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YY/T 1547.2-2017Immobilization device for body positioning used in radiation therapy - Part 2: Vacuum cushion (English PDF)

放射治疗用体位固定装置第2部分：真空负压垫

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

May 2, 2017

Implementation date

April 1, 2018

Scope

YY/T 1547.2-2017 is the English-translated version of 放射治疗用体位固定装置第2部分：真空负压垫.

YY/T 1547.2-2017 is the Chinese pharmaceutical industry standard for the vacuum cushion used to immobilise the patient for radiotherapy, the bag of beads that is shaped around the body and then evacuated so that it holds its form.

It is the second part of the YY/T 1547 series and sets the performance requirements and the test methods, covering the airtightness and the vacuum retention over time, the firmness and the stability of the shaped cushion, the strength of the envelope and the valve, 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 1547.2-2017

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

Preface
1 Scope
2 Normative references
3 Requirements
3.1 External identification
3.2 random files
3.3 Dimensions
3.4 sealing performance
3.5 compression performance
3.6 Biocompatibility
3.7 Appearance
4 test methods
4.1 External identification
4.2 random files
4.3 Dimensions
4.4 sealing performance
4.5 compression performance
4.6 Biocompatibility
4.7 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 section is YY/T 1547 part 2. 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 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 document. 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 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 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 1

Should provide the product dimensions and deviations.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 22 pages — is available in the English PDF.

Referenced standards

Normative references

GB/T 16886.1Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

Similar standards

YY/T 1547.1-2017|YY/T 1694-2020|YY/T 1537-2017|YY/T 1896-2023|YY/T 1711-2020|YY/T 1538-2017

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