GB 9706.228-2020Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis (English PDF)

Foreword

GB 9706 "Medical Electrical Equipment" is divided into the following parts:

---Part 1: General requirements for basic safety and basic performance;

---Part 1-3: General requirements for basic safety and basic performance Parallel standard: Radiation protection of diagnostic X-ray equipment;

---Part 2-1: Specific requirements for the basic safety and basic performance of electron accelerators with energy from 1MeV to 50MeV;

---Part 2-2: Special requirements for the basic safety and basic performance of high-frequency surgical equipment and high-frequency accessories;

---Part 2-3: Special requirements for basic safety and basic performance of short-wave treatment equipment;

---Part 2-4: Special requirements for the basic safety and basic performance of cardiac defibrillators;

---Part 2-5: Special requirements for the basic safety and basic performance of ultrasonic physical therapy equipment;

---Part 2-6: Special requirements for the basic safety and basic performance of microwave therapy equipment;

---Part 2-8: Special requirements for the basic safety and basic performance of therapeutic X-ray equipment with an energy of 10kV to 1MV;

---Part 2-11: Special requirements for basic safety and basic performance of gamma beam therapy equipment;

---Part 2-12: Special requirements for the basic safety and basic performance of intensive care ventilators;

---Part 2-13: Special requirements for basic safety and basic performance of anesthesia workstations;

---Part 2-16: Specific requirements for basic safety and basic performance of hemodialysis, hemodiafiltration and hemofiltration equipment;

---Part 2-17: Special requirements for basic safety and basic performance of automatic control brachytherapy after-installation equipment;

---Part 2-18: Specific requirements for basic safety and basic performance of endoscopic equipment;

---Part 2-19: Special requirements for basic safety and basic performance of infant incubators;

---Part 2-22: Special requirements for basic safety and basic performance of laser equipment for surgery, plastic surgery, treatment and diagnosis;

---Part 2-24: Specific requirements for basic safety and basic performance of infusion pumps and infusion controllers;

---Part 2-25: Special requirements for basic safety and basic performance of electrocardiograph;

---Part 2-26: Specific requirements for the basic safety and basic performance of EEG machines;

---Part 2-27: Special requirements for basic safety and basic performance of ECG monitoring equipment;

---Part 2-28: Special requirements for the basic safety and basic performance of medical diagnostic X-ray tube components;

---Part 2-29: Specific requirements for the basic safety and basic performance of radiotherapy simulators;

---Part 2-36: Specific requirements for the basic safety and basic performance of in vitro lithotripsy equipment;

---Part 2-37: Special requirements for the basic safety and basic performance of ultrasonic diagnostic and monitoring equipment;

---Part 2-39: Specific requirements for the basic safety and basic performance of peritoneal dialysis equipment;

---Part 2-43: Special requirements for the basic safety and basic performance of interventional X-ray equipment;

---Part 2-44: Special requirements for the basic safety and basic performance of X-ray computed tomography equipment;

---Part 2-45: The basic safety and basic performance of mammography equipment and mammography stereotaxic devices Claim;

--- Part 2-54: Specific requirements for the basic safety and basic performance of X-ray photography and fluoroscopy equipment;

---Part 2-60: Special requirements for basic safety and basic performance of dental equipment;

---Part 2-63: Special requirements for the basic safety and basic performance of extraoral imaging dental X-ray machines;

---Part 2-65: Specific requirements for the basic safety and basic performance of intraoral imaging dental X-ray machines;

---Part 2-66: Special requirements for basic safety and basic performance of hearing equipment and hearing equipment system:

This part is part 2-28 of GB 9706:

This section was drafted in accordance with the rules given in GB/T 1.1-2009:

This part replaces GB 9706.11-1997 "Medical Electrical Equipment Part 2: Medical Diagnostic X-ray Source Components and X-ray Tube Groups Compared with GB 9706.11-1997, the main technical changes are as follows:

--- Increased the applicability of wet pretreatment (see:201:5:7);

---The method of dielectric strength test has been added (see:201:8:8:3);

---Modified the method of "X-ray tube assembly spatter and/or tube implosion risk test" (see Appendix AA, 45:2 of the:1997 edition);

---Added the requirement to record EMC-related risks in the risk management file (see:201:17);

--- Added warnings and safety instructions (see:201:7:9:2:2);

---Deleted the requirements of the X-ray tube instructions [see 6.8:2aa of GB 9706.11-1997)];

---Deleted the requirements of the X-ray source assembly instruction manual [see 6.8:2dd of GB 9706.11-1997];

