ORDER OF THE GOVERNMENT OF THE REPUBLIC OF KAZAKHSTAN

of January 30, 2010 No. 47

About approval of the technical regulation "Requirements to Biological Safety of Implants"

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 Biological Safety of Implants".

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 January 30, 2010, No. 47

Technical regulation "Requirements to Biological Safety of Implants"

1. Scope

1. This technical regulation "Requirements to Biological Safety of Implants" (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 requirements to biological safety of implants (further - safety).

2. Objects of technical regulation are the implants relating to code of the Commodity nomenclature of foreign economic activity of the Republic of Kazakhstan - 9021 (further - the RK Commodity Nomenclature of Foreign Economic Activity code) concerning which this Technical regulation establishes requirements to safety, including:

1) "Heart valves, the implanted pacemakers, artificial limbs of vessels, neurostimulators", and also vascular and intra organ stenta;

2) "Endoprostheses of joints, bones, sheaves, sinews, vertebras, cartilages. Devices for osteosynthesis", and also the intraocular lenses and products replacing vitreous body;

3) "Implants for plasticity of soft fabrics".

3. Types and types of the implants which are potential sources of harm are determined by functional characteristics of implant:

1) inactive:

devices for osteosynthesis;

endoprostheses of joints;

artificial valves of heart;

artificial limbs of blood vessels, vascular clip-on earrings, means for endovazalny embolization of vessels and vascular stenta;

intra vascular catheters with hypodermic port;

grids from synthetic polymeric materials for plasticity of belly wall and diaphragm, artificial limbs of sheaves and sinews;

silicone and other artificial limbs for correction of shape of face, mammary gland;

intraocular drainages and lenses.

2) Active diagnostic:

the implanted identification and diagnostic microchips.

3) Active therapeutic:

pacemakers, including with function of defibrillation;

the implanted stimulators of nerves and muscles;

artificial ventricle of heart;

the implanted batchers of medicines;

the software of the active implanted therapeutic and diagnostic medical products.

4. Each of types of implants can be divided on groups of uniform materials of product:

1) from metals and alloys;

2) from ceramics;

3) from synthetic polymers, including with drawing on surface (or content) biologically active agents;

4) combined, including using biopolymers.

5. Each of types of implants can be divided on methods of implantation and removal from organism:

1) in the operational way;

2) endovazalno;

3) endoscopic (through gleam of hollow bodies);

4) laparoscopic.

6. Requirements of this Technical regulation extend both to implants in general, and to all its components separately, and also coverings of components of implants.

2. Terms and determinations

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

1) 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;

2) harmful effects - causing damage to the patient, personnel or the environment; impact of factors of the habitat, the lives creating threat or to health of the person, or threat of life or to health of future generations;

3) danger - potential source of harmful effects;

4) safety of product - set of the normalized properties of product of medical appointment or medical equipment and conditions of its application providing prevention of harmful effects in case of its use;

5) biological safety of product - the lack of harmful effects which is most reducing risk of its application for life and health of the person, and also life and health of the subsequent generations;

6) implantation - introduction in human body of product of medical appointment or medical equipment for replacement or correction of function of bodies or systems of organism for long period of time or for life;

7) implants - products of medical appointment or the medical equipment contacting to the following fabrics of the internal circle of organism:

with bone;

with soft fabrics and intercellular liquid;

with blood;

with fabrics of parenchymatous bodies;

8) inactive implants - the therapeutic implanted products of medical appointment intended for treatment of the patient or simplification of its condition compensating anatomic defect or changing anatomy with the medical purpose; not using autonomous and external power sources;

9) active therapeutic implants - the therapeutic implanted products of medical appointment or the medical equipment intended for treatment of the patient or simplification of its condition, using autonomous or external power sources;

10) active diagnostic implants - the diagnostic implanted products of medical appointment or the medical equipment intended for control of physiological parameters of organism, using autonomous or external power sources;

11) habitat factors - biological (virus, bacterial and others), chemical, physical (noise, vibration, ultrasound, infrasound, the thermal, ionizing, not ionizing and other radiations), social and other factors of the habitat (natural or artificial) which make or can make impact per capita and (or) the state of health of future generations;

12) sharp toxic action - the harmful effects on human body which are shown in 24 hours after implantation;

13) chronic toxic action - the harmful effects on human body which are shown as a result of cumulative action of products of destruction of material of which the implant is made;

14) 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.

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