Decree No. 195 / 2005 Coll.
Ordonnance governing conditions for the prevention and spread of infectious diseases and health requirements for the operation of health care establishments and social care institutions
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26.05.2005
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195
DECLARATION
of 18 May 2005
adapting the conditions for the prevention and spread of infectious diseases and the hygiene requirements for the operation of health care establishments and social care institutes
According to Article 108 (1) of the Act No. 258 / 2000 Coll., on the protection of public health and on the amendment of certain related laws, as amended by Act No. 320 / 2002 Coll. and Act No. 274 / 2003 Coll., (hereinafter referred to as "the Act") for the implementation of § 16 (2) (b), § 17 (1), § 17 (5), § 18 (1), § 20 (a), § 45 (3), § 62 (1), § 62 (4) (a) and (b), § 70 (1), § 72 (1) (a):
PREPARATION OF EQUIPMENT AND DISSEMINATION
Method and extent of reporting of infectious diseases except hospital diseases
(Paragraph 62 (1) of the Law)
(1) Reporting
(a) newly identified diseases, including suspected or recurrent tuberculosis or other mycobacteriosis, of the deaths of persons not registered in the group of active tuberculosis or other mycobacteriosis (hereinafter referred to as "tuberculosis or other mycobacteriosis subject to reporting) and of tuberculosis or other mycobacteriosis in persons not registered in the group of active tuberculosis who have died for other causes, shall be reported on a form marked" Compulsory Reporting of tuberculosis and other mycobacteriosis "- SEVT 011 3;
(b) for persons dispensed in the active tuberculosis group, once a year it shall be submitted on a form marked "Control report of tuberculosis and other mycobacteriosis" - SEVT 012 3; This form shall also be used for the detection of the death of a person dispensed in an active tuberculosis group and for the detection that a person dispensed in that group does not have active tuberculosis or mycobacteriosis and for the transfer of such person into an inactive tuberculosis group;
(c) for persons included in the group of active tuberculosis and other mycobacteriosis, who are subject to a change of surname, birth number and dissertation shall be submitted on a form marked "Data change report for persons in the tuberculosis registry" - SEVT 013 2;
(d) the positive result of the mycobacteriological examination shall be submitted on the form marked "Report of the positive result of the mycobacteriological examination" set out in Annex 5;
(e) sexual illness, including suspicion of such disease (reception / syphilis /, gonorrhoea /, soft ulcer / ulcus molle /, fourth genital disease / Lymphogranuloma venereum /, Granuloma venereum / Donovanosis / and STD caused by viral acanthema agents), and of death and suspicion of death, shall be given on a form marked "Report of Sex Disease" - SEVT 017 2;
(f) the suspicion, occurrence or death of other infectious diseases, with the exception of the infectious diseases listed in Annex 1, shall be submitted on a form bearing the word "communicable disease" - SEVT 14 7900;
(g) infectious diseases are administered by the person providing care to the competent public health authority and the competent doctor who registers the patient. The registered physician shall record these facts. The report shall be made on the above forms.
(2) Dispensing equipment means a medical facility which monitors the health status of natural persons in order to prevent or eliminate the causes of deterioration of the health status or functions of individual bodies and systems.
(3) In the event of the risk of further epidemiological spread of the infectious disease referred to in paragraph 1, the person providing the care shall report immediately by telephone or fax or by e-mail to the competent public health authority and shall subsequently confirm it on the prescribed form. In the same way, reports shall be reported in case of suspicion of yellow fever, cholera, plague, spills, haemorrhagic Fever Ebola, Marburg and Lassa and other equally serious infectious diseases.
(4) The diseases listed in Annex 1 are only reported in bulk. The report shall be submitted immediately by telephone and shall be confirmed without undue delay by fax or e-mail.
Method of reporting hospital diseases
[Paragraph 16 (2) (b) of the Law]
The notification of a mass occurrence of a hospital disease and a hospital disease which has led to severe damage to or death shall be submitted immediately, as a rule by telephone or fax or by e-mail to the competent public health authority, and shall then be certified on the form marked "Infectious disease notification '.
