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Test for Particulate Contamination

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The FDA has asked intravenous and infusion medical device manufacturers to provide data regarding particulates to evaluate the potential effects the use of their device may have on patients. When a medical device is deployed or exposed to a patient, particles may be released and lodge in their vascular capillary system.

Whether these particles are harmful to patients is determined by their size, shape, composition, and where and to what degree they cause an occlusion. The source of these particulates may be the manufacturing process, the environment, the product packaging or the device itself.

SAXOCON has the tools and laboratory set up to provide you with comprehensive data to document whether your device is within acceptable particulate limits, including:

  • Class N2 clean workspaces
  • Filtration units
  • Microscopes for analysing filters
  • Inspection of device surface integrity using SEM.

Why choose us?

SAXOCON analytical services for test for particulate contamination give you access to:

  • Extensive expertise in the measurement and characterisation of materials and surfaces
  • A multidisciplinary team of highly skilled scientists and experts
  • We are ISO 13485-certified and work with GLP-based standards

Delivery

SAXOCON generates and compiles all physical characterisation data needed to support the biological evaluation of your product.

This service helps you comply with the following standards and guidelines:

USP Standards

USP 788
USP 789
USP 789
USP 776

ISO Standards

ISO 14708
ISO 8536-4
ISO 10079
ISO 8871-3
ISO 17853:2011
DIN EN ISO 16232

ATSM Standards

ASTM F311 – 08(2020)
ASTM F312 – 08
ASTM F2743-11(2018)

Diverse

DS/EN 45502-1:2015
VDA 19.1
AAMI TIR 42
MDR 2017/745, Annex I, 10.4.1

VDI 2083 Blatt 21, Reinheit von Medizinprodukten im Herstellungsprozess“

FDA guidance: class II special controls guidance document for certain percutaneous transluminal coronary angioplasty (PTCA) catheters