GOST 31209-2003
ГОСТ 31209-2003
|
|
Containers for blood and its components. Requirements for chemical and biological safety and methods of testing
Контейнеры для крови и ее компонентов. Требования химической и биологической безопасности и методы испытаний
Status: Effective - Introduced for the first time. IUS 10-2013
This standard applies to single-use polymeric sterile containers (hereinafter referred to as containers) intended for taking blood, dividing it into components, as well as storing, transporting and transfusing them. The standard establishes the requirements of chemical and biological safety and verification methods for acceptance, acceptance and certification tests. The requirements of this standard are mandatory.
Настоящий стандарт распространяется на полимерные стерильные контейнеры однократного применения (далее - контейнеры), предназначенные для взятия крови, разделения ее на компоненты, а также их хранения, транспортирования и переливания. Стандарт устанавливает требования химической и биологической безопасности и методы проверки при приемочных, приемо-сдаточных и сертификационных испытаниях. Требования настоящего стандарта являются обязательными
Choose Language:
Format: Electronic (pdf/doc)
Approved: Federal Agency for Technical Regulation and Metrology,
11/29/2012
SKU: RUSS70748
The Product is Contained in the Following Classifiers:
Evidence base (TR CU, Technical Regulation of the Customs Union) »
019/2011 TR CU. On safety of personal protective equipment »
Regulations and standards (to ТР ТС 019/2011) »
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 »
11.040 Medical equipment »
11.040.20 Apparatus for blood transfusion, infusion and injection »
National standards »
11 HEALTH »
11.040 Medical equipment »
11.040.20 Apparatus for blood transfusion, infusion and injection »
The Document References:
GOST 10163-76: Reagents. Soluble starch. Specifications
GOST 10782-85: Glass bottles for blood, transfusion and infusion preparations/compounds
GOST 12026-76: Filter paper for laboratory application
GOST 14919-83: Household electric ranges, electric plates and electric frying ovens
GOST 15860-84: Steel welded cylinders for liquefied hydrocarbon gases at pressure up to 1.6 MPa.
GOST 17433-80: Industrial purity. Compressed air. Grades of contamination
GOST 1770-74: Laboratory volumetric glassware. Cylinders, beakers, measuring flasks, test tubes. General specifications
GOST 20490-75: Reagents. Potassium permanganate. Specifications
GOST 22280-76: Reagents. Tri-sodium citrate 5,5-aqueous. Specifications
GOST 22860-93: Cadmium of high purity. Specifications
GOST 22861-93: Lead of high purity. Specifications
GOST 23932-90: Laboratory glassware and equipment. General specifications
GOST 2405-88: Pressure gauges, vacuum gauges, pressure-vacuum gauges, pressure meters, draft gauges and draft-pressure gauges
GOST 24104-2001: Laboratory scales. General technical requirements
GOST 24297-87: Input inspection of products. General provisions.
GOST 244-76: Photographic grade sodium thiosulphate, crystalline - specification
GOST 25336-82: Laboratory glassware and equipment. Basic parameters and dimensions
GOST 29227-91: Laboratory glassware. Graduated pipettes. Part 1. General requirements
GOST 29251-91: Laboratory glassware. Burettes. Part 1. General requirements
GOST 3022-80: Technical hydrogen. Specification
GOST 3118-77: Reagents. Hydrochloric acid. Specifications
GOST 4108-72: Reagents. Barium chloride, 2-aqueous. Specifications
GOST 4204-77: Reagents. Sulphuric acid. Specifications
GOST 4232-74: Reagents. Potassium iodide. Specifications
GOST 4233-77: Reagents. Sodium chloride. Specifications
GOST 4461-77: Reagents. Nitric acid. Specifications
GOST 5457-75: Dissolved acetylene and gaseous acetylene for technical purposes. Specifications
GOST 5556-81: Medical absorbent cotton
GOST 5905-2004: Metal chrome. Technical requirements and conditions of delivery
GOST 5962-67: Rectified ethyl alcohol. Specifications
GOST 6672-75: Cover glasses for micropreparations. Specifications
GOST 6709-72: Distilled water. Specifications
GOST 7164-78: SSI self-balancing servoinstruments. General specifications
GOST 8.423-81: State system for ensuring the uniformity of measurements. Mechanical stop-watches. Methods and means for verification
GOST 859-2001: Copper. Grades
GOST 860-75: Tin. Specifications
GOST 8728-88: Plasticizers. Specifications
GOST 9147-80: Laboratory porcelain ware and apparatus. Specifications
GOST ISO 7886-1-2011: Sterile hypodermic syringes for single use. Part 1. Syringes for manual use
GOST R 51652-2000: Rectified ethyl alcohol of food raw material. Specifications
GOST R 53228-2008: Non-automatic weighing instruments. Part 1. Metrological and technical requirements. Tests
The Document is Referenced By:
Decision 30: On approval of the list of products in respect of which the customs declaration is accompanied by a document about the conformity assessment requirements of the technical regulations of the Customs Union "On safety of agricultural and forestry tractors and trailers to them" (TR TS 031/2012) (as amended on March 21, 2017)
