ISTA / ASTM Transit Validation

Medical Device Transit Testing

Shipping validation is mandatory for CE marked medical devices. MET’s medical device transit testing protocols follow the philosophy of ISO 11607-1 - Packaging for terminally sterilized medical devices. Requirements for materials, sterile barrier systems and packaging systems.

Medical device transit testing is usually applied to complete shipping cartons of products, from single product packs (if supplied in such a format) to complete pallets. The shipping simulation process subjects the package to multiple conditions, and to the rigours of transport and handling: random vibration, vehicle stacking, impact and compression. We offer a choice of ASTM or ISTA testing protocols and a variety of pre-conditioning regimes.

Pre-conditioning Options:

Conditions Temperature Relative Humidity
 Tropical  +38°C  85%
 Desert  +50°C  low
 Frozen  -20°C  low
 Ambient/Wet  +23°C  85%

Other Pre-Conditioning options are available on request. 

Medical Device Transit Testing Protocols:
ASTM D4169 - Standard Practice for Performance Testing of Shipping Containers and Systems includes:

  • Air Transport - Long Haul
  • ASTM D5276, sch. A: Initial manual handling. Drop on each side from 15 inches - visual inspection
  • ASTM D642, sch. C: Vehicle stacking. Calculate stacking load, compress - visual inspection
  • ASTM D999, sch. F: Loose load vibration. Vibrate at 40Hz for 40 minutes, turning twice - visual inspection
  • ASTM D4728, sch. E: Vehicle vibration. 2-200Hz at RMS 0.52G for 180 minutes, turning twice - visual inspection
  • ASTM D5725, sch. A: Final manual handling. Drop each side from 15 inches and base 30 inches, x 2 - examined by visual inspection

 

Transit Simulation, Compression Test Transit Simulation, Concentrated Impact Test