Government Decree No. 179 / 2004 Coll.
Government Regulation laying down technical requirements for veterinary technical equipment
Valid
Effective from 01.05.2004
Text versions:
01.05.2004
21.04.2004
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179
GOVERNMENT REGULATION
of 31 March 2004
laying down technical requirements for veterinary technical means
The Government orders pursuant to Section 22 of Act No. 22 / 1997 Coll., on Technical Requirements for Products and on the Amendment and Addition of Certain Acts, as amended by Act No. 71 / 2000 Coll. and Act No. 205 / 2002 Coll., ("the Act ') to implement Sections 12 (1) (a) to (d), 12 (3) and 13 (2) of the Act:
Basic provisions
This Regulation lays down, in accordance with the law of the European Communities (1), the technical requirements for veterinary technicals.2)
(1) The products defined under this Regulation are veterinary technical resources within the meaning of Article 12 (1) (a) of the Act. (2)
(2) For the purposes of this Regulation, the veterinary technical resources (2) are to be broken down into the electrical veterinary technical means listed in Annex 1 to this Regulation (hereinafter referred to as "electrical veterinary technical means") and other veterinary technical means.
(3) No veterinary technical means shall be considered as:
(a) reagents, reaction results, calibrators, control materials, instruments, instruments and equipment intended by the manufacturer for the use of in vitro samples of animal bodily fluids and tissues to obtain information on the physiological or pathological state or on the congenital anomaly of the animal, or for the determination of safety and compatibility with potential recipients or for the monitoring of therapeutic measures, including sample containers intended by the manufacturer for the use of in vitro;
(b) transplants, tissues or cells of animal or human origin, except for other veterinary technical means manufactured using inanimate or dead tissue of animals or non-living products derived from animal tissue.
(1) An electrical veterinary technical device may be placed on the market if the conformity assessment procedure establishes that its characteristics comply with the technical requirements laid down in the harmonised Czech technical standard, (3) it is manufactured in accordance with good technical practice with regard to the principles of safety in force in the European Communities and that it cannot endanger the safety of persons, domestic animals or property when properly used for the purpose for which it is produced.
(2) The other veterinary technical means may be placed on the market where the conformity assessment procedure establishes that their characteristics comply with the essential requirements for other veterinary technical devices set out in Annex 2 to this Regulation, shall be manufactured in accordance with good technical practice in terms of safety principles and may not endanger the safety of persons, domestic animals or property when properly used for the purpose for which they are produced.
(3) Where a product imported into the Czech Republic has been placed on the market in other Member States of the European Communities in accordance with the relevant legislation transposing the law of the European Communities, it shall be deemed to have been placed on the market in the Czech Republic in accordance with the requirements of this Regulation.
Conformity assessment procedures
Conformity assessment shall be carried out by the manufacturer or importer of the veterinary technical device (2) in accordance with the conformity assessment procedure (4) of this Regulation.
Where the manufacturer or importer finds compliance with the requirements laid down in Article 3 (1), the manufacturer or importer shall issue a written declaration of conformity in accordance with Article 7 (1) or place a mark of conformity in accordance with Article 7 (3) on the electrical veterinary technical device.
(1) If the manufacturer or importer finds that the characteristics of another veterinary technical device comply with the requirements laid down in Article 3 (2), he shall issue a written declaration of conformity in accordance with Article 8.
(2) The assessment of the conformity of another veterinary technical device shall include the issue of the technical documentation of another veterinary technical device (hereinafter referred to as "technical documentation ') referred to in paragraph 3. The technical documentation shall be kept by the manufacturer or importer for at least 5 years after the manufacture or import of the last piece of another veterinary technical device and shall be submitted to the competent authorities on request.
(3) The technical documentation must enable the assessment of the conformity of another veterinary technical device with the requirements laid down in this Regulation; the technical documentation shall include in particular:
(a) a general description of the type of other veterinary technical means, including the intended variants;
(b) design drawings, prepared production technologies and schematics of parts, sub-assemblies or circuits of other veterinary technical means,
(c) descriptions and explanations necessary to understand the above drawings, schemes and functions of another veterinary technical device;
(d) a list of technical standards or regulations which have been fully or partially applied and a description of the solutions approved to meet the essential requirements, where the technical standard or legislation has not been fully applied;
(e) a description of the methods of sterilisation used for another veterinary technical device placed on the market in a sterile state and ensuring that sterile conditions are maintained throughout the period of application of another veterinary technical device;
(f) the conformity of another veterinary technical device with metrological requirements if it is another veterinary technical device with a measuring function;
(g) instructions for the use of another veterinary technical device and a proposal for a label to be placed on another veterinary technical device.
