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.
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.
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.
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.
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.
国内薬機法において、すべての能動型医療機器は2023年3月より「JIS T 0601-1-2:2018(Ed.4.0)」に適合する必要があります。
医療機器の EMC 試験実施する上で製造業者が知っておくべきことを解説します。
Middle East and Africa