GOST R 56329-2014

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  ГОСТ Р 56329-2014

GOST R 56329−2014 Products medical electric. Lithotripters. Technical requirements for public procurement

GOST R 56329−2014

NATIONAL STANDARD OF THE RUSSIAN FEDERATION

PRODUCTS MEDICAL ELECTRIC

Lithotripters. Technical requirements for public procurement

Medical electrical equipment. Equipment for extracorporeally induced lithotripsy. Technical requirements for governmental purchases

OKS 11.040.55
OKP 94 4200

Date of introduction 2016−01−01

Preface

1 was DEVELOPED by limited liability company «Medtekhstandart (Medtekhstandart»)

2 SUBMITTED by the Technical Committee for standardization TC 011 «Medical instruments, apparatus and equipment"

3 APPROVED AND put INTO EFFECT by the Federal Agency for technical regulation and Metrology of December 25, 2014 N 2122-St

4 INTRODUCED FOR THE FIRST TIME


Application rules of this standard are established in GOST R 1.0−2012 (section 8). Information about the changes to this standard is published in the annual (as of January 1 of the current year) reference index «National standards» and the official text changes and amendments — in monthly information index «National standards». In case of revision (replacement) or cancellation of this standard a notification will be published in a future issue of information index «National standards». Relevant information, notification and lyrics are also posted in the information system of General use — on the official website of the Federal Agency for technical regulation and Metrology on the Internet (gost.ru)

Introduction

This standard specifies the basic requirements that should be contained in the specifications for state purchases of lithotripters.

When carrying out a procurement technical specifications in some cases, include technical requirements, not corresponding to the purpose of equipment procurement: either too specific or redundant, or indirectly related to its consumer properties.

International analogues of the present standard does not exist. This standard reflects the specific national forms of public procurement of medical equipment and can only be a national standard.

1 Scope

This standard specifies the General requirements for the preparation of the technical specifications (TS) and their design when conducting state procurement of medical equipment (MO): lithotripters (lithotripsy).

This standard is a private standard against GOST R 55719.

This standard applies to state and municipal procurement of MO. The standard does not apply to non-state procurement MO.

This standard applies to devices intended for lithotripsy systems, x-ray and ultrasound localization.

This standard does not apply to the device of shock wave therapy in orthopedics.

2 Normative references

This standard uses the regulatory references to the following standards:

GOST R 55719−2013 Products medical electric. Requirements to the contents and preparation of technical specifications for tender documentation in public procurement of high-tech medical equipment

GOST R IEC 60601−1-2010 Products medical electric. Part 1. General safety requirements taking into account the main functional characteristics

GOST R IEC 60601−1-2−2014 Products medical electric. Part 1−2. General safety requirements taking into account the main functional characteristics. Parallel standard. Electromagnetic compatibility. Requirements and tests

GOST R IEC/60788−2009 Products medical electric. Dictionary

Note — When using this standard appropriate to test the effect of reference standards in the information system of General use — on the official website of the Federal Agency for technical regulation and Metrology on the Internet or in the annual information index «National standards» published as on January 1 of the current year, and the editions of the monthly information index «National standards» for the current year. If replaced with a reference standard, which was given an undated reference, then it is recommended to use the current version of this standard, taking into account all enabled in this version modifications. If replaced with a reference standard, which is given a dated reference, it is recommended to use the version of this standard referred to above by year of approval (acceptance). If after approval of this standard in the reference standard, which is given a dated reference, a change affecting a provision to which reference, the provision is recommended to be applied without taking into account this change. If the reference standard is cancelled without replacement, the position in which reference is made to him, recommended to be used in part not affecting this link.

3 Terms and definitions

This standard applies the following terms with respective definitions:

3.1 anode voltage: the potential Difference is applied between the anode and cathode x-ray tube.

3.2 anode current: the electric current of the electron beam striking the target x-ray tube.

3.3 sensor: piezoelectric transducer in the housing with located in the same electronic circuit and a liquid (if it fills the case) and attached the cable of the sensor with a remote control.

3.4 diaphragm Device to form a beam — a device for limiting the radiation field.

3.5 discrete mode (): Mode ultrasonic diagnostic equipment in which the ultrasonic excitation of a transformation or group of ultrasonic transducers involves the use of only one method of diagnosis.

