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          Standardized management of the central sterile supply

          Standardized management of the central sterile supply

          (fourth draft) in 2006 July 15~17 conference modification

          Chapter I General Provisions

          Article 1 in order to strengthen the central sterile supply medical institutionsmanagement, iatrogenic transmission of disease prevention and control, ensure medical safety, according to the "management approach" hospital infection, the enactment of this specification.

          Article second of this code is applicable to the territory of the people's Republic ofmedical institutions above the county level.

          Third medical institutions should be in accordance with the centralized management mode, all of the repeated use and the need for cleaning and disinfection, sterilization of medical instruments, appliances, articles by the central sterile supply and supply. Encourage conditional medical sterilization and supplyservices to provide basic medical institutions near. Disinfection supply center of medical institutions to provide disinfection and supply service for other medical institutions, must be approved by the administrative department of health, district.

          Construction of the central sterile supply fourth medical institutions should be itsscale, tasks and development planning to adapt, the work of sterilization supplymanagement as an important part of medical quality management, ensure medical safety.

          Disinfection of central sterile supply fifth medical institutions must comply with the"basic requirements" and "measures for the administration of hospital infectiondisinfection management measures". Where the need for disinfection, sterilization of medical instruments, equipment and articles must first wash and disinfection or sterilization. Special infectious diseases (tetanus, anthrax, prion etc.)contaminated equipment shall implement special procedures and processes.

          Sterilization and supply center in sixth medical institutions above the county levelmust meet the requirements of this specification.

          Chapter second basic requirements

          The first section personnel requirements

          Seventh medical institutions should be based on the disinfection supply workload and the post demand, scientific, reasonable allocation of nurse, disinfection staffand technical workers and staff.

          All personnel engaged in the work of sterilization supply must be approved by therelevant job training, to master the knowledge of prevention and control of all kinds of diagnosis and treatment of infection equipment cleaning, disinfection andpersonal protection Hospital; should follow the standard prevention principle,strictly abide by the relevant rules and regulations.

          Second buildings and facilities requirements

          Article eighth disinfection supply center building should be based on the principle of hospital infection prevention and control in accordance with the following requirements:

          One, clean, no pollution, regional environment is relatively independent; adjacentclinical departments, to receive, send; should not be located in the basement andhalf basement ventilation, daylighting is good.

          Two, the architectural design should conform to the requirements of hospital construction standards, and should be considered to meet the needs of the futuredevelopment of function, task.

          Three, the layout of the building should be divided into office area and work area.The working area is divided into storage decontamination area, check the packaging, sterilization items, three division clear, area should actual barrier,decontamination area and check the packaging area set up access buffer (band)and goods channel.

          Article ninth of sterilization and supply center of regional function should meet the following requirements:

          A, graphic design in favor of sterilization and supply center to achieve "sewage toclean" work flow. There shall be no cleaning cross or goods return;decontamination area of main pollution materials recovery and classification,cleaning, accept delivery under the vehicle, plastic box washing disinfection work;

          Dressing inspection and packaging, inspection and packaging area mainly forgoods production, sterilization and other work; storage and distributed storage area mainly sterilization sterilization items.

          Two, office area set the staff locker room, duty room, office, bathroom etc..

          Three, washing facilities shall be in accordance with the "medical staff handhygiene norms". Sterile goods storage area is not appropriate for the sink. Notmop pool logistics route; floor drain should adopt anti-overflow type, the seweroutlet should take prevention measures; sewage should be concentrated into thehospital sewage treatment station.

          Four, the ceiling, the walls should be smooth and seamless, easy to clean and disinfect; corner should adopt arc-shaped design to reduce dead. The ground should be non-slip, easy cleaning, corrosion resistance of. A power socket withbuilt-in waterproof safety.

          Tenth regional air to flow from clean to dirty, temperature is 20 ℃ ~ 25 ℃, relative humidity should not store check the packaging area and sterilized articles is greater than 60%. Lighting facilities should meet the needs of equipment inspection etc..

          Eleventh medical institutions should be based on the size, mission, disinfection and supply type and reasonable configuration workload of cleaning and disinfection equipment and facilities.

          One, the cleaning and disinfection of equipment and facilities: equipped with Wurecovery vehicle and classification table, mechanical cleaning and disinfectionequipment, manual cleaning trough and the corresponding cleaning supplies,pressure water gun, pressure gun, ultrasonic cleaning machine, dryer, the vehicle cleaning device. Cleaning and disinfection equipment shall be in accordance with the relevant provisions of the state.

          Two, inspection, packaging equipment: equipped with auxiliary lighting device and lighting magnifying equipment inspection table, dressing and device packagingmachine, instrument cabinet, dressing cabinet, packaging materials andmachine, sealing machine and cleaning items loader cutting.

          Three, sterilization equipment and facilities: equipped with pressure steam sterilizer, aseptic goods unloading car basket, etc.. According to the need to be equipped with dry heat sterilization and cold sterilization device. All kinds ofsterilizer shall comply with the national standard, and is provided with asupporting auxiliary equipment.

          Four, storage, distribution facilities; sterilized goods storage shelf and send a car.

          Five, according to the work need to be equipped with personal protective suppliescorresponding, including goggles, masks, masks, hats, gloves, rainwear (apron)and protective shoes.

          Third sections of material

          All materials used in disinfection supply center includes a cleaning agent,washing water, lubricants, disinfectant, packaging materials (special packing materials containing rigid containers, etc.), monitor material, should be in accordance with the relevant national requirements.

          Twelfth clean agent requirements: according to the bubble cleaner without equipment material, pollutant types to choose suitable, minimize the method of cleaning by physical friction.

          An alkaline cleaning agent, pH value is more than 7.5, to deal with all kinds oforganic matter removal effect better, corrosive to metal articles, not speed up the return of rust phenomenon.