List of infectious diseases where isolation is ordered in hospital or medical institutions' bed departments and in the case of diseases which are compulsory
(Articles 45 (3) and 70 (1) of the Law)
The list of infectious diseases at which isolation and treatment must always be ordered in the infectious ward or, where appropriate, in the tuberculosis ward or in the venerology ward of the hospital, and the treatment of which natural persons are required to undergo, is set out in Annex 2.
Medical examinations for natural persons performing epidemiological activities
[K § 20 (a) of the Act]
A natural person carrying out epidemiological activities shall be subjected to medical examinations and examinations,
(a) if it is affected by a diarrhoea, feverish or feverish disease or other infectious disease or if it is suspected of being infected (1); or
(b) if it has been in epidemiological contact with patients with diarrhoea, viral hepatitis or other serious infectious diseases at the workplace, at home or at the place of residence of a natural person carrying out epidemiological activity.
Principles for the collection and examination of biological material and the necessity of the request
[Paragraph 62 (4) (a) and (b) of the Act]
(1) The collection and examination of biological material shall be carried out according to the following hygiene requirements:
(a) the collection of biological material in a health facility may be carried out only in the reception room or, exceptionally, in a space which satisfies the essential hygiene requirements for the collection of biological material;
(b) biological material shall be collected with regard to pathogenesis of the infectious disease;
(c) for diagnosis, the material is usually taken at an acute stage of infectious disease; in the case of serological tests, a second sample shall be taken two to three weeks after the first sample is taken, otherwise as appropriate,
(d) biological material is generally collected prior to the initiation of chemotherapy or antibiotics,
(e) only sterile tools, sterile aids and disposable gloves shall be used to be collected, and only for one treated natural person; gloves shall be latex or vinyl which comply with the requirements of the specific legislation2); the permeability of gloves must correspond to their use and the risk of biological agents; the strength of their walls must not significantly reduce the sensitivity of hands;
(f) the biological material must be stored in standardised containers and in decontaminated containers;
(g) immediately after collection, the biological material shall be transported in such a way that it is not degraded by physical effects and risks to individuals.
(2) The report of the laboratory finding is to be given immediately to the medical practitioner who sent the biological material for examination. A positive laboratory finding confirming infectious etiology shall be reported by the laboratory to the competent public health authority according to the location of the patient.
(3) The application for the examination of biological material must contain the name, surname, birth number and date of birth of the person under investigation, which has not been assigned a birth number, the address of the person under investigation in the Czech Republic, the identification number of the medical institution and its address, the nameplate, the signature and the telephone number of the doctor requesting the examination of the biological material, the name of the health insurance company of the natural person under investigation, the type of material, the date and hour of collection, the date of the first symptoms of the infectious disease, the type of antibiotic therapy and its start, the clinical diagnosis and the type of examination required. During transport there shall be no contamination of the request with transported biological material.
Requirements for the location and instrumentation and material equipment of a laboratory carrying out laboratory tests for human immunodeficiency virus
[Paragraph 72 (1) (a) of the Law]
(1) For the detection of antigens and antibodies against human immunodeficiency virus using standard laboratory methods, the laboratory shall be equipped with certified laboratory equipment and tools.
(2) The blood donor transfusions carry out all mandatory serological tests in one test facility in a joint investigation laboratory.
HYGIENIC REQUIREMENTS FOR THE OPERATION OF HEALTH EQUIPMENT AND SOCIAL INSTALLATIONS
Receipt and treatment of natural persons in health care establishments and institutions
(Paragraph 17 (1) of the Law)
(1) The reception and treatment of natural persons in health care institutions or social care institutions, their examination and provision of vital functions by sewers and catheters may be carried out only in the reception room or, exceptionally, in an area which meets the basic hygiene requirements for the collection of biological material.
