ORDER OF THE GOVERNMENT OF THE REPUBLIC OF KAZAKHSTAN

of June 7, 2010 No. 529

About approval of the technical regulation "Requirements to Safety of Medical Equipment and Products of Medical Appointment"

For the purpose of implementation of the Law of the Republic of Kazakhstan of November 9, 2004 "About technical regulation" the Government of the Republic of Kazakhstan DECIDES:

1. Approve the enclosed technical regulation "Requirements to Safety of Medical Equipment and Products of Medical Appointment".

2. This resolution becomes effective after six months from the date of the first official publication.

 

Approved by the order of the Government of the Republic of Kazakhstan of June 7, 2010, No. 529

Technical regulation "Requirements to Safety of Medical Equipment and Products of Medical Appointment"

Chapter 1. General provisions

1. Scope

1. This technical regulation "Requirements to Safety of Medical Equipment and Products of Medical Appointment" (further the Technical regulation) is developed according to the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system", the Law of the Republic of Kazakhstan of November 9, 2004 "About technical regulation" and establishes safety requirements to medical equipment and products of medical appointment, and also processes of their lifecycle.

2. Subjects to regulation of this Technical regulation are the medical equipment and products of medical appointment entering the Single commodity nomenclature of foreign economic activity of custom union made in the Republic of Kazakhstan and imported into the Republic of Kazakhstan (further - ETN foreign trade activities CU), according to appendix 1 to this Technical regulation.

3. Identification of medical equipment and products of medical appointment is performed in the way:

1) visual survey;

2) establishments of identity of the name;

3) establishments of the ETN foreign trade activities codes of TS;

4) readings of information provided on packaging, container, the label, label, the plate, the operational document of medical equipment and the instruction on medical application of products of medical appointment.

2. Terms and determinations

4. In this Technical regulation the following main terms and determinations are used:

1) active medical equipment - the medical equipment generating energy of any type or putting in action tools for impact in general or selectively on certain functional system, body or tissues of the person;

2) contamination - undesirable entering of impurity of chemical or microbiological origin or foreign material into initial material, intermediate product or medicinal substance in course of production, sampling, packaging or repacking, storage or transportation;

3) safety of products of medical appointment and medical equipment - lack of the unacceptable risk connected with damnification of life, to health of the person, the environment taking into account combination of probability of realization of dangerous factor and severity of its effects;

4) products of medical appointment - the products and materials used for holding preventive, diagnostic and medical actions: the medical tools, dental, consumable, dressing and sutural materials fixing bandages and devices, products of medical optics;

5) the component part to products of medical appointment and medical equipment - the product and (or) the device applied as component of product of medical appointment or medical equipment, provided by the producer for use according to functional purpose of products of medical appointment and medical equipment;

6) medical equipment - the devices, devices and the equipment used separately in complexes or systems in the medical purposes for prevention, diagnostics, treatment of diseases, rehabilitation, scientific research of medical nature;

7) repair of medical equipment and products medical naznacheniyasovokupnost of works on elimination of defects and to recovery of non-failure operation of medical equipment and products of medical appointment in case of their application;

8) risk of application of products of medical appointment and medical equipment - the probable frequency of emergence of danger or probable strengthening of severity of the state of health of patients, the personnel operating products and other persons from damage suffered;

9) the operational document of medical equipment - the document developed by the producer of medical equipment for the consumer, determining service regulations of medical equipment and reflecting the data certifying the values of key parameters and characteristics (properties) of medical equipment, guarantee and the data guaranteed by the manufacturer on its operation during the service life established by the producer;

10) the user of medical equipment and products of medical appointment - person servicing medical equipment and product of medical appointment to destination (medical and technical personnel);

11) maintenance of medical equipment and products of medical appointment - set of the systematic works providing detection of defects and the prevention of refusals in case of their application, and also in case of storage and transportation;

12) efficiency of products of medical appointment and medical equipment - set of the characteristics providing achievement of preventive, diagnostic and (or) medical effect;

13) marking of products of medical appointment and medical equipment - the texts, trademarks, symbol and drawings bearing information for the consumer and applied on labels, counterlabels, kolyeretka labels, packaging (container) or it is direct on product of medical appointment and medical equipment;

14) electromagnetic compatibility of products of medical appointment and medical equipment - capability of products of medical appointment and medical equipment to function well in their electromagnetic situation, without creating inadmissible electromagnetic hindrances to something in this situation;

15) commissioning - set of the works directed to preparation of medical equipment and products of medical appointment to proper use in the expected place of operation;

16) the technical means used in transfusion and infusional therapy - products of medical appointment: devices, devices, tools and devices, including the devices and systems of single application intended for capture, conversion, storage and clinical use of donor blood, its components and medicines, and also krovezameshchayushchy means;

17) transfusion and infusional therapy - introduction to the patient of components and medicines of donor blood, krovezameshchayushchy solutions with the medical purpose;

18) technical testing - establishment of compliance of technical characteristics of medical equipment and products of medical purpose of technical documentation.

