Partners save 15% on every standard

Valid

GB/T 15476-2026Multifunctional measuring instruments for kidney and thyroid (English PDF)

肾及甲状腺多功能测量仪

Open the GB/T 15476-2026 preview as PDF

Preview — first pages of GB/T 15476-2026 (full document: 17 pages)

This is a limited preview

Buy now to download the full PDF (17 pages)

Issued by

SAMR; SAC

Level / Type

National · Recommended

Issue date

July 2, 2026

Implementation date

February 1, 2027

Scope

GB/T 15476-2026 is the English-translated version of 肾及甲状腺多功能测量仪.

GB/T 15476-2026 is the Chinese national standard covering the nuclear medicine instrument that measures kidney and thyroid function by following a radiotracer with external detectors - the renogram and the thyroid uptake study. It fixes the composition of the instrument, the performance requirements on the detectors and the electronics, the safety, the test methods and the marking. It replaces GB/T 15476-2008. It was issued on 2 July 2026 and takes effect on 1 February 2027, replacing GB/T 15476-2008. The document is under the responsibility of the Standardization Administration of China. This page is published from the official record of the 2026 edition; the clause text of a standard this recent is not yet in circulation, and the figures, limits and tables it contains are those of the document itself, delivered in full with the English translation.

Document preview — GB/T 15476-2026

National Standard of the People's Republic of China

ICS: 27.120
Classification: F 87
Replacing: GB/T 15476-2008

Issued by: State Administration for Market Regulation; Standardization Administration of the PRC

1 Scope
4 Technical Requirements
4.2 General Requirements
4.2.3 Data Measurement and Result Output during Functional Check
4.3 Radiation Characteristics
4.4 Alignment characteristics
4.5 Electrical Characteristics
4.7 Electromagnetic Compatibility
5 Test Methods
5.16 Electrical Characteristics
5.18 Electromagnetic Compatibility
6 Inspection Items
7 Marking, Packaging, Transportation and Storage
7.2 Packaging

1 Scope

This document specifies the technical requirements, inspection items, markings, packaging, and transportation of the multifunctional renal and thyroid measuring instrument (hereinafter referred to as the "instrument"). The requirements for storage are described, along with the corresponding test methods. This document applies to diagnostic instruments that use NaI(Tl) crystals as detectors and employ radionuclides to examine the function of the human kidneys and thyroid gland. The instrument serves as the basis for the design, manufacture, and inspection of this type of product.

4 Technical Requirements

4.1 Instrument Composition The instrument mainly consists of a probe, support arm, column, secondary instrument, and connecting cables.

4.2 General Requirements

4.2.1 Appearance The coating on the instrument surface should be firm and smooth, and there should be no rust, cracks, peeling coating, or loose fasteners.

4.2.2 Mechanical properties The motion mechanism should be flexible, with the probe moving up and down and rotating freely on the column and arm, without any mechanical malfunctions.

4.2.3 Data Measurement and Result Output during Functional Check

4.2.3.1 The instrument should have the function of normalizing measurement data.

4.2.3.2 The instrument should have the function of numerical output and graphical display of measurement data.

4.2.3.3 The instrument should be able to display the left and right kidneys, kidney index, time for C segment to decrease by 1/2, peak time and 15-minute residual rate.

4.2.3.4 The instrument should have the function of displaying thyroid iodine uptake rate.

4.3 Radiation Characteristics

4.3.1 Energy Nonlinearity Energy nonlinearity should be better than ±5%.

4.3.2 Energy Resolution The energy resolution of the 137Cs radioactive source should not exceed 9%.

4.3.3 Background count rate The background count rate should not exceed 500 min^-1.

4.3.4 Point Source Sensitivity The point source sensitivity should be no less than

0.18 min^-1·Bq^-1.

4.3.5 Repeatability The repeatability of the instrument should not exceed 0.05.

4.3.6 Nonlinearity of activity response The nonlinearity of the activity response should be better than ±15%. 4.3.7 8h stability The instrument should be powered on continuously for 8 hours, and the additional error should be better than ±3%.

4.3.8 Multi-probe consistency The relative deviation of the activity response between each probe should be better than ±5%.

4.4 Alignment characteristics

4.4.1 Point Source Response Curve When the 131I point source moves along a plane centered on the geometric center (marker point) of the detector crystal with a radius equal to the working distance, at the collimator... Within the field of view, the count rate is greater than or equal to 90% on the axis; when moved to 1.2R (R is half the diameter of the field of view), the count rate is less than... When the count rate is moved from 50% on the axis to 1.4R, it is less than 5% on the axis. See Appendix A for details on the point source and its structural dimensions.

