YY/T 1547.1-2017 (YY/T1547.1-2017, YYT 1547.1-2017, YYT1547.1-2017)
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| YY/T 1547.1-2017 | English | 119 |
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Immobilization device for body positioning used in radiation therapy—Part 1: Thermoplastic
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YY/T 1547.1-2017
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Standards related to: YY/T 1547.1-2017
| Standard ID | YY/T 1547.1-2017 (YY/T1547.1-2017) | | Description (Translated English) | Immobilization device for body positioning used in radiation therapy--Part 1: Thermoplastic | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C43 | | Classification of International Standard | 11.040.60 | | Word Count Estimation | 6,675 | | Date of Issue | 2017-05-02 | | Date of Implementation | 2018-04-01 | | Drafting Organization | Beijing Medical Device Testing Institute, Cancer Hospital of Chinese Academy of Medical Sciences, Guangzhou Si An Medical Technology Co., Ltd., Guangzhou Kelai Ruidi Medical Equipment Co., Ltd., Shandong Xinhua Medical Devices 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) | | Proposing organization | China Food and Drug Administration | | Issuing agency(ies) | State Food and Drug Administration | YY/T 1547.1-2017
Immobilization device for body positioning used in radiation therapy-Part 1. Thermoplastic
ICS 11.040.60
C43
People's Republic of China pharmaceutical industry standards
Radiation therapy with body position fixtures
Part 1. Thermoplastic films
Part 1.Thermoplastic
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 2
3.4 softening temperature 2
3.5 Tensile properties 2
3.6 linear shrinkage rate 2
3.7 Stickiness 2
3.8 Hardness 2
3.9 Biocompatibility 2
3.10 appearance 2
4 test methods 2
4.1 External identification 2
4.2 random files 2
4.3 Dimensions 2
4.4 softening temperature 2
4.5 Tensile properties 3
4.6 Linear shrinkage 3
4.7 Stickiness 3
4.8 Hardness 3
4.9 Biocompatibility 3
4.10 appearance 3
Foreword
YY/T 1547 "radiotherapy position fixtures" has been completed in two parts.
--- Part 1. Thermoplastic film;
--- Part 2. Vacuum negative pressure pad.
This part of YY/T 1547 Part 1.
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 section is drafted by Beijing Medical Device Inspection Institute, Chinese Academy of Medical Sciences Cancer Hospital, Guangzhou Si An Medical Technology Co., Ltd.,
Guangzhou Kelai Reidi Medical Equipment Co., Ltd., Shandong Xinhua Medical Devices Co., Ltd.
The main drafters of this section. Camp Jiao Chun, Xie soldier, Liu Xi, Zhang Yin, Shi Xiangyang, Zhou Guohuang, Tian Zhaofeng.
Radiation therapy with body position fixtures
Part 1. Thermoplastic films
1 Scope
This part of YY/T 1547 specifies the performance requirements and test methods of the thermoplastic film for the position fixtures for radiotherapy.
This section applies to radiation therapy for the fixed position of the thermoplastic film (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 2411 Plastics and hard rubbers Determination of indentation hardness (Shore hardness) using a durometer
GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and test in risk management process
GB/T 22864 towels
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 product is suitable for use in human body parts in radiotherapy;
d) the use of product materials;
e) the size of the product;
f) the recommended period of use of the product;
g) Product shaping operation methods, including softening temperature, softening time, shaping time;
h) product setting time or shrinkage curve;
i) warning to prevent the skin from being cut off causing infection;
j) Warning to prevent scalding of the skin tissue;
k) Emergency treatment in use;
For example, quickly unlock.
l) storage methods and environmental conditions before and after use of the product;
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