(2) The medical history of the recipient physician of a sleeper medical institution or social care institution shall record important anamnestic data for the possible occurrence of a hospital disease, including the identification of a travel and epidemiological history and, where appropriate, carry out appropriate examinations, taking into account the overall health status of the natural person. In addition, the doctor shall perform clinical and serological examinations on arrival using one non-specific and one specific reaction in all pregnant women in the third and seventh months of pregnancy, in the cord blood of each newborn, in each woman prior to abortion and in all persons 15 to 65 years of age admitted to the first hospitalisation in the dermatoenerological ward and in persons 15 to 65 years of age admitted to other wards, if the physician considers this justified. The admission of drug addicts to detoxification into bed medical facilities shall be subject to testing of basic markers of viral hepatitis. Where, in view of the natural person's medical condition, acceptance is necessary when an infectious disease is suspected, isolation and barrier measures shall be carried out and, where appropriate, the receiving doctor shall arrange for transfer to the appropriate department. A similar obligation applies to general practitioners, medical practitioners and counselling in outpatient facilities. Children shall be examined for which infectious disease has been experienced and whether they are properly vaccinated.
(3) Natural persons are located in a preventive care facility, in particular according to the health status and manner or extent of healthcare, taking into account and implementing epidemiological aspects.
(4) Clothes and footwear of natural persons are stored in a central dressing room, or in closets in rooms or in closets in rooms intended for this purpose. Clothes and shoes of patients cannot be stored in rooms in intensive care facilities.
(5) The following hygiene requirements shall be complied with when receiving and treating patients in medical establishments:
(a) health professionals shall carry clean personal protective equipment only for their own departments; when working at another workplace, they use only the protective equipment of this workplace, meaning the organisational department and the department of a narrower or special part of the workplace; health professionals in operational facilities and in the berth of medical facilities must refrain from wearing jewelry, watches and artificial nails on their hands;
(b) health care professionals may only approach investigations and treatments after washing hands; disinfecting hands must always be carried out after medical performance in natural persons, after handling biological material and used laundry and always before each parenteral performance and whenever a barrier treatment regime is applied to prevent the emergence of hospital diseases; one-off material which is stored in covered containers shall be used to wipe hands;
(c) when treating natural persons, health professionals must use barrier care techniques at all workplaces, in particular at workplaces of urgent and intensive care; all personal hygiene aids, as well as thermometers, bowls and other devices, must be individualised to patients in bed health care facilities, which must be identical to the patient throughout the stay;
(d) for parenteral procedures, health professionals must use only sterile tools and sterile devices; for endoscopes and other optical instruments, at least a higher degree of disinfectant followed by a sterile water rinsing; for digestible endoscopes (except operations), they shall provide a two-stage disinfectant followed by water-purified rinse (Aqua purificata) 3; a separate sterile needle and a sterile syringe should always be used for each patient;
(e) for operational performance, health professionals must use sterile protective clothing, footwear reserved only for the workplace and sterile equipment (disposable or classical sterilisation aids) and comply with the principles of asepsis; for other performance in which skin and mucous membranes are broken or already damaged, communication with the body cavity or, where appropriate, non-physiological access to the body, the protective equipment shall be chosen in relation to the performance, load and risk to the patient; the protective equipment must be individualised for each person and must be postponed immediately after execution;
(f) used tools and equipment contaminated with biological material shall not be cleaned by health care professionals without prior decontamination by disinfectant agents guaranteeing the virucidal effect; disposable syringes and needles are discarded without manual separation; a special device or device may be used to separate the needle from the syringe to eliminate the risk for which the prohibition on manual separation is justified, except for the application pistol, the use of which is governed by the manufacturer's instructions. Returning the guards to used needles is not allowed;
(g) hospital diseases must be prevented by complying with any existing measures against the spread of infectious diseases and thereby by unnecessary prolongation of hospitalisation; adequate support for tissue oxidation, circulation and tissue nutrition must be provided for persons;
(h) increased attention must be paid to individuals with risk factors such as immunodeficiency, invasive performance, surgery, controlled breathing, haemoperfusion, haemodialysis, diabetes mellitus, malignant neoplasms, age over 60, cardiovascular disease and obesity;
(i) the supervision of compliance with the principles of personal hygiene by natural persons located must be ensured; proper hygiene cleaning must be ensured before and after operations. The residence and movement of persons in health care establishments and social care institutes must also be ensured from an anti-epidemic point of view, by the separate location of natural persons according to the risk of the disease being created and, where appropriate, the transmission of the disease;
(j) visits to patients must be conducted with regard to the operation, the nature of the separation and the condition of the patient at a time to be determined by the physician. No flowers are placed in intensive care, surgical and gynecological centres; the visits use protective clothing when entering the intensive care or anaesthesior-resuscitation department;
(k) the handling and preparation of the diet shall be carried out in accordance with a special legislation4);
(l) in the case of a newborn, proper credeisation must be carried out as part of the care provided.