4.4.2 Shielding Leakage Rate The shielding leakage rate of the shielding cover should be less than 10%.

4.5 Electrical Characteristics

4.5.1 Protective grounding impedance For plug-connected (non-fixed connection) equipment, the protective connection impedance should not exceed 0.1Omega. If the equipment has a non-removable power supply... For power cords, the impedance between the power cord protective conductor plug pins and each accessible component of the protective connection should not exceed 0.2Omega.

4.5.2 Contact Current Under normal operating conditions, the leakage current between the equipment casing and the reference test ground should not exceed 1mA DC.

4.5.3 Voltage Test The test should not result in electrical gap arcing or solid insulation breakdown, and corona effects and similar phenomena (such as single instantaneous flashes) are not considered. After the test, the equipment should be inspected. The equipment and its components should be free of damage (e.g., scorch marks), and should function normally when powered on and maintain its performance. characteristic.

4.6 Environmental adaptability The instrument requires the following environmental conditions.

a) Power supply. AC220V (10-12%), 50Hz±3Hz; the relative error of the instrument should be better than ±5%.

b) Rated high temperature. 40°C, the relative error of the instrument should be better than ±20%;

c) Rated low temperature. 0°C, the relative error of the instrument should be better than ±20%;

d) Constant humidity and temperature. relative humidity 85% (30°C), the relative error of the instrument should be better than ±10%.

4.7 Electromagnetic Compatibility

4.7.1 Electrostatic Discharge Immunity The instrument should meet the requirements of Class 2 in GB/T 17626.2, and be able to withstand ±4kV air discharge and ±4kV contact discharge interference. After that, it should be able to work normally.

4.7.2 Electrical Fast Transient/Bulk Immunity The instrument should meet the requirements of Class 3 in GB/T 17626.4, and the AC power port of the instrument should be subjected to a peak voltage of ±2kV under repeated conditions. It should be able to work normally after interference at a frequency of 5kHz.

4.7.3 Surge Immunity The instrument should meet the requirements of Class 3 in GB/T 17626.5, and the AC power supply port of the instrument should have a line-to-line voltage of 1.0kV; line-to-line voltage. It should be able to work normally after being subjected to interference from an open-circuit test voltage of 2.0kV.

4.7.4 Immunity test for voltage dips, short interruptions and voltage variations on the power supply input line The instrument should meet the Class 2 usage requirements in GB/T 17626.11 and should be able to work normally.

5 Test Methods

5.1 Test Conditions The placement of the point source should conform to the point source response curve specified in this document, and a minimum distance of not less than 10cm should be ensured for the field of view diameter. The radioactive source used for testing should be calibrated. When conducting various tests, the instrument should be set within the specified energy window. The reference conditions and standard test conditions for instrument testing are shown in Table 1.

5.2 Test Equipment Devices without multichannel analysis capabilities. multichannel analyzer, computer. Equipment with multichannel analysis capabilities. computer.

5.3 Appearance The appearance of the instrument is inspected visually.

5.4 Mechanical Properties For manually controlled equipment, the support arm for moving up and down/rotating the instrument should move smoothly without jamming; tightening the fixing screws should ensure the support arm remains in a fixed position without slipping; Rotate each probe to ensure that the probe is aligned with the target position. For automatically controlled equipment, the height of the outrigger and the orientation of the probe toward the target position can be controlled by a computer.

5.5 Data Measurement and Output during Functional Check Visual inspection.

5.6 Energy Nonlinearity Detection was performed using a set of gamma-ray sources comprising at least three different energy gradients. A multichannel analyzer was used to acquire the corresponding energy spectra of the radioactive sources. By selecting fewer than three characteristic peaks, the functional relationship between the energy of the characteristic peak and the corresponding channel address can be approximated by a quadratic polynomial, as shown in formula (1). The nonlinearity of the quantity is represented by the quadratic fitting constant b2.

5.7 Energy Resolution Position the 137Cs radioactive source along the probe axis and adjust the distance from the probe marker to ensure a net characteristic peak count of no less than 10,000. The resolution is calculated using formula (2).

5.8 Background count rate Under standard test conditions, the instrument measures for no less than 10 minutes within the specified energy window, and the background count rate is calculated.

5.9 Point Source Sensitivity Place the 131I radioactive source (activity range. 7.4 × 10^4 Bq ~ 118.4 × 10^4 Bq) on the probe axis, select a measurement time t, and ensure the total count... Not less than 10000.After the measurement is completed, record the total value G. The point source sensitivity is calculated according to formula (3).

5.10 Repeatability Place the 131I radioactive source (activity range. 7.4 × 10^4 Bq ~ 118.4 × 10^4 Bq) on the probe axis, with the center of the radioactive source at the probe marker point. The distances are equal. Ten measurements are taken, each lasting 5 minutes. The count for each measurement is Ni, and the test value Vi is calculated using formula (4).

