YY/T 1601-2018 English PDF (YYT1601-2018)

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YY/T 1601-2018: Ultrasonic surgical equipment for osseous tissue
YY/T 1601-2018
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.60
C 41
Ultrasonic surgical equipment for osseous tissue
ISSUED ON: JANUARY 19, 2018
IMPLEMENTED ON: JANUARY 01, 2019
Issued by: China Food and Drug Administration
Table of Contents
Foreword ... 3 
1 Scope ... 4 
2 Normative references ... 4 
3 Terms and definitions ... 4 
4 Technical requirements ... 5 
5 Test methods ... 7 
6 Inspection rules ... 9 
7 Marks and user’s manual ... 10 
Ultrasonic surgical equipment for osseous tissue
1 Scope
This Standard specifies technical requirements, test methods, inspection rules,
marks and user's manual for ultrasonic surgical equipment for osseous tissue
(hereinafter referred to as the equipment).
This Standard is applicable to ultrasonic surgical equipment for osseous tissue.
This Standard is not applicable to ultrasonic tooth cleaning device for removing
plaque and stones on teeth.
2 Normative references
The following referenced documents are indispensable for the application of
this document. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any
amendments) applies.
GB/T 191, Packaging and storage marks
GB 9706.1-2007, Medical electrical equipment - Part 1: General
requirements for safety
GB/T 9969-2008, General Principles for Preparation of Instructions for Use
of Industrial Products
GB/T 14710-2009, Environmental requirement and test methods for medical
electrical equipment
YY/T 0644-2008, Ultrasonic - surgical systems - Measurement and
declaration of the basic output characteristics
3 Terms and definitions
For the purposes of this document, the terms and definitions defined in YY/T
0644-2008 as well as the followings apply.
3.1 ultrasonic surgical equipment for osseous tissue
Surgical equipment powered by ultrasound, of which the frequency is generally
The output sound power of each type of tip of each ultrasonic hand-held
component shall be within the range announced by the manufacturer.
4.8 Duty cycle
If the main amplitude of the tip is modulated, its duty cycle or range of duty cycle
shall conform to the manufacturer's published value.
4.9 Static (no load) electrical power
The measured static (no-load) electrical power shall be less than the maximum
value of the static (no-load) electrical power of each ultrasonic handheld
component published by the manufacturer.
4.10 Maximum electric power
The measured maximum electric power shall be less than the maximum electric
power value of each ultrasonic handheld component published by the
manufacturer.
4.11 Power reserve index
The power reserve index shall conform to the value published by the
manufacturer.
4.12 Main sound output area
If applicable, the output area of the main sound of each type of tip shall conform
to the manufacturer's published value.
4.13 Output area of secondary transverse vibration sound
If applicable, the secondary transverse vibration sound output area of each type
of tip shall conform to the manufacturer's published value.
4.14 Liquid flow
The manufacturer shall publish the adjustment range of liquid flow. The error of
liquid flow relative to the nominal value shall not exceed ±10%.
4.15 Noise
It shall not be greater than 90dB (A-weighted).
4.16 Features to be published in user’s manual
a) Main amplitude at the tip of the treatment head;
b) Area of the main sound output of the treatment head;
5.5 Excitation frequency
Measure according to the method specified in 6.3.1 of YY/T 0644-2008. The
result shall meet the requirements of 4.5.
5.6 Tip vibration frequency
Measure according to the method specified in 6.4 of YY/T 0644-2008. The
result shall meet the requirements of 4.6.
5.7 Exported output sound power
Measure according to the method specified in 6.5.1 of YY/T 0644-2008. The
result shall meet the requirements of 4.7.
5.8 Duty cycle
Measure according to the method specified in 6.8 of YY/T 0644-2008. The
result shall meet the requirements of 4.8.
5.9 Static (no load) electrical power
Measure according to the method specified in 6.9 of YY/T 0644-2008. The
result must not exceed the published value.
5.10 Maximum electric power
Measure according to the method specified in 6.10 of YY/T 0644-2008. The
result must not exceed the published value.
NOTE: Simulated tip loads can use bone approximations, such as phenolic plastic and so
on.
5.11 Power reserve index
According to the results of 5.9 and 5.10, calculate the power reserve index
according to the method specified in 6.13 of YY/T 0644-2008.
5.12 Main sound output area
According to the definition of 3.9 in YY/T 0644-2008, calculate according to the
method specified in 6.11 in YY/T 0644-2008.
5.13 Output area of secondary transverse vibration sound
According to the definition of 3.15 in YY/T 0644-2008, calculate according to
the method specified in 6.12 in YY/T 0644-2008.
5.14 Liquid flow
c) When requested by the national quality supervision department.
6.3.2 Type inspection items
All requirements specified in this Standard. The number of samples for type
inspection is one.
6.3.3 Determination for conformity of type test
In the inspection items, if there are items that do not meet the requirements, it
is allowed to repair the nonconforming items. After the adjustment and repair,
for the items that may be related to the failure, the retest must all meet the
requirements, otherwise it shall be determined as failure.
The inspection items and determination rules for quality supervision and
inspection shall be separately stipulated by the quality supervision agency.
7 Marks and user’s manual
7.1 Marks
7.1.1 The following marks shall be on the equipment:
a) Manufacturer’s name;
b) Product named and model;
c) Power used;
d) Production date or exit-factory number;
e) Other marks required by applicable standards and regulations.
7.1.2 The following marks shall be on the box:
a) Manufacturer's name and address;
b) Product name, model, quantity;
c) Weight, volume (length × width × height);
d) For "fragile items", "upward", "fear of rain" and other words or marks, the
text and graphics shall comply with the relevant provisions of GB/T 191-
2008;
e) Other marks required by applicable standards and regulations.
7.2 Accompanying documents