Decree of the Ministry of Health of the Czech Republic No. 49 / 1993 Coll.
Decree of the Ministry of Health of the Czech Republic on technical and material requirements for medical equipment
Valid
Effective from 22.01.1993
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49
DECLARATION
Ministry of Health of the Czech Republic
of 21 December 1992
on technical and material requirements for medical equipment
The Ministry of Health of the Czech Republic provides pursuant to § 70 (1) (c) of Act No. 20 / 1966 Coll., on the care of the health of the people, as amended by the Act of the Czech National Council No. 548 / 1991 Coll. (full text with effect for the Czech Republic No. 86 / 1992 Coll.), and under § 4 (2) (b) of the Czech National Council Act No. 160 / 1992 Coll., on health care in non-state health establishments:
(1) The technical and material requirements for outpatient care facilities, medical care facilities, medical rescue services and the transport of patients and injured persons are set out in the Annex to this Decree.
(2) Technical and material requirements for the equipment of other medical devices are set out in the characterisation directives. 1)
The Decree of the Ministry of Health of the Czech Republic No. 208 / 1992 Coll., on technical and material requirements for medical equipment is hereby repealed.
This decree shall take effect on the day of its publication.
Minister:
MUDr. Lom v. r.
Annex to Decree No 49 / 1993 Coll.
TECHNICAL AND IMPORTANT REQUIREMENTS FOR EQUIPMENT OF HEALTH EQUIPMENT
Common provisions
(1) Medical devices must:
(a) constitute an operational whole;
(b) be located in such a way as to allow easy access to patients and the arrival of motor vehicles;
c) be located in non-residential areas of objects with non-safe operation, 1)
(d) be equipped with approved instrument health technology, 2)
(e) ensure effective disposal of special medical waste in accordance with specific regulations, 3)
(f) to ensure the supply of drinking water and waste water disposal;
(g) be equipped with a heating system;
(h) be equipped with an accessible telephone line.
(2) Medical equipment shall meet the following requirements for the environment of medical structures:
(a) operating rooms which have the character of permanent work or stay shall be provided with direct daytime lighting and window ventilation; other operating rooms, including the waiting room of patients in which direct lighting and ventilation cannot be achieved for technical reasons (for example, when putting equipment into an existing building, when reconstructing) or not suitable for operating purposes, shall be provided with artificial lighting and ventilation by air-conditioning equipment.
b) Operating rooms shall have a clearance of 3,0 m. If the nature of the existing building in which the medical facility is to be located does not technically allow this height to be attained (for example when being built into an existing building), a light height lower than or equal to 2,5 m may be allowed. Communication and adjacent spaces shall have a clearance of not less than 2,4 m.
(c) At least 15 m3 of airspace and at least 2 m2 of free floor space shall be allocated to one person in the offices and other rooms intended for continuous work, provided that a larger area is not required for reasons of operational requirements. The quality of microclimatic conditions shall be assessed in the absence of compliance with that airspace volume. The following microclimatic conditions shall be observed:
1. minimum air temperature
Office 22 ° C,
preparation rooms 22 ° C,
waiting rooms 20 ° C,
2. Relative humidity 30 to 50%.
With a volume of 15 m3 per person, a single air exchange per hour shall be achieved. If the volume of airspace in the room is below 15 m3 per person, the requirement for a specified air exchange shall be increased in an appropriate proportion.
d) The waiting area for patients must have an area of at least 2,0 m2 per patient position at the smallest area of the room of 8,0 m2.
I. Medical facilities outpatient care
1.
(1) Outpatient care facilities can be built as separate (doctor's office, dental laboratory, etc.) or as a combined outpatient facility.
(2) Medical outpatient care facilities shall have access to newly built medical facilities by barrier-free horizontal roads, ramp or lift in accordance with specific regulations; 4) when placing a medical facility in existing premises where wheelchair access cannot be technically addressed, patients with reduced mobility must be provided with alternative care (visiting service, etc.).
(3) An outpatient care facility consists of:
(a) basic spaces, i.e. operating rooms where health care is provided (office, prepping or room where basic activity is carried out), and accessories for patients (waiting room, patient WC);
(b) secondary areas, i.e. sanitary facilities for staff, cleaning rooms and warehouses.
(4) The basic premises of outpatient care facilities shall be addressed as follows:
a) The office is dealt with either as one room, i.e. a common workplace for doctors and nurses, or as a doctor's office and a prep room in which the main workplace is a nurse. There shall be a direct door connection between the office and the office.
(b) The waiting room of patients must be directly connected to the preparation or surgery.
(c) the patient toilet shall have a hall equipped with a sink with running water or a washing machine with running water in the toilet cabin. For safety reasons, the toilet door shall be open outwards.
(5) The emergency care facilities may not be directly part of the essential rooms, but must be located in such a way that they are accessible. They can be common to multiple medical facilities outpatient care. The adjacent areas shall be addressed as follows:
(a) The sanitary facility for staff consists of a dressing room, a washroom and a toilet. If it is not possible to create a separate toilet for employees for technical reasons (e.g. when putting medical devices into flats), a common toilet for patients and employees may be allowed.
b) The cleaning chamber may be replaced by a cleaning cabinet.
c) The warehouse may be replaced by lockers.
(6) Outpatient care facilities, which also use narcotic and psychotropic substances in the provision of healthcare, must be equipped with a safe for compulsory storage (4a) of these substances.
