YY/T 1547.1-2017Immobilization device for body positioning used in radiation therapy - Part 1: Thermoplastic (English PDF)
放射治疗用体位固定装置 第1部分：热塑膜
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
May 2, 2017
Implementation date
April 1, 2018
Scope
YY/T 1547.1-2017 is the English-translated version of 放射治疗用体位固定装置 第1部分：热塑膜.
YY/T 1547.1-2017 is the Chinese pharmaceutical industry standard for the thermoplastic sheet used to immobilise the patient for radiotherapy, the mask that is warmed, moulded to the body and then hardens.
It is the first part of the YY/T 1547 series and sets the performance requirements and the test methods, covering the softening temperature and the working time, the shrinkage and the dimensional stability after moulding, the strength and the rigidity of the hardened mask, the perforation pattern and the attenuation of the treatment beam. Issued on 2 May 2017, it has applied since 1 April 2018.
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Document preview — YY/T 1547.1-2017
National Standard of the People's Republic of China
- ICS
- 11.040.60
- Classification
- C 43
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Preface
- 1 Scope
- 2 Normative references
- 3 Requirements
- 3.1 External identification
- 3.2 random files
- 3.3 Dimensions
- 3.4 softening temperature
- 3.5 Tensile properties
- 3.6 linear shrinkage rate
- 3.7 Stickiness
- 3.8 Hardness
- 3.9 Biocompatibility
- 3.10 appearance
- 4 test methods
- 4.1 External identification
- 4.2 random files
- 4.3 Dimensions
- 4.4 softening temperature
- 4.5 Tensile properties
- 4.6 Linear shrinkage
- 4.7 Stickiness
- 4.8 Hardness
- 4.9 Biocompatibility
- 4.10 appearance
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.
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 document. 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 1
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;
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 18 pages — is available in the English PDF.
Referenced standards
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Related Standards
GB/T 16886.1-2022 — Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
GB/T 22864-2020 — Towels
GB/T 2411-2008 — Plastics and ebonite -- Determination of indentation hardness by means of a durometer (shore hardness)
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