Chapter 2. Dangerous factors (risks)

5. Treat dangerous factors (risks) arising in the course of lifecycle of medical equipment and products of medical appointment:

1) imperfection of design, engineering procedures or control systems of products of serial and mass production;

2) application in production of not permitted materials;

3) loss of quality characteristics in use;

4) lack of reliable information.

Chapter 3. Conditions of the address of medical equipment and products of medical appointment in the market of the Republic of Kazakhstan

6. Necessary condition of the address of medical equipment and products of medical appointment in the market is compliance to the requirements established by this Technical regulation.

7. Realization of medical equipment and products of medical appointment is not allowed:

1) not undergone state registration in the Republic of Kazakhstan;

2) with expired useful life or applications;

3) not conforming to requirements of this Technical regulation;

4) through warehouses of temporary storage of medical equipment and products of medical appointment;

5) without the reliable and complete information for the consumer (marking, the operational document of medical equipment, the instruction on medical application of product of medical appointment).

Chapter 4. Requirements to safety of medical equipment and products of medical appointment and processes of their lifecycle

1. Safety of medical equipment and products of medical appointment

8. The medical equipment and products of medical appointment which are in circulation in the territory of the Republic of Kazakhstan shall be safe, not doing harm of life or to health of the patient or user.

9. Medical equipment and products of medical appointment shall:

1) to provide protection of the patient and user against mechanical damages, against the increased level of vibration, noise, thermal and ionizing radiation;

2) to ensure electromagnetic compatibility, electric, chemical safety of application;

3) is made of safe materials;

4) to be supplied with necessary amount of information on safety of the operation and application specified in the operational document of medical equipment, the instruction on medical application of product of medical appointment, marking;

5) to contain the materials on physical properties excluding possibility of harming health of the patient or user in case of application, transportation, storage because of loss of hermeticity, durability, contamination and impacts of factors of the environment;

6) it is safe to be applied together with materials, substances and gases to which they come into contact. If medical equipment and product of medical appointment are intended for application with medicines, they shall be developed and made taking into account compatibility with the corresponding medicines according to regulating documents on the quality and safety regulating the specified means.

2. Requirements to safety of the medical equipment and products of medical appointment radiating or generating radiations

10. The medical equipment radiating or generating radiations shall be developed and manufactured so that exposure of patients, users to radiation was minimized, considering purpose of each specific type of medical equipment, but at the same time use of its appropriate established levels for the therapeutic and diagnostic purposes was not limited.

11. The user of the medical equipment intended for generation of the dangerous levels of radiation necessary for the specific medical purposes which advantage is considered more considerable than the danger consisting in radiation shall have opportunity to manage such radiation.

12. The medical equipment intended for generation of potentially dangerous ionizing radiation shall be supplied with visual or sound warning facilities about such radiation.

13. Impact on patients, users of inadvertent collateral or scattered radiation shall be minimized.

14. The medical equipment intended for generation of ionizing radiation shall provide possibility of change and regulation of quantitative, geometrical and qualitative indexes of radiation, considering purpose of medical equipment, and also to provide the corresponding image and (or) final quality for the planned medical purpose in case of the minimum impact on the patient and the user.

15. The medical equipment generating ionizing radiation and intended for therapeutic radiology (radiology) shall be designed and manufactured so that to provide reliable control and management of radiation dose, type, energy and distribution of beam.

16. The operational document of the medical equipment generating radiation shall contain the detailed information about nature of radiation, remedies of the patient or user, about the correct operation and methods of exception of the risk connected with the wrong installation (installation).

3. Requirements to safety of the medical equipment connected to the power supply or with the internal power supply

17. Medical equipment which part electronic programmable systems are shall be developed for ensuring repeatability, reliability and efficiency of these systems according to its appointment.

18. Medical equipment in case of which operation safety of patients depends on the internal power supply (power supply) shall be equipped with means of determination of condition of the power supply (power supply).

19. Medical equipment when which using safety of patients depends on the external power supply (power supply) shall have system of the alarm system for the warning of violations in power supply.

20. The medical equipment intended for control of one or several clinical parameters of the patient shall be equipped with the corresponding systems of the alarm system for the warning of the user and the patient of the situations capable to lead to death of the patient or to serious deterioration in state of his health.

21. In case of development and production of medical equipment:

1) the risk of emergence of electromagnetic fields which can break operation of other equipment or equipment in usual conditions shall be minimized;

2) danger of accidental defeat shall be excluded by electric current in case of regular operation and in the conditions of single violation provided that medical equipment is established correctly according to the instruction for installation (operation).

Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info