To ensure that your injection systems (auto-injectors, needles and syringes) comply with applicable requirements and meet safety requirements, LNE supports you from the design stage right through to market launch of your products, offering a wide range of services.
Whether you are a manufacturer of injection systems (auto-injector pens, needles, syringes, etc.) or a pharmaceutical company needing to validate the performance of combination products (syringes and medicines), LNE supports you in meeting your requirements for regulatory compliance, performance, safety and innovation.
Compliance with standards and regulations
In order to obtain and maintain CE marking, minimise the risk of non-compliance and accelerate access to international markets, you need to:
- Comply with Regulation (EU) 2017/745 (MDR) on medical devices,
- Meet the applicable ISO standards (ISO 11608 for injection systems, ISO 7886 for syringes and ISO 7864 for hypodermic needles),
- Ensure metrological traceability and the safety of the device.
LNE offers the following services:
- Compliance testing with applicable standards and performance evaluation,
- Assistance with regulatory compliance and preparation for CE marking,
- CB Scheme certification for electronic injection systems to facilitate access to international markets and potentially reduce costs and lead times through a single test campaign (safety, EMC, cybersecurity) recognised in all target countries.
Device Performance and Reliability
To reduce malfunctions and injection-related incidents, assess performance over the intended service life, and meet expectations for reliability and patient comfort, you need to:
- Ensure dosing accuracy, injection force, mechanical strength and safety of use (protected needles, automatic triggering, etc.),
- Test robustness against variations in temperature, pressure or during transport.
LNE offers the following services:
LNE carries out all the tests specified in the relevant standards for the systems in question, including in particular: syringes, hypodermic needles, auto-injector pens, cartridges, and their connectors.
Tests on syringes and hypodermic needles
- Syringes for manual use in accordance with ISO 7886-1:2017
- Verification of critical dimensions and nominal volume
- Leakage tests (air/liquid)
- Piston sliding force tests
- Mechanical strength tests (breakage, deformation)
- Tests on the legibility and durability of markings
- Syringes with injury prevention features in accordance with ISO 7886-3
- Assessment of safety device activation
- Verification of the effectiveness of the anti-needle-stick mechanism in accordance with ISO 23908
- Functional tests following simulated use
- Syringes for motorised syringe pumps in accordance with ISO 7886-2
- Mechanical compatibility with the injection system
- Functional tests specific to automated use
- Sterile single-use needles in accordance with ISO 7864:2016 and ISO 9626:2016
The tests carried out include, in particular:- Verification of geometric dimensions (diameter, length, thickness)
- Bending and tensile strength tests
- Penetration and bevel performance tests
- Quality of the connection to the syringe
Tests on connectors and connection systems
We carry out tests designed to ensure the safety of connections and to prevent connection errors:
- Luer connectors in accordance with ISO 80369-7 and ISO 80369-20
- Compatibility and non-interconnection tests
- Separation and pressure resistance tests
- Connection leak-tightness tests
Tests on injection pens and auto-injectors
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Injection pens (reusable or single-use) in accordance with the ISO 11608 series
- Dose accuracy, verified under various environmental conditions (high and low temperatures) and following various preconditioning procedures (climatic storage, vibration, transport simulation, etc.)
- Functional tests of the injection mechanism
- Activation and release force tests
- Mechanical robustness tests (drops, use cycles)
- Cartridges for injection devices
- Dimensional compatibility tests
- Leak-tightness tests
- Mechanical strength tests
- Verification of suitability for use in injection systems
In addition, LNE offers the following services:
Validation of sterile packaging
- Transport simulation (to assess the behaviour of the device and its packaging when subjected to various stresses associated with the distribution cycle)
- Accelerated and real-time ageing
- Sterile barrier performance tests (ISO 11607)
Connected auto-injector pens
- Electrical safety in accordance with IEC 60601-1, to ensure the basic safety of products and users with regard to electrical and mechanical risks, etc.
- Electromagnetic compatibility (EMC) in accordance with IEC 60601-1-2, to ensure the proper functioning of products in their electromagnetic environment and to ensure that they do not interfere with it
- Radio-frequency testing to assess the radio performance and regulatory compliance of radio technologies integrated into the device (e.g. Bluetooth®, NFC), including tests for emissions, immunity and human exposure to electromagnetic fields, in accordance with the applicable requirements for radio equipment
- Cybersecurity assessment : threat modelling, cyber assessments and penetration tests (“pentests”) on embedded products, to ensure their security and robustness, particularly against cyberattacks
Innovation and development of new devices
To meet the growing demand for home care and self-administration, integrate smart sensors while maintaining compliance, and reduce the environmental footprint, manufacturers need to:
- Develop more ergonomic, connected or eco-designed devices.
- Validate the performance of new materials or smart mechanisms.
LNE offers the following services:
- Support for R&D and metrological prototyping.
- Environmental assessment and life cycle assessment (LCA).
- Validation of embedded electronic systems (safety, electromagnetic compatibility, reliability).
Why choose LNE?
- A multidisciplinary expert recognised nationally and internationally in the medical and healthcare sector (testing, certification, metrology, technical and regulatory support, etc.), supported by its subsidiary GMED, a notified body and a major player in the sector,
- A single site, accredited by Cofrac* and within the scope of the applicable accreditation, to carry out all the tests required for conformity assessment,
- Tailored support, from design through to regulatory validation,
- Tests carried out in accordance with the requirements of the MDR (EU Regulation 2017/745) and recognised expertise in the ISO 7886, ISO 7864 and ISO 11608 standards.
*List of accreditations, sites and scopes available at cofrac.fr