3.6 the product for extracorporeal lithotripsy: a Device for treatment ekstrakorporalna of the generated pressure pulses.

3.7 mark goals: Mark (dot) which is used to indicate the position of the target (in this case, the location of the stone).

3.8 multifunction ultrasonic diagnostic equipment:Ultrasonic diagnostic equipment which is designed for more than one clinical application.

3.9 elimination raster: a Device of radiation absorbing lamellae and transparent to radiation in the gaps between them, mounted in front of the image receptor for reducing the incident scattered radiation and increase thus the x-ray image contrast.

3.10 the target position: the Position in space where the manufacturer requires the operator to crushing.

3.11 receiver x-ray image: the Device is the same effect a fluorescent screen or radiographic film that is designed for both direct and not direct conversion x-ray image into a visible image.

3.12 the size of the input fields of the URI: field Size at the input plane of the x-ray image receiver, which can be used to transfer x-ray images in certain conditions.

3.13 x-ray tube: a Vacuum device for generating x-ray radiation by bombarding the target anode with electrons coming from the cathode and driven by the electric field.

3.14 x-ray machine: Equipment consisting of the x-ray generator, its associated devices and auxiliary equipment. X-ray machines used in devices for x-ray localization using mobile racks type «C-arm». A tripod can move the «emitter + receiver» in the vertical and horizontal planes with a rotation along two axes, implementing any provision of the system emitter-receiver relative to the patient placed on the table system.

3.15 the x-ray radiator: Cover x-ray tube installed therein x-ray tube.

3.16 x-ray image: the image Potential in the x-ray beam, the intensity distribution of which is modulated by the object.

3.17 radioscopie: the Technique for obtaining continuously or periodically a series of x-ray images (fluoroscopy) and presenting them simultaneously and continuously in the visible image.

3.18 ultrasonic diagnostic equipment: medical electrical intended for ultrasound examination.

3.19 amplifier x-ray image; URI: a Device for converting x-ray images into intensified visible image with the use of additional energy source for this amplification.

3.20 localization device: a Device used to determine the target position in three-dimensional space.

3.21 positioning device: a Device that calculates the matching position of the target.

3.22 the focal volume: the Volume in space representing a spatial volume bounded by the outline (-6 dB) isobars of maximum impulse sound pressure.

3.23 characteristics of the emission (ultrasound): the Combination of a particular set of characteristics of an ultrasonic beam sensor (depending on the aperture of the radiation intensity distribution in the cross section of the beam and the relative time/phase delay over the aperture, which determines the focal length and focus of the beam) and the electrical excitation of the sensor, assuming any continuous wave form with varying amplitude.

3.24 extracorporeal lithotripsy: Lithotripsy in the patient’s body with pulses of pressure generated outside the patient.

3.25 electrocardiograph; ECG: Medical electrical product and owned the electrodes for the production of electrocardiograms for diagnostic purposes.

4 General requirements for contents of technical specification for state procurement of medical equipment

4.1 TK is developed by the customer. TK determines the placement of the purchase order MO.

Responsibility for the completeness and adequacy of the TOR lies with the customer.

4.2 When preparing a specification for the purchase of MO it is prohibited to specific trademarks, service marks, trade names, patents, useful models, industrial samples, appellations of origin or names of the manufacturer (except for the cases specified separately).

4.3 in the formation of TK it is necessary to consider the scope of the lithotripter, which will define the concept of construction and composition of the components of his system, and also be guided by the following principles:

— certainty;

— reasonableness of detail of the requirements.

4.3.1 the Principle of certainty:

The certainty principle provides for the presence in TK of clear requirements for quality and functional characteristics of the lithotripter. The party placing the order according to specifications required to identify the placement of the order and the result of execution of the contract to fully satisfy the need of the customer in the lithotripter.

4.3.2 the Principle of reasonableness of detail of requirements:

Details of the requirements for the description of the subject of the order must be at the level of actual needs of the customer. Requirements to the subject of the order should clearly respond to the needs of the customer, on the basis of the intended purpose of the goods, works, rendering of services. Details of the requirements for the subject of the order beyond necessity leads to an increase in the value of the order, reduction of participants of placing of the order (restriction of competition, i.e. the violation of the Antimonopoly legislation), increases the likelihood of non-publication order. Conversely, the lack of detail can lead to the forced purchase of cheap, poor quality, second-hand, etc. of the goods (works, services).

