TRGS 402 on inhalative hazardous substances
…defines measures to minimise the exposure of employees to hazardous substances through inhalation.
The name MEDiLEX stands for software that has been specially developed for the field of medical device legislation. It contains all European directives, legal and regulatory texts, which are regularly updated by the BAYOOSOFT team. The software therefore helps you to maintain the regulatory conformity of your medical devices with regard to these regulations. To ensure that you do not overlook anything, related regulations are cross-referenced with each other – a decisive advantage over the analogue loose-leaf collection.
As laws and regulations in Germany and Europe are constantly being updated, there was a new release of MEDiLEX in September 2023. This means that we have brought all laws, regulations, guidelines and all other documents up to date. A large number of amendments, new versions and new additions within the technical regulations are particularly worth mentioning. In addition, the Medical Technology Professions Act (MTBG), the NiSV and the BMGBGebV have also been included in our collection.
We present all the changes in our article.
Special Fees Ordinance of the Federal Ministry of Health (BMGGebV): The ordinance regulates the fees charged in connection with various tasks and services of the Federal Ministry of Health. These include, for example, fees for the authorisation of medical products, the monitoring and regulation of the healthcare system and various other health-related matters.
Ordinance on the protection against harmful effects of non-ionising radiation when used on humans (NiSV): This is a German ordinance that regulates the protection against non-ionising radiation when it is used in medical applications on humans. Non-ionising radiation comprises various types of radiation, including electromagnetic radiation in the non-ionising range, such as ultrasound, infrared and laser radiation.
AMR 3.3 – Holistic occupational health care: This includes measures for the prevention of health risks in the workplace, the early detection of work-related health hazards and the promotion of employee health. The rule provides guidance and recommendations on how companies and employee representatives can jointly develop and implement suitable measures to improve health protection in the workplace.
TRBS 1115: The rule contains guidelines and recommendations for the safe operation and maintenance of measuring and control equipment in companies and organisations. Such equipment is present in many working environments to monitor, control and regulate processes. Their proper functioning is essential to prevent accidents and workplace risks.
Law on Professions in Medical Technology (MTBG): The MTBG sets out the legal basis for training and activities in various medical technology professions, including, for example, medical-technical radiology and X-ray diagnostics, and medical-technical laboratory assistance. These professions are of great importance to the healthcare sector, as they play an important role in the diagnosis and treatment of patients.
EU legislation
German laws
All current versions of these laws and regulations can now also be found in MEDiLEX.
Technical rules are documents that define technical requirements, standards or guidelines for specific products, processes or services. These rules serve to ensure safety, quality, efficiency and interoperability in various technical areas.
MEDiLEX has been supplemented by the new versions of these technical rules:
If you already have MEDiLEX access, you can also read all changes directly under “Updates”.
Use our free trial version for 14 days and get to know MEDiLEX straight away. Which advantages of the interactive loose-leaf collection can you utilise for yourself? Find out now.
Do you have any questions? Then please contact us using our contact form. We look forward to your enquiry.