GOST 25047-87
ГОСТ 25047-87
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Complete exfusion, infusion and transfusion devices of the single application
Устройства комплектные эксфузионные, инфузионные и трансфузионные однократного применения
Status: Effective - Supersedes. The limitation of the effectiveness period has been lifted: Protocol No. 3-93 of the IGU dated 03.03.93 (IUS 5-6-1993)
The standard applies to complete single-use exfusion, infusion and transfusion devices (hereinafter referred to as devices) intended for taking blood from a donor, for infusing recipients with solutions and transfusions of blood and its components, as well as blood substitutes and other transfusion media from glass and polymer containers. The standard establishes requirements for devices manufactured for the needs of the national economy and export to countries with a temperate and tropical climate.
Стандарт распространяется на комплектные эксфузионные, инфузионные и трансфузионные устройства однократного применения (далее - устройства), предназначенные для взятия крови у донора, для вливания реципиенту растворов и переливания крови и ее компонентов, а также кровезаменителей и других трансфузионных сред из стеклянных и полимерных емкостей. Стандарт устанавливает требования к устройствам, изготавливаемым для нужд народного хозяйства и экспорта в страны с умеренным и тропическим климатом.
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Format: Electronic (pdf/doc)
Approved: Gosstandart of the USSR,
3/20/1987
SKU: RUSS19765
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 »
11.040 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 »
National Standards for KGS (State Standards Classification) »
Latest edition »
R Health. Sanitation and hygiene items »
R2 Equipment and tools of medical institutions »
R22 Devices, apparatus, accessories and equipment used in surgery, in dental and autopsy practice. Anesthetic and artificial respiration devices »
National Standards for OKSTU »
MEDICAL EQUIPMENT »
Devices and apparatus for treatment. Anesthetic devices. Devices for replacing the functions of organs and body systems »
The Document is Replaced With:
GOST 25047-2023: Complete exfusion, infusion and transfusion devices for single use. Technical conditions
As a Replacement Of:
GOST 25047-81: Devices complete, for exfusion, infusion and transfusion single use. Basic dimensions, general technical requirements and test methods
The Document References:
GOST 10459-87: Base paper for gummed tape
GOST 13511-91: Boxes of corrugated board for food-stuffs, matches, tobacco and detergents. Specifications
GOST 13513-86: Crates from corrugated cardboard for meat and milk industry products
GOST 14192-96: Cargo marking
GOST 15150-69: Machines, instruments and other industrial products. Modifications for different climatic regions. Categories, operating, storage and transportation conditions as to environment climatic aspects influence
GOST 15846-2002: Production for transportation to the areas of Far North and similar regions. Packing, marking, transportation and storage
GOST 16337-77: High-pressure polyethylene. Specifications
GOST 18242-72: Statistical acceptance inspection by alternative feature inspection plans
GOST 18251-87: Gummed tape on paper substrate. Specifications
GOST 18321-73: Statistical quality control. Item random sampling methods
GOST 20435-75: Universal metallic closed container of nominal gross mass 3,0 tn. Specifications
GOST 20790-93: Medical instruments, apparatus and equipment. General specifications
GOST 22852-77: Corrugated fibre boxes for products of instruments making industry. Specifications
GOST 2364-74: Angles for wood cases. Specifications
GOST 24634-81: Wooden boxes for export products. General specifications
GOST 28840-90: Machines for tension, compression and bending tests of materials
GOST 3560-73: Sealing tepe
GOST 9481-2001: Corrugated board boxes for chemical threads. Specifications
GOST R 50444-92: Medical instruments, apparatus and equipment. General specifications
OK 005-93: All-Russia Classification of Products (Part 1)
OK 005-93: All-Russia Product Classification (OKP) (Part 13)
OK 005-93: All-Russia Classification of Products (OKP)
OK 005-93: All-Russia Classification of Products (Part 17)
OK 005-93: All-Russia Product Classification (OKP) (Part 3)
OK 005-93: All-Russia Classification of Products (OKP) (Part 4)
OK 005-93: All-Russia Classification of Products (Part 5)
OK 005-93: All-Russia Classification of Products (Part 6)
OK 005-93: All-Russia Product Classification (OKP) (Part 7)
OK 005-93: All-Russia Classification of Products (OKP) (Part 8)
OK 005-93: All-Russia Classification of Products (part 9)
OK 005-93: All-Russia Classification of Products (OKP) (Part 10)
OK 005-93: All-Russia Classification of Products (Part 11)
OK 005-93: All-Russia Classification of Products (part 12)
OK 005-93: All-Russia Classification of Products (OKP) (Part 14)
OK 005-93: All-Russia Classification of Products (part 15)
OK 005-93: All-Russia Classification of Products (Part 16)
OK 005-93: All-Russia Classification of Products (Part 17)
OK 005-93: All-Russia Classification of Products (Part 18)
OK 005-93: All-Russia Classification of Products (Part 19)
OK 005-93: All-Russia Classification of Products (Part 18)
OK 005-93: All-Russia Classification of Products (Part 21)
OK 005-93: All-Russia Classification of Products (OKP) (Part 22)
The Document is Referenced By:
GOST 31597-2012: Polymeric containers for blood and components for single use. Technical requirements. Test methods
GOST R 15.013-2016: System of products development and launching into manufacture. Medical devices
GOST R 50892-96: Elastic couplings with a toroid-shape shell. Specifications
GOST R 51622-2000: Polymeric containers for blood and components for single use. Technical requirements. Test methods
GOST R 57629-2017: Medical devices. General safety and compatibility requirements for single use infusion sets
PR 64-05-001-2002: Rules of organization of clean manufactures and control of quality of medical products from polymers, woven and nonwoven materials, having contact with blood
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