          Two, cleaning agent pH value of 6.5 ~ 7.5, no corrosion to metal.

          Three, acid cleaning agent pH ≤ 6.5, dissolved place to inorganic solid particles,corrosive to metal articles.

          Four, multienzyme by adding a variety of enzyme in detergent, strongdecontamination ability, rapid decomposition of protein and fat and other organicpollutants; has the antirust function, and cleaning agents and medical equipmenthas good compatibility.

          Article thirteenth the washing water requirements: due to cold and hot watersupply, water shall be in accordance with the people's Republic of China national standard GB5749 85 "drinking water health standards"; should be equipped withsoftened water, deionized water or distilled water, the water quality standards should be consistent with the Chinese national laboratory grade three standardrooms with standard GB6682 - 92, conductivity less than 5 μ s/cm (25 )

          Chemical index every year deal with the washing water to detect, determine whether it meets the softened water and deionized water or distilled water standards.

          Article fourteenth requirements: lubricant should be water-soluble, composition accords with the requirements of Pharmacopoeia, have better compatibility withhuman tissue. Will not damage the metal material permeability, mechanical and other properties. Having a surface tension is very low, surface activity, highhydrophobicity and better resistance to shear performance.

          A, paper packaging materials: conform to "GB/T-19633 2005 packaging for terminally sterilized medical devices" requirements.

          Two, cotton packing material: should not bleached cotton yarn for '120, first before use should be high temperature washing, degreasing to plasma treatment,frequency of use shall not exceed 50 times; no damage, no sewing use.

          Three, non-woven packaging materials: for textile fiber and / or non-woven fiberconnection net, not including mineral fiber. The microbial resistance to waterbarrier, sex, compatible with human tissue, breathable, resistant to salt, surfaceabsorption, toxicology tests, the maximum equivalent aperture, drape, tensile strength, wet tensile strength and bursting strength should be consistent with the relevant provisions of the state, and for medical use, should be a one-time use.

          Four, paper-plastic packaging materials:

          The 1 paper should be consistent with the requirements of paper packaging materials.

          2 plastic film: with two layers or multilayer co-extrusion, may not use the toxicmaterial, plastic film can not appear defect pinhole, must not have any foreign body, and comply with the relevant provisions of the package

          Article fifteenth the requirements of packaging materials

          A, paper packaging materials: conform to "GB/T-19633 2005 packaging for terminally sterilized medical devices" requirements.

          Two, cotton packing material: should not bleached cotton yarn for '120, first before use should be high temperature washing, degreasing to plasma treatment,frequency of use shall not exceed 50 times; no damage, no sewing use.

          Three, non-woven packaging materials: for textile fiber and / or non-woven fiberconnection net, not including mineral fiber. The microbial resistance to waterbarrier, sex, compatible with human tissue, breathable, resistant to salt, surfaceabsorption, toxicology tests, the maximum equivalent aperture, drape, tensile strength, wet tensile strength and bursting strength should be consistent with the relevant provisions of the state, and for medical use, should be a one-time use.

          Four, paper-plastic packaging materials:

          The 1 paper should be consistent with the requirements of paper packaging materials.

          2 plastic film: with two layers or multilayer co-extrusion, may not use the toxicmaterial, plastic film can not appear defect pinhole, must not have any foreign body, and comply with the relevant provisions of the package

          Five, closed rigid container requirements

          Closed rigid container materials, design, structure and surface should be cleaned and sterilized for internal and external, all angles should be a circular arc. Rigid containers or parts of the material should not be used with electrostatic inductionmaterial. Rigid containers shall be designed and manufactured into security stackloading form, into the sterilizer, in rigid containers between the steam and / or free air circulation. Deformation of rigid containers not permanent, performance parameter does not change, the sealing performance to meet the relevant requirements.

          Six, non closed rigid container requirements: in addition to and seal the content is not required, the rest should be consistent with the closed rigid container requirements.

          Sixteenth monitoring the material requirements: monitoring material should be the Ministry of health disinfection products, hygiene license documents, used within the period of validity. The self-made test standard should be consistent with therelevant requirements of package "disinfection technical specifications".

          The third chapter management and responsibility

          Article seventeenth of sterilization and supply center management involves many departments, the quality of its work directly influence the medical quality and medical safety. Medical institutions should be cleaning, disinfection, sterilization and supply center of sterilization quality control in hospital infection management,the relevant departments in the dean and hospital infection management committee under the leadership of perform the following duties:

          1. Responsible for the sterilization and supply center disinfection, sterilizationsupplies, its responsibilities:

          1, establish and improve the system, operating procedures, quality control measures, and the concrete implementation, ensuring the safe use of medicalsupplies;

          2 was involved in the purchase of medical equipment, disposable medical supplies, quality acceptance of clean dressing, regular medical supplies, the quality analysis of consumables, and put forward opinions and suggestions for improvement:

          3 to establish quality traceability system: found the problem, timely investigationand improvement, ensure timely, safe supply of goods;

          4 the implementation of staff training, improve the quality of personnel;

          5 closely with the department contact, understand each department professional characteristics, infection and its reasons, common hospital equipment, special requirements of products processing and opinions;

          6 Master suddenly without water, power outages, equipment failure and accidentemergency measures. Proficiency in the safe operation of the technology, thedangerous occupation exposure factors countermeasures;

          7 responsible for cleaning, disinfection, sterilization equipment daily maintenance,and set up equipment files, complete preservation of relevant information.

