[Webinar Series on Medical Device Safety Standards from the Basics 2025] Session 3: Reprocessing Validation of Medical Devices (ISO 17664)

UL Japan

In diagnosis and treatment, many medical devices come into contact with the human body of patients. This can include contact with healthy skin, as well as contact with wounds or circulating blood and tissues. Naturally, these devices must undergo processes such as cleaning, disinfection, and sterilization to ensure they are in a condition suitable for contact with the human body. Reprocessing of medical devices, including cleaning, disinfection, and sterilization, is often carried out by healthcare institutions. To ensure proper reprocessing, medical device manufacturers are required to provide information regarding reprocessing through user manuals and accompanying documents. In this webinar, we will introduce the items that medical device manufacturers should provide to healthcare institutions regarding the reprocessing process as required by international standards, as well as the specific reprocessing requirements for cleaning, disinfection, and sterilization. We will also discuss lifecycle testing to ensure that reusable medical devices are always safe. Content: 1. ISO 17664 and the reprocessing of medical devices 2. Cleaning 3. Disinfection 4. Sterilization 5. Lifecycle testing

Date and time Tuesday, Apr 22, 2025
11:00 AM ～ 11:50 AM
Capital
Entry fee Free

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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 safety testing (ISO 10993-1, FDA, USP)
Able to respond to pharmaceutical applications in various countries.

In biological safety testing, regulatory authorities in each country require certification of ISO/IEC 17025 and test results conducted under GLP (Good Laboratory Practice) conditions at the time of application. UL Solutions' testing laboratory is accredited by IAS (International Accreditations Service, Inc.) of the United States, a member organization of ILAC (International Laboratory Accreditation Cooperation) MRA (Mutual Recognition Arrangement), and is valid when regulatory authorities in various countries demand accredited and GLP-compliant testing and evaluation.
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)
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
Medical Device EMC Testing Services
Manufacturers need to demonstrate compliance with regulations regarding safety and performance requirements to ensure product safety and market entry.

The conformity of medical devices to EMC has recently become a significant issue, as it can pose a threat to life. If a product does not conform to the intended environment, it becomes difficult to ensure safety compliance and to achieve its intended effects. EMC testing evaluates the potential for interference between nearby products and the risk of injury or damage to people and the surrounding environment. Additionally, these tests assess the compatibility of devices under the intended electromagnetic environment. In many countries, EMC, radio, and radio frequency (RF) exposure and safety requirements are established. For medical products, several standards are set regarding testing, risk management, basic safety, and essential performance. For example, medical devices sold in the United States must comply with IEC 60601-1-2, 4th edition. The IEC 60601-1-2, 4th edition defines the fundamental safety and essential performance of medical devices concerning radiation and immunity to electromagnetic interference. As of the latest information, the U.S. Food and Drug Administration (FDA) has recognized the 4.1 edition as a Recognized Consensus Standard in December 2023.
[Seminar] Session 2: Introduction to Testing and Evaluation Standards for Medical Devices - EMC Testing
Overview of Medical Device Regulations and Key Points of Safety Testing and Evaluation!

【Target Audience】 ■ Personnel in charge of regulatory affairs, quality control, and development at medical device manufacturers ■ Those who want to confirm the basic aspects of IEC 60601-1-2 ■ Those who are having trouble with the content of documents such as test plans *For more details, please refer to the related links or feel free to contact us.