[Medical Device Safety Standards Introductory Seminar Series 2024] Session 3: Biocompatibility Evaluation of Respiratory Gas Pathways (ISO 18562)

UL Japan

ISO 18562 requires testing and evaluation of particulate matter, volatile organic solvents, and condensation that occurs in medical devices with respiratory gas pathways, playing a crucial role in ensuring safe use. This seminar will provide a simple introduction to the testing and evaluation content of ISO 18562. It will be beneficial not only for manufacturers of medical devices that already have respiratory gas pathways but also for those planning to develop such devices in the future. Additionally, there was a revision of the ISO 18562 standard in March of this year, and we will also introduce the key points of that revision. You can check the details of the seminar by clicking the "Details & Registration" button below.

Date and time Thursday, Jul 11, 2024
02:00 PM ～ 02:45 PM
Capital
Entry fee Free

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Medical device product safety standards evaluation, testing, and certification services.
Compliance with IEC 60601, IEC 61010, and various individual standards.

■ Technical consultation ■ Structural evaluation services ■ Contracted business testing ■ Testing laboratory accreditation ■ EMC testing and wireless standard testing ■ Radio wave regulations in various countries
Testing and evaluation services related to medical devices
Providing solutions for the global market.

■ Product safety standards evaluation, testing, and certification services ■ EMC testing services ■ Software evaluation services ■ Cybersecurity testing services for medical devices ■ Biological evaluation and biocompatibility testing services ■ ISO 13485 quality management system audit and registration services
Biological evaluation and biocompatibility testing services
In addition to the ISO 10993 series, it is possible to comply with FDA guidance, Ministry of Health, Labour and Welfare guidelines, and the United States Pharmacopeia (USP).

■ Biological evaluation plan and report (including toxicity evaluation) ■ Biocompatibility testing (ISO 10993/USP87, USP88) ■ Chemical analysis testing (ISO 10993-18) ■ Biocompatibility evaluation of respiratory gas pathways (ISO 18562) ■ Validation of cleaning and disinfection processes (ISO 17664-1 and -2, ISO 15883-5, ANSI/AAMI ST98 (US), etc.) ■ Validation of sterilization processes (steam sterilization) (ISO 17665-1) ■ Aseptic barrier systems and packaging systems (ISO 11607-1) ■ Peel testing (EN 868-5), burst testing (ASTM F 2054/F2054M-13), bubble testing (ASTM F 2096-11) ■ Air permeability testing and microbiological airtightness testing ■ Transportation testing and quality control of packaging materials ■ Packaging validation (ISO 11607-2)