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

 

Project

Reference EN 61847:1998
Title Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics
Project Number 11693
Abstract/Scope This standard specifies: - the essential non-thermal output characteristics of ultrasonic surgical units; - methods of measurement ot these output characteristics; - those characteristics which should be declared by the manufacturers of such equipment. This standard is applicable to equipment which meets the requirements of a, b and c below: a) ultrasonic surgical systems operating in the frequency range 20 kHz to 60 kHz; and b) ultrasonic surgical systems, whose use is the fragmentation or cutting of human tissue, whether or not those effects are delivered in conjunction with tissue removal or coagulation; and c) ultrasonic surgical systems, in which an acoustic wave is conducted by means of a specifically designed wave guide to deliver energy to the surgical site.
Status
Published

Status

Current Stage code 6060
Current Stage code date 1998-02-24
Current Stage code deadline 1998-10-01
Deadline date for vote  

Legal

Directive(s)  
Mandate(s)  
Order Voucher  

Details

IEC Technical Body IEC/TC 87
Reference Document IEC 61847:1998 (EQV)
ICS 11.040.01 - Medical equipment in general
17.140.50 - Electroacoustics
Keywords Ultrasonics; Surgical system; Measurement
Note EN following parallel vote
A-Deviation(s)  
Special National Condition(s)  

Environment

Clause
Categories - Aspects
Product Life Cycle
Information

History

Stage
Date
Deadline Date
Documents
6060 1998-02-24 1998-10-01 export to doc file  EN
6020 1998-02-02 1998-05-02  
5099 1998-01-01 1998-02-01  
5062 1997-11-18 1998-01-01  
5020 1997-08-22 1997-10-31  
1090 1997-08-18 1997-08-22  

Implementation Dates

date of Ratification (DOR) (1) 1998-01-01
date of Availability (DAV) (2) 1998-02-24
date of Announcement (DOA) (3) 1998-04-01
date of Publication (DOP) (4) 1998-10-01
date of Withdrawal (DOW) (5) 1998-10-01

Relations

Supersedes  
Superseded by  
Normative reference (6) IEC 60500:1974
EN 61205:1994

(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.