          Two. The nursing management department shall perform the following duties in the management of sterilization and supply center:

          1 responsible for the management of sterilization and supply center, and itsperformance in the nursing management;

          2 regular organization of sterilization and supply center guide, quality supervisionand evaluation;

          3 according to the rational allocation of workload and allocation of sterilization and supply center staff: the staff of sterilization and supply center of sterilization supplyprofessional knowledge training system, will continue its education into theeducation planning, and their learning, communication conditions;

          4 according to the requirements of this code, reconstruction of sterilization and supply center, expansion and new, put forward constructive views:

          5 coordinate with logistics, equipment and other related departments, to ensure material supply disinfection supply center and normal operation:

          6 from iatrogenic infection caused by medical instruments, with the Department of nosocomial infection management of survey and control.

          Three. The equipment management department shall perform the following duties in the management of sterilization and supply center:

          Regular maintenance and repair of 1 personnel responsible for the equipment of disinfection supply center, set up equipment maintenance records, guarantee normal running of equipments; found the problem, and actively take emergencymeasures;

          2 responsible for the purchase of the equipment audit (certification, technical parameters), fit the work equipment; the establishment of the factory equipment maintenance quality audit system;

          3 on the equipment used, the anomaly judgment and maintenance training and guidance to the staff of sterilization and supply center organization method, make the equipment manual and equipment processing guidelines when exception;

          4 pairs of disposable sterile medical articles, dressing the procurement of raw materials strictly implement the relevant provisions, to ensure the quality ofpurchased materials.

          Four. The logistics department shall perform the following duties in themanagement of sterilization and supply center:

          1 sterilization and supply center in new construction, renovation and expansion,the architectural design must comply with the relevant laws, regulations and these rules, it shall seek the relevant departments and the sterilization and supply centerstaff views;

          2 ensure the disinfection supply center of water, electricity, compressed air andsteam supply and quality, regular facilities, maintenance and repair work pipeline;

          3 to provide sterilization and supply center in the normal work of the materialconditions, and do a good repair and complement.

          Five. Department of nosocomial infection management shall perform the following duties in the management of sterilization and supply center:

          1 according to the characteristics and the central sterile supply work and relatedprofessional / post situation, prevention and control of hospital infectionknowledge training;

          2 of sterilization and supply center for cleaning, disinfection, sterilization ofguidance and supervision work and quality monitoring, periodic inspection and evaluation;

          3 organization, coordination of sterilization and supply center and related departments of medical apparatus and instruments iatrogenic infections caused by investigation and analysis, put forward the improvement measures;

          4 of sterilization and supply center new construction, reconstruction andexpansion of the hygienic design review; the cleaning, put forward opinions andindicators of the quality of disinfection and sterilization equipment.

          Article eighteenth of sterilization and supply center shall establish and perfectrules and regulations, including the work of management, monitoring, disinfection and isolation, occupation protection instruments and equipment management,emergency plan, recording and tracking system and emergency quality control process, and earnestly implement.

          The fourth chapter training

          The nineteenth set of sterilization and supply center staff training system, the new staff trained and qualified rear can mount guard; the people's Republic of Chinaspecial equipment operating personnel of pressure steam sterilization equipmentoperating personnel must also be made of the quality supervision department issued the "". Now personnel should installment accepted job training.

          A Ministry of Health established by the hospital management, hospital infection management, nursing management, supply management, clinical microbiology,disease control, hospital architecture, composed of experts quality supervision departments and disinfection and sterilization equipment of disinfection supplypost training expert advisory group, establishing practical training base, andperform the following duties:

          1 develop training standards, disinfection and supply the on-the-job training program, training materials, training base and training assessment standards,and supply the progress of the work according to the domestic and foreign,continuous improvement.

          For more than 2 local teachers and provincial medical institutions disinfectionsupply center management personnel with professional theory and practicaltraining;

          3 for the post of sterilization and supply center to provide guidance and counselingtraining;

          4 related information provides the specification and implementation of job training.

          Two. The province, autonomous region, municipality directly under the central government, the health administrative departments at the provincial (including autonomous regions, municipalities directly under the central government, the same below) to set up a training group of disinfection supply position of Hospital Infection Management Advisory Committee of experts, establish training bases,and perform the following duties;

          1 according to the specification and relevant national policies, training thedisinfection supply post formulate implementation plans;

          The 2 bear medical institutions disinfection supply of job training in this area;

          Provide guidance and consultation to the area around 3 disinfection supply of job training;

          4 related information provides the specification and implementation of job training.

          Three. All team members and the state of disinfection and supply base of teachertraining base training.

          Four. In a convenient, economical, practical principles, encouraging the adoption of network training.

          Article twentieth of sterilization and supply center staff and training base ofteachers should participate in the disinfection and supply relevant knowledge,continuing education courses and academic exchange activities; disinfection supply center managers and base of teacher training each year not less than 20 hours, other working personnel of not less than 8 hours.

          The fifth chapter of sterilization and supply the technical operation procedure

          Twenty-first equipment cleaning, disinfection / sterilization should follow therecycling, classification, cleaning, disinfection, inspection, packaging, sterilization,storage and distribution of the basic work flow.

          Recovery of twenty-second contaminated instruments and articles:

          Departments should be promptly removed. Use after pollution equipment obviousdirt, prevent dry, closed temporarily, as soon as possible by the disinfection supply center processing.

          The instruments and articles in special infectious diseases should be put in thepollution prevention device pollution diffusion, and indicate the type of infectiondiseases.

          Two. The recovery of contaminated equipment

          1 disinfection supply center staff time to the departments to use collection after the use of the equipment, goods, recovery using closed recovery vehicle or collecting box, in accordance with the provisions of the route, closed transport;

          Contaminated instruments, 2 recovered items, should be timely check, check and record, decontamination treatment as soon as possible; to avoid the use ofdepartment inventory. Instruments Verification of pollution, reduce the probability ofcross contamination;

          Disposable sterile items such as medical waste 3 after use, shall not be allowed to enter the central sterile supply recovery and operation treatment;

          4 recovery vehicle or collecting box after each use should be clean and disinfect,drying and storage.

          Twenty-third instruments, cleaning items, including classification, detergent soak,cleaning, rinsing and drying.

