YY/T 0106-2021 (YY/T0106-2021, YYT 0106-2021, YYT0106-2021) & related versions
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(General technical conditions of medical diagnostic X-needle machine)
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General specifications for medical diagnostic X-ray equipment
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YY/T 0106-2021: PDF in English (YYT 0106-2021)
YY/T 0106-2008
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.50
C 43
Replacing YY/T 0106-2004
General specifications for
medical diagnostic X-ray equipment
ISSUED ON. OCTOBER 17, 2008
IMPLEMENTED ON. JANUARY 1, 2010
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and definitions ... 6
4 Classification and composition ... 6
5 Requirements ... 6
6 Test methods ... 11
Foreword
This Standard replaces YY/T 0106-2004 General specifications for medical
diagnostic X-ray equipment.
Compared with YY/T 0106-2004, the main changes are as follows.
- Rewrote Clause 1 and defined the application scope of this Standard;
- Added Clause 3 Terms and definitions;
- Revised Clause 4 to define the product’s classification and composition
requirements;
- Reorganized Clause 5, so as to make the clauses and sub-clauses of this
Standard clearer; revised or deleted some clauses and sub-clauses;
- Deleted Appendix A (informative) Applicable national standards and
industrial standards for X-ray equipment;
- Deleted Appendix B (normative) Safety.
This Standard was proposed by China Food and Drug Administration.
This Standard shall be under the jurisdiction of Sub-committee on Medical X-
ray Equipment and Utensils of National Technical Committee on Medical
Appliances of Standardization Administration of China.
Drafting organizations of this Standard. Beijing Wandong Medical Equipment
Co., Ltd., and Liaoning Provincial Medical Device Testing Institute.
Main drafters of this Standard. Lu Jinming, Sun Lijuan, Liu Baishi and Chen
Yong.
This Standard replaces the following previous standards.
- YY/T 0106-1993;
- YY/T 0106-2004.
General specifications for
medical diagnostic X-ray equipment
1 Scope
This Standard specifies the classification, requirements and test methods of
medical diagnostic X-ray equipment (hereinafter referred as X-ray equipment,
for short).
This Standard is applicable to medical diagnostic X-ray equipment. For medical
diagnostic X-ray equipment with national or industrial specific standard
requirements, it shall perform the appropriate national or industrial specific
standards.
This Standard is not applicable to X-ray equipment for computed tomography.
2 Normative references
The following standards contain the provisions which, through reference in this
Standard, constitute the provisions of this Standard. For dated references, the
subsequent amendments (excluding corrections) or revisions do not apply to
this Standard. However, the parties who enter into agreement based on this
Standard are encouraged to investigate whether the latest versions of these
documents are applicable. For undated reference documents, the latest
versions apply to this Standard.
GB 9706.1-2007 Medical electrical equipment - Part 1. General
requirements for safety (IEC 60601-1.1988, IDT)
GB 9706.3-2000 Medical electrical equipment Part 2. Particular
requirements for the safety of high-voltage generators of diagnostic X-ray
generators (idt IEC 60601-2-7.1998)
GB 9706.11-1997 Medical electrical equipment - Part 2. Particular
requirements for the safety of X-ray source assemblies and X-ray tube
assemblies for medical diagnosis (idt IEC 60601-2-28.1993)
GB 9706.12-1997 Medical electrical equipment - Part 1. General
requirements for safety - 3. Collateral standard. General requirements for
radiation protection in diagnostic X-ray equipment (idt IEC 60601-1-3.1994)
GB 9706.14-1997 Medical electrical equipment - Part 2. Particular
requirements for the safety of associated equipment of X-ray equipment (idt
IEC 60601-2-32.1994)
GB 9706.15-1999 Medical electrical equipment - Part 1. General
requirements for safety - 1. Collateral standard. Safety requirements for
medical electrical systems (idt IEC 60601-1-1.1995)
GB 9706.23-2005 Medical electrical equipment - Part 2-43. Particular
requirements for the safety of X-ray equipment for interventional procedures
(IEC 60601-2-43.2000, IDT)
GB 9706.24-2005 Medical electrical equipment - Part 2-45. Particular
requirements for the safety of mammographic X-ray equipment and
mammographic stereotactic devices (IEC 60601-2-45.2001, IDT)
GB/T 10149 Terminology and symbol for medical X-ray equipment
GB/T 10151 Medical diagnostic X-ray equipment - Specifications for high
voltage cable plugs and sockets
GB/T 19042.1-2003 Evaluation and routine testing in medical imaging
departments - Part 3-1. Acceptance test-Imaging performance of X-ray
equipment for radiographic and radioscopic systems (IEC 61223-3-1.1999,
IDT)
GB/T 19042.3-2005 Evaluation and routine testing in medical imaging
departments - Part 3-3.Acceptance tests - Imaging performance of X-ray
equipment for digital subtraction angiography (DSA) (IEC 61223-3-3.1996,
IDT)
YY 0076-1992 Coating classifications for metal product - Technical
conditions
YY/T 0202 Specifications for medical diagnostic X-ray device for
tomography
YY/T 0291-2007 Environmental requirements and test methods for medical
x-ray equipment
YY 0505-2005 Medical electrical equipment Part 1-2. General
requirements for safety Collateral standards. Electromagnetic compatibility
Requirements and tests (IEC 60601-1-2.2001, IDT)
value;
b) Power frequency. 50 Hz ± 1 Hz;
c) Power resistor stipulated by the product standard (stipulated adapted
power resistor shall not be less than the values stipulated in Table 101
of 10.2.2a) of GB 9706.3-2000);
d) Power capacity stipulated by the product standard.
