EN 45502-1: Implants for surgery - Active implantable medical devices - General requirements for...

EN 45502-2-2 specifies requirements that are applicable to IMPLANTABLE CARDIOVERTER DEFIBRILLATORS and the functions of ACTIVE IMPLANTABLE MEDICAL DEVICES intended to treat tachyarrhythmia. The tests that are specified in EN 45502 are type tests and are to be carried out on samples of a device to show compliance. EN 45502-2-2 is also applicable to some non-implantable parts and accessories of the devices (see Note 1). The characteristics of the IMPLANTABLE PULSE GENERATOR or LEAD shall be determined by either the appropriate method detailed in this standard or by any other method demonstrated to have accuracy equal to, or better than, the method specified. In the case of dispute, the method detailed in this Particular Standard shall apply. Any aspect of an ACTIVE IMPLANTABLE MEDICAL DEVICE intended to treat bradyarrhythmias is covered by EN 45502–2-1 Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (Pacemakers). NOTE 1: The device that is commonly referred to as an ACTIVE IMPLANTABLE MEDICAL DEVICE may in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify some requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device. NOTE 2: The terminology used in this European Standard is intended to be consistent with the terminology of Directive 90/385/EEC. NOTE 3: In this European Standard, terms printed in small capital letters are used as defined in Clause 3. Where a defined term is used as a qualifier in another term, it is not printed in small capital letters unless the concept thus qualified is also defined. NOTE 4: Particular requirements for congestive heart failure devices are under consideration. These types of devices are not covered by this standard.

The EN 50082-1 standard for EMC immunity requirements applies to electrical and electronic apparatus intended for use in the residential, commercial and light-industrial environment, as described in Clause 5, for which no dedicated product or product-family immunity standard exists.   Industrial environments according to EN 50082-1 are characterized by the existence of one or more of the following conditions: Industrial locations and medical apparatus, e.g. the presence of welding machines. Heavy inductive or capacitive loads are frequently switched. Current and associated magnetic fields are high. Immunity requirements in the frequency range 0 Hz to 400 GHz are covered. No measurements need to be performed at frequencies where no requirements are specified. The EN 50082-1 standard applies to any apparatus intended to be directly connected to a public low-voltage mains network or connected to a dedicated DC source which is intended to interface between the apparatus and the low-voltage public mains network. It also applies to apparatus which is battery operated or is powered by a non-public but non-industrial low-voltage power distribution system if this apparatus is intended to be used in the locations described in Clause 5. This standard has been superseded by EN 61000-6-1.

The EN 50082-2 standard for EMC immunity requirements applies to electrical and electronic apparatus intended for use in the industrial environment, as described in Clause 5, for which no dedicated product or product-family immunity standard exists. Apparatus designed to radiate electromagnetic energy for radio communications purposes as defined by the ITU are excluded from this standard. Immunity requirements in the frequency range 0 Hz to 400 GHz are covered. Apparatus covered by this standard is not intended for connection to a public mains network but is intended to be connected to a power network supplied from a high or medium-voltage transformer dedicated for the supply of an installation feeding manufacturing or similar plant. This standard applies to apparatus intended to operate in industrial locations or proximity to industrial power installations. This standard also applies to battery operated apparatus intended to be used in the locations described in Clause 5. This standard was in use from September 15, 1995 to April 15, 2002, at which point it was then superseded by EN 61000-6-2.

EN 50173 group of standards specifies: The structure and configuration of the backbone cabling subsystems of generic cabling systems within the types of premises defined by the EN 50173 series of standards Channel performance requirements in support of the EN 50173 series of standards Link performance requirements in support of the EN 50173 series of standards Backbone cabling reference implementations in support of the standards in the EN 50173 series Component performance requirements in support of the standards in the EN 50173 series The standard series of EN 50173 is divided into five areas for various applications and covers application-neutral communication cablings for information technology.   EN 50173-1 General requirements EN 50173-2 Office buildings EN 50173-3 Industrially used buildings EN 50173-4 Private residential units EN 50173-5 Computing centers There is also a difference in the individual components such as cables and connection technology and also in the installation of these components. The individual components are classified into the following categories:   Category 5 up to 100 MHz Category 6 up to 250 MHz Category 6A up to 500 MHz Category 7 up to 600 MHz Category 7A up to 1000 MHz A distinction is drawn between installed components according to transmission classes:   Class D up to 100 MHz Class E up to 250 MHz Class EA up to 500 MHz Class F up to 600 MHz Class FA up to 1000 MHz Certification and checking of the limiting values for the measurement technology of the installed transmission routes. A distinction is drawn between two models for the transmission routes for the cabling. Permanent links are those which cover the laid installation cable and also the patch panel permanently connected to the end of the cable and the junction box. Channel Links are those where the patch cable also used in the patch panel and the junction box can also be