2. Requirements for minimum areas of offices (professional workplaces) and their necessary medical equipment and furniture
A - Department of Medical Physician for Adults
| a) plochy provozních místností: | |
| ordinace | 15 m2 |
(b) equipment:
a table for doctors with two places for doctors and patients,
table with a minimum height of 60 cm with a flashlight and a mobile table,
optotypes and altimeter weight,
table for the administrative work of the nurse,
the working area for the preparation of medical material and an indicative laboratory examination,
a steriliser where there is no possibility of contractual supplies from central sterilisation or the supply of disposable material;
medicine cabinet and refrigerator and medical supplies,
sink,
wash basin,
Strip with seat and rack.
B - Department of a general practitioner for children and adolescents
| a) plochy provozních místností: | |
| ordinace | 15 m2 |
(b) equipment:
a table for doctors with two places for doctors and patients,
table with a minimum height of 60 cm with a flashlight and a mobile table,
a changing table with a weight for infants,
optotypes and altimeter weight,
table for the administrative work of the nurse,
the working area for the preparation of medical material and an indicative laboratory examination,
a steriliser where there is no possibility of contractual supplies from central sterilisation or the supply of disposable material;
medicine cabinet and refrigerator and medical supplies,
sink,
wash basin,
Strip with seat and rack.
C - The office of the female doctor
| a) plochy provozních místností: | |
| ordinace | 15 m2 |
(b) equipment:
a table for doctors with two places for doctors and patients,
a table with a minimum height of 60 cm with a lamp and a mobile table,
a table of examination for gynecological examinations with a scooter, a doctor's seat and a mobile sink,
Altimeter weight,
table for the administrative work of the nurse,
the working area for the preparation of medical material and an indicative laboratory examination,
a steriliser where there is no possibility of contractual supplies from central sterilisation or the supply of disposable material;
medicine cabinet and refrigerator and medical supplies,
sink,
wash basin,
Strip with seat and rack.
D - Dental doctor's office
| a) plochy provozních místností: ordinace5) | 15 m2 |
| místnost pro zubní rtg | 6 m2 |
| (nemusí být, je-li zajištěno jinak) | |
| temná komora | 2 m2 |
| (nezřizuje se, není-li rtg nebo je-li možnost automatizovaného vyvolávání filmů) | |
(b) equipment:
dental set with chair and accessories, flashlight, spittoon, compressed air supply and suction,
lockers for the storage of tools, aids and medicines,
the storage area for the instruments used,
the working space for the preparatory and administrative work of the nurse,
a steriliser where there is no possibility of contractual supplies from central sterilisation or the supply of disposable material;
sink,
wash basin,
a rtg dental device and a imaging device, unless it is possible to use rtg of another device.
E - Dentistry laboratory
| a) plochy provozních místností: laboratoř | 8 m2 |
(minimum area of laboratory for 1 permanent dental technician at a light height of 3,0 m; 5 m2 added to each additional workplace)
instrument room 13 m2 (only set up at the dental laboratory where metals are processed; is not a permanent workplace)
(b) equipment:
1. laboratory without metal processing
Dentist table with suction, drill and kane, independent for each working position of the dental technician,
work desk (polisher, grinder, polymer),
plaster table,
a digester,
sink,
wash basin,
2. metal processing laboratory
(a) laboratory
Dentist table with suction, drill and kane, independent for each working position of the dental technician,
a weighing table,
wash basin,
(b) Instrument Room
work desk (polisher, grinder, polymer),
plaster table,
digestor (cooker, furnace),
a casting machine,
sink,
(c) compressor with compressed air distribution (shall be located outside the laboratory for noise and vibration protection reasons).
F - Internal office
| a) plochy provozních místností: ordinace | 15 m2 |
(b) equipment:
a table for doctors with two places for doctors and patients,
a couchette or table of inquiry,
ecg (may not be in the case of subsets where ecg examination is not part of qualified standard care),
table for the administrative work of the nurse,
medicine cabinet and refrigerator and medical supplies,
tool cabinet,
an instrument table,
lamp,
a steriliser where there is no possibility of contractual supplies from central sterilisation or the supply of disposable material;
sink,
wash basin,
Strip with seat and rack.
G - Surgical surgery
(a) areas of operating rooms:
| ordinace | 15 m2 |
| sádrovna | 15 m2 |
| zákrokový sálek | 20 m2 |
| umývárna lékařů | 3 m2 |
| sterilizace | 5 m2 |
(gypsum and step room with accessories are not an essential part of the surgical office; they shall be established according to the expected range of services provided; The doctor's washroom may be part of the intervention hall)
(b) equipment:
1. surgery
a table for doctors with two places for doctors and patients,
a table of inquiry with steps, a lamp and a storage mobile table for tools and equipment,
table for the administrative work of the nurse,
the working area for the preparation of medical material,
instrument and medicinal cabinet,
a refrigerator for medicinal products,
a steriliser where there is no possibility of contractual supplies from central sterilisation or the supply of disposable material;
wall negatoscope,
sink,
medical sink,
a strip with a seat and a rack,
2nd gypsum
a table with two seating positions,
a table of inquiry with steps, a lamp and a storage mobile table for tools and equipment,
the working area for the preparation of medical material,
medical cabinet,
wall negatoscope,
sink,
seat and rack,
3. step hall
operating table with operating lamp,
tool table,
a small narcotic device with accessories and a seat,
3 detergents aseptic, stainless,
stand for sterilisation drums or table for sterile material,
an infusion bottle stand,
medical equipment cabinet,
waste container with insert,
an operating linen and gloves cabinet,
4. doctor's washroom
medical sink,
apron rack,
a galoshes stand,
used linen trolley,
cap and mouthpiece drum,
5. sterilisation
tool sterilizer,
medical equipment cabinet,
work plate with seat,
2 sinks,
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Regulation Information
| Citation | Decree of the Ministry of Health of the Czech Republic No. 49 / 1993 Coll., on technical and material requirements for medical equipment |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 22.01.1993 |
|---|---|
| Effective from | 22.01.1993 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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