YY/T 1763-2021Medical electrical equipment—Medical light ion beam equipment—Performance characteristics (English PDF)

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009.

This standard uses the redrafting method to amend and adopt IEC 62677:2017 "Medical Electrical Equipment Performance Characteristics of Medical Light Ion Beam Equipment".

The technical differences between this standard and IEC 62677:2017 and the reasons are as follows.

--- Regarding normative reference documents, this standard has made adjustments with technical differences to adapt to my country's technical conditions and adjustments.

The situation is collectively reflected in Chapter 2 "Normative Reference Documents", and the specific adjustments are as follows.

- Replace IEC 60601-1:2005 AMD1.2012 with GB 9706.1 modified to adopt international standards;

- Replace IEC 60580:2000 with GB/T.20012 which is equivalent to adopting international standards;

- Since there are no specific clauses cited in the main body of this standard, IEC 60601-2-1:2009, IEC 60601-2-1:2009/ AMD1.2014.

--- Added terms and definitions "patient support device" (see 3.49).

The Chinese documents that have a consistent correspondence relationship with the normatively cited international documents in this standard are as follows.

---GB/T 18987-2015 radiotherapy equipment coordinates, movement and scale (IEC 61217:2008, IDT) This standard has made the following editorial changes.

--- In order to supplement the explanation that the bed surface includes both the bed surface and the seat surface, to avoid causing ambiguity on the bed surface, 3.40 adds Note 2;

---Position accuracy and position repeatability should be in mm, 6.7.1e) 8), 9) editing errors, modify "cm" to "mm", Consistent with Appendix A;

---Revised the editing error of 6.6 in Appendix A of IEC 62677:2017, and changed "30mm" to "300mm";

--- Deleted the "Terms and Definition Index" in IEC 62677:2017.

Introduction

This standard specifies the performance characteristics and publication methods of radiation therapy light ion beam equipment. In addition to the performance characteristics required to be announced In addition to the indicators, the corresponding test conditions and test methods are also included for the type test of light ion beam equipment. Through the performance characteristics in accordance with this standard The sexual publication method enables direct comparison between the performance data of equipment of different manufacturers.

The test methods specified in this standard are recommended and can be replaced by other equivalent and appropriate methods. However, it should be fully realized that this standard The performance characteristics of light ion beam equipment specified by the standards are closely related to its test methods and test conditions. The tests specified in this standard cannot ensure Any light ion beam equipment meets its claimed performance during its working life. Due to the differences in equipment produced by different manufacturers, the system Manufacturers can add more detailed information and special tests for each performance characteristic in their accompanying documents. This standard stipulates The performance, test methods, and performance announcement methods are as basic and universal as possible. Medical electrical equipment Medical light ion beam equipment Performance characteristics

1 Scope

This standard specifies the performance characteristics and test procedures of medical light ion beam equipment.

This standard applies to light ion beam equipment with a single nuclear energy range of 10MeV~500MeV for the purpose of radiotherapy.

This standard does not apply to ion beam equipment other than light ion.

2 Normative references

The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this document. For undated reference documents, the latest version (including all amendments) is applicable to this document.

GB 9706.1 Medical electrical equipment Part 1: General requirements for basic safety and basic performance (GB 9706.1-2020,

IEC 60601-1:2012, MOD)

GB/T.20012 Medical electrical equipment dose area product meter (GB/T.20012-2005, IEC 60580:2003, IDT)

IEC 60601-2-64:2014 Medical Electrical Equipment Part 2-64.Basic Safety and Basic Performance of Light Ion Beam Medical Electrical Equipment Special requirements (Medicalelectricalequipment-Part 2-64.Particularrequirementsforthebasicsafetyandes- sentialperformanceoflightionbeammedicalelectricalequipment) IEC TR60788:2004 Medical electrical equipment term definition compilation (Medicalelectricalequipment-Glossaryof definedterms)

IEC 61217:2011 Radiotherapy equipment-coordinates, movement and scale (Radiotherapy equipment-Coordinates, movementsandscales)

3 Terms and definitions

GB 9706.1, GB/T.20012, IEC 60601-2-64:2014, IEC TR60788:2004 and the following terms and definitions Applies to this document.