4.4 Technical requirements listed in the TOR for the supply of lithotripter are issued for each type of equipment included in the system separately, and shall contain:

— the text of the General requirements;

table of technical parameters of system components.

In the text of the General requirements included basic data requirements for the supplied equipment.

In the preparation of the General requirements be aware that they should not be restrictive. Standards and technical specifications specified in the tender documentation should ensure compliance with basic technical requirements and other requirements to the procured equipment.

In the text of the General requirements may specify specific standards adopted in international practice, which must conform to the purchased equipment and national standards of the Russian Federation.

4.5 the Customer in the formation of the TOR for the lithotripter may include in the TOR a requirement that the lithotripter must meet high requirements to its performance in comparison with the mandatory requirements of this standard in the manner prescribed by law. In this case the Customer is obliged to clearly explain and set appropriate increased consumer, technical and/or functional characteristics, the requirements for lithotripters.

The customer is also entitled to claim the compliance of the lithotripter technical regulations and national standards and in those cases when mandatory compliance with such requirements of the legislation of the Russian Federation is not provided. In such cases, the customer must describe in the specification, such requirements, but has no right to demand copies of documents on conformity of goods, works and services for such requirements.

Table 4.6 technical indicators should be designed in such a way as to ensure the widest possible competition during the competition and at the same time give a clear idea about the standards of safety performance.

Table technical indicators of the lithotripter in the TOR should be developed based on the relevant performance requirements of the structure of the complex of equipment purchased.

The list of technical requirements may contain links to standards and other normative technical documents.

All are listed in the tables of technical performance requirements, standards and criteria are minimal.

4.7 Requirements for completeness of the lithotripter are specified by the customer, based on the proposed scope of its medical use and used medical technology.

5 Composition of system component devices

A lithotripter is a system of treatment using shock waves for extracorporeal lithotripsy ESWL with the possibility of obtaining images through x-ray and ultrasound localization and for diagnosis when used as an integrated device forming the image in the composition of the lithotripter.

— the basic system*;

— the shock wave generator;

device positioning shock waves;

— a table for the patient;

— ultrasonic localization*;

system x-ray localization*;

the ECG system;

device control system of the lithotripter;

— special software;

— test objects and devices for the control of the lithotripter;

— additional devices and accessories for major components of the composition of the lithotripter.

Note — an asterisk (*) marked accessories and the system defined by the customer depending on the purpose, type and model of the lithotripter.

6 Main technical characteristics specified in the technical specification

6.1 has the following characteristics (parameters) that should be included in the TOR for public procurement.

6.2 the Lithotripter:

6.2.1 supply Voltage, V.

6.2.2 Frequency, Hz.

6.2.3 Power consumption, kVA (maximum short term).

6.2.4 Weight, kg (total system).

6.3 shock wave Generator:

— with the control unit of the shock head and the display of operating modes type «tachscrin», size in inches.

6.3.1 source Type shock wave (principle of generation).

6.3.2 penetration Depth (focal length), mm.

6.3.3 Focal volume (the amount of focus in the longitudinal and transverse direction at the level of «-6 dB»).

6.3.4 aperture Diameter, mm.

6.3.5 the Limits of adjustable pressure focus, MPA.

6.3.6 energy flux Density, MJ/mm.

6.3.7 noise Level, dB.

6.3.8 Volume of water in the system L.

6.3.9 the Frequency of generation of shock waves, Hz.

6.3.10 Device positioning shock waves:

— move the height, mm;

— vertical move.

Table 6.4 (universal) for the patient:

6.4.1 activation time min/interval.

6.4.2 the Maximum patient weight, kg.

6.4.3 height adjustment, mm (up/down).

6.4.4 Longitudinal path of moving forward and backward.

6.4.5 Cross the path of moving left/right, mm.

6.4.6 Isocentric tilt (around the middle of the table), degrees.

6.4.7 Isotonicity tilt (around the end of the table), degrees.

6.4.8 table Dimensions, mm (length/width/height).

6.5 ultrasonic localization:

6.5.1 Type of system.

6.5.2 Mode of forming images:

mode (2D/3D);

— M-mode;

— movie mode.

6.5.3 ultrasound Sensor (built-in or located on an external bracket):

— working frequency, MHz;

— matrix;

— the angle of rotation, degrees/sector;

— the displacement sensor in the axial direction, mm.

