YY/T 0128-2004 English PDF (YY/T0128-2004)

YY/T 0128-2004: Protective devices against diagnostic medical X-radiation. Device and tool
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YY/T 0128-2004
YY
PHARMACEUTICAL INDUSTRY STANDARD
ICS 11.040.50
C 43
Replacing YY 0128-1993
Protective devices against diagnostic medical X-radiation -
Device and tool
ISSUED ON. NOVEMBER 08, 2004
IMPLEMENTED ON. NOVEMBER 01, 2005
Issued by. National Medical Products Administration
Substituted
Table of Contents
Foreword... 3
1 Scope and purpose... 4
2 Normative references... 4
3 Terms and definitions... 5
4 Requirements... 5
5 Test method... 9
6 Inspection rules... 10
7 Marking and labeling... 12
8 Packaging, transportation, storage... 12
Protective devices against diagnostic medical X-radiation -
Device and tool
1 Scope and purpose
1.1 Scope
This standard applies to medical diagnostic X-ray radiation protection devices (hereinafter
referred to as devices) and protective tools (hereinafter referred to as tools).
The devices involved in this standard include medical diagnostic X-ray radiation protective
screen (hereinafter referred to as protective screen), medical diagnostic X-ray radiation
protective room (hereinafter referred to as protective room), medical diagnostic X-ray radiation
protective door (hereinafter referred to as protective door), medical diagnostic X-ray radiation
protective chair (hereinafter referred to as protective chair).
The tools covered by this standard include medical diagnostic X-ray radiation protective glasses
(hereinafter referred to as protective glasses), medical diagnostic X-ray radiation protective
shields (hereinafter referred to as protective shields), medical diagnostic X-ray radiation
protective curtains (hereinafter referred to as protective curtains).
The above products are used for protection against medical diagnostic X-ray radiation.
1.2 Purpose
This standard specifies the types, requirements, test methods, inspection rules, marking,
labeling, packaging, transportation, storage of devices and tools.
2 Normative references
The clauses in the following documents become clauses of this standard through reference in
this standard. For all dated referenced documents, all subsequent amendments (excluding errata)
or revisions are not applicable to this standard. However, parties to an agreement based on this
standard are encouraged to study whether the latest versions of these documents can be used.
For all undated referenced documents, the latest versions are applicable to this standard.
GB/T 191-2000 Packaging - Pictorial marking for handling of goods
GB/T 2829-2002 Sampling procedures and tables for periodic inspection by
attributes (apply to inspection of process stability)
YY 0292.1-1997 Protective devices against diagnostic medical X-radiation - Part 1.
Determination of attenuation properties of materials (idt IEC 61331-1.1994)
4.2.2 The lead equivalent of the protective room shall meet the following requirements.
a) The lead equivalent of the front and two sides of the perspective room shall not be less
than 0.5 mmPb;
b) The lead equivalent of the front of the photography room (including the observation
window) shall not be less than 1.0 mmPb; the lead equivalent of the two sides shall not
be less than 0.5 mmPb;
c) The lead equivalent of other surfaces shall not be less than 0.25 mmPb (except for the
contact between the bottom edge and the ground).
4.2.3 The door of the protective room shall be flexible to open and close, without rebound.
4.2.4 When the perspective room is matched with the fluorescent screen, it shall be convenient,
reliable, flexible to operate.
4.2.5 Visible light entering the fluoroscopy room shall not affect the diagnosis.
4.2.6 The protective room used for both fluoroscopy and photography shall meet the
requirements of the photographic protective room.
4.2.7 The bottom edge of the photographic protective room, which uses the ground as the
bottom surface, shall be in contact with the ground.
4.3 Protective chair
4.3.1 Type and basic structural dimensions of the protective chair.
a) The protective chair is movable and detachable;
b) The projection width of the front shield of the protective chair shall not be less than 900
mm; the projection width of the side shield shall not be less than 150 mm;
c) The total height of the shielding part of the protective chair shall not be less than 850 mm
(including casters). The height of the bottom edge of the shielding plate on the front and
both sides from the ground shall not be greater than 80 mm;
d) The protective chair shall have a bench. The bench and the shielding part shall be an
integrated structure; the bench shall be able to move forward and backward.