---Deleted the requirements of the X-ray tube technical specification [see 6.8:3aa of GB 9706.11-1997)];

--- Delete the requirements of the technical specification of the beam limiting device [see 6.8:3cc of GB 9706.11-1997];

--- Deleted the requirements of the X-ray source assembly technical specification [see 6.8:3dd of GB 9706.11-1997];

---Modified the requirements of the X-ray tube assembly instructions [see:201:7:9:2:101, 6:8:2bb in the:1997 edition];

---Modified the requirements of the X-ray tube assembly technical specification [see:201:7:9:3:101, 6:8:3bb in the:1997 edition]:

This part uses the redrafting law to amend and adopt IEC 60601-2-28:2017, Medical Electrical Equipment Part 2-28: Medical Diagnosis Special requirements for basic safety and basic performance of X-ray tube components":

The technical differences between this part and IEC 60601-2-28:2017 and the reasons are as follows:

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

The situation is collectively reflected in the chapter "Normative Reference Documents", with specific adjustments as follows:

- Replace IEC 60601-1-3:2013 with GB 9706.103-2020 which is modified to adopt international standards;

- Replace IEC 60336 with YY/T 0063 which is equivalent to adopting international standards;

- Replace IEC 60522 with YY/T 0062 which is equivalent to adopting international standards;

- Added reference to GB/T 5465.2-2008;

--- Delete the last sentence of the third paragraph in the International Standard:201:1:3 "Alotherpublishedcolateralstandardsinthe IEC 60601-1seriesapplyaspublished":

This section also made the following editorial changes:

---All terms are represented in bold;

--- Deleted the term index of the international standard;

--- YY/T 0466.1 has been added to the references;

---YY/T 0316-2016 has been added to the references:

Please note that certain contents of this document may involve patents: The issuing agency of this document is not responsible for identifying these patents:

This part is proposed and managed by the State Drug Administration:

The previous versions of the standards replaced by this part are as follows:

---GB 9706.11-1997:

Medical electrical equipment-Part 2-28: Medical diagnosis Basic safety and basic performance of X-ray tube components Dedicated requirements

201.1 Scope, purpose and related standards in addition to the following, Chapter 1 of the general standard 1) applies:

1) The general standard refers to GB 9706.1-2020 "Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Basic Performance":

201.1.1 Scope

replace:

This part of the GB 9706 series of standards is applicable to the basic safety of X-ray tube assemblies and their components intended for medical diagnosis and imaging and basic performance:

ME equipment referred to in the general standard GB 9706.1 and the parallel standard GB 9706.103, in this special standard refers to X-ray tubes Components, if a certain chapter or article is specifically expected to apply only to ME equipment or only to ME systems, then in the title and content of the chapter or article Will be explained: If this is not the case, the chapter or article applies to both ME equipment and ME systems:

Note: This section also applies to the X-ray source assembly and the X-ray tube assembly of the X-ray tube head:

201.1.2 Purpose

replace:

The purpose of this section is to establish specific requirements for the basic safety and basic performance of medical diagnostic X-ray tube components:

201.1.3 Parallel standards Supplement:

This section refers to Chapter 2 of the general standard and applicable parallel standards listed in:201:2 of this specific standard:

GB 9706.103-2020 is applicable after Chapter 203 is revised: YY0505, IEC 60601-1-6, YY0709, IEC 60601-1-9, IEC 60601-1-10, IEC 60601-1-11 and IEC 60601-1-12 are not applicable:

Note 101: YY0505 is not applicable because: the risk of X-ray tube components outside the system may only be reflected in the risk caused by the difference in the electromagnetic environment:

Note 102: IEC 60601-1-6 and YY0709 are not applicable because: X-ray tube assembly is not a stand-alone device:

Note 103: X-ray tube components are not within the scope of application of IEC 60601-1-10, IEC 60601-1-11 and IEC 60601-1-12:

201.1.4 Specific standards replace:

The specific standards can modify, replace or delete the requirements contained in the general standards or parallel standards to apply to the ME equipment under consideration:

Other basic safety and basic performance requirements can be added Specific standard requirements take precedence over general standard requirements:

In this section, GB 9706.1 is called the general standard: Parallel standards are indicated by their standard numbers:

The numbering of the chapters and articles in this part corresponds to the general standard by adding the prefix "201" (for example,:201:1 in this special standard corresponds to the general standard Standard Chapter 1), or by adding the prefix "20×" to correspond to the applicable parallel standard, where × is the last digit of the parallel standard number