医療機器の微生物学的試験(英語) 

試験は、革新的な設計を信頼性と市場性に富んだ製品に具現化するための重要なステップです

試験は、革新的な設計を信頼性と市場性に富んだ製品に具現化するための重要なステップです

SAFEGUARD PATIENT HEALTH WITH MICROBIOLOGICAL TESTING

Medical devices have helped to improve the quality of healthcare for many years. This is reinforced by the high level of safety procedures and risk assessments when manufacturing the devices. The goal of every medical device manufacturer is to produce devices that fulfil the intended function while also protecting patients’ health. Therefore, manufacturers must continuously ensure that their medical devices meet the highest quality control standards. One of the ways to evaluate a device’s safety is to examine the presence of harmful pathogens that contaminate the devices. This is accomplished through microbiological testing.

WHAT IS MICROBIOLOGICAL TESTING FOR MEDICAL DEVICES?

Microbiological testing of a medical device refers to tests for the presence and risk of microbial contaminants. Methods may include testing of bioburden levels, presence of endotoxin, and methods for sterility assurance. It is an important subset of the quality and safety controls as it assesses the biological risk of contaminants to eliminate or reduce the possibility of infections to patients. This is further supported by environmental monitoring and microbial control of the entire manufacturing process. Microbiological testing may be applicable to non-sterile medical devices as they may need to be monitored and/or controlled for the presence of objectionable microorganisms.

Sterility assurance of medical devices is one of the requirements set forth by global medical device regulations. Ensuring consistent microbiological testing during manufacturing is imperative to product quality and patient safety.

HOW CAN WE HELP YOU?

TÜV SÜD provides high-quality microbiological testing services for all types of medical devices to meet the latest requirements of global regulators. Our team of dedicated medical device experts and project managers have years of experience and understanding of regulatory requirements, intercepting issues early for rectification. This saves a vast amount of time and resources for manufacturers, who can then successfully meet their targets for product development and placement of the medical device on the global market. 

WHY CHOOSE US?

TÜV SÜD is a one-stop solution for medical device testing with a comprehensive portfolio of testing services, from software validation and AI applicability to functional safety, biocompatibility and microbiological testing. Our global team of medical health and services professionals come from the medical industry with years of experience. Their deep expertise underpins our astute understanding of global device safety and accreditation requirements, keeping us ahead of the latest developments and ensuring that all emerging regulatory needs are met.

OUR SERVICES AT A GLANCE

TÜV SÜD provides the following services to help manufacturers perform microbiological testing. These are required by the International Organisation for Standardisation (ISO), the US Food and Drug Administration (FDA), Technical Information Reports (TIR) from the Association for the Advancement of Medical Instrumentation (AAMI), International Electrotechnical Commission (IEC) and the European Standards (EN), alongside environmental monitoring and microbial control procedures. 

  • Bioburden Testing - ISO 11737-1 & ISO 11137: Bioburden testing is conducted to quantify the microorganisms (total microbial count) found on a medical device before sterilisation.
  • Sterility Testing - ISO 11737-2, ISO 11138, ISO 14161, ISO 13060 & EN 285: Sterility testing is required to ensure the medical devices are free of viable microorganisms.
  • Reprocessing Validation - ISO 17664, ISO15883, AAMI & FDA: Validation of reprocessing instructions for cleaning, disinfection and sterilisation are performed for example typically on reusable surgical instruments to ensure devices continue to meet the performance specifications. These also help address the risks associated with reprocessing and shelf-life testing wherever required by regulators. Regulators also differ in terms of their testing requirements:
    • Instead of the ISO 17664 requirements, the FDA follows its own set of guidelines and refers to the AAMI’s TIR 12 and 30. 
    • The FDA provides manufacturers with the option of disinfection or sterilisation testing. All three steps are required by the EU. 
    • Minimum temperature requirements for moist heat sterilisation differ between the FDA and other regulatory bodies. 
  • Endotoxin Testing - ISO 11737-3: Bacterial endotoxin testing is required to detect blood-harming endotoxins on the medical device. 
  • Packaging Validation & Shelf-life Testing - ISO 11607-1: Packaging tests for terminally sterilised medical devices determine whether the packaging can protect the device’s sterility from transport to storage. Shelf-life tests ensure the microbial control and integrity of the device in storage.
  • Antimicrobial Testing: Antimicrobial testing is conducted on surfaces of medical devices to ascertain their ability to kill and eliminate the growth of microorganisms.

YOUR BENEFITS AT A GLANCE

  • Expert partnership: TÜV SÜD provides a wealth of expertise that is underpinned by years of knowledge in regulatory compliance within the medical industry, making us a trusted partner of choice for product quality and safety.
  • Reduce time to global markets: With our in-depth insight of global product quality and regulatory requirements, TÜV SÜD supports you in optimising costs and minimising time-to-market.
  • Single source testing solution: With a comprehensive portfolio of medical device testing services meeting regulatory requirements across global markets, TÜV SÜD is a one-stop solutions provider for medical device manufacturers across the EU, the U.S. and the Asia Pa

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