5.2 Electric power
5.2.1 The maximum output power
For X-ray equipment which works in continuous mode and/or intermittent mode,
it shall stipulate the corresponding combination of X-ray tube voltage and X-ray
tube current that causes the maximum output power.
5.2.2 Nominal electric power
It shall stipulate that when loading time is 0.1 s, X-ray tube voltage is 100 kV,
the maximum constant electrical power output provided by X-ray equipment in
kW is the nominal electric power. If this value cannot be preselected, it can use
the X-ray tube voltage value which is the closest to 100 kV AND the closest
loading time value, however, it shall not be less than 0.1 s.
The nominal electric power shall be provided with the combination of X-ray tube
voltage, X-ray tube current and loading time.
5.3 Loading factors and control
5.3.1 X-ray tube voltage
X-ray tube voltage shall comply with the following requirements.
a) For X-ray equipment which works in continuous mode and/or intermittent
mode, it shall stipulate X-ray tube voltage adjustment range and
adjustment method;
b) Product standard shall stipulate the deviation of X-ray tube voltage value,
but it shall at least comply with.
- For mammography X-ray equipment, requirements in 50.103.1 of GB
9706.24-2005;
- For other X-ray equipment, requirements in 50.103.1 of GB 9706.3-
2000.
If applicable, the ancillary equipment shall stipulate rotation angle range,
longitudinal, lateral and vertical range of movement as well as its deviation.
5.5.2 Indicated value of Length
The deviation value between indicated value of length and actual value shall be
within ± 5% of the indicated value.
5.5.3 Indicated value of angle
The deviation value between indicated value of angle and actual value shall be
stipulated by the product standard.
5.5.4 Braking force
Linear movement part in mechanical device shall have braking device
(excluding the one in suspension device of which braking is nor required), and
its braking force shall not be less than 100 N.
5.5.5 Start-up force
Under continuous X-ray radiation conditions, for the movement part which
requires manual operation, the start-up force shall not be greater than 50 N.
5.5.6 Load bearing
The device that supports adult patients shall be able to work as normal after
bearing 100 kg of weight.
5.5.7 Noise
When X-ray equipment is operating in idling state (non-load bearing state), the
noise it produces shall not be greater than 70 dB (A weighting network)
(excluding unsustainable and aperiodic noise within 3 s).
NOTE. It shall consider the composite noise produced by possible composite
movement.
5.6 Software features
If applicable, the product standard shall stipulate the features of operation
software.
5.7 X-ray tomography apparatus
It shall comply with the requirements of YY/T 0202.
5.8 High voltage cable plug and socket
Sound level meter probe is 1 m away from X-ray equipment surface and 1.5 m
away from the ground. Use sound level meter “A” weighting network to measure.
Calculate based on the maximum noise value.
6.6 Software features
Practical operation and observation.
6.7 X-ray tomography apparatus
Conduct according to the provisions of YY/T 0202.
6.8 High voltage cable plug and socket
Conduct according to the provisions in 5.8.
6.9 Appearance
Visual observation.
6.10 Environment test
Conduct according to the provisions of YY/T 0291-2007.
6.11 Safety
Conduct according to the provisions of GB 9706.1-2007, GB 9706.3-2000, GB
9706.11-1997, GB 9706.12-1997, GB 9706.14-1997, GB 9706.15-1999, GB
9706.23-2005, GB 9706.24-2005 and YY 0505-2005.
......
| Standard ID | YY/T 0106-2021 (YY/T0106-2021) | | Description (Translated English) | (General technical conditions of medical diagnostic X-needle machine) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C43 | | Classification of International Standard | 11.040.50 | | Word Count Estimation | 17,114 | | Date of Issue | 2021-09-06 | | Date of Implementation | 2022-09-01 | | Summary | This standard specifies the classification and composition, requirements and test methods of medical diagnostic X-ray machines. This standard applies to medical diagnostic X-ray machines. For medical diagnostic X-ray machines that have national or industry-specific standards, the corresponding national or industry-specific standards should be implemented at the same time. This standard does not apply to X-ray computed tomography equipment. |
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