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EN 61847:1998

Current

Current

The latest, up-to-date edition.

Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics

Published date

24-02-1998

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INTRODUCTION
1 Scope
2 Normative references
3 Definitions
4 List of symbols
5 General measurement requirements
    5.1 Operating conditions
    5.2 Load conditions
    5.3 Preparation for measurements
6 Measurement procedures
    6.1 Primary tip vibration excursion
    6.2 Secondary tip vibration excursion
    6.3 Drive frequency
    6.4 Tip vibration frequency
    6.5 Derived output acoustic power and output acoustic
          power
    6.6 Directivity pattern
    6.7 Primary tip vibration excursion modulation
    6.8 Duty cycle
    6.9 Quiescent electrical power
    6.10 Maximum electrical power
    6.11 Primary acoustic output area
    6.12 Secondary acoustic output area
    6.13 Power reserve index
7 Declaration of output characteristics
Figures
Annexes
A Measurement methods and conditions
B Theory of operation of ultrasonic surgical devices
C Bibliography
ZA Normative reference to international publications with
    their corresponding European publications

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.

Committee
CLC/SR 87
DocumentType
Standard
PublisherName
European Committee for Standards - Electrical
Status
Current

Standards Relationship
CEI EN 61847 : 1999 Identical
SN EN 61847 : 1998 Identical
DIN EN 61847:1998-09 Identical
NEN EN IEC 61847 : 1998 Identical
IEC 61847:1998 Identical
PN EN 61847 : 2002 Identical
NBN EN 61847 : 1998 Identical
NF EN 61847 : 2006 Identical
BS EN 61847:1998 Identical
UNE-EN 61847:2000 Identical

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I.S. EN 62127-1:2007 ULTRASONICS - HYDROPHONES - PART 1: MEASUREMENT AND CHARACTERIZATION OF MEDICAL ULTRASONIC FIELDS UP TO 40 MHZ (IEC 62127-1:2007 (EQV))
BS EN 80601-2-58:2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery
EN 62127-1:2007/A1:2013 ULTRASONICS - HYDROPHONES - PART 1: MEASUREMENT AND CHARACTERIZATION OF MEDICAL ULTRASONIC FIELDS UP TO 40 MHZ (IEC 62127-1:2007/A1:2013)

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