CENELEC
Project
| Reference | EN 45502-2-2:2008 |
|---|---|
| Title | Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators) |
| Project Number | 8622 |
| Abstract/Scope | This Part 2-2 of EN 45502 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. This part of EN 45502 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 particular 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. |
| Status |
Published
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Status
| Current Stage code | 6060 |
|---|---|
| Current Stage code date | 2008-03-31 |
| Current Stage code deadline | 2008-10-01 |
| Deadline date for vote |
Legal
| Directive(s) | AIMD (90/385/EEC) |
|---|---|
| Mandate(s) | M/432 |
| Order Voucher | BC/CLC/02-89 |
Details
| IEC Technical Body | IEC/SC 62D |
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| Reference Document | |
| ICS | 11.040.40 - Implants for surgery, prosthetics and orthotics |
| Keywords | Medical device; Implantable; Safety; Tachyarrhythmia; Defibrillator |
| Note | EN 45502-2-1:2003 & EN 45502-2-2 supersede EN 50061:1988 + A1:1995 * Published as a CENELEC standard (one logo) |
| A-Deviation(s) | |
| Special National Condition(s) |
Environment
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Clause
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Categories - Aspects
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Product Life Cycle
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Information
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History
Implementation Dates
| date of Ratification (DOR) (1) | 2007-05-01 |
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| date of Availability (DAV) (2) | 2008-03-31 |
| date of Announcement (DOA) (3) | 2007-11-01 |
| date of Publication (DOP) (4) | 2008-10-01 |
| date of Withdrawal (DOW) (5) | 2010-05-01 |
Relations
| Supersedes | EN 50061:1988 EN 50061:1988/A1:1995 EN 50061:1988/A1:1995/corrigendum Oct. 1995 |
|---|---|
| Superseded by | |
| Normative reference (6) | ANSI/AAMI PC69:2007 EN 980:2008 EN 45502-1:1997 EN 45502-2-1:2003 EN 60068-2-27:1993 EN 60068-2-47:2005 EN 60068-2-64:1994 IEC 60878:1988 |
(1) Date of ratification (dor) date when the Technical Board notes the approval of an EN (and HD for CENELEC), from which time the standard may be said to be approved
(2) Date of availability (dav) date when the definitive text in the official language versions of an approved CEN/CENELEC publication is distributed by the Central Secretariat
(3) Date of announcement (doa) latest date by which the existence of an EN (and HD for CENELEC), a TS or a CWA has to be announced at national level
(4) Date of publication (dop) latest date by which an EN has to be implemented at national level by publication of an identical national standard or by endorsement
(5) Date of withdrawal (dow) latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn
(6) This list of normative references is purely indicative. The only official list of normative reference is the list of the published standard.