          A classification according to different material, equipment shape, precision and the degree of pollution classification.

          Two. According to the equipment types and properties, using different methods of cleaning, manual cleaning, mechanical cleaning.

          Heat-resistant, resistant to equipment and material wet appropriate uses mechanical cleaning method.

          Precision, complex instruments should first manual cleaning, then themechanical cleaning or hand wash.

          (a) the preliminary processing, manual cleaning is suitable for serious pollution of the precision, complex equipment and can not be used in mechanical cleaningprocessing equipment.

          Operation manual cleaning includes preliminary washing, detergent soak, scrub(ultrasonic cleaning, rinsing and drying).

          Serious pollution or organic dry preliminary processing solid device comprises the steps of cleaning agent for washing (wash), and then, by mechanical cleaning methods.

          Precision, cleaning method of complex instruments including washing, detergentsoak, wash (brushing), the mechanical cleaning methods.

          Matters needing attention:

          Personal protective 1 staff in accordance with the provisions.

          The use of special equipment cleaning tank 2 cleaning, special enzyme cleanerand special brush or sponge, after disinfection.

          3 manual cleaning process should be fully open device coupling, combination instrument complex should be opened.

          4 in the flow of water for washing, to wash in the washing liquid, prevent the generation of aerosols.

          (two) the mechanical cleaning: including the ultrasonic cleaning, spray cleaning,cleaning is suitable for most devices. Device operation according to the manufacturer's instructions.

          1 ultrasonic cleaning method: suitable for metal instruments, glass and otherhard materials equipment, not suitable for rubber and plastic material equipmentcleaning.

          2 spray cleaning methods: the procedure includes the initial cleaning, washing,rinsing and disinfection (lubrication), suitable for metal, plastic, rubber, glass,cleaning and disinfection of latex and other types of material equipment.

          Automatic cleaning machine for cleaning method: 3 ultrasonic spray from a singleclass or 4~5 cleaning tank in series, cleaning procedures including cleaning,ultrasonic wash, rinse or to the final rinsing, sterilizing, drying, cleaning and disinfection temperature and spray cleaning machine.

          4 note:

          (1) according to the ultrasonic cleaning water pollution situation timely replacement.

          (2) there is rust equipment must first rust, then the mechanical cleaning.

          (3) device coupling must be fully open, container, tube and placed in a specialwash rack cleaning. Must contact the water surface and the lumen devices.

          (4) cleaning equipment warehouse or sink after use must be cleaned every day.

          (5) weekly inspection automatically added cleaning agents pipe is smooth,accurate control of cleaning agent.

          (6) with power supply equipment shall not be used for cleaning method, can bestained with cleaner gauze or sponge to clean.

          Cleaning and maintenance of twenty-fourth devices should choose special cleaning equipment agent and lubricant, its use and operation should be carried out in accordance with product instructions for use, the use of principle:

          1. According to the species and material equipment selection of alkaline, neutral,acidic, enzyme cleaning agents and lubricants.

          Two. The cleaning and disinfection of equipment should use liquid detergent, do not use abrasive products such as detergent and other cleaning.

          Three. Different cleaning agent shall not be mixed use.

          Four. The equipment can not plastic and aluminum materials using acidic cleaning agents and lubricants.

          Twenty-fifth principles should be based on water cleaning method andprocedures for the use of the water of different water quality, including water,softened water, deionized water or distilled water.

          A mechanical cleaning should be used to soften water, the final rinse and disinfection using deionized water.

          Two. Heat sterilization using deionized water or distilled water.

          Three. The final rinse manual cleaning using deionized water or distilled water.

          Twenty-sixth instruments, disinfection

          A cleaning and disinfection using thermal machine cleaning and disinfection, thedisinfection temperature should be:

          , low risk items and equipment: 90 degrees Celsius over one minute or A0>600;

          Items and equipment of high risk: 90 degrees 5 minutes or A0>3000.

          Two. Do not use heat cleaning and disinfecting machine equipment, goods after cleaning by physical (heat) disinfection disinfection method.

          The twenty-seventh instrument disinfection process in deionized water or distilled water to add special water-soluble instrument lubricant, cannot use paraffin oil,water insoluble oils solvent for equipment maintenance and lubrication.

          Twenty-eighth cleaning, equipment and material after disinfection by method ofdrying:

          A mechanical drying: temperature 70 degrees ~90 degrees celsius. Generalmetal instruments for 15~20 minutes, plastic equipment such as ventilator pipe,30~40 minutes.

          Two. Not suitable for high temperature drying equipment, available clean gauzewipe dry or use 95% alcohol wipe dry.

          Three. All kinds of equipment prohibited the use of method of placing the natural drying in the air.

          Article twenty-ninth inspection and packaging after cleaning, disinfection, dryingequipment, goods, check in check the packaging, packaging sterilization.

          A cleaning quality inspection visual inspection or use a magnifying glass check,after cleaning the equipment should be smooth, no residue, no stains, stains and scale, the instrument surface including joint, etc. shall not have stains teeth.Unqualified equipment should be returned to the processing.

          Two. The equipment function check equipment functional integrity, flexibility,occlusion, edge devices, needle sharp degree etc..

          Three. With the display assembly kit:

          The 1 set, basin, bowl ware items, should be the individual packaging, packagingshould open the lid, if it must be more items are packaged together, opening all the utensils should be directed toward the same direction; stacked, ware spacedwith absorbent towels, gauze or medical absorbent paper, in order to steam.Penetration.

          2 need to be disassembled must be disassembled, syringe needle bolt, must be separated; scissors and forceps and coupling devices must be opened; lumengoods around the place, can not be discounted, joint switch should be open, to maintain patency of the lumen, and sterilization factor all contact surfaces.

