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Standard Overview Products Used in Testing Related Compliance Standards

Standard Overview
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.

Related EN Standards

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EN 45502-1: Implants for surgery - Active implantable medical devices - General requirements for...
This Part 1 of EN 45502 specifies requirements that are generally applicable to ACTIVE IMPLANTABLE MEDICAL DEVICES. NOTE 1 For particular types of ACTIVE IMPLANTABLE MEDICAL DEVICES, these general requirements are supplemented or modified by the requirements of particular standards which form additional parts of this European Standard. The tests that are specified in EN 45502 are type tests and are to be carried out on samples of an ACTIVE IMPLANTABLE MEDICAL DEVICE to show compliance. This Part 1 of EN 45502 is applicable not only to ACTIVE IMPLANTABLE MEDICAL DEVICES that are electrically powered but also to those powered by other energy sources (for example by gas pressure or by springs). This Part 1 of EN 45502 is also applicable to some non-implantable parts and accessories of the ACTIVE IMPLANTABLE MEDICAL DEVICES. 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. For more information and to purchase this standard go to standards.cen.eu
EN 50082-1: Electromagnetic compatibility - Generic immunity standard - Part 1: Residential...
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.
EN 50082-2: Electromagnetic compatibility - Generic immunity standard - Part 2: Industrial...
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: Information technology - Generic cabling systems
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