IEC 61847:1998
Current
The latest, up-to-date edition.
Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
English, Spanish, Castilian
30-01-1998
FOREWORD
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
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 |
TC 87
|
DevelopmentNote |
Also numbered as BS EN 61847. (09/2005) Stability Date: 2018. (09/2017)
|
DocumentType |
Standard
|
Pages |
31
|
PublisherName |
International Electrotechnical Committee
|
Status |
Current
|
Standards | Relationship |
NEN EN IEC 61847 : 1998 | Identical |
PN EN 61847 : 2002 | Identical |
AS/NZS 4512:1999 | Identical |
CEI EN 61847 : 1999 | Identical |
EN 61847:1998 | Identical |
DIN EN 61847:1998-09 | Similar to |
UNE-EN 61847:2000 | Identical |
NF EN 80601-2-58:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-58: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LENS REMOVAL DEVICES AND VITRECTOMY DEVICES FOR OPHTHALMIC SURGERY |
BS EN 62127-1 : 2007 | ULTRASONICS - HYDROPHONES - PART 1: MEASUREMENT AND CHARACTERIZATION OF MEDICAL ULTRASONIC FIELDS UP TO 40 MHZ |
NF EN 62127-1 : 2008 AMD 1 2013 | ULTRASONICS - HYDROPHONES - PART 1: MEASUREMENT AND CHARACTERIZATION OF MEDICAL ULTRASONIC FIELDS UP TO 40 MHZ |
EN 80601-2-58:2015 | Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery |
ANSI/AAMI/IEC 80601-2-58:2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-58: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LENS REMOVAL AND VITRECTOMY DEVICES FOR OPHTHALMIC SURGERY |
ISO 16142-1:2016 | Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards |
BS ISO 16142-1:2016 | Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards |
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 |
IEC 62127-1:2007+AMD1:2013 CSV | Ultrasonics - Hydrophones - Part 1: Measurement and characterizationof medical ultrasonic fields up to 40 MHz |
IEC 80601-2-58:2014+AMD1:2016 CSV | Medical electrical equipment - Part 2-58: Particular requirementsfor the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery |
13/30271473 DC : 0 | BS EN 80601-2-58 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-58: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LENS REMOVAL DEVICES AND VITRECTOMY DEVICES FOR OPHTHALMIC SURGERY |
CSA C22.2 No. 80601-2-58 : 2010 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-58: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LENS REMOVAL DEVICES AND VITRECTOMY DEVICES FOR OPHTHALMIC SURGERY |
I.S. EN 80601-2-58:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-58: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LENS REMOVAL DEVICES AND VITRECTOMY DEVICES FOR OPHTHALMIC SURGERY |
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)) |
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) |
IEC 60500:2017 | Underwater acoustics - Hydrophones - Properties of hydrophones in the frequency range 1 Hz to 500 kHz |
IEC 61205:1993 | Ultrasonics - Dental descaler systems - Measurement and declaration of the output characteristics |
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