          3 set weight not exceeding 7 kg, dressing bag weight not exceeding 5 kg. Goods packaging volume exhaust pressure steam sterilizer shall not be more than 30CM* 30CM * 25CM; vacuum and pressure steam sterilizer goods packaging volumeshall not be more than 30CM * 30CM * 50CM.

          Four. The device packaging:

          The species and quantity of 1 check instrument.

          2 cloth layers shall not be less than two.

          3 the use of packaging materials shall conform to the packing material requirements.

          4 note:

          (1) rigid containers (Cassette) must be a cleaning, cleaning method and cleaning equipment; using filter paper should be a replacement.

          (2) disposable plastic packaging materials, sealing width should be greater than 6MM, which ensure the heat sealing tight integrity.

          (3) sharp should add protection sleeve.

          Five sterile packet identification:

          1 sterilization bags must be packed tight binding, moderate, the use of topicalchemical instructions tape sealing.

          2 sterilization package shall be marked with product name, sterilization date,expiration date, codenamed operation personnel, sterilization pot, pot, etc..

          Loading thirtieth sterilized articles

          A. Loading: exhaust, loading capacity of vacuum pressure steam sterilizer cabinetchamber volume should not exceed 80% and 90%, loading capacity of vacuumand the pulsation vacuum pressure steam sterilizer which shall not be less than the cabinet chamber volume 10% and 5%, in order to prevent "small volumeeffect".

          Two. Try similar items will be the same pot sterilization; different items with potsterilization, textile items should be placed in the upper layer, metal equipmentitems are placed in the lower.

          Three. Articles do not pile up at the time of loading, should use special sterilizationframe or basket; all kinds of items should be placed according to requirements,equipment package Yingping, basin dish items should be inclined or inverted,textile items should be placed vertically, and automatic opening and closing the mesh containers should be flat, glass bottle bottom without holes vessel itemsshould be inverted or side; sterilizing package container opening should be consistent, in order to facilitate the steam entry and air discharge; should be a certain distance between sterilization package (greater than or equal to 2.5CM), in order to facilitate the replacement of steam air; inner wall and door items can notcontact sterilizer, in order to prevent inhalation of condensed water.

          Four. The use of exhaust sterilizer, big bag upper, lower small bag.

          Five. Loading paper-plastic packaging should be consistent with thecorresponding sterilizer (including pressure steam sterilizer, epoxy ethane sterilizer, hydrogen peroxide plasma sterilization and low formaldehyde sterilizersetc.) for loading requirements of instructions.

          Six. Record sterilized goods type, quantity, sterilizer number, cooker, sterilization,sterilization temperature, sterilization, sterilization time, operators and archiving.

          Article thirty-first sterilization should be based on equipment, materials use,selection of suitable properties of sterilization.

          The pressure steam sterilization.

          1 Classification according to the degree of cold air and discharge divided intopressure steam sterilizer and vacuum pressure steam sterilizer.

          2 Scope applicable to high temperature resistant, not afraid of wet sterilization ofmedical equipment and goods, cannot be used for sterilization of vaseline oil andpowder.

          3 sterilization operation method should follow the product operation manual.

          Sterilization of 4 fast pressure steam sterilizer is suitable for small, emergencygoods; not suitable for selection of such equipment for routine sterilization. Fast pressure steam sterilization can be divided into the exhaust, vacuum andpressurized exhaust. Specific operation method should follow the productoperation manual. The general disinfection requirements sterilization itemsexposed; remove items should be used.

          Two. Dry heat sterilization

          1 Scope applicable to not resistant to heat, sterilization, steam or gas cannot penetrate the articles such as glass, grease, sterile powder and metal products.

          2 sterilization operation method of sterilization temperature and time were: 160degrees Celsius, 170 degrees Celsius, 2H; 1H; 180 degrees Celsius, 30MIN. And in strict accordance with the product operation manual.

          3 note:

          (1) the glassware before sterilization should be dry.

          (2) should choose packaging materials for heat conduction.

          (3) sterilization items not with the sterilizer and the inner wall of the cavity bottomcontact.

          (4) goods packaging shoulds not be too big, not more than 10CM * 10CM * 20CM,placing items can not be more than 2/3 of the height of the sterilizer, allow sufficient space should be between articles.

          (5) oil, powder thickness of not more than 0.635CM, vaseline gauze stripthickness of not more than 1.3CM.

          (6) the temperature is above 170 degrees Celsius, organic matter can becarbonized, organic sterilization, the temperature is not too high.

          (7) after sterilization to when the temperature dropped to 40 degrees below can be opened.

          (8) sterilization time should achieve sterilization temperature after the beginning of the calculation.

          Ethylene oxide sterilization three.

          1 scope of application of ethylene oxide sterilization items of damage to light,strong penetrating power, suitable for electronic equipment, optical instruments,medical instruments, endoscopic. The dialyzer, not heat, sterilization of medical articles not resistant to wet.

          2 sterilization operation method of ethylene oxide sterilization must be carried out in a special period of ethylene oxide sterilizer. The specific methods of operationshould be strictly according to the operation manual.

          3 note:

          (1) sterilization objects cannot have too much water or water, so as not to affect theeffect of sterilization.

          (2) to load the goods should use the metal basket or metal frame, and a gap is reserved between items, sterilization items can not contact the wall. The loadingamount can not exceed the total volume of the 80%.

          (3) packaging materials should be used in medical crepe paper, paper plastic compound bag, ventilation type rigid containers etc..

          (4) pay attention to fire prevention using ethylene oxide sterilization, ventilation.

          (5) after sterilization items within the residual ethylene oxide should not exceed the relevant provisions of the state.

          (6) epoxy ethane is not applicable to the food, liquid, sterilizing grease andpowder.

          (7) monitoring for epoxy ethane concentration every year deal with sterilization environment.

          Four hydrogen peroxide plasma sterilization.

