ISO 18562: Analytical testing and advising services

Emmace Consulting has a vast experience in evaluating inhaled and nasal drug products (OINDP) and is well equipped to perform testing of medical devices that are in indirect contact via the airways according to the ISO standard 18652 (Biocompatibility Evaluation of Respiratory Gas Pathways in Healthcare Applications).

For respiratory and ventilation devices, a key component of the biocompatibility evaluation is measuring chemicals and particles that may be released into the breathing gas pathway and reaching the patient.

The new ISO 18562 standard, Biocompatibility Evaluation of Respiratory Gas Pathways in Healthcare Applications, provides guidance and standardization for evaluating respiratory and ventilation devices.

This series of standards includes the following four parts:

  • ISO/DIS 18562-1 – Part 1: Evaluation and testing within a risk management process
  • ISO/DIS 18562-2 – Part 2: Tests for emissions of particulate matter
  • ISO/DIS 18562-3 – Part 3: Tests for emissions of volatile organic compounds (VOCs)
  • ISO/DIS 18562-4 – Part 4: Tests for leachables in condensate

These standards apply to all medical devices, parts, and accessories that may contact the breathing gas pathway.

To meet these standards is an essential for clearance to the market of respiratory and ventilation devices and accessories. Ventilators, anesthesia workstations (including gas mixers), masks, oxygen conserving equipment, oxygen concentrators, nebulizers, low pressure hoses, humidifiers, heat and moisture exchangers, resuscitators, breathing systems, respiratory gas monitors, respiration monitors, mouth pieces, breathing tubes, breathing systems filters and Y-pieces are all examples of devices that needs to be tested according to this ISO standard.

The enclosed chamber of an incubator, including the mattress and the inner surface of an oxygen hood, are considered to be gas pathways and are also addressed.

Emmace Consulting is providing analytical services and advising on a CRO basis regarding testing and clearance according to these ISO standards.

For more information please see: (part 1), (part 2), (part 3) (part 4)

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