In order to bring your medical devices to market, you need to demonstrate the performance of their various packagings, including maintaining sterility according to ISO 11607-1 when it comes to sterile barrier systems. To ensure that they are protected until delivery, you need to verify the performance of all the packaging protecting your devices, including transport packaging.
To support manufacturers and enable them to market their products with confidence, the LNE offers a global range of services to validate performance:
- sterile packaging systems (e.g. bags, blister packs, vials, etc.) for medical devices,
- non-sterile packaging systems (e.g. secondary packaging, transit packaging, etc.)
- transport packaging in general (boxes, boxes, groupage boxes, etc.)
NEW - The LNE has just obtained the extension of its COFRAC* Tests n° 1-0606 accreditation for medical device packaging (ISO 11607-1).
*Sites and scopes on Cofrac.fr.
Validation of medical device packaging
Validation of medical device packaging is achieved by conducting the following tests:
- Accelerated aging in temperature and/or humidity to ensure the integrity of the sterile barrier and validate the stability of the packaging according to the protocols of the ASTM F1980 standard "Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices"
- Pre-conditioning: tests (temperature, humidity, pressure, etc.), aimed at simulating as fully as possible the climatic conditions that the MD will be able to encounter at all stages of its distribution circuit, according to the ISO 14 971 "Risk Management of Medical Devices" and ASTM D4332 "Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing" standards.
- Transport simulation: tests (shock, drop, compression, vibrations, etc.) to evaluate the behavior of the product and its packaging when subjected to various stresses related to their distribution cycle, according to ASTM D4169 "Standard Practice for Performance Testing of Shipping Containers and Systems", ISTA, etc.
- Performance testing of sterile barrier systems according to ISO 11607-1:
- Visual inspection of seals according to ASTM F1886 "Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection"
- Element integrity (sealing) according to ASTM F1929 "Standard test method for detecting seal leaks in porous medical packaging by dye penetration"
- Sealing strength on a bag or blister according to NF EN 868-5 (Annex D - Method for determining the strength of the seal for bags and sheath material) or according to ASTM F88 "Standard Test Method for Seal Strength of Flexible Barrier Materials"
- Peelability according to the NF EN 868-5 standard (Annex E) "Method for determining the peelability characteristics of laminated paper/plastic film"
- Internal pressure according to ASTM F2096 "Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)".
Fiches détaillées de la prestation
Afin de répondre aux exigences des normes NF le LNE qualifie et évalue la performance du couple emballage-produit.
Téléchargez la fiche détaillée
Our recognition of competence
- Tests carried out under Cofrac* accreditation n° 1-0606 (in french)
- LNE, an organization certified by the International Transportation Safety Association (ITSA)
*Sites and scopes available on cofrac.fr.
Means and equipment
To carry out these tests, the LNE has many means at its disposal
Additional services
Why choose LNE
- A single point of contact and a single site to carry out all your tests: a single shipment and recovery of the samples to be tested, saving time and reducing costs.
- A renowned multidisciplinary player in the medical-health field thanks to its extensive expertise (regulatory compliance tests, calibration, technical-regulatory assistance, packaging qualification, medical biology reference materials, etc.), and its subsidiary GMED, a certification body and notified body, a major player in the sector.
- An organization recognized by national and international regulatory bodies, with more than 20 years of experience in the medical field and the majority of its services accredited by COFRAC*.
- Comprehensive expertise to qualify packaging regardless of the constituent materials (paper-cardboard, plastics, laminates and composites) and the type of packaging (unit, grouping, etc.).
- Quality and usable test reports to facilitate presentation to the notified body.
- ISO 17025 accredited testing laboratories by COFRAC*.
* List of accreditations, sites and scopes available on cofrac.fr