          1 suitable for thermolabile, not wet the sterilization of medical instruments, such as various endoscopic instruments, metal, glass and ceramic productssterilization. Not be used to sterilize the implant.

          2 hydrogen peroxide gas plasma sterilization sterilization method of operationmust be carried out in the hydrogen peroxide plasma sterilizer special, specific methods of operation should be strictly in accordance with the operation manual.

          3 note:

          (1) sterilization items must be fully dry, special packing materials and containers.

          (2) a plant fiber material can not be sterilized articles, including paper, sponge,cotton, wood, oil, powder etc..

          (3) stainless steel tube length is less than or equal to 500MM, diameter greater than or equal to 1MM; polyethylene and polytetrafluoroethylene material length is less than or equal to 2M, diameter greater than or equal to 1MM. When the articlelength 1M~2M, diameter 1MM~5MM, requiring the use of reinforcing agent.

          (4) at the time of loading surface should be towards a direction; sterilization itemsmay not touch the sterilization chamber wall; sterilized goods loading height from the cavity top 8CM.

          (5) each sterilisation cycle should be different items together, not only on metal articles.

          Five. Low formaldehyde steam sterilization

          1 suitable for sensitive to heat, sterilization of medical supplies and corrosive.

          2 methods of formaldehyde sterilization sterilization operation must be in lowformaldehyde sterilizers dedicated in. The specific methods of operation should be strictly in accordance with the operation manual.

          3 note:

          (1) the use of formaldehyde sterilization, must be conducted in formaldehyde sterilizers, not available natural evaporation method.

          (2) there must be sealed and reliable performance of the sterilizer, sterilizationprocess may have formaldehyde gas leakage.

          (3) the temperature and humidity to the sterilization effect, relative humidity andtemperature should be kept constant.

          (4) packaging materials used for polyethylene film, cellophane, becauseformaldehyde is difficult to penetrate.

          (5) sterilization items should be placed between the open, should have a certain gap, the surface should be exposed to formaldehyde gas, effectively contact.

          (6) to remove the residual formaldehyde gas must be available after sterilization,exhaust ventilation or ammonia neutralization method.

          Six. Low temperature sterilization of peracetic acid (content to be added)

          Article thirty-second sterile goods unloading

          A local cooling pressure steam sterilization items after removing kept away from the air or cold air entrance. Cool completely before the goods, not on the coldsurface, prevent the generation of condensation water; do not use hand to touch the sterilized articles in cooling process.

          Two. Check the integrity of the packaging, sterilization drying condition, if damaged, wet bag, should be regarded as sterilization failure.

          Three. Sterilization package lost or misplaced unclean shall be regarded aspollution.

          Four. Check the chemical instructions tape color, not up to the requirements orquestionable, to sterilization.

          Store thirty-third sterilized articles

          A storage area should beprofessionally managed sterilization items, according to their regulations, and pay attention to hand hygiene, other irrelevant personnelshall not enter.

          Two. The sterilizing articles storage; all sterilization items should be carefully examined, meet the requirements before entering the storage area storingsterilized articles; a one-time use of sterile medical appliance shall be removedbefore entering the sterilization packaging goods store.

          1 sterile goods storage areas should be clean, dry. The temperature should be 20degrees Celsius to 25 degrees Celsius, relative humidity should be less than 60%.

          2 sterilization items should be stored in clean cabinets or racks; storage rack(cabinet) must be 20CM-25CM, 5CM-10CM from 50CM from the wall, ceiling.

          3 sterilization items should be placed by classification, position fixing, clear marking, and arranged according to the order is valid, expired.

          The validity period of 4 sterile goods storage: at a temperature below 25 degrees Celsius, the temperature is lower than 60% of the storage conditions, cotton packing material and the rigid container, valid for a period of 10 to 14 days, other environmental storage period for 7 days; goods valid medical non-woven clothand rigid container packaging for 1 months; goods period of medical crepe paperpackaging for 3 months; paper-plastic bag packaging items are valid for 6 months.

          5 has been sterilized articles shall not sterilized articles together.

          Three. The sterilizing articles issued: should be used according to the needs ofthe Department, in accordance with the provisions of the route by hand, issuedclosed-end transport vehicle or vessel, and make the record, including articles issued date, Department, product name, specifications, quantity, sender,receivers etc.. Attention should be paid when the sterilization:

          The truck, 1 deliver goods containers tools should be daily cleaning, disinfectionafter storage.

          2 from the sterilization articles issued item cannot return the storage area.

          3 expired sterilization items to be removed from the storage area, to cleaning and sterilization packaging.

          Four. The use of sterile disposable medical supplies should be designatedsupervision, should check the inspection certificate in disinfection supply center,packaging is in line with the requirements of mark clear, clean, includingpackaging no stains, water stains, mildew, packaging no damage, deformation.

          1 storage check and record the date of warehousing, product name,specifications, quantity, production factory, production batch number, date of expiry date, sterilization.

          2 regular goods inventory and records, do, consistent.

          3 found unqualified products, should immediately stop the issuance and use of,and inform the relevant departments.

          Cleaning and disinfection and treatment methods of thirty-fourth special infected patients after using instruments

          A special infections including tetanus, gas gangrene, anthrax and prion infection.The processing method is as follows:

          1 tetanus, gas gangrene, anthrax patients equipment after use, should be a high level disinfection, use mechanical or manual cleaning method for cleaning.

          2 prion infection in patients after apparatus used for disposal in accordance withthe requirements of "technical standard for disinfection".

          Note two:

          1 the strict implementation of personal protection and disinfection and isolation system.

          2 transport equipment must be thoroughly cleaned, disinfected.

          With a cleaning agent 3 used must be.

          Personal protection staff thirty-fifth disinfection supply center

          To comply with the standard. The precautionary principle, take correspondingmeasures.

