Distribution testing 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.
The most frequently used standards are:
- ISTA Procedure 3A: Packaged-Products for Parcel Delivery System Shipments 70kg (150 lb) or Less (standard, small, flat or elongated)
- ASTM D4169: Standard Practice for Performance Testing of Shipping Containers and Systems
Medical device transit testing is usually applied to complete shipping cartons of products from single product packs (if supplied this 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. In order to provide worst case 'real life' conditions these inputs can be preceded by a variety of pre-conditioning regimes.
Other Pre-Conditioning options are available on request.
Medical Device Transit Testing Protocols typically include:
- 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, repeat - visual inspection
- ISO 11607 Sterile Barrier Validation – A Reminder
- ISO 11607 Requirements change for 2019 - New Packaging Standards for Medical Devices
- ISO11607 Medical Device Packaging
- Air Transport Validation of PFSs and Auto-injectors
- Can Shelf Life Testing Be Dissociated From Transit Testing?
- Accelerated Ageing for Medical Device Packs What Temperature?