ICS 11.040 - Medical equipment
Nowadays, the health sector is heard by every inhabitant of the planet. New industries appear, sales of goods are spreading more and more actively. But it must be remembered that medical equipment is responsible for the life and health of people, which is why its full compliance with international standards is necessary. Regulation of the use of medical electrical equipment prevents the occurrence of risky situations. When it comes to people's lives, the level of demanded responsibility and compliance with absolutely all norms and rules grows significantly. We will tell about the most important standards in the medical industry that you need to know if your business is related to the production, use and any interaction with medical equipment.
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
The specification of medical equipment requires more narrow-profile and in-depth knowledge in a particular area. Each type of medical system has its own standards. The document applies to the basic safety and essential performance of Medical Equipment (ME) equipment and ME systems in the presence of electromagnetic disturbances and to electromagnetic disturbances emitted by medical equipment and medical systems. First parts of the standard will give you understanding of safety measures specifications for medical equipment usage.
Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
Home healthcare environment increases in popularity of demand with every day. More than that special standards for this area continue its development. This International Standard applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems for use in the home healthcare environment. This International Standard applies regardless of whether the equipment or system is intended for use by a lay operator or by trained healthcare personnel. It describes in detail the methods of use to comply with all security demands. That is why we want to point out the significant importance of standards awareness even for home healthcare equipment. Stay up to the news with following the link to our website.
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
The usage and production of electrical medical equipment is developing at the pace of innovative technologies. The scale of production is expanding and the popularity of these products is increasing. EN 60601-1-6:2010 specifies a process for a manufacturer to analyze, specify, design, verify and validate usability, as it relates to basic safety and essential performance of medical electrical equipment. This usability engineering process assesses and mitigates risks caused by usability problems associated with correct use. We recommend that you remain aware of this standard if your business is connected with medical equipment production.
Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
Environment stands for the lives of all people on Earth. Of course technologies are developing, but the main thing to focus on is to keep all new systems safe. That is why new standards for medical equipment that regulate environmental safety are created. The objective of this collateral standard is to improve the environmental impact for the entire range of medical electrical equipment, taking into account all stages of the product life cycle: - product specification; - design; - manufacturing; - sales, logistics, installation; - use; - end of life management. This means protecting the environment and human health from hazardous substances, conserving raw materials and energy, minimizing the generation of waste, as well as minimizing the adverse environmental impacts associated with waste. The criteria needed to reach this goal must be integrated into all stages of the medical electrical equipment life cycle from the specification stage to end of life management. Follow the link to the website for more detailed information about this important document.
Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers
Production of separate details is responsible for the general safety of using medical equipment to which it is used. Standards are created not only for the process of usage, but also for the production. This means that awareness of new standards in the area of medical equipment appliances is at the same level of importance as general ones. EN 60601-1-10:2008 specifies requirements for the development (analysis, design, verification and validation) of a physiologic closed-loop controller as part of a physiologic closed-loop control system in medical electrical equipment and medical electrical systems to control a physiologic variable.This collateral standard applies to various types of PCLC, e.g. linear and non-linear, adaptive, fuzzy, neural networks.This collateral standard applies to a closed-loop controller that sets the controller output variable in order to adjust (i.e., change or maintain) the measured physiologic variable by relating it to the reference variable. In case you are interested in the mentioned document contact Iteh.
Medical electrical equipment - Part 2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment
Short-wave therapy is widely used nowadays in medical sector. That is why importance of its regulation has significantly arose. IEC 60601-2-3:2012 specifies the requirements for the basic safety and essential performance of short-wave therapy equipment. Short-wave therapy equipment are defined as medical equipment for the therapeutic treatment of a patient by exposure to electric or magnetic fields produced in the frequency range of more than 13 MHz but not exceeding 45 MHz. As far as this document has narrow specification, we recommend to get aware about it in more detailed way with contacting Iteh.
Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment
One more important document that regulates medical equipment production and usage is EN 60601-2-6:2015. It specifies the minimum requirements considered to provide for a practical degree of safety in the operation of microwave therapy equipment. This particular standard amends and supplements IEC 60601-1 (third edition, 2005 and amendment 1, 2012). This second edition cancels and replaces the first edition of IEC 60601-2-6, published in 1984. That point emphasizes one more time that staying up to date with new standards can influence the image of your company and the productiveness of performance on the market.
Medical electrical equipment - Part 2-8: Particular requirements for the basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
Narrowly specified norms and documents sometimes are neglected with companies for several reasons. One of them is that the standards are changing every day. One of very important documents that can influence the business that is connected with medical equipment is EN 60601-2-8:2015. It establishes particular basic safety and essential performance requirements for therapeutic X-ray equipment with nominal X-ray tube voltages in the range 10 kV to 1 MV when connected to alternating current supply mains. It includes the requirements for accuracy and reproducibility of performance to the extent that these are related to radiation quality and the quantity of ionizing radiation produced and thus must be considered as aspects of safety. This second edition cancels and replaces the first edition of IEC 60601-2-8. This edition constitutes a technical revision which brings this standard in line with the third edition of IEC 60601-1 and its collateral standards. We strongly recommend to follow the link to the website if your company acts in the field of the mentioned equipment.
Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment
Sometimes medical equipment can be used for treatment but at the same time causing some dangerous effects after. In such a case the usage of equipment is obligatory for decreasing the possibility of occurring negative results. One of the documents that specifies such a case is EN 60601-2-11:2015. The document applies to the basic safety and essential performance of gamma beam therapy equipment, including multi-source stereotactic radiotherapy equipment. This particular standard of the 60601 series, establishes requirements to be complied with by manufacturers in the design and construction of gamma beam therapy equipment. It states tolerance limits beyond which interlocks must prevent, interrupt or terminate irradiation in order to avoid an unsafe condition. Type tests which are performed by the manufacturer, or site tests, which are not necessarily performed by the manufacturer, are specified for each requirement. If you are a manufacturer whose company has active its connected with gamma beam therapy equipment, get acquainted with our standard by following the link to the Item website.
Standards are the key for your successful performance on the market
To sum, we would like to say that we have mentioned only some of the most used standards in the medical sector. Today, medicine is one of the most sought-after areas in the life of the whole planet. More and more business services arise associated with it, which is why compliance with correct international standards is mandatory. That is why we strongly recommend to stay up to date with the latest developments and updates in the field of international standards. More than that we emphasize the fact that standards can be applicable for manufacturers both medical equipment, parts, and appliances, they can also be important for environmental issues and home usage. If you have any questions about the details and specifics of the recommended documents, contact iTeh ( https://standards.iteh.ai ) to clarify all the details you are interested in. We are always ready to help you in selecting international standards for the area in which your business operates. iTeh Inc stands for safe and productive development.
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