4.3.2 The lead equivalent of the front and side shielding parts of the protective chair shall not
be less than 0.5 mmPb.
4.3.3 When the bench is subjected to a load of 135 kg, the protective chair and bench shall not
be permanently deformed.
4.3.4 The protective chair shall be equipped with casters, which shall be flexible to push and
turn, and shall be equipped with a brake device. The brake device shall be reliable and easy to
operate. When braking, the casters shall not rotate.
4.4 Protective door
4.4.1 Protective doors are divided into two types. sliding door and vertical-hinged door; the
opening methods can be divided into two types. manual and electric.
4.4.2 Lead equivalent of protective door.
a) The lead equivalent of the door in the machine room, which has a capacity of 100 kV and
less than 500 mA, shall not be less than 1.5 mmPb;
b) The lead equivalent of the door in the machine room, which has a capacity of 100 kV ~
125 kV and less than 500 mA, shall not be less than 2.0 mmPb;
c) The lead equivalent of the door in the machine room, which has a capacity greater than
125 kV and more than 500 mA, shall not be less than 3.0 mmPb;
d) The lead equivalent of the door in the CT machine room shall not be less than 3.0 mmPb.
4.4.3 The door for patients to enter and exit should be installed on the secondary protective wall.
4.4.4 If the door must be installed on the main protective wall, its lead equivalent shall be
increased by 1 mmPb on the original basis.
4.4.5 The door shall not only have sufficient lead equivalent, but also have certain strength and
collision resistance, to enable it to operate smoothly. The axis of the vertical-hinged door shall
be durable; the door frame and door shall have the same protection ability.
4.4.6 The main body of the sliding door shall be larger than the door opening; the left and right
sides and the top of the door shall be larger than the door opening by more than 100 mm; the
bottom of the door shall be more than 50 mm below the ground.
4.4.7 The sliding door shall be as close to the wall as possible. The gap between the protective
door and the wall shall be controlled within 10 mm.
4.4.8 The operating noise of the electric door shall not be greater than 70 dB (A).
4.5 Protective glasses
4.5.1 The lead equivalent of the lens shall not be less than 0.25 mmPb.
4.5.2 The transmittance of the lens, for light with a wavelength of 550 nm, shall not be less than
80%.
4.5.3 The lens shall not have visible bubbles.
4.5.4 The lens shall not have visible stripes and other non-uniformities.
4.7.3.4 For protective curtains with light-transmitting plates, the light-transmitting plates shall
have a transmittance of not less than 80% for light with a wavelength of 550 nm.
4.8 Appearance
The appearance shall meet the following requirements.
a) The appearance of the device and tool shall be neat and beautiful; the surface shall be
clean; the color shall be uniform; there shall be no defects such as scratches and cracks;
b) If there are painted parts in the device and tool, the painted parts shall meet the appearance
requirements of YY/T 91055;
c) If there are electroplated parts in the device and tool, the electroplated parts shall meet
the appearance requirements of YY 0076.
5 Test method
5.1 Lead equivalent test
5.1.1 The test tube voltage shall meet the following requirements.
a) For devices and tools with tube voltage below 125 kV (including 125 kV), the test voltage
is 125 kV; the total filtration is above 2.5 mmAl;
b) For devices and tools with tube voltage above 125 kV (excluding 125 kV), the test voltage
is 150 kV; 0.5 mmCu filtration shall be added;
c) The test value of the test tube voltage shall not be less than 90% of the specified test
voltage value;
d) The X-ray measuring instrument used in the test should be an ionization chamber X-ray
irradiation meter.
5.1.2 The test layout shall meet the following requirements.
a) The standard lead sheet substitution method (film density test method may also be used)
is used for measurement; the lead equivalent is calculated by interpolation method and
expressed in mmPb;
b) The test device is shown in Figure 2 of YY 0292.1-1997;
c) When measuring with standard lead sheets, there shall be no less than 3 points each time,
and no less than 3 measurements for each point; the average value shall be taken. The
lowest value shall be taken for the three-point measurement. The thickness of the selected
standard lead sheet shall cover and be close to the value of the lead equivalent of the
sample under test;
d) The purity of the standard lead sheet is 99.9%; the thickness accuracy is ±0.01 mm; the
repeated reading accuracy of the measuring instrument and device shall not be less than
±5%;
e) No items that may cause X-ray scattering, such as X-ray beds, chairs, hangers, etc., shall
be placed within the space of 1 m of the sample under test.
