International Standards and Conformity Assessment for all electrical, electronic and related technologies

 

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

Status

Current Stage code 4060
Current Stage code date 2013-07-29
Current Stage code deadline 2013-08-19
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

Clause
Categories - Aspects
Product Life Cycle
Information

History

Stage
Date
Deadline Date
Documents
4060 2013-07-29 2013-08-19 export to doc file  EN
4020 2013-04-26 2013-07-26 export to doc file  EN  FR  DE
3099 2013-02-15    
4060 2010-12-21 2011-03-21 export to doc file  EN
4020 2010-07-16 2010-12-17 export to doc file  EN  FR  DE
3099 2010-05-01 2010-07-16  
1099 2010-05-01 2010-11-01  
1000 2010-03-15 2010-04-30  

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.