Medical Device Testing — Request Coordination
Laboratory Vortex is a coordination and matching service, not a testing laboratory. We review your device, stage and testing plan, then route the request to independent laboratories whose published capabilities appear to fit. Each laboratory quotes and contracts with you directly, and you confirm accreditation scope with them.
Services
- Biocompatibility (ISO 10993 series): Cytotoxicity, sensitization, irritation, systemic toxicity, chemical characterization and extractables/leachables, planned against your biological evaluation.
- Sterile barrier packaging: Seal strength, package integrity and leak testing, distribution simulation and aging supporting ISO 11607 packaging validation.
- Accelerated and real-time aging: Aging protocols referencing ASTM F1980, with post-aging functional and package testing.
- Electrical safety and EMC: Testing for medical electrical equipment referencing the IEC 60601 family, where your device is in scope.
- Materials and mechanical testing: Tensile, fatigue and material identification for polymers and metals (e.g. ASTM D638, ASTM E8/E8M).
- Medical plastics and colorant changes: Reference/candidate comparison, documented composition and exposure, with provider-proposed characterization and risk-based biological/chemical interpretation—not a universal panel.
- IVD and biomarker assay evidence: Intended-use-specific feasibility, analytical versus clinical performance, specimen/reagent stability and software considerations; RUO work does not establish clinical clearance.
- Not sure what is needed: Describe the device and intended use; we help frame the request before it reaches laboratories.
- Risk-based biological evaluation: Contact type, duration, finished materials and process changes determine evidence needs. Not every device requires every endpoint; no automatic test panel or FDA approval is promised.
- Chemical characterization and toxicological assessment: Separate material composition, extraction/use-release chemistry and exposure-based interpretation; device, drug-container and combination-product scopes differ.
- Microbiology, sterilization and reprocessing: Sterility, bioburden and endotoxin measurements differ from process validation. Reusable-device cleaning, disinfection and sterilization instructions need separately scoped evidence.
Standards and methods
- ISO 10993 series: A family of parts covering the biological evaluation framework (Part 1) and specific endpoint tests and chemical characterization. Which parts apply depends on the device's nature and duration of body contact.
- ISO 11607 (Parts 1 & 2): Requirements for sterile barrier systems and validation of forming, sealing and assembly processes. Referenced tests commonly include seal strength, integrity, aging and distribution.
- ISO 13485: A quality management system standard, not a test method. Context only: manufacturers often expect suppliers and laboratories to support their QMS documentation. Certification of a supplier is not implied by any listing.
- IEC 60601 family: General requirements for basic safety and essential performance, plus collateral and particular standards. Applies only to medical electrical equipment and systems.
- ASTM F1980: A guide for accelerated aging using elevated temperature to support shelf-life claims, normally followed by real-time aging confirmation.
- ASTM F88/F88M: Measures the force required to separate a seal. Used for sterile barrier and other flexible packaging seals.
- ASTM F1929: Detects seal leaks in porous medical packaging using a dye penetrant.
- ASTM F2096: Detects gross leaks in packaging by pressurizing the package under water.
- ASTM D638: Tensile testing of plastic specimens to determine strength, modulus and elongation.
- ASTM E8/E8M: Tensile testing of metals to determine yield strength, tensile strength and elongation.
- USP <711>: A pharmacopeial dissolution test. Relevant to drug-device combination products or drug-containing components, not to most devices.
What testing does my device need?
IVD specimen, reagent and calibrator stability
Compatibility: biological vs material/drug-container