Publication details
| Publication CODE |
Title |
| NBN EN 45502-1:1997 (2018-04) |
ACTIVE IMPLANTABLE MEDICAL DEVICES
PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
| |
| Price Excl. VAT |
Total number of pages, tables and drawings |
|
67.00 €
|
41 P.. |
Description
This Part 1 of EN 45502 specifies requirements that are generally applicable to ACTIVE IMPLANTABLE MEDICAL DEVICES. For particular types of ACTIVE IMPLANTABLE MEDICAL DEVICES, these essential 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 a device to show compliance. This Part 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 of EN 45502 is also applicable to some non-implantable park and accessories of the devices (see note 1). 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
|
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.
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|
|
Status
| Status |
Registered trilingual Belgian standard EN or FR or DE |
| Situation |
Withdrawn
Replaced by
NBN EN 45502-1:2015
|
|
Origin
| Committee |
JWGAIMD
See TC 62WGXA1 (field of TC 62)
|
Approval
| BEC Approval |
1997-03-11 |
| NBN Approval |
1997-10-10 |
| Belgian Official Journal |
1998-05-20 |
| Registration |
156121 |
| Numbers identifying the european directives |
90/385/EEC
(Active implantable medical devices)
|
| ICS-Code (International Standards Classification) |
11.040.01
|
| NBN Status |
New |
|
| Date of ratification (d.o.r.) |
2018-04-20 |
| Date of availability (d.a.v.) |
2018-04-20 |
| Date of announcement (d.o.a.) |
1997-09-01 |
| Date of publication (d.o.p.) |
1998-03-01 |
| Date of withdrawal former edition (d.o.w.) |
1998-03-01 |
|
Correspondences with international standards
| Relation |
International standard |
Date |
| is identical to |
EN 45502-1:1997
|
1997-08-27 |
Relations to belgian/foreign publications
| Type |
Origin |
Code |
Date |
| Document |
Foreign |
HD 323.2.14 |
|
| Document |
Foreign |
HD 323.2.36 |
|
| Standard |
Foreign |
ISO 8601 |
|
| Standard |
Belgium |
NBN EN 50540 |
|
| Standard |
Belgium |
NBN EN 50556 |
|
| Standard |
Belgium |
NBN EN 60068-2-32 |
|
| Standard |
Belgium |
NBN EN 60068-2-47 |
|
| Standard |
Belgium |
NBN EN 60601-1 |
|
| Standard |
Belgium |
NBN EN 60601-1-1 |
|
| Standard |
Belgium |
NBN EN 60601-1-2 |
|
| Standard |
Belgium |
NBN EN 60601-1-4 |
|
| Standard |
Belgium |
NBN EN 60601-2-27 |
|
| Standard |
Belgium |
NBN EN 60801-2 |
|
| Standard |
Belgium |
NBN EN 868-1 |
|
| Standard |
Belgium |
NBN EN 980 |
|
|