Declaration of conformity of veterinary technical means
Declaration of conformity of electrical veterinary technical means
(1) The manufacturer or importer of an electrical veterinary technical device shall, on the basis of conformity assessment (Section 5), issue a written declaration of conformity of the electrical veterinary technical device, unless otherwise provided for in this Regulation.
(2) The model declaration of conformity for an electrical veterinary technical device is set out in Annex 3 to this Regulation.
(3) The manufacturer or importer of an electrical veterinary technical device may place, on the basis of the conformity assessment referred to in Article 5, on an electrical veterinary technical device or, if this is not possible, on its packaging, instructions for use or on a guarantee certificate a mark of conformity, the model of which appears in Annex 4 to this Regulation; in this case, a written declaration of conformity of the electrical veterinary technical device need not be issued. The position of the conformity mark shall be visible, easily legible and indelible.
Declaration of conformity of other veterinary technical means
The declaration of conformity of another veterinary technical device shall be drawn up in Czech and, where appropriate, English and shall contain the following particulars:
(a) the identification details of the manufacturer or importer issuing the certificate of conformity (name, name, surname or business name, address of the place of permanent residence or residence, where applicable, 5) the place of business and the identification number, if any, if any, if it is a natural person, or the name, registered office and identification number, if it is a legal person);
(b) identification data of another veterinary technical device (name, type, make, model series, for the imported other veterinary technical device also identification data of the manufacturer referred to in (a);
(c) a description of another veterinary technical device, the intended purpose of its use and, where appropriate, other particulars characterising another veterinary technical device;
(d) the list of technical regulations, technical standards and harmonised Czech technical standards used in conformity assessment and, where applicable, the list of specific legislation6) used in conformity assessment;
(e) the identity data of the accredited person, if the manufacturer or importer used the accredited person (name or, where applicable, name, surname, business name, address of the place of residence or residence, 5) the place of business and the identification number, if any, if it is a natural person or business name, registered office and identification number, if it is a legal person, including the certificate number and the date of issue),
(f) the date and place of issue of the certificate of conformity, the names and functions of the responsible persons of the manufacturer or importer and their signatures;
(g) a declaration by the manufacturer or importer that:
1. the characteristics of another veterinary technical device satisfy the essential requirements set out in Annex 2 to this Regulation and, where appropriate, the requirements of other technical regulations and procedures;
2. another veterinary technical device is safe for use under normal conditions and achieves the purpose for which another veterinary technical device is intended,
3. another veterinary technical device is intended for single use only, if it is intended for single use only,
4. another veterinary technical device is intended for re-use, provided that it is intended for re-use under specified conditions,
5. the manufacturer or importer has taken measures to ensure the conformity of another veterinary technical device placed on the market with the technical documentation and with the essential requirements set out in Annex 2 to this Regulation.
Where there is a change in the facts which may affect the conformity of the characteristics of the veterinary technical device (2) with regard to the requirements laid down in this Regulation, the manufacturer or importer shall re-assess the conformity in accordance with this Regulation.
Protective measures
(1) Where it is found that an electrical veterinary technical device may endanger the safety of persons, domestic and livestock animals or property, even if it complies with the requirements of this Regulation, it shall be subject to specific legislation. 7)
(2) The competent authorities of the Member States of the European Union and the Commission of the European Communities must be informed immediately of the imposition of a safeguard measure.
Transitional provision
Valid certificates or other documents issued under existing legislation may be used for conformity assessment purposes under this Regulation, provided that they are not cancelled under the conditions laid down by law.
Efficacy
This Regulation shall enter into force on the date of the entry into force of the Treaty of Accession of the Czech Republic to the European Union.
Prime Minister:
PhDr. Špidla v. r.
Minister for Agriculture:
Ing. Palas v. r.
Příloha č. 1
Annex No. 1 to Government Decree No. 179 / 2004 Coll.
Electrical veterinary equipment
1. Diagnostic equipment (except equipment with defibrillation discharge protection).
1.1. A device independent of external influence designed to scan information from living creatures.
1.1.1. Equipment to determine biopotentials.
1. Equipment and related accessories for diagnostic and monitoring purposes for the study or monitoring of electrical activity or electrical characteristics of living creatures:
- electroencephalographs and electrocorticographs,
- electromyographs,
- electroretinographs,
- electron stagmographs.
