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YY 0096-2019Co-60 teletherapy unit (English PDF)

钴-60远距离治疗机

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Issued by

NMPA

Level / Type

Industry · Mandatory

Issue date

May 31, 2019

Implementation date

December 1, 2020

Scope

YY 0096-2019 is the English-translated version of 钴-60远距离治疗机.

YY 0096-2019 is the Chinese pharmaceutical industry standard for the cobalt-60 teletherapy unit used in radiation therapy.

It sets the requirements and the test methods for the machine, covering the source and its housing and the leakage radiation, the accuracy of the field size and of the light and radiation field coincidence, the geometry of the gantry, the collimator and the couch and of the isocentre, the timer and the accuracy of the delivered dose, the interlocks and the emergency return of the source, and the safety of the installation. Issued on 31 May 2019, it applies from 1 December 2020.

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Document preview — YY 0096-2019

National Standard of the People's Republic of China

ICS
11.040.60
Classification
C 43
Replacing
YY 0096-2009

Issued by: National Medical Products Administration of the People's Republic of China

Contents

  • Foreword
  • 1 Scope
  • 2 Normative references
  • 3 Terms and Definitions
  • 4 Requirements
  • 4.1 Environmental conditions
  • 4.2 Performance
  • 4.3 Electrical Safety
  • 5 Test method
  • 5.1 Test conditions
  • 5.2 Performance
  • 5.3 Electrical Safety
  • Appendix A (Normative Appendix) Method of Measuring Absorbed Dose Rate

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard replaces YY 0096-2009 "Cobalt-60 Teletherapy Machine".

Compared with YY 0096-2009, the main technical changes except the editorial modification are as follows.

--- Removed the introduction (see the introduction of the 2009 edition);

--- Normative references have added GB/T 17857 and YY 0505 (see 2);

--- Revised some terms and definitions (see 3, 3 of the 2009 edition);

--- Removed "type and basic parameters" (see 4 of the 2009 edition);

--- Increased performance requirements for the treatment bed (see 4.2.10);

--- Increased the requirement for absorbed dose rate (see 4.2.11);

--- Revised the test method for the error of the isocenter position (see 5.2.1, 6.5 of the 2009 edition);

--- Revised the test method for the trimmed penumbra width (see 5.2.2, 6.6 of the 2009 edition);

--- Revised the test method for the deviation between the field and the radiation field boundary (see 5.2.5, 6.9 of the 2009 edition);

--- Revised the test method for the display of the radiation field (see 5.2.8, 6.12 of the 2009 edition);

--- Revised electrical safety requirements and test methods (see 4.3, 5.3, 2009 editions 5.14, 6.15);

--- Removed "noise" (see 5.11 of the 2009 edition);

--- Removed the "look" (see 5.12 of the 2009 edition);

--- Removed the "ruler scale" (see 5.13 of the 2009 edition);

--- Removed the "radiation head movement" [see.2009 edition of 5.7a)];

--- Removed the "inspection rules" (see 7 of the 2009 edition);

--- Removed "flag, packaging, transportation, storage" (see 8 of 2009 edition);

--- Removed the appendix "Test methods for isocenter locations" (see Appendix A of the 2009 edition);

--- Added "Measurement method for absorbed dose rate" (see Appendix A).

1 Scope

This standard specifies the requirements and test methods for the Cobalt-60 remote treatment machine.

This standard applies to the cobalt-60 remote treatment machine (hereinafter referred to as the treatment machine), which is mainly used for medical treatment for radiation therapy.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this document. For undated references, the latest edition (including all amendments) applies to this document.

GB 9706.1 Medical electrical equipment - Part 1. General requirements for safety

GB 9706.17 Medical electrical equipment - Part 2. Particular requirements for safety of gamma beam therapy equipment

GB/T 17857 Medical radiology terms (radiation therapy, nuclear medicine and radiation dosimetry equipment) A mechanism that stores functions such as storing a radiation source and emitting a radiation beam.

YY 0505 Medical electrical equipment - Part 1-2. Safety general requirements. Parallel standard. Electromagnetic compatibility requirements and testing

3 Terms and definitions

The following terms and definitions as defined in GB 9706.1, GB 9706.17 and GB/T 17857 apply to this document.

3.1 Radiation head

A mechanism that stores functions such as storing a radiation source and emitting a radiation beam.

3.2 Penumbra

Since the source is a non-point source, there is a certain volume, and the scattering of the rays in the radiation field and the thickness of the useful rays passing through the collimator are inconsistent, Make a certain gradient from large to small in the vicinity of the determined radiation field edge, 80% absorbed dose at the radiation beam axis in the radiation range Point and the area covered by the 20% absorbed dose point.

3.3 (Gamma beam) teletherapy

The distance (SSD) between the radiation source and the skin is not less than the gamma ray beam emitted by the radionuclide placed in the radiation source assembly. External beam medical treatment performed at 50 cm.

4 Requirements

4.1 Environmental conditions

Unless otherwise stated in the documentation, the following conditions should be met.

a) Ambient temperature range. 10 ° C ~ 40 ° C;

b) Relative humidity range. 30%~75%;

c) Atmospheric pressure range. 70kPa~106kPa.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 20 pages — is available in the English PDF.

Referenced standards

Editions of YY 0096

EditionTitleRevisionStatus
YY 0096-2019Co-60 teletherapy unitcurrent editionCurrent
YY 0096-2009Co-60 teletherapy unitprevious editionSuperseded

This page sells the current edition, YY 0096-2019. Earlier editions are listed for reference only.

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