Decision 30: On the list of international and regional (interstate) standards, and in their absence - national (state) standards, resulting in voluntary compliance with the requirements of technical regulations of the Customs Union "On Personal Protective Equipment Safety" (TR CU 019/2011), and the list of international and regional (interstate) standards, and in their absence - national (state) standards, containing rules and methods of research (tests) and measurements, including
GOST 31597-2012: Polymeric containers for blood and components for single use. Technical requirements. Test methods
GOST 34901-2022: Medical devices. System for evaluation of biological effect. General requirements for research (tests)
GOST R 52770-2016: Medical devices. Safety requirements. Methods of sanitation-chemical and toxicological tests
Customers Who Viewed This Item Also Viewed:
 |
Metals. Methods of tension test
Language: English
|
Manual are welding. Welding joints. Main types, design elements and dimensions
Language: English
|
Vessels and apparatus. Norms and methods of strength calculation
Language: English
|
Weldable deformed reinforcing rolled products of A500C and B500C classes for reinforcement of concrete constructions. Specifications
Language: English |
Welding steel wire. Specifications
Language: English
|
Safety guidelines. Standardized methods of control of basic materials (semi-finished products), welded joints and surfacing of NPP equipment and piping. Dye penetrant inspection
Language: English
|
Bearing and enclosing structures. Updated living edition of SNiP 3.03.01-87
Language: English
|
Corrosion protection of buildings structures. Updated living edition of SNiP 2.03.11-85
Language: English
|
Standardized methods of testing of basic materials (semifinished products, weld joints and surfacing of equipment and piping of npp. Ultrasonic inspection. Part I. Control of basic materials (semifinished products)
Language: English
|
Steel and alloys. Methods for detection and determination of grain size
Language: English
|
Armour clothes. Classification and general technical requirements
Language: English |
Steel. Metallographic methods for the determination of non-metallic inclusions
Language: English
|
Welded reinforcing products and inserts, welded, lap and mechanical joints for reinforced concrete structures. General specifications
Language: English
|
Welded joints of reinforcement and inserts for reinforced concrete structures. Types, constructions and dimensions
Language: English
|
Reinforcing rolled products for reinforced concrete constructions. Specifications
Language: English
|
Steel and corrosion resistant alloys. Test methods for resistance to intergranular corrosion
Language: English
|
Armored clothing. Classification and general specifications
Language: English |
 |
|
YOUR ORDERING MADE EASY!
RussianGost.com is an industry-leading company with stringent quality control standards and our dedication to precision, reliability and accuracy are some of the reasons why some of the world’s largest companies trust us to provide their national regulatory framework and for translations of critical, challenging, and sensitive information.
Our niche specialty is the localization of national regulatory databases involving: technical norms, standards, and regulations; government laws, codes, and resolutions; as well as RF agency codes, requirements, and Instructions.
We maintain a database of over 220,000 normative documents in English and other languages for the following 12 countries: Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Moldova, Mongolia, Russia, Tajikistan, Turkmenistan, Ukraine, and Uzbekistan.
Placing Your Order
Please select your chosen document, proceed to the ‘checkout page’ and select the form of payment of your choice. We accept all major credit cards and bank wire transfers. We also accept PayPal and Google Checkout for your convenience. Please contact us for any additional arrangements (Contract agreements, PO, etc.).
Once an order is placed it will be verified and processed within a few hours up to a rare maximum of 24 hours.
For items in stock, the document/web link is e-mailed to you so that you can download and save it for your records.
For items out of stock (third party supply) you will be notified as to which items will require additional time to fulfil. We normally supply such items in less than three days.
Once an order is placed you will receive a receipt/invoice that can be filed for reporting and accounting purposes. This receipt can be easily saved and printed for your records.
Your Order Best Quality and Authenticity Guarantee
Your order is provided in electronic format (usually an Adobe Acrobat or MS Word).
We always guarantee the best quality for all of our products. If for any reason whatsoever you are not satisfied, we can conduct a completely FREE revision and edit of products you have purchased. Additionally we provide FREE regulatory updates if, for instance, the document has a newer version at the date of purchase.
We guarantee authenticity. Each document in English is verified against the original and official version. We only use official regulatory sources to make sure you have the most recent version of the document, all from reliable official sources.