(6) The reception and treatment of persons in social care institutions shall be treated in a similar manner to the reception and treatment of persons in medical institutions, except for the procedures referred to in points (a), (c), (e), (g), (j) and (l) of paragraph 5.
Sterilisation, higher degree of disinfection, disinfection
(Paragraph 17 (1) and (5) of the Law)
(1) The procedures and methods, including their control, set out in Annex 3 shall be used to sterilise, increase the degree of disinfectant and disinfectant.
(2) Reused medical devices are cleaned, disinfected and sterilised according to the manufacturer's instructions. Disposable devices shall not be repeatedly used or sterilised.
Laundry handling
(Paragraph 18 (1) of the Act)
(1) The replacement of bedding shall be carried out as necessary, at least once a week, after contamination and after operational performance and, where appropriate, the dressing and after release or transfer of the patient.
(2) In medical institutions, one-off material, which is changed after each patient, is used to cover examination tables and couches where the exposed part of the patient's body is used.
(3) The manner in which the laundry is to be stored, transported, washed and handled by health care institutions or social care institutions, as well as laundry equipment, is laid down in Annex 4 to this Decree.
(4) The same mode of handling laundry from health care facilities also applies to premises for reception of laundry.
Cleaning of facilities for preventive care and social care institutions
(Paragraph 17 (1) of the Law)
(1) Cleaning of all premises of preventive care facilities and social care institutions is carried out daily on a moist basis. This cleaning method shall be consistent with the floor covering. In the operating and intervention halls where invasive procedures are performed, cleaning is carried out before the start of the operational programme and after each patient. In intensive care facilities, in rooms where biological material is collected, in laboratories and children's departments of all types, cleaning is performed three times a day. In the case of cleaning operations carried out by cleaning firms in health care establishments, the responsible healthcare professional responsible shall proceed in accordance with the relevant contract. Technical cleaning procedures form an integral part of the operating rules.
(2) Normal detergents (detergents) may be used in standard departments when cleaning. Common detergents and disinfectants with virucidal effect are used in intensive care facilities, operating and intervention rooms, surgical and infectious workplaces, laboratories and where biological material and invasive performance are collected, in toilets and bathrooms and in other workplaces specified by the operating order (5).
(3) Each workplace has its own cleaning equipment or cleaning machine, except for standard outpatient and bedside departments of the same type and the nature of the composition of individuals.
(4) When contaminating premises and areas with biological material, immediate decontamination of the stained site shall be carried out by covering the mule or paper wadding with an effective disinfectant solution, filling with absorption granules, etc., after exposure shall be cleaned in the usual manner. Used beds and mattresses are disinfected either in the room by washing the disinfectant or decontaminated in the central bedroom after each release of the patient.
(5) All waste is removed daily, the waste generated by the patient's bed immediately. Hazardous waste 6) is stored in separate covered containers, preferably flammable, or in closed containers. Small waste, including disposable needles, shall be stored in hard, closed and flaming containers without further handling. The maximum time between waste collection and final disposal is 72 hours in winter and 48 hours in summer. In the case of longer withdrawal intervals for final disposal, waste from medical facilities must be stored at low temperatures in a warehouse for that purpose. The temperature for storage of anatomical and infectious waste shall not exceed between 3 and 8 ° C. Highly infectious waste must be disposed of directly following the generation of waste by certified technological equipment.