5.11 Nonlinearity of Activity Response The nonlinearity of the instrument's activity response was detected using a set of 137Cs radioactive sources with increasing activity. This set of standard activity sources (activity range. 7.4 × 10^-6) The uncertainty of 104 Bq to 118.4 × 104 Bq should be less than 4% (k=2), and their reference activities are as follows:

a) 7.4 × 10^4 Bq;

b) 14.8 × 10^4 Bq;

c) 29.6 × 10^4 Bq;

5.16 Electrical Characteristics

5.16.1 The protective connection impedance shall be in accordance with the relevant provisions in GB/T 19661.1.

5.16.2 The contact current shall be in accordance with the relevant provisions in GB/T 19661.1.

5.16.3 Voltage tests shall be conducted in accordance with the relevant provisions of GB/T 19661.1.

5.17 Environmental adaptability The rated high temperature, rated low temperature and constant humidity and heat tests of the instrument shall be conducted in accordance with the relevant provisions of GB/T 8993. The power supply test of the instrument shall be conducted in accordance with the relevant provisions of GB/T 34138.

5.18 Electromagnetic Compatibility

5.18.1 Electrostatic Discharge Immunity The electrostatic discharge immunity of the instrument shall be tested in accordance with the relevant provisions of GB/T 17626.2.

5.18.2 Electrical Fast Transient/Bulk Immunity The electrical fast transient/burst immunity of the instrument shall be tested in accordance with the relevant provisions of GB/T 17626.4.

5.18.3 Surge Immunity The surge immunity of the instrument shall be in accordance with the relevant provisions of GB/T 17626.5.

5.18.4 Immunity test for voltage dips, short interruptions and voltage variations on the power supply input line The instrument's immunity to voltage dips, short interruptions, and voltage variations on the power supply input line shall comply with the relevant provisions of GB/T 17626.11. It will proceed as scheduled.

6 Inspection Items

Product quality inspection is divided into type inspection and factory inspection. The inspection items and order shall be performed in accordance with Table 2.

7 Marking, Packaging, Transportation and Storage

7.1 Marking The exterior of the instrument should display the product model, product name, trademark, manufacturer's name, production number, date of manufacture, equipment safety classification, and product registration information. Nameplate markings such as catalog number should be clear and easily recognizable. The power supply connection (mains input socket) of the instrument should be labeled with the power type and input power. For fuses that are accessible from outside the instrument, their rated values should be marked next to the fuse. The main power switch of the instrument should be clearly marked with its "on" and "off" positions. The positions of all exposed adjustment knobs and switches on the instrument, as well as the signal sockets, should be clearly marked with numbers, text, or other visually intuitive methods.

7.2 Packaging

7.2.1 General Requirements Shockproof and moisture-proof measures must be in place to ensure that the instrument is not damaged under the prescribed transportation and storage conditions. The packaging box should be labeled "Precision Instrument" or "Small Instrument". The packaging should include signs such as "Handle with care," "Do not invert," and "Keep from rain," and the graphics should conform to the specifications in GB/T 191.A product inspection certificate should be included inside the packaging box. Certificate of conformity, instruction manual, packing list, etc.

7.2.2 Certificate of Conformity The certificate of conformity should have the following markings.

a) Product model and name;

b) Manufacturer's name;

c) Production number;

d) Inspection date;

e) Inspector code.

7.2.3 Packing List The packing list should include the following markings.

a) Product model and name;

b) Manufacturer's name and address;

c) Corporate trademarks;

d) Manufacturing date;

7.2.4 Product Manual The product manual should include the following.

a) Brief description of the working principle;

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 17 pages — is available in the English PDF.

Editions of GB/T 15476

Edition	Title	Revision	Status
GB/T 15476-2026	Multifunctional measuring instruments for kidney and thyroid	current edition	Current
GB/T 15476-2008	Multifunctional measuring instruments for kidney and thyroid	previous edition	In force until 1 February 2027

This page sells the current edition, GB/T 15476-2026. Earlier editions are listed for reference only.

How to Buy GB/T 15476-2026

1Add to cart. Click the "Buy GB/T 15476-2026" button on this page. You can add more standards before checkout.
2Checkout. Enter your email and billing details. Payment is processed securely by Stripe (cards, Apple Pay, Google Pay supported).
3Instant delivery (0–9 sec). Delivery is automatic: within seconds of payment you'll receive an email with a secure download link. The link stays valid for 72 hours.
4Invoice included. A tax invoice is attached to the confirmation email. Need a custom invoice? Contact us.