Networks Europe Jul-Aug 2019 - Page 30

30 NETWORKING certification and quality marks. When in doubt, always check with an expert. Scalability ensures expenditure is always perfectly in line with current requirements. Installation can be 60% faster than traditional network designs. When selecting switches and other network components to be used in a medical environment, it’s essential to check that these not only meet required specifications but also match the strategic vision for growth and service development and that they comply with the relevant local legislation. Appropriate isolation corresponding to IEC / EN 60601-1, for example, can prevent unwanted voltage differentials occurring between devices linked to network cabling and provide safety protection for the entire system. EN 60601-1-2 and ISO 14971 offer standardised processes for guarding devices against equipment malfunctions caused by electromagnetic interference. Implementing these standards, as part of risk management and installation procedures, helps to reduce the total cost of devices throughout their lifetime, is essential to achieving compliance with regulatory requirements and helps to ensure the safety of all the people coming into contact with the devices. IEC 60601-1 classifies the network connection between a medical device and the Ethernet network as a potential source of danger. A leakage current can occur as a result of voltage differences between the grounding potentials of connected network components. Unshielded cables fail to provide galvanic isolation for data connections in accordance with hospital standards and poor EMC performance makes them unsuitable for medical applications. IEC 60601-1 requires two means of protection from electric shock to be applied in electrical medical equipment and systems. If one means of protection fails, the other takes effect, thereby protecting patients as well as operators of the equipment. When introducing communications and data systems into a medical environment, it’s essential that all the right precautions are taken. However, not all network components offer overcurrent protection, double insulation, isolated power systems and circuit breakers and so on as a standard. Before installing any medical equipment, it’s vital to verify it has been tested in the right way and has all the appropriate Standards for medical electrical equipment IEC 60601-1 defines general safety and security requirements for medical electrical equipment and systems in the hospital network, which the manufacturer has specified for diagnosis, treatment or patient monitoring. Compliance with IEC60601- 1 has become a requirement for the commercialisation of electrical medical equipment in many countries worldwide. The EN 60601 standards family is derived from IEC 60601. Part 1 (EN 60601-1) covers basic safety and performance for Medical Electrical Equipment (MEC) and Part 2 covers requirements for specific product groups. All new and existing medical devices sold in the EU have to conform to the new version of the standard, EN 60601-1-2, introduced on January 1, 2019. If non-medical equipment is introduced into a larger system, suitability for use in a medical environment must be inspected. IEC 80001 attempts to balance patient safety, effectiveness, data and system security and interoperability using a risk management framework. This is a process standard, which doesn’t detail the networking of medical device systems. OSHA Standard 29 CFR 1910 Subpart S – Electrical requires that every piece of electrical equipment used in the workplace should be factory-certified or tested and labelled by a nationally recognised testing laboratory (NRTL). ISO standards for medical devices are covered by ICS 11.100.20 and 11.040.01, as well as ISO 13485 and ISO 14971 for quality and risk management. ISO 13485:2003 is applicable to all providers and manufacturers of medical devices, components, contract services and distributors of medical devices and is widely used as the basis for regulatory compliance. Other standards apply to electrical and networking equipment in the healthcare environment, as well as many other kinds of national and supranational regulation. The EU Medical Device Directive, for example, relates to the safety and performance of medical devices. A manufacturer aiming to introduce a medical device onto the European market must meet the requirements of this directive and apply a CE mark from a Notified Body. A practical solution for medical networks Fibre to the Office (FTTO) infrastructures combine copper and fibre with intelligent conversion, offering great bandwidth reserves, lower energy and maintenance costs, less patching and significantly improved flexibility. A fibre network normally needs floor distribution rooms every 90m, but FTTO does away with this. Scalability ensures expenditure is always perfectly in line with current requirements. Installation can be 60% faster than traditional network designs. No floor distributors and cooling elements are needed, reducing energy consumption by up to 70%. Downtime is further reduced thanks to standard network security features. The centralised structure means less costly and easier servicing of the network. Regardless of size and complexity, FTTO networks can also be easily and cost-effectively managed from a single location. Dedicated medical FTTO switches and other network components are available that comply with the specialist requirements for medical electrical equipment. n www.networkseuropemagazine.com