(6) Biological waste (7), such as withdrawn parts of the organs, amputated parts of the limbs, glands with internal secretion, and certain secretions and secretions, such as stomach and intestinal juices, the content of biliodigestive and enterocal fistulae and other substances, is stored as hazardous waste.
(7) The painting of rooms in medical facilities shall be carried out according to the nature of the activity; Intervention and operating rooms, intensive care units, sampling rooms, laboratories, infectious ward, infant and newborn wards are painted once a year, others once every two years. The painting of the room is always done in medical facilities if the walls and ceilings are contaminated with biological material. Construction works may not be carried out in the premises of the medical establishment, or its organisational or operational components, for which it has been independently processed and approved by the Operating Regulations 5). This prohibition applies to the same extent to social welfare institutions.
(8) Cleaning and disinfection shall be carried out in medical emergency and transport vehicles of the sick and injured before inclusion, once a day in the driver's cab and in the patient's compartment. In the event that the sanitary vehicle is stained with biological material, disinfectant and mechanical cleansing shall always be carried out before the next transport.
(9) In vehicles for the transport of patients affected by communicable diseases, the driver's cab shall be disinfected once a day and the patient's space after each transport of a disinfectant with a wide range of efficacy.
(10) In view of the potential spread of infectious diseases, health care establishments shall carry out routine protective disinsectisation and exertification, the frequency of which is established in the operating order (5).
FINAL PROVISIONS
Decree No. 440 / 2000 Coll., which regulates the conditions for the prevention and spread of infectious diseases and the hygiene requirements for the operation of health facilities and social care institutions, is hereby repealed.
This Decree shall take effect on 1 July 2005.
Minister:
Doc. MUDr. Emmer, CSc.
Příloha č. 1
Annex No 1 to Decree No 195 / 2005 Coll.
List of infectious diseases reported to the public health authority only in the event of a mass occurrence
1. Acute respiratory disease (e.g. dg. J00, J03, J04-J06, J10-J18, J20-J22) x
2. Conjunctivitis (e.g. dg. H10, B) 30x)
3. Mastitis (for example dg. 091) x)
4. Skin inflammatory infectious and fungal diseases (e.g. dg. L00-L08, B00, B07, B08, B09, B35- B37) x
5. Stomatitis (e. g. dg. K05, K12) x)
6. Observed (e.g. dg. B85) x)
Příloha č. 2
Annex No 2 to Decree No 195 / 2005 Coll.
List of infectious diseases where isolation is ordered in hospital or medical institutions' bed departments and in the case of diseases which are compulsory
1. Acute viral inflammation of the liver
2. Antrax
3 Dengue
4. Haematological Fever
5.
6. CNS infection interpersonal
7. Plague
8. Parathyphus
9. Syphilis in stage I and stage II
10. Portable polio
11. Pertussis in acute stage
12. Ricketsiosis
13. SARS and febrile states of undetected aetiology with a positive travel history
14.
15. Trains
16. Tubericide
17. Typhoid
18. Amebic dysentery
19. Bacular dysentery in acute stage of disease *
20. Diphtheria
21. Other infections subject to World Health Organisation reporting
Příloha č. 3
Annex No 3 to Decree No 195 / 2005 Coll.
Methods of sterilisation and its control, methods of higher degree of disinfection, methods of disinfection and its control
A. STERILISATION
Instruments, appliances and articles intended to be sterilised and pre-sterilised shall be used in accordance with the manufacturer's instructions. An integral part of sterilisation is pre-sterilisation preparation of articles, control of the sterilisation process and sterilised material, monitoring and recording of the set parameters by showing and registering devices incorporated in the steriliser and checking the effectiveness of sterilisation by non-biological and biological indicators. Each sterilisation cycle shall be documented.