6.5.4 Ultrasonic module:

monitor display size, cm/inch;

memory, HD, MB;

device to reproduce images in a range of levels, times chromaticity.

6.5.5 Localization, method of obtaining, inline/online.

6.6 System x-ray localization:

6.6.1 Type x-ray machine.

6.6.2 x-ray generator monoblock:

— operating frequency, Hz;

— the range of anode voltage, kV;

— the range of the anode current, mA.

6.6.3 the x-ray radiator/x-ray tube:

— type;

— type of anode;

— focus is large, small, mm.

6.6.4 Collimator:

— type;

field, mmmm.

6.6.5 Receiver (detector) x-ray system:

— type (URI/flat panel digital detector).

6.6.5.1 URI:

— size of work fields, cm/inch;

— TV-camera (digital/analog);

— size of active area, pixel;

— bandwidth, MHz;

— spatial resolution on the margins, line pair/mm.

6.6.6 Screening raster:

— type/model;

— ratio, ratio;

the number of lamellae, l/cm.

6.6.7 Settings flat-panel digital detector:

— type/model;

— resolution spatial line pair/mm;

— size of active area, pixel;

— pixel size, K;

— DQE (quantum efficiency), percent.

6.6.8 Availability of modes fluoroscopy:

— continuous;

single;

pulse (frequency, pulse/s).

6.6.9 measurement Device works dose area (DAP):

— measuring range (1−100 cGy·cm).

6.7 System ECG:

6.7.1 Type (integrated/modular/standalone).

6.7.2 characteristics of the ECG module:

— signal characteristics:

a) the amplitude of the signal;

b) the duration of signal, MS.

— the input impedance of the receiver signal, Ω;

monitoring system, banalnosti.

6.8 Device management system lithotripter:

— built-in offline workstation for imaging ultrasound/x-ray monitor, the type parameters;

— the function of the image processing;

— showing a preview of a previously received images;

storage in DICOM 3.0, BMP, and others.

system x-ray localization;

— transferability of data;

— automatic positioning of drum heads (navigation) device positioning drum head, on the specified data target (target) on the monitor screen of a workstation;

— the availability of data about the patient;

— memory images, GB (number of shots).

6.9 Special software (FOR):

— Archiving snapshots in the system (HIS)/(RIS);

— Registration and statistical evaluation of the lithotripter;

— Compatibility of the lithotripter with other devices medical equipment Department.

6.10 Test objects and devices for quality control of the lithotripter:

6.10.1 Control-focused devices:

— checking and adjusting containment systems of the lithotripter should be conducted with a test-focusing device for ultrasonic precision aiming and focusing device for x-ray aiming).

6.10.2 Test objects for determining the quality parameters of the head shock wave generator.

6.11 Additional devices and accessories:

6.11.1 Additional sensors for ultrasound localization, type/model frequency, MHz:

— by appointment:

a) for built-in use.;

b) for standalone PCs.;

C) for biopsy.;

d) transrectal multifaceted.

6.11.2 Additional devices for x-ray localization:

— kasutatavatele tripod «C-arm» for the film (size), mm/inch;

interface image transfer DICOM 3.0 format.

6.11.3 Additional devices to the table:

— armrests, EA.;

— pedal foot.;

— side support.

6.11.3.1 Urological set:

— footing.;

urological duck.;

— tray cassettes.

6.11.4 Additional imaging device (a hard copy):

laser multiformat camera type, film format, cm/inch;

— thermal printer medical, format max cmcm (paper, film).

6.12 the List of normative documents, which must comply with the lithotripter, is given in Appendix A.

7 Requirements for registration of technical specifications

7.1 an Example of a medico-technical characteristics are given in Appendix B.

7.2 it is Possible to include additional requirements, justified by the customer from the standpoint of carrying out the necessary research in accordance with the profile of the medical institution.

Annex a (mandatory). The list of normative documents, which must comply with the lithotripter

Appendix A
(required)

Table A. 1

Note — In this, the private standard is not given the list of standards that must be met by the major system components of the lithotripter. The list of standards should be defined additionally in the composition of the system components of the lithotripter.

Annex B (reference). An example of the technical characteristics of lithotripter

Appendix B
(reference)

Note — in table B. 1 quantitative and qualitative values are informative.


Table B. 1