie, MN and Fountain Valley, CA. Learn more about the different testing services provided at each location.

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