The operator is responsible for the quality of sterilisation media required by the manufacturer of the sterilisation apparatus. Technical inspection of sterilisation apparatus shall be carried out to the extent specified by the manufacturer, for old instruments without technical documentation 1 times a year. The sterilisation is carried out by trained health professionals. Central sterilization is responsible for the operation and quality of a healthcare professional who graduated from specialisation studium8) or certification course, event. another trained medical professional.
Only authorised repairers perform the sterilisation equipment, repairs and periodic service.
I. Pre-sterilisation preparation
Pre-sterilisation is a set of activities prior to self-sterilisation resulting in clean, dry, functional and packaged medical devices for sterilisation. All tools and equipment used shall be considered to be contaminated. If intended for repeated use, they shall be decontaminated immediately after use in the dishwasher or manually.
The cleaning is carried out in washing machines in an acid, alkaline or enzymatic medium. Disinfection is performed thermically at 90 ° C and above for 10 minutes or thermo-chemically using a prescribed disinfectant at 60 ° C for 20 minutes. Where the effectiveness and suitability of other parameters for the operation of dishwashers are demonstrated, they shall be used under the conditions laid down by public health authorities. Continuous checks on the effectiveness of the washing and disinfection process in dishwashers shall be carried out on a regular basis by physical or chemical tests or bioindicators, as instructed by the manufacturer, at least once a week. The service of the dishwasher on the indicators monitors whether the washing and disinfection cycle is performed according to the selected program.
Manual washing of tools and equipment takes place only after they have been disinfected in a device with viral effectiveness.
The preparations and procedures for disinfection and washing shall be chosen in such a way as not to damage the treated material. Water rinsing will remove any residues of the substances used.
Cleaning by ultrasonic frequency 35 kHz is used to supplement cleaning after previous hand or machine washing and disinfection.
After washing, the tools or devices shall be thoroughly dried before packaging, then inspected and discarded. Proper drying is an important prerequisite for the desired effect of each sterilisation method.
The last phase of pre-sterilisation preparation is the insertion of articles intended to be sterilised into suitable packaging to protect them from microbial contamination after sterilisation. The material shall be stored in the sterilisation chamber in such a way as to enable the sterilisation medium to penetrate as easily as possible. During sterilisation, the chamber is filled in only 3 / 4 of the volume and the material is stored in such a way that it does not touch the walls. The filling is identical for all types of sterilisation.
II. Method of sterilisation
Only sterilisation devices may be used under the conditions laid down for medical devices. 9)
The sterilisation unit (STJ) is a block of dimensions 300 mm x 300 mm x 600 mm.
Pressure [kPa, bar] means absolute pressure relative to vacuum (i.e. normal atmospheric pressure is 100 kPa, 1 bar).
A rich steam is a water steam whose temperature and pressure correspond exactly to the steam saturation curve.
II.1. Physical sterilisation
II.1.1.
The wet heat sterilisation (rich water vapour) in steam appliances is suitable for medical devices made of metal, glass, porcelain, ceramics, textiles, rubber plastics and other materials resistant to the following sterilisation parameters:
| Jmenovitá sterilizační teplota (teplota syté vodní páry) | Tlak (zaokrouhleno) | Přetlak (zaokrouhleno) | Doba sterilizační expozice | Poznámka | ||
|---|---|---|---|---|---|---|
| °C | kPa | bar | kPa | bar | min | |
| 121 | 205 | 2,05 | 105 | 1,05 | 20 | |
| 134 | 304 | 3,04 | 204 | 2,04 | 4 | Pouze pro nebalené kovové nástroje k okamžitému použití sterilizované v přístrojích, kde se provádí vakuový a BD test a které dosahují ve fázi odvzdušňování tlaku alespoň 13 kPa. Nepoužívá se v CS a SC. |
| 134 | 304 | 3,04 | 204 | 2,04 | 7 | Pouze v přístrojích, kde se provádí vakuový a BD test a které dosahují ve fázi odvzdušňování tlaku alespoň 13 kPa. |
| 134 | 304 | 3,04 | 204 | 2,04 | 10 | |
| 134 | 304 | 3,04 | 204 | 2,04 | 60 | Pro inaktivaci prionů ve spojení s alkalickým mytím* |
* Instruments that have been in contact with the tissues of patients with established CJD disease must be destroyed, must not be resterilised.