2. Equipment and related accessories.
1.1.2. Device to scan other parameters.
1. Equipment and related equipment for the detection of infrared radiation of living organisms for diagnostic purposes:
- thermal cameras,
- thermographs,
- radiation thermometers.
2. Equipment and related accessories for the observation of acoustic expressions and sensitivity of living creatures:
- electric stethoscopes,
- phonocardioscopes and phonocardigraphs, if they are not intended for cardiovascular procedures,
- audiometers,
- audio phones.
3. Equipment and related accessories:
- ballistic graphs,
- electronic thermometers intended solely for cardiovascular procedures.
1.2. Devices to extract information from living creatures that depend on external influences.
1.2.1. Electrical current equipment.
Equipment and related accessories, using electrical current directly on living organisms:
- skin resistance measuring instruments,
- instruments for pulmonary or vascular impedance reography.
1.2.2. Equipment using other energy sources.
1. Ophthalmological diagnostic equipment and accessories, as follows:
- eye lighting devices: slit lamps, eye mirrors, spectral light sources, opthalmoscopes,
- eye observation, imaging and measurement equipment: opthalmometers, refractometers, tonometers, photometers, retinoscopes, corneal microscopes,
- opthalmological diagnostic files, consisting of the abovementioned opthalmological devices and supplemented by the necessary auxiliary equipment: sockets, stands, chairs.
2. Equipment and related accessories designed to improve visibility by monocular or binocular magnification for diagnostic purposes and used to observe surgical procedures (except high frequency surgery):
- surgical microscopes,
- scoops,
- otoscopes,
- dermatoscopes.
3. Equipment and related accessories for local lighting of examined or treated areas
- front lamps,
- front mirrors with lighting,
- hand lamps with fluorescent lamps,
- oral lamps.
2. Therapeutic devices.
2.1. Special therapeutic devices.
2.1.1. Electrical power equipment.
Equipment and related accessories developing electrically charged or ionised air, steam or fog, with the aim of achieving charge or ionisation by using:
- high voltage,
- electron emissions from hot metal.
2.1.2. Devices using other forms of energy.
1. Equipment and related accessories intended for certain mechanical manifestations in medicine:
- vibrator,
- water-jet massage apparatus,
- out-of-body cardiac massage apparatus.
2. Equipment and related accessories for the manufacture of hot air and water or other vapour for medical purposes (excluding ultrasonic apparatus):
- heat and mechanical evaporators of solid or liquid substances for inhalation purposes,
- hot air baths.
2.2. Electrosurgical equipment.
2.2.1. Electrical equipment.
Equipment and related accessories using low frequency electrical power for the production of heat for electrocautics:
- electrocautics equipment,
- parts or sets of electrical equipment for electrocautics.
2.2.2. Devices using other forms of energy.
1. Equipment and related accessories for therapeutic purposes in opthalmology:
- eye treatments,
- eye magnets.
2. Equipment and related accessories.
3. Equipment and related accessories for the production of certain mechanical manifestations in medicine:
- drills, saws or polishing machines for dentistry and surgery,
- water-powered machines.
2.3. Devices to support or replace body functions (except implanted pacemaker and other implanted devices).
2.3.1. Equipment for support or replacement by other means.
Equipment to support or replace certain body functions:
- artificial limbs,
- tools for the paralyzed.
3. Equipment other than those referred to in points 1 and 2.
Equipment and accessories for handling and placement of animals for surgical and dental purposes:
- operating tables,
- operational units,
- dental units.
Příloha č. 2
Annex No 2 to Decree-Law No 179 / 2004 Coll.
Essential requirements for other veterinary technical means
I. General requirements
1. Other veterinary technical means shall be designed and manufactured in such a way that, when used under the specified conditions and for the intended purpose of use, they do not endanger the clinical condition, health or safety of the animal or the safety or health of a person serving or using another veterinary technical device (hereinafter referred to as "the provider ') or other natural persons, provided that any risks which may be related to the use of another veterinary technical device are acceptable compared to their benefit to the animal and correspond to a high level of health and safety protection. Other veterinary technical means shall be designed in such a way that, when it is used, the legislation in force in the field of environmental protection or the protection of animals against abuse is not infringed.
2. The solutions chosen by the manufacturer in the design and construction of another veterinary technical device shall comply with the principles of safety and the current level of science and technology.
When selecting the most suitable solution, the manufacturer shall base the following principles in the following order:
2.1. Eliminate or minimise any risks (safe design and construction) of a veterinary technical device;
2.2 to take, where appropriate, appropriate protective measures including, where appropriate, warnings against hazards which cannot be excluded,
2.3. Inform providers of the persistence of risks due to failure to achieve the full perfection of the safeguards implemented.
