GB 9706.103-2020Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance. Collateral Standard: Radiation protection in diagnostic X-ray equipment (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 1-3 of GB 9706:

This section was drafted in accordance with the rules given in GB/T 1:1-2009:

This part replaces GB 9706:12-1997 ``Medical Electrical Equipment Part 1: Safety General Requirements III: Parallel Standard Diagnostic X

General Requirements for Radiation Protection of X-ray Equipment:

Compared with GB 9706:12-1997, the main technical changes in this part are as follows:

---Adjusted in accordance with the standard structure of GB 9706:1-2020, while paying attention to the radiation protection of all diagnostic X-ray equipment

Use requirements and introduce the concept of risk management;

---The calibration of dosimetry has been added (see 5:2:2);

---The general requirements for radiation dose information, dose instructions, clinical protocols, deterministic effects and the

Risk (see 5:2:4);

---In the radiation management, dosimetry instructions, automatic control systems and scattered radiation reduction have been added (see 6:4:5, 6:5, 6:6);

---The imaging performance adds the requirements of system performance, nominal focus value, radiation detector or X-ray image receiver (see 6:7:2,

6:7:3, 6:7:4);

---The X-ray tube voltage waveform is added to the radiation quality (see 7:2);

---Modified the value of the half-price layer of X-ray equipment (see 7:1, 29:201:2 in the:1997 edition);

--- Deleted the test method of the correspondence between the X-ray field and the image receiving surface (see 29:203:4 in the:1997 edition);

--- Deleted the attenuation test of the residual radiation (see 29:207:2 of the:1997 edition):

This part uses the redrafting law to amend and adopt IEC 60601-1-3:2013 Medical Electrical Equipment Part 1-3: Basic Safety and Basic Safety

The general requirements for this performance are collateral standards: radiation protection of diagnostic X-ray equipment:

The technical differences between this part and IEC 60601-1-3:2013 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 Chapter 2 "Normative Reference Documents", and the specific adjustments are as follows:

* Replace IEC 60601-1:2012 with GB 9706:1-2020 which is modified to adopt international standards;

* Replace ISO 497 with GB/T 19764 which is equivalent to adopting international standards;

* Replace IEC 60366 with YY/T 0063-2007 which is equivalent to adopting international standards:

This section has made the following editorial changes:

---All terms are represented in bold;

--- In 5:2:4:6, the original IEC text is "localregulationsforRADIATIONPROTECTION", which will be revised during standard conversion

Changed to "Chinese radiation protection laws and regulations";

--- 13:2 IEC original "Note: ThefirsteditionofIEC 60601-1-3exemptedaspecifiedlistofequip-

mentwhichisnowsubjecttoparticularstandards:" (GB 9706:12-1997 has a clear

The list of equipment exempted from implementation, now these equipment also need to meet the requirements of the special standard), based on the requirements of the standard version in this

The body of the document is not converted;

--- Deleted "Term Index";

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 9706:12-1997:

Medical electrical equipment Part 1-3: Basic safety and

General requirements for basic performance

Collateral Standard: Radiation Protection of Diagnostic X-ray Equipment

1 Scope, purpose and related standards

1:1 Scope

This part of GB 9706 applies to the basic safety of medical electrical equipment and medical electrical systems (hereinafter referred to as ME equipment and ME systems):

Full and basic performance:

This section applies to X-ray equipment and its components that diagnose, plan, or guide medical operations through patient radiological images:

1:2 Purpose

The purpose of this collateral standard is to supplement the general standard by stipulating general requirements and serve as the basis for formulating specific standards:

The purpose of this collateral standard is to establish general requirements for X-ray radiation protection in X-ray equipment: It is to make patients, operators, work

The radiation received by personnel and the public is kept at a reasonable level as low as possible without endangering the benefits of the radiation process: For this union

The general requirements specified by the listed standards, other special standards may use appropriate values and/or measurement methods: Implement general requirements or adopt special standards

In the risk management process, reasonable reasons should be explained:

This collateral standard only considers radiation protection related to X-ray radiation:

For another important aspect of radiation protection, that is, the requirements for the control of electrical energy required to generate X-ray radiation are in GB 9706:1 and related equipment:

In the dedicated standards for the safety and basic performance of the equipment:

1:3 Related standards

1:3:1 GB 9706:1

For ME equipment and ME systems, this collateral standard is a supplement to GB 9706:1:

When referring to GB 9706:1 or this collateral standard, whether alone or in combination, the following conventions are used:

--- "General Standard" refers to GB 9706:1;

--- "This Parallel Standard" refers to GB 9706:103;

--- "This standard" refers to the combination of the general standard and this parallel standard:

1:3:2 Specific standards

The requirements in the specific standards take precedence over the corresponding requirements in this parallel standard:

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 article

Pieces: For undated references, the latest version (including all amendments) applies to this document:

GB 9706:1-2020 Medical electrical equipment Part 1: General requirements for basic safety and basic performance (IEC 60601-1:

2012, MOD)