YY/T 1547.2-2017 (YY/T1547.2-2017, YYT 1547.2-2017, YYT1547.2-2017)
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| YY/T 1547.2-2017 | English | 109 |
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Immobilization device for body positioning used in radiation therapy—Part 2: Vacuum cushion
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YY/T 1547.2-2017
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Standards related to: YY/T 1547.2-2017
| Standard ID | YY/T 1547.2-2017 (YY/T1547.2-2017) | | Description (Translated English) | Immobilization device for body positioning used in radiation therapy--Part 2: Vacuum cushion | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C43 | | Classification of International Standard | 11.040.60 | | Word Count Estimation | 5,540 | | Date of Issue | 2017-05-02 | | Date of Implementation | 2018-04-01 | | Drafting Organization | Beijing Medical Devices Testing Institute, Guangzhou Kelai Reidi Medical Equipment Co., Ltd., Shandong Xinhua Medical Devices Co., Ltd., Sichuan Ruidi Medical Technology Co., Ltd. | | Administrative Organization | National Technical Committee for Medical Appliance Standardization Technical Committee on Radiation Therapy, Nuclear Medicine and Radiological Equipment (SAC/TC 10/SC 3) | | Regulation (derived from) | China Food & Drug Administration Announcement 2017 No. 49 | | Proposing organization | China Food and Drug Administration | | Issuing agency(ies) | State Food and Drug Administration | YY/T 1547.2-2017
Immobilization device for body positioning used in radiation therapy-Part 2. Vacuum cushion
ICS 11.040.60
C43
People's Republic of China pharmaceutical industry standards
Radiation therapy with body position fixtures
Part 2. Vacuum negative pressure pad
Part 2.Vacuumcushion
2017-05-02 released
2018-04-01 implementation
State Food and Drug Administration released
Directory
Preface Ⅰ
1 range 1
2 Normative references 1
3 Requirements 1
3.1 External identification 1
3.2 random files 1
3.3 Dimensions 1
3.4 sealing performance 2
3.5 compression performance 2
3.6 Biocompatibility 2
3.7 Appearance 2
4 test methods 2
4.1 External identification 2
4.2 random files 2
4.3 Dimensions 2
4.4 sealing performance 2
4.5 compression performance 2
4.6 Biocompatibility 2
4.7 Appearance 2
Foreword
YY/T 1547 "radiotherapy position fixtures" has been completed in two parts.
--- Part 1. Thermoplastic film;
--- Part 2. Vacuum negative pressure pad.
This section is YY/T 1547 part 2.
This section drafted in accordance with GB/T 1.1-2009 given rules.
Please note that some of this document may be patentable. The issuing agencies of this document do not bear the responsibility of identifying these patents.
This part is proposed by the State Food and Drug Administration.
This part of the National Medical Standardization Technical Committee of Radiotherapy, Nuclear Medicine and Radiological Equipment Sub-Technical Committee
(SAC/TC10/SC3).
This part of the drafting unit. Beijing Medical Device Inspection Institute, Guangzhou Kelai Ruidi Medical Equipment Co., Ltd., Shandong Xinhua Medical Devices Unit
Co., Ltd., Sichuan Ruidi Medical Technology Co., Ltd.
The main drafters of this section. Camp Jiao Chun, Xie soldier, Chen Jing, Zhou Guohuang, Tian Zhaofeng, Fan Yonglin.
Radiation therapy with body position fixtures
Part 2. Vacuum negative pressure pad
1 Scope
This part of YY/T 1547 specifies the performance requirements and test methods for the vacuum negative pressure pad of the positioner for radiation therapy.
This section applies to radiation therapy for vacuum position fixed vacuum pad (hereinafter referred to as the product).
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version applies to this article
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and test in risk management process
3 requirements
3.1 external logo
External logo should contain at least the following content.
a) product name, model or specification;
b) manufacturer's name, address and trademark;
c) date of manufacture;
d) Serial number or lot number.
3.2 random files
Random documents should contain at least the following content.
a) product name, model or specification;
b) manufacturer's name, address and trademark;
c) the surface material and filler material of the product;
d) the product dimensions;
e) the product is recommended for use;
f) storage methods and environmental conditions before and after use of the product;
g) product cleaning methods;
h) the method of shaping the product;
i) the product's set vacuum pressure;
j) product disposal methods;
k) the effect of the product on the patient's body surface dose and beam attenuation during radiotherapy;
l) Provide a recommended method of patient identification.
3.3 Dimensions
Should provide the product dimensions and deviations.
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