GOST R EN 13060-2011
ГОСТ Р ЕН 13060-2011
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Small steam sterilizers
Стерилизаторы паровые малые
Status: Effective - Introduced for the first time
This standard specifies performance requirements and test methods for small steam sterilizers used for medical purposes or for materials for which there is the likelihood of contact with blood or body fluids. This standard applies to small steam sterilizers with automatic control, in which steam is generated using electric heaters or steam generated by an external system relative to the sterilizer is used. This standard applies to small steam sterilizers, mainly used for sterilizing medical devices that cannot accommodate a sterilization module (300 x 300 x 600 mm) and have a chamber with a volume of not more than 60 liters. This standard does not apply to small steam sterilizers used to sterilize liquids or pharmaceutical products. This standard does not define safety requirements related to hazards associated with the area in which the sterilizer is used (for example, flammable gases). This standard does not specify the requirements for verification and routine control of sterilization by means of moist heat.
Настоящий стандарт определяет требования к рабочим характеристикам и методам испытаний малых паровых стерилизаторов, используемых для медицинских целей или для материалов, для которых существует вероятность контакта с кровью или жидкостями организма. Настоящий стандарт распространяется на малые паровые стерилизаторы с автоматическим управлением, в которых пар вырабатывается с помощью электрических нагревателей или используется пар, генерируемый внешней относительно стерилизатора системой. Настоящий стандарт распространяется на малые паровые стерилизаторы, используемые главным образом для стерилизации медицинских изделий, не способные вместить стерилизационный модуль (300 х 300 х 600 мм) и имеющие камеру объемом не более 60 л. Настоящий стандарт не распространяется на малые паровые стерилизаторы, используемые для стерилизации жидкостей или фармацевтических продуктов. Настоящий стандарт не определяет требований техники безопасности, относящихся к опасностям, связанным с зоной, в которой используется стерилизатор (например, к легковоспламеняющимся газам). Настоящий стандарт не определяет требований к проверке и текущему контролю стерилизации посредством влажного тепла
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Format: Electronic (pdf/doc)
Approved: Federal Agency for Technical Regulation and Metrology,
9/22/2011
SKU: RUSS72873
The Product is Contained in the Following Classifiers:
PromExpert »
SECTION I. TECHNICAL REGULATION »
V Testing and control »
4 Testing and control of products »
4.13 Testing and control of products of engineering industry »
4.13.2 Machines and equipment for special purposes »
4.13.2.11 Equipment and instruments for medical industry »
ISO classifier »
11 HEALTH »
11.080 Sterilization and disinfection »
National standards »
11 HEALTH »
11.080 Sterilization and disinfection »
ISO classifier »
11 HEALTH »
11.080 Sterilization and disinfection »
11.080.01 Sterilization and disinfection in general »
National standards »
11 HEALTH »
11.080 Sterilization and disinfection »
11.080.01 Sterilization and disinfection in general »
National Standards for KGS (State Standards Classification) »
Latest edition »
R Health. Sanitation and hygiene items »
R2 Equipment and tools of medical institutions »
R26 Apparatus, accessories and equipment used for sterilization, distillation, disinfection and disinsection »
The Document References:
GOST 14254-96: Degrees of protection provided by enclosures (IP Code)
GOST R 50793-95: Hexagon head bolts with thread to head, product grades A and B. Specifications
GOST R 51350-99: Safety requirements for electrical equipment for measurement, control, and laboratory use. Part 1. General requirements
GOST R 51402-99: Noise of machine. Determination of power levels of noise sources using sound pressure. Survey method using an enveloping measurement surface over a reflecting plane
GOST R 51522-99: Electromagnetic compatibility of technical equipment. Electrical equipment for measurement, control and laboratory use. Requirements and test methods
GOST R 51935-2002: Steam large sterilizers. General technical requirements and test methods
GOST R IEC 61010-2-041-99: Safety requirements for electrical equipment for measurement, control and laboratory use. Part 2-041. Particular requirements for autoclaves using steam for the treatment of medical materials and for laboratory processes
GOST R ISO 11140-1-2000: Sterilization of health care products. Chemical indicators. Part 1. General requirements
GOST R ISO 13485-2004: Medical devices. Quality management systems. System requirements for regulatory purposes
GOST R ISO 18472-2009: Sterilization of health care products. Biological and Chemical indicators. Test equipment
The Document is Referenced By:
GOST R 56139-2014: Functional foods. Methods for detection and enumeration of probiotic microorganisms
GOST R 56201-2014: Functional food products. Methods for the determination of bifidogenic properties
