CENELEC
Project
| Reference | prEN 45502-1:2013 |
|---|---|
| Title | Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer |
| Project Number | 22891 |
| Abstract/Scope | 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 device that is commonly referred to as an ACTIVE IMPLANTABLE MEDICAL DEVICE can 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 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 The terminology used in this European Standard is intended to be consistent with the terminology of Directive 90/385/EEC. |
| Status |
Enquiry stage
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Status
| Current Stage code | 4020 |
|---|---|
| Current Stage code date | 2013-04-26 |
| Current Stage code deadline | 2013-07-26 |
| Deadline date for vote | 2012-04-30 |
Legal
| Directive(s) | AIMD (90/385/EEC) |
|---|---|
| Mandate(s) | M/432 |
| Order Voucher |
Details
| IEC Technical Body | |
|---|---|
| Reference Document | |
| ICS | 11.040.40 - Implants for surgery, prosthetics and orthotics |
| Keywords | |
| Note | 2013-02-19 - 2nd ENQ editing allocated to aclausse@cencenelec.eu * D137/C020: NWI approved - Target date for vote: 2012-04-30 * Will supersede EN 45502-1:1997 |
| 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) | |
|---|---|
| date of Availability (DAV) (2) | |
| date of Announcement (DOA) (3) | - |
| date of Publication (DOP) (4) | - |
| date of Withdrawal (DOW) (5) | - |
Relations
| Supersedes | EN 45502-1:1997 |
|---|---|
| Superseded by | |
| Normative reference (6) |
(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.
