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

 

Project

Reference EN 61010-2-101:2002
Title Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
Project Number 7604
Abstract/Scope Applies to equipment intended for in vitro diagnostic (IVD) medical purposes. This is used for the examination of specimens, including blood and tissue samples, derived from the human body. The standard also covers self-test IVD medical equipment for use by lay persons.
Status
Published

Status

Current Stage code 6060
Current Stage code date 2002-11-15
Current Stage code deadline 2003-09-01
Deadline date for vote  

Legal

Directive(s) IVD (98/79/EC)
Mandate(s) M/095
Order Voucher  

Details

IEC Technical Body IEC/TC 66
Reference Document IEC 61010-2-101:2002 (MOD)
ICS 11.040.55 - Diagnostic equipment
19.080 - Electrical and electronic testing
Keywords Laboratory equipment; Medical equipment; In vitro diagnostic; Measurement; Safety
Note Former prEN 61010-2-081 * D124/130: BTTF 88-1 disbanded - Work referred to SR 66
A-Deviation(s)  
Special National Condition(s)  

Environment

Clause
Categories - Aspects
Product Life Cycle
Information

History

Stage
Date
Deadline Date
Documents
6060 2002-11-15 2003-09-01 export to doc file  EN  FR  DE
5099 2002-09-01 2003-01-01  
5061 2002-06-24 2002-09-01  
5020 2001-11-23 2002-05-24  
1090 1998-09-28 2001-11-30  
1000 1996-03-05 1996-09-05  

Implementation Dates

date of Ratification (DOR) (1) 2002-09-01
date of Availability (DAV) (2) 2002-11-15
date of Announcement (DOA) (3) 2003-03-01
date of Publication (DOP) (4) 2003-09-01
date of Withdrawal (DOW) (5) 2005-09-01

Relations

Supersedes  
Superseded by FprEN 61010-2-101:2012
Normative reference (6) EN ISO 14971:2000

(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.