EN 50191 is about providing protection against electric shock. The standard addresses specifically the erection and operation of electrical test installations in the workplace. It incorporates provisions from 11 other European Norm standards to provide details of good engineering practice when testing electrical equipment. Two harmonized standards are referred to in the text of EN 50191: HD 384 for voltages up to 1000 V and HD 637S1 for voltages exceeding 1000 V. Both documents are used when considering equipment for which the power supply does not fall within the scope of EN 50191. Table I lists other standards used as normative references. It is important to note that EN 50191 has no reference to CE marking or any other manufacturing product standard. The standard details five definitive test installations and the levels of protection required: Test Station with Automatic Protection against Direct Contact. The use of test enclosures encapsulates the device under test (DUT) and prevents any contact when the tests are applied. Test Station without Automatic Protection against Contact. This could be a product that is too large to allow the use of a test enclosure. Prohibited areas must be used with fixed barriers to prevent access to the DUT from unauthorized personnel. Test Laboratories and Experimental Stations. Each test area within a laboratory must be individually protected and isolated. A common emergency cutoff could increase risk to another area, increasing possible hazards at other test stations. Temporary Test Station. A skilled engineer conducts testing on a client's site or sets up a one-time test station to test a specially designed device. Individual assessment of the area and exclusion zones must be implemented to provide for the specific location and situation. Test Station without Test Personnel in Permanent Attendance. In situations in which automated production line or life testing is undertaken, full protection from

EN 55011 is a product family standard (largely based on CISPR 11) for industrial, scientific and medical (ISM) equipment and electro-discharge machining (EDM) and arc welding equipment. This standard sets forth procedures for the measurement of radio-frequency (RF) disturbances and limits within the frequency range of 9 kHz to 400 GHz. Requirements for ISM lighting apparatus and UV irradiators operating at frequencies within the ISM frequency bands defined by the ITU Radio Regulations are also contained in EN 55011. ISM equipment or appliances tested against EN 55011 under the EMC Directive are designed to generate and use locally, RF energy for industrial, scientific, medical, domestic or similar purposes, excluding applications in the field of telecommunication. Typical ISM applications are the production of physical, biological, or chemical effects such as heating, ionization of gases, mechanical vibrations, hair removal and acceleration of charged particles. Compliance with this standard gives a partial presumption of conformity with the European EMC Directive, 2004/108/EC. EN 55011 is an emission only standard covering radiated and conducted emissions. Most products will also require an assessment of immunity standards, such as: (1) EN 61326-1 – Electrical equipment for measurement, control, and laboratory use; or (2) EN 61000-6-2 – Generic Standards Immunity for industrial environments. These aforementioned two specifications contain additional requirements for electromagnetic interference and transient phenomenon. Additionally, devices powered via AC mains may require additional testing for power line harmonics and power line flicker. Although the term medical is in the title of this standard, EN 55011 does not apply directly to medical devices within the scope of the Medical Device Directive 93/42/EEC. The reason is that for medical devices falling within the scope of 93/42/EEC, the EMC directive does not apply directly, but

EN 55022 is a modified derivative of CISPR 22 that applies to information technology equipment (ITE) as defined as any equipment: – Which has a primary function of either (or a combination of) entry, storage, display, retrieval, transmission, processing, switching or control of data and of telecommunication messages and which may be equipped with one or more terminal ports typically operated for information transfer; – With a rated supply voltage not exceeding 600 V. Procedures are given for the measurement of the levels of spurious signals generated by the ITE and limits are specified within the standard for protection of radio services in industrial, commercial or residential environments in the frequency range of 9 kHz to 400 GHz for both class A and class B equipment. The intention of this publication is to establish uniform requirements for the radio disturbance level of the equipment contained in the scope, to fix limits of disturbance, to describe methods of measurement and to standardize operating conditions and interpretation of results. Compliance with this standard gives partial presumption of conformity with the European EMC Directive, 2004/108/EC. Most products will also require assessment to the companion standard EN 55024, for immunity to electromagnetic interference and transient phenomenon. Additionally, devices powered via the AC mains, may require additional testing for power line harmonics and power line flicker. Information Technology Equipment (ITE), as would be tested for EN 55022, includes computer hardware and software, operating systems, web-based information and applications, telephones and other telecommunications products, video equipment and multimedia products, information kiosks, and office products such as photocopiers and fax machines. All European Standards, including EN 55022, are shaped by consensus among enterprises, public authorities, consumers, and trade unions, through a consultation process

EN 61000-6 is an electromagnetic compatibility (EMC) standard developed to keep interference between electronic devices under control to reduce disturbance and improve immunity in residential, industrial, and commercial environments. EN 61000-6 has four parts to date comprised of the following: 1) EN 61000-6-1: Electromagnetic compatibility (EMC) - Part 6-1: Generic standards - Immunity for residential, commercial and light-industrial environments Applies to electrical and electronic apparatus intended for use in residential, commercial and light-industrial environments both indoor and outdoor. Immunity requirements in the frequency range 0 Hz to 400 GHz are covered. This generic EMC immunity standard is applicable if no relevant dedicated product or product-family EMC immunity standard exists. This standard applies to apparatus intended to be directly connected to a low-voltage public mains network or connected to a dedicated DC source which is intended to interface between the apparatus and the low-voltage public mains network. This standard applies also to apparatus which is battery operated or is powered by a non-public, but non-industrial, low-voltage power distribution system if this apparatus is intended to be used in the locations. This standard supersedes EN 50082-1. 2) EN 61000-6-2: Electromagnetic compatibility (EMC) - Part 6-2: Generic standards - Immunity for industrial environments Applies to electrical and electronic apparatus intended for use in industrial environments. Immunity requirements in the frequency range 0 Hz to 400 GHz are covered. This generic EMC immunity standard is applicable if no relevant dedicated product or product-family EMC immunity standard exists. This standard applies to apparatus intended to be connected to a power network supplied from a high or medium voltage transformer dedicated to the supply of an installation feeding manufacturing or similar plant, and intended to operate in or in proximity to