Explanatory notes: CS - central sterilisation - performs complete pre-sterilisation preparation and sterilisation of medical devices
SC- sterilisation centre - performs only sterilisation of medical devices
BD - Bowie-Dick Test
The wet heat sterilisation is controlled by ČSN EN 554 "Sterilisation of medical means of validation and regular control of wet heat sterilisation." The standard determines the requirements for the qualification of personnel, the technical equipment of the apparatus, the quality of the sterilisation medium, sterilised material, sterilisation process, test apparatus, maintenance, validation and revalidation. Steam sterilisers shall be equipped with an antibacterial filter. The exception may be granted for small table sterilisers equipped with only type N sterilisation cycles.
The deviation of the actual temperature in the sterilisation area from the set temperature during the sterilisation exposure ranges from 0 ° C + 3 ° C.
Category of steam sterilisation apparatus according to sterilisation programmes:
A) - up to 1 sterilisation unit according to EN 130 60:
1. Apparatus incorporating sterilisation cycles of a type N serves only for sterilisation of unpacked tools without cavities. Not used for porous material. These instruments shall have at least a thermometer or a pressure gauge.
2. Apparatus equipped with type B sterilisation cycles are used for sterilisation of packed and unpackaged materials that tolerate operating temperatures. These devices have a thermometer and pressure gauge and allow for a vacuum and daily BowieDick test.
3. Apparatus equipped with type S sterilisation cycles are only used for sterilisation of the products specified by the manufacturer of the steriliser.
B) Apparatus exceeding 1 sterilisation unit:
Apparatus with a chamber capacity of more than 1 sterilisation unit, with a vapour outlet outside the chamber, a heated casing and a pump, allowing for interruption of air extraction prior to sterilisation exposure.
The sterilisation cycle in these devices is automatically run according to the selected program. The apparatus has a built-in thermometer and pressure gauge with sensors independent of control sensors and the ability to register, print, or print values and have a program to perform a vacuum and daily Bowie-Dick test.
In this category, packed and unpackaged materials are sterilised.
II.1.2.
Sterilisation by flowing hot air - is intended for medical devices made of metal, glass, porcelain, ceramics and stoneware. Hot air sterilisation shall be carried out in instruments with forced circulation of air at parameters:
| Teplota (°C) | Čas (min.) |
|---|---|
| 160 | 60 |
| 170 | 30 |
| 180 | 20 |
The hot air steriliser shall not be opened after the sterilisation cycle has ended until it has cooled to at least 80 ° C. The apparatus has a built-in thermometer coupled with a time controller that measures the sterilisation exposure until the set temperature is reached.
The deviation of the actual temperature in the sterilisation area from that set during the sterilisation exposure ranges from -1 ° C + 5 ° C.
II.1.3.
Plasma sterilisation - uses plasma generated in a high frequency electromagnetic field that acts in high vacuum on pairs of hydrogen peroxide or other chemicals. Sterilisation parameters and conditions of sterilisation, as well as the types of material which are sterilised in this way, are given by the instrument type. Plasma sterilisation is not used to sterilise porous and absorbent material and cellulose-based material.
II.1.4.
Radiation sterilisation - the effect causes gamma radiation at a dose of 25 kGy. It is used in the industrial production of sterile disposable material, possibly for sterilisation of exspirated medical material. This is done according to EN 552.
II.1.5. Where the effectiveness and suitability of other sterilisation methods for a particular purpose is demonstrated, they shall be used under conditions laid down by the public health authority.
II.2. Chemical sterilisation
Chemical sterilisation is intended for material which cannot be sterilised in physical ways. The sterilisation medium is the gases of the prescribed composition and concentration.
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Regulation Information
| Citation | Decree No. 195 / 2005 Coll. |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 26.05.2005 |
|---|---|
| Effective from | 01.07.2005 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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