Publication details
| Publication CODE |
Title |
| NBN EN 45502-2-1:2004 (2003-12) |
ACTIVE IMPLANTABLE MEDICAL DEVICES
PART 2-1: PARTICULAR REQUIREMENTS FOR ACTIVE IMPLANTABLE MEDICAL DEVICES INTENDED TO TREAT BRADYARRHYTHMIA (CARDIAC PACEMAKERS) |
| |
| Price Excl. VAT |
Total number of pages, tables and drawings |
|
113.00 €
|
93 P.. |
Description
This Part 2-1 specifies requirements that are applicable to those ACTIVE IMPLANTABLE MEDICAL DEVICES intended to treat bradyarrhythmias. 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 2-1 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 Part 2-1 or by any other method demonstrated to have an accuracy equal to, or better than, the method specified. In the case of dispute, the method detailed in this Part 2-1 shall apply. Any features of an ACTIVE IMPLANTABLE MEDICAL DEVICE intended to treat tachyarrhythmias are covered by EN 45502-2-2.
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.
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| Class |
C
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Available files
ATTENTION: Belgian registered standards (NBN EN or NBN HD) are generally
only available in English or French. Only the cover page is translated
and the document itself is in English or in French.
|
DE version
|
EN version
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FR version
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Status
Origin
| Committee |
JWGAIMD
See TC 62WGXA1 (field of TC 62)
|
Approval
| BEC Approval |
2003-09-01 |
| NBN Approval |
2004-10-20 |
| Belgian Official Journal |
2005-01-11 |
| Registration |
155820 |
| Numbers identifying the european directives |
90/385/EEC
(Active implantable medical devices)
|
| ICS-Code (International Standards Classification) |
11.040.40
|
| NBN Status |
New |
|
| Date of ratification (d.o.r.) |
2003-09-01 |
| Date of availability (d.a.v.) |
2003-12-22 |
| Date of announcement (d.o.a.) |
2004-03-01 |
| Date of publication (d.o.p.) |
2004-09-01 |
| Date of withdrawal former edition (d.o.w.) |
2005-09-01 |
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Correspondences with international standards
| Relation |
International standard |
Date |
| is identical to |
EN 45502-2-1:2003
|
2003-12-22 |
Relations to belgian/foreign publications
| Type |
Origin |
Code |
Date |
| Document |
Foreign |
ANSI/AAMI PC69 |
|
| Document |
Foreign |
ANSI/AAMI PC69-2000 |
|
| Standard |
Foreign |
ISO 11318 |
|
| Standard |
Foreign |
ISO 5841-3 |
|
| Standard |
Belgium |
NBN EN 28601 |
|
| Standard |
Belgium |
NBN EN 45502-1 |
|
| Standard |
Belgium |
NBN EN 45502-2-2 |
|
| Standard |
Belgium |
NBN EN 60068-2-27 |
|
| Standard |
Belgium |
NBN EN 60068-2-47 |
|
| Standard |
Belgium |
NBN EN 60068-2-64 |
|
|
