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GOST R 51935-2002

ГОСТ Р 51935-2002

Steam large sterilizers. General technical requirements and test methods

Стерилизаторы паровые большие. Общие технические требования и методы испытаний

Status: Not effective - Canceled. Registration information 657-st dated 11/01/2012 (official site of Rosstandart)

This standard establishes the general technical requirements for large steam sterilizers and determines their test methods. Large steam sterilizers can be used in healthcare and in the industrial production of medical devices. This standard does not apply to small steam sterilizers, steam sterilizers used to sterilize pharmaceutical solutions, and fire heated sterilizers.

Настоящий стандарт устанавливает общие технические требования к большим паровым стерилизаторам и определяет методы их испытаний. Большие паровые стерилизаторы могут быть использованы в здравоохранении и при промышленном производстве медицинских изделий. Настоящий стандарт неприменим к малым паровым стерилизаторам, к паровым стерилизаторам, используемым для стерилизации фармацевтических растворов, и к стерилизаторам с огневым нагревом

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Format: Electronic (pdf/doc)

Approved: Gosstandart of Russia, 9/6/2002

SKU: RUSS72868

Price: $693.00



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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 » 11.080.10 Equipment for sterilization »

National standards » 11 HEALTH » 11.080 Sterilization and disinfection » 11.080.10 Equipment for sterilization »

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 12.2.085-82: Vessels working under pressure. Safety valves. Safety requirements

GOST 23941-2002: Noise of machines. Methods for determination of noise characteristics. General requirements

GOST 24569-81: Occupational safety standards system. Steam and hot-water boilers. Marking

GOST 29322-92: Standard voltages

GOST 6651-94: Thermal converters of resistance. General technical requirements and test methods

GOST R 50267.0.2-2005: Medical electrical equipment. Part 1-2. General requirements for safety. Electromagnetic compatibility. Requirements and test methods

GOST R 51318.14.1-99: Electromagnetic compatibility of technical equipment. Radio disturbance from household appliances, electric tools and similar apparatus. Limits and test methods

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 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 13683-2000: Sterilization of health care products. Requirements for validation and routine control of moist heat sterilization in health care facilities

The Document is Referenced By:

GOST 10444.1-84: Canned food. Preparation of reagent solutions, dyes, indicators and culture media for microbiological analysis

GOST 12044-93: Agricultural seeds. Methods for determination of disease infestation

GOST 23454-79: Milk. Methods for determination of the inhibitors

GOST 26972-86: Corn, flour, grouts and oatmeal for children's food. Methods of microbiological analysis

GOST 27543-87: Confectionery. Equipment, materials, reagents and culture media for microbiological analyses

GOST 27930-88: Milk and milk products. Biological-calorimetric method for determination of the total bacteria number

GOST 30360-96: Seeds of essential oil crops. Methods for determination of disease infestation

GOST 30705-2000: Infant milk products. Method for determination of the total amount of mesophilic aerobic and elective anaerobic bacteria

GOST R 51577-2000: Liquid oral hygiene products. General specifications

GOST R 51632-2000: Technical aids for disabled persons. General technical requirements and test methods

GOST R 52687-2006: Fermented-milk product, enriched with bifidum bifidobacteria. Specifications

GOST R 52711-2007: Manufacturing of juice products. Microbiological control methods using special microbiological nutrient media

GOST R 54354-2011: Meat and meat products. General requirements and methods of microbiological testing

GOST R 54653-2011: Organic fertilizers. Methods of microbiological analysis

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 EN 13060-2011: Small steam sterilizers

GOST R ISO 11140-1-2009: Sterilization of health care products. Chemical indicators. Part 1. General requirements

GOST R ISO 11140-3-2007: Sterilization of care products. Chemical indicators. Part 3. Class 2 indicators for steam penetration test sheets

Methodical Recommendations FC/4022: Methods of microbiological control of soil. Methodical Recommendations.

MR 11-3/278-09: Methods for detecting bacteria of the genus Salmonella in food using the Vidas / miniVidas analyzer manufactured by BioMerieux, France

MU 3.5.1.3439-17: Evaluation of the sensitivity to disinfectants of microorganisms circulating in medical organizations

MUK 4.2.1990-05: Control of air removal in steam sterilization chambers

MUK 4.2.2884-11: Methods of microbiological control of environmental objects and food products using petrilar

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

TU 9462-001-53908805-2006: Glass syringe filling ampoules for medicines

TU 9462-001-84299122-2010: Ampoules medical colorless and brown from glass of the 1st hydrolytic class

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