          Two. In different regions of the staff, according to the work of the different. Take different protection measures, protection products in the corresponding.

          Three. The decontamination district staff shall wear work clothes, waterproofaprons, gloves, protective screen or mask.

          Four. According to the different sterilization methods should focus on the prevention of the following matters:

          1 heat sterilization: dry heat sterilization should be to prevent the burning: pressure steam sterilization should be to prevent the explosion accidents and may cause to operating personnel burns accident.

          2 UV, microwave disinfection: should avoid direct exposure to the human body.

          3 gas chemical disinfection, sterilization agent: should prevent leakage of toxic and harmful disinfection gas, often to test the concentration of the gas sterilizationenvironment, ensure the safety scope stipulated by the state: the EO sterilizationagent, but also to prevent the occurrence of combustion and explosion accident.

          4 liquid chemical disinfection, sterilization agent: should prevent allergies andmay have on the skin, mucous injury.

          5 the sharp instruments and appliances should take effective measures of protection, to avoid the possibility of thorn, cutting the harm to the human body.

          Monitoring, inspection and verification of the sixth chapter

          Article thirty-sixth shall monitor the quality of the person responsible for thecleaning, disinfection, sterilization, including process monitoring, chemical monitoring and biological monitoring, and deal with the cleaning, disinfectionequipment, drying, packaging and sterilization of inspection and verification.

          Monitoring cleaning quality.

          The 1 routine monitoring in check the packaging process:

          2 the use of cleaning and disinfection machine for process monitoring loading,temperature, time etc.:

          3 irregular spot checks, cleaning quality checks of 1 - 3 for sterilizing package all items.

          Monitoring of disinfection quality in two.

          1 thermal disinfection should be monitored, recorded every sterilizationtemperature and time or A0 value.

          The main performance parameters of each detection equipment cleaning and disinfection, should also test equipment and overhaul the newly installed after.

          2 chemical disinfection should be carried out according to the relevant provisions of the concentration, effect monitoring.

          3 quarterly irregularly on the disinfection effect of sampling, and check whether in strict accordance with the instructions.

          Three monitoring of sterilization quality.

          1 the quality of pressure steam sterilization monitoring pressure steam sterilization should use the process monitoring method, chemical monitoring and biological monitoring method. Vacuum pressure steam sterilization should also be B - D test.

          (1) physical monitoring each sterilization must continuously monitor and recordthe temperature, pressure, sterilization time sterilization parameters.

          (2) the chemical monitoring including package sterilization chemical instructionsmonitoring, package sterilization chemical instructions monitoring and bulkchemical instructions monitoring.

          Every sterilization bag should be affixed with the bag outside chemical instructionstape or package instructions card, high dangerous goods package should be placed inside the package sterilization chemical indicator, by observing changes in instructions tape or card color, to determine whether after sterilization andeligibility.

          (3) the biological monitoring method should be once a week, the spores of Bacillus stearothermophilus (ATCC7953 or SSIK31 strain) for the biological monitoring of sterilization quality of sterilizer. Above biological monitoring bag in the exhaust port, and a positive control.

          Sterilization of implantable devices, serious pollutants must each pot biologicalmonitoring.

          The packaging materials and new methods of sterilization should also be carried out biological monitoring.

          Equipment and overhaul the newly installed equipment to be biologicalmonitoring, monitoring methods should be consistent with the relevant requirements of GB18278-2000.

          Biological monitoring is unqualified, should immediately continuous redo two times experiments, such as qualified, only need to analyze the reasons of previous unqualified, if still not qualified, will be back to recall the last monitoring compliance since all sterilization items, new sterilization.

          (4) the B-D test forevacuum steam sterilizer shall daily begin B-D testing for sterilization before running, the B-D test qualified rear can use.B-D test failure,should be timely find the reasons are improved.

          New equipment installation and overhaul should be B-D test and repeated 3 times, qualified rear can use.

          (5) PCD (sterilization process challenge device): batch monitoring and cavityinstrument sterilization quality monitoring on sterilization items.

          Monitoring fast pressure steam sterilization 2, fast pressure steam sterilizationquality must use physical method, chemical method and biological monitoring method for monitoring. Monitoring method according to the manufacturer's instructions.

          3, dry heat sterilization quality monitoring of dry heat sterilization should be everypot temperature monitoring, each packet of chemical monitoring and weekly usingBacillus subtilis var.niger (ATCC9372) for biological monitoring. In addition an annual physical monitoring. When monitoring a plurality of probes of multi-point temperature detecting instrument were placed in each layer, in sterilizer, each point, shut the door, will lead out, observed by the recorder of temperature rise andduration. If the temperature is shown to reach the preset temperature within a set time, the sterilization temperature is qualified.

          Equipment and overhaul the installation of the new equipment should also bephysical monitoring method and biological detection method (5 times) were monitored, qualified rear can use.

          Monitoring of 4 low temperature sterilization quality: low temperature sterilization methods including ethylene oxide sterilization. Hydrogen peroxide gas plasmasterilization, low formaldehyde steam sterilization, peracetic acid low temperature sterilization, the sterilization quality according to the manufacturer's instructions to use physical monitoring method, chemical method and biological monitoringmonitoring method for monitoring.

          Article thirty-seventh of sterilization and supply center should be regular cleaning,disinfection of water conductivity on the observation, to determine whether it meets the requirements for use.

          Article thirty-eighth sterilizer installed, verify and overhaul after the regular inspection

          A sterilizing equipment should be validated in installation and overhaul, includingdetermination of sterilization process parameters, such as the temperature,pressure and concentration, vacuum pressure steam sterilizer should also betested for B-D. The sterilizer is validated must through the biological monitoring.

          Two. Pressure steam sterilizer for thermometer, pressure gauge, each year on the timing device and a safety valve for detection and verification by the third party, andbiological monitoring of sterilization quality.