3. Other veterinary technical means shall be effective as specified by the manufacturer and shall be designed, manufactured and packaged to be applicable to one or more of the functions specified by the manufacturer.
4. The loading of another veterinary technical device which may occur under normal operating conditions shall not adversely affect its characteristics, characteristics and efficacy within the meaning of points 1, 2 and 3 of this Annex to the extent that the clinical condition or safety of animals or, where appropriate, of providers or other persons is not jeopardised during the period of application of another veterinary technical device, as determined by the manufacturer.
5. Other veterinary technical means shall be designed, manufactured and packaged in such a way that:
- its characteristics, characteristics or efficiency for the intended use have not been adversely affected by the conditions of transport or storage, while maintaining the manufacturer's instructions and information,
- allow for easy use.
6. Any side effects of another veterinary technical device shall only constitute an acceptable risk compared to its anticipated effects.
II. Specific requirements
7. Infections and microbial contamination.
7.1. Any other veterinary technical device, including its manufacturing process, shall be designed, taking into account the current state of scientific knowledge and the purpose of use, in such a way as to eliminate or minimise the risk of transmission of infection by other veterinary technical means to animals, providers or other natural persons or the risk of contamination by those persons of another veterinary technical device.
7.2. Any other veterinary technical device, supplied in sterile form, shall be designed, manufactured and packaged in disposable protective packaging and, where appropriate, appropriate procedures shall ensure that it is sterile when the other veterinary technical device is placed on the market and remains sterile under the storage and transport conditions laid down by the manufacturer until the protective device is opened.
7.3. Other veterinary technical means, supplied in sterile condition, shall be produced and sterilised in accordance with the appropriate European Pharmacopoeia procedure.
7.4. The packaging system of a non-sterile other veterinary technical device shall ensure a specified level of purity of another veterinary technical device. If another veterinary technical device is to be sterilised before use, its packaging system shall minimise the risk of microbiological contamination. The packaging system shall be suitable for the use of a sterilisation method specified by the manufacturer.
7.5. An identical or similar veterinary technical device which is placed on the market at the same time in both sterile and non-sterile conditions shall be mutually distinguished by packaging or marking.
8. Construction and characteristics of another veterinary technical device in relation to the surrounding environment.
8.1. Where another veterinary technical device is intended for use in conjunction with another veterinary technical device or equipment, the kit thus established, including the interconnection system, shall be safe and shall not interfere with the stated effectiveness of each veterinary technical device. Any restriction on the applicability of another veterinary technical device shall be indicated on the label or in the instructions for its use.
8.2. Other veterinary technical means shall be designed and manufactured in such a way as to eliminate or minimise risks:
- injury to persons or animals,
- interaction with other veterinary technical means commonly used in a particular investigation or therapy,
- resulting from the ageing of the materials used or the loss of accuracy of the measuring or control mechanism, where appropriate, as well as from the fact that another veterinary technical device cannot be maintained or calibrated.
9. Other veterinary technical means with measuring function.
9.1. Another veterinary technical device with a measuring function shall be designed and manufactured in such a way as to provide sufficient accuracy and stability within the specified accuracy limits, taking into account the intended purpose of its use; the accuracy limits are specified by the manufacturer.
9.2. The results of measurements carried out by another veterinary technical means with a measuring function shall be expressed in appropriate international units or other established scientific units.
10. Radiation protection.
10.1. General requirement.
10.1.1. Another veterinary technical device shall be designed and manufactured in such a way that exposure to the animal, provider or other natural persons is reduced to the lowest possible extent, taking into account the intended purpose of use, without thereby restricting the use of the necessary levels of radiation for diagnostic and therapeutic purposes.
10.2. Required radiation.
10.2.1. Where another veterinary technical means is intended to emit radiation at hazardous levels but necessary for a specific purpose in veterinary medicine, the benefit of which is considered to be appropriate to that risk, the provider shall be able to control the level of such emissions. This other veterinary technical device shall be designed and manufactured in such a way as to guarantee the reproducibility and tolerance of the relevant parameters.
10.2.2. Where another veterinary technical device is intended to emit potentially dangerous visible or invisible radiation, another veterinary technical device shall, where possible, be provided with a display and, where appropriate, an audible warning to alert such radiation emissions.
10.3. Unwanted radiation.
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Regulation Information
| Citation | Government Regulation No. 179 / 2004 Coll., laying down technical requirements for veterinary technical equipment |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 21.04.2004 |
|---|---|
| Effective from | 01.05.2004 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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