5.2 Light transmittance test
Select 3 points on the sample at random, to make measurement separately with a
spectrophotometer; take the minimum value.
5.3 Impact test of protective door strength
Use a standard test hammer to check; there shall be no dents that seriously affect the appearance.
5.4 Noise inspection
Use a noise detector to measure a round trip at a height of 1.5 m, which is 1 m from the outside
of the door. The maximum single measurement value shall not exceed 70 dB (A); the
instantaneous noise shall not be counted.
5.5 Dimensions
Use general measuring tools to inspect.
5.6 Appearance
Visual inspection.
5.7 Painted parts
Make measurement according to the method specified in YY/T 91055 Paint coating for medical
devices - Classification and specification.
5.8 Electroplated parts
Make measurement according to the method specified in YY 0076 Coating classifications for
metal product - Technical conditions.
6 Inspection rules
6.1 Devices and tools shall be inspected by the technical inspection department of the
manufacturer; they can only be delivered after passing the inspection.
6.2 Devices and tools must be submitted for acceptance in batches. The acceptance inspection
is divided into batch-by-batch inspection (exit-factory inspection) and periodic inspection (type
inspection or routine inspection).
YY/T 0128-2004
YY
PHARMACEUTICAL INDUSTRY STANDARD
ICS 11.040.50
C 43
Replacing YY 0128-1993
Protective devices against diagnostic medical X-radiation -
Device and tool
ISSUED ON. NOVEMBER 08, 2004
IMPLEMENTED ON. NOVEMBER 01, 2005
Issued by. National Medical Products Administration
Substituted
Table of Contents
Foreword... 3
1 Scope and purpose... 4
2 Normative references... 4
3 Terms and definitions... 5
4 Requirements... 5
5 Test method... 9
6 Inspection rules... 10
7 Marking and labeling... 12
8 Packaging, transportation, storage... 12
Protective devices against diagnostic medical X-radiation -
Device and tool
1 Scope and purpose
1.1 Scope
This standard applies to medical diagnostic X-ray radiation protection devices (hereinafter
referred to as devices) and protective tools (hereinafter referred to as tools).
The devices involved in this standard include medical diagnostic X-ray radiation protective
screen (hereinafter referred to as protective screen), medical diagnostic X-ray radiation
protective room (hereinafter referred to as protective room), medical diagnostic X-ray radiation
protective door (hereinafter referred to as protective door), medical diagnostic X-ray radiation
protective chair (hereinafter referred to as protective chair).
The tools covered by this standard include medical diagnostic X-ray radiation protective glasses
(hereinafter referred to as protective glasses), medical diagnostic X-ray radiation protective
shields (hereinafter referred to as protective shields), medical diagnostic X-ray radiation
protective curtains (hereinafter referred to as protective curtains).
The above products are used for protection against medical diagnostic X-ray radiation.
1.2 Purpose
This standard specifies the types, requirements, test methods, inspection rules, marking,
labeling, packaging, transportation, storage of devices and tools.
2 Normative references
The clauses in the following documents become clauses of this standard through reference in
this standard. For all dated referenced documents, all subsequent amendments (excluding errata)
or revisions are not applicable to this standard. However, parties to an agreement based on this
standard are encouraged to study whether the latest versions of these documents can be used.
For all undated referenced documents, the latest versions are applicable to this standard.
GB/T 191-2000 Packaging - Pictorial marking for handling of goods
GB/T 2829-2002 Sampling procedures and tables for periodic inspection by
attributes (apply to inspection of process stability)
YY 0292.1-1997 Protective devices against diagnostic medical X-radiation - Part 1.
Determination of attenuation properties of materials (idt IEC 61331-1.1994)
4.2.2 The lead equivalent of the protective room shall meet the following requirements.
a) The lead equivalent of the front and two sides of the perspective room shall not be less
than 0.5 mmPb;
b) The lead equivalent of the front of the photography room (including the observation
window) shall not be less than 1.0 mmPb; the lead equivalent of the two...