          Three. Every three years by the third party with multi-point temperature physicalmonitoring detector for each layer of the sterilizer, within, the temperature of hot air sterilizer.

          Four. Low temperature sterilization validation according to the manufacturer's instructions.

          Five. Biological monitoring equipment installation and overhaul after shall conform to the requirements.

          Maintenance of the thirty-ninth equipment should be in accordance with the use of products for daily inspection and cleaning of the sterilizer.

          The seventh chapter quality control process records and traceability requirements

          Article fortieth of sterilization and supply center should be recorded and trackingthe quality control process, records should be easy to identify and trace. The sterilization quality record retention period should be greater than or equal to three years.

          Article forty-first shall establish cleaning, disinfection equipment and operationprocess records, including:

          A daily record. Operation status of mechanical cleaning and disinfectionequipment or retained equipment printing.

          Two. The parameters and the sterilization effect of record sterilizer.

          1 minutes of each sterilization information including sterilization date, sterilizationpot, pot, the number of primary goods, loading, sterilizing procedures, operatorsignature or symbol.

          2 minutes of each sterilization operation procedure parameters.

          Monitoring results of 3 records sterilization quality and archived.

          Forty-second operation instrument package should be labeled information card.Information card includes sterilization, sterilization pot, pot dates, times, the package name or number, name of sterilization package or code, date of expiry.

          Users in the check be affixed to the nursing record of operation.

          Article forty-third to establish continuous quality improvement system and measures, found problems in a timely manner, and the establishment of sterilized articles recall system.

          Article forty-fourth of sterilization and supply center information managementgradually realize the process record, record and tracking to achieve sterile items.

          The eighth chapter by-laws

          Article forty-fifth provinces, autonomous regions, municipalities directly under the central government, the health administrative department according to the actual situation of this specification and the local, make provision for the county medical institutions disinfection and supply management.

          Disinfection supply not forty-sixth medical institutions to implement centralized management of disinfection supply, the operation room should refer to the implementation of this standard.

          Society of disinfection supply center management implemented by referring to the present rules.

          Article forty-seventh the cleaning and disinfection of endoscopes in medical institutions. Oral medical instrument, can be based on the 2004.2005 yearspromulgated the "cleaning and disinfection of the endoscopes specification (2004 Edition) > >, < < medical dental equipment disinfection technology standard > >operation management, can also be composed of sterilization and supply centerunified cleaning, disinfection treatment set.

          Disinfection supply room of the hospital acceptance standards "promulgated in 1988 (Trial)" abolished at the same time, the other is inconsistent with the normsto this specification shall prevail.

          Article forty-eighth the specification of the implementation date of promulgation.

          Appendix terminology

          1 disinfection supply center: take all the repeated use of hospital medical instruments, appliances, cleaning and disinfection, sterilization and sterilizationitems supplies department.

          2 decontamination area: for equipment and material recycling can be repeateduse, classification, cleaning and disinfection of the area, water recycling,equipment cleaning and disinfection and pollution disposal area.

          3 check the packaging area: strictly after the cleaning and disinfection of reusableutensils before sterilization after inspection, supporting, packaging, use sterilization device for sterilization area.

          Store 4 sterilized articles: cooling, for sterile goods storage, storage, distribution region.

          5 cleaning: cleaning is by physical or chemical methods will be washing theorganic articles, inorganic matter and microbe to reduce as much as possible to a safe level.

          6 cleaning: for completing various cleaning disinfection, auxiliary facilitiesrequired, shall ensure that the equipment does not have the pollution, the cleaning tank material with acid, alkali, corrosion resistant, easy care, does not damage the equipment, less pollution and other properties, should be supportingpipe lavage device, pressure water gun, pressure air and water control.

          7 cleaning and disinfecting device: mainly used for cleaning of contaminated items, cleaning device with a spray cleaning device and automatic ultrasonicspray cleaner, semi-automatic, fully automatic ultrasonic cleaning line ultrasonic cleaning device are equipped with thermal sterilization function.

          8 spray cleaner: through the spray arm rotating jet out certain pressure watercleaning and disinfection equipment, complete machine. The instruments and articles in different should wash rack adopts corresponding, but also through thepump into the cleaning agent to improve the cleaning effect.

          9 ultrasonic cleaner: using ultrasonic oscillation in the water produced by the"cavitation" cleaning machine, ultrasonic cleaning machine is fully automatic,semi-automatic and desktop type.

          10: is the centralized management of all needed medical supplies, reprocessing,instruments include recycling, cleaning, disinfection, sterilization, disinfection and supply center to issue focused by the management mode.

          11 dates: on the key elements of the sterilization process and results are recorded, save for future reference, can realize tracking.

          12 cleaning agent: composed of surface active agent and auxiliary components,has enhanced and improved preparation of cleaning effect, should not abrasive,non-toxic, non-corrosive characteristics, natural degradation, no adhesion, no residual.

          13 PCD (sterilization process challenge device): a simulation device must beresistant to the sterilization process. The interior can be placed chemical or biological indicator, for batch monitoring items. The B-D test, the cavity equipmentsterilization monitoring.

          14 rigid containers: material, design, structure and surface of goods containers forinternal and external cleaning and sterilization. Its angle should be in a circular arc shape, material should not with electrostatic induction material. Rigid containersshall be designed and manufactured into security stack loading form, into thesterilizer, in rigid containers between the steam and / or free air circulation.Deformation rigid containers not permanent, performance parameters will not change; the maximum allowable sterilization load is 10 kg; the service life of not less than 500 times the use of cycle requirements; life cycle washer should be not less than 100 cycle or 6 months; the surface of the container should be marked with the name or trademark of the manufacturer or supplier.

          | Updated:2009.06.25    Source:    Clicks:34650

          皖公網安備 34118102000163號

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