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

 

Project

Reference EN 60601-2-16:1998
Title Medical electrical equipment - Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment
Project Number 5728
Abstract/Scope Specifies the minimum safety requirements for single patient haemodialysis, haemodiafiltration and haemofiltration equipment. These devices are intended for use either by medical staff or under the supervision of medical expertise, including haemodialysis, haemodiafiltration and haemofiltration equipment operated by the patient.
Status
Published

Status

Current Stage code 6060
Current Stage code date 1998-04-09
Current Stage code deadline 1999-01-01
Deadline date for vote  

Legal

Directive(s) MDD (93/42/EEC)
Mandate(s) M/023; M/432
Order Voucher BC/CLC/93-01

Details

IEC Technical Body IEC/SC 62D
Reference Document IEC 60601-2-16:1998 (EQV)
ICS 11.040 - Medical equipment
11.040.20 - Transfusion, infusion and injection equipment
Keywords Medical equipment; Haemodialysis; Haemodiafiltration; Haemofiltration; Safety
Note EN following parallel vote * Supersedes HD 395.2.16 S1 * Corrigendum to EN issued December 1999
A-Deviation(s)  
Special National Condition(s)  

Environment

Clause
Categories - Aspects
Product Life Cycle
Information

History

Stage
Date
Deadline Date
Documents
6060 1998-04-09 1999-01-01  
5099 1998-04-01 1998-05-01  
5062 1998-01-26 1998-04-01  
5020 1997-10-17 1997-12-31  
1090 1997-10-13 1997-10-17  
1000 1993-08-31    

Implementation Dates

date of Ratification (DOR) (1) 1998-04-01
date of Availability (DAV) (2) 1998-04-09
date of Announcement (DOA) (3) 1998-07-01
date of Publication (DOP) (4) 1999-01-01
date of Withdrawal (DOW) (5) 2001-01-01

Relations

Supersedes HD 395.2.16 S1:1989
Superseded by FprEN 60601-2-16:2008
Normative reference (6) ISO 594-2:1991
ISO 3744:1994
IEC 60513:1994
EN 60529:1991
corr. May 1993
EN 60601-1:1990
corr. July 1994
A1:1993
A2:1995
A11:1993
A12:1993
A13:1996
EN 60601-1-2:1993
corr. December 1997
EN 60651:1994
A1:1994
HD 481.3 S1:1987
EN 60804:1994
:
:
A2:1994

(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.