GOST R 57989-2017: Specialized food products. Methods for the detection of foodborne pathogens based on polymerase chain reaction
MU 1.1.3545-18: Methods for the accelerated determination of Campylobacter bacteria in food products and evaluation of their antibiotic resistance
MU 3.5.1.3439-17: Evaluation of the sensitivity to disinfectants of microorganisms circulating in medical organizations
MUK 4.2.3143-13: Determination of the antibiotic activity of enzymes of microbial (bacterial and fungal) origin for use in the food industry
MUK 4.2.3248-14: Microbiological measurement of the concentration of the cells of the microorganism Rhodococcus jialingiae 1kp VKPM Ac-1957 in the air of the working area
MUK 4.2.3249-14: Microbiological measurement of the concentration of Rhodococcus jialingiae 1 kp VKPM Ac-1957 in the atmospheric air of populated areas. Methodical instructions
MUK 4.2.3250-14: Microbiological measurement of the concentration of Azotobacter chroococcum
MUK 4.2.3251-14: Microbiological measurement of the concentration of Azotobacter chrooccum BH-1811 VKPM B-9029 in the atmospheric air of populated areas. Methodical instructions
MUK 4.2.3252-14: Microbiological measurement of the concentration of Bacillus mucilaginosus Vas-10 VKPM B-8966 in the air of the working area
MUK 4.2.3253-14: Microbiological measurement of the concentration of Bacillus mucilaginosus Bac-10 VKPM-8966 in the atmospheric air of populated areas. Methodical instructions
MUK 4.2.3254-14: Microbiological measurement of the concentration of Lysinibacillus xylanilyticus 5 rb VKPM B-11685 in the working area air
MUK 4.2.3255-14: Microbiological measurement of the concentration of L. xylanilyticus 5 rb VKPM B-11685 in the atmospheric air of populated areas. Methodical instructions
MUK 4.2.3256-14: Microbiological measurement of the concentration of cells of the microorganism Yarrowia lipolytica 2kp VKPM Y-4043 in the air of the working area
MUK 4.2.3257-14: Microbiological measurement of the concentration of Yarrowia lipolytica 2kp VKPM Y-4043 in the atmospheric air of populated areas. Methodical instructions
MUK 4.2.3380-16: Microbiological measurement of concentration of Pseudomonas aureofaciens VKM-2391D in air of working area
MUK 4.2.3381-16: Microbiological measurement of concentration of Pseudomonas aureofaciens VKM-2391D in atmospheric air of populated areas
MUK 4.2.3382-16: Microbiological measurement of concentration of strain Bacillus amyloliquefaciens OPS-32 in air of working area
MUK 4.2.3383-16: Microbiological measurement of concentration of strain Bacillus amyloliquefaciens OPS-32 in atmospheric air of populated areas
MUK 4.2.3384-16: Microbiological measurement of concentration of Komagataella (Pichia) pastoris VKPM Y-4225 in air of working area
MUK 4.2.3385-16: Microbiological measurement of concentration of Komagataella (Pichia) pastoris VKPM Y-4225 in air of working area
MUK 4.2.3433-17: Microbiological measurement of concentration of Beijerinckia fluminensis Bf 2806 VKPM B-12258 in air of working area
MUK 4.2.3434-17: Microbiological measurement of concentration of Beijerinckia fluminensis Bf 2806 VKPM B-12258 in atmospheric air of populated areas
MUK 4.2.3435-17: Microbiological measurement of the concentration of Paenibacillus mucilaginosus Pm 2906 VKPM B-12259 in the air of the working area
MUK 4.2.3436-17: Microbiological measurement of concentration of Paenibacillus mucilaginosus Pm 2906 VKPM B-12259 in atmospheric air of populated areas
MUK 4.2.3437-17: Microbiological concentration measurement of Trichoderma asperellum OPF-19 in air of working area
MUK 4.2.3438-17: Microbiological measurement of Trichoderma asperellum OPF-19 concentration in atmospheric air of populated areas.
MUK 4.2.3526-18: Method for microbiological measurement of the concentration of Bacillus thuringiensis ssp. toumanoffi 25 in the air of the working area
MUK 4.2.3527-18: Method for microbiological measurement of the concentration of Bacillus thuringiensis ssp. toumanoffi 25 in the atmospheric air of populated areas
MUK 4.2.3528-18: Method for microbiological measurement of the concentration of Corynebacterium glutamicum H150 (Brevibacterium flavum) VKPM B-12692 in the air of the working area
MUK 4.2.3529-18: Method of microbiological measurement of Corynebacterium glutamicum (Brevibacterium flavum) H150 VKPM B-12692 in the atmospheric air of populated areas
MUK 4.2.3530-18: Method of microbiological measurement of the concentration of Beauveria bassiana ORV-43 in the air of the working area
MUK 4.2.3531-18: Method of microbiological measurement of the concentration of Beauveria bassiana ORV-43 in the atmospheric air of populated areas
MUK 4.2.3566-19: Method of microbiological measurement of the concentration of Komagataella (Pichia) pastoris BRC VKPM Y-4394 in the atmospheric air of urban and rural settlements
MUK 4.2.3567-19: Method of microbiological measurement of the concentration of Komagataella (Pichia) pastoris BRTs VKPM Y-4394 in the air of the working area
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