OST 64-02-003-2002
ОСТ 64-02-003-2002
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Products of the medical industry. Technological regulations of production. Content, procedure of development, coordination and approval
Продукция медицинской промыш��енности. Технологические регламенты производства. Содержание, порядок разработки, согласования и утверждения
Status: Not defined by law. In connection with the entry into force of the Federal Law of December 27, 2002 N 184-ФЗ "On Technical Regulation"
The industry standard establishes general requirements for the procedure for the development, maintenance, coordination and approval of technological regulations for the production of medicines and their intermediates * produced by specialized enterprises. The industry standard does not apply to products for which design documentation is available, medical glass and glassware.
Отраслевой стандарт устанавливает общие требования к порядку разработки, содержанию, согласованию и утверждению технологических регламентов производства лекарственных средств и их полупродуктов*, производимых специализированными предприятиями. Отраслевой стандарт не распространяется на продукцию, на которую имеется конструкторская документация, медицинское стекло и изделия из него.
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Format: Electronic (pdf/doc)
Approved: Ministry of Industry, Science and Technology of the Russian Federation,
4/15/2003
SKU: RUSS123177
The Product is Contained in the Following Classifiers:
Construction (Max) »
Standards »
Industry Standards and Specifications »
Industry standards »
PromExpert »
SECTION I. TECHNICAL REGULATION »
II Standardization »
2 Activities and organization of work on standardization »
ISO classifier »
11 HEALTH »
11.040 Medical equipment »
11.040.01 Medical equipment in general »
The Document References:
GN 1.1.701-98: Hygienic criteria for rating the necessity for setting up MACS and TSELS of harmful substances in the occupational air, the ambient air of residential areas and the water of water bodies. Hygienic norms
GN 2.1.5.689-98: Maximum permissible Concentrations (Macs) of Chemicals in the Water of Facilities Used for Domestic Drinking and Recreation Purposes
GN 2.1.5.690-98: Tentative permissible levels (TPLs) of chemicals in the water of water objects used for drinking and domestic-recreation purposes
GN 2.1.6.695-98: Maximum permissible Concentrations (Macs) of Air Pollutants in Inhabited Places
GN 2.1.6.696-98: Tentative safe exposure levels (TSELs) of pollutants in the air of residential areas
GN 2.1.6.711-98: Maximum Allowable Concentrations (PDK) of Producer Microorganisms, Bacteria Preparations, and Their Components in the Atmosphere in Populated Areas
GN 2.2.5.686-98: Maximum Allowable Concentrations (PDK) of Hazardous Substances in Workplace Air. Hygienic Standards
GN 2.2.5.687-98: Tentative Safe Exposure Levels (OBUV) of Hazardous Substances in Workplace Air
GN 2.2.6.709-98: Maximum allowable concentrations (MACs) of microorganism-producens, bacterial products and their components in the occupational air
GOST 12.1.004-91: Fire safety. General requirements
GOST 12.1.005-88: General sanitary requirements for working zone air
GOST 12.1.007-76: Noxious substances. Classification and general safety requirements
GOST 12.1.010-76: Explosion safety. General requirements
GOST 12.1.011-78: Explosive mixtures. Classification and test methods
GOST 12.1.016-79: Work area air
GOST 12.1.019-79: Occupational safety standards system. Electric safety. General requirements and nomenclature of kinds of protection
GOST 12.1.041-83: Fire and explosion safety of combustible dusts
GOST 12.1.044-89: Fire and explosion hazard of substances and materials. Nomenclature of indices and methods of their determination
GOST 12.2.003-91: Industrial equipment. General safety requirements
GOST 12.2.016-81: Occupational safety standards system. Gas compressing equipment. General safety requirements
GOST 12.2.020-76: Explosion proof electrical apparatus. Terms and definitions. Classification. Marking
GOST 12.2.085-82: Vessels working under pressure. Safety valves. Safety requirements
GOST 12.3.002-75: Occupational safety standards system. Manufacturing processes. General safety requirements
GOST 12.4.021-75: Ventilation systems. General requirements
GOST 15.005-86: Creation of articles manufactured individually or in small batches and assembled at the place of operation
GOST 17.2.3.02-78: Regulations for establishing permissible emissions of noxious pollutants from industrial enterprises
GOST 17768-90: Medicine remedies. Packing, marking, transportation and storage
GOST 2.301-68: Unified system for design documentation. Formats
GOST 21.404-85: System of design documents for construction. Industrial process automation. Instrumentation symbols for use in diagrams
GOST 27.002-89: Industrial product dependability. General principles. Terms and definitions
GOST 27.003-90: Reliability in engineering. Make-up and general rules for assigning reliability requirements
GOST 27.410-87: Industrial product dependability. Inspection methods of reliability indices and plans of check tests on reliability
GOST R 12.1.052-97: Occupational safety standards system. Substans (material). Safety passport. Basic principles
GOST R 12.3.047-98: Occupational safety standards system. Fire safety of technological processes. General requirements. Methods of control
GOST R 51330.9-99: Electrical apparatus for explosive gas atmospheres. Volume 10. Classification of hazardous areas
GOST R IEC 61241-3-99: Electrical apparatus for use in the presence of combustible dust. Part 3. Classification of areas
NPB 105-95: Determination of Rooms and Buildings Categories on Explosion and Fire Hazard
NPB 110-99: The list of buildings, constructions, rooms and equipment subject to protection by automatic extinguishing units and automatic fire alarm
OND-86: Methodology for calculating atmospheric concentrations of harmful substances contained in enterprise emissions
PB 03-108-96: Process pipeline design and safe operation rules
PB 03-110-96: Safety regulations on pressurized storage of liquefied petroleum gas and highly inflammable liquids
PB 03-182-98: Safety Requirements for Aboveground Storage Facilities for Liquid Ammonia
PB 03-221-98: Rules of development, manufacture and application of diaphragm safety devices
PB 09-170-97: General rules on explosion safety for explosive- and fire-hazardous chemical, petrochemical plants and oil refineries
PB 09-224-98: Safety rules for productions using inorganic acids and alkalis
PB 09-297-99: Rules of setup and safe operation of compressor units with piston compressors operating on dangerously explosive and noxious gases
PB 10-115-96: Regulations of design and safe operation of pressure vessels
PB 12-245-98: Safety Requirements for Gas Supply Facilities
PPB 01-93*: Fire Safety Rules in the Russian Federation
R 2.2.755-99: Hygienic Criteria for Evaluation and Classification of Labor Conditions by Indexes of Harmfulness and Danger of Industrial Environment and Working Process Difficulty and Intensity
RD 09-251-98: Provision on procedure of formulation and content of section “safety operation of production plant” of process regulations
SanPiN 2.1.4.544-96: Requirements for Water quality of Uncentralized Sources of Water Supply. Sanitary Protection of Water Sourсes
SanPiN 2.1.4.559-96: Potable water. Hygienic requirements to water quality in centralized potable water systems. Quality control
SNiP 1.06.05-85: Regulation on construction design supervision of enterprises, buildings and installation by design organizations
SNiP 2.04.03-85: Sewage. External systems and structures
SNiP 2.04.09-84: Automatic fire protection systems
SNiP 2.11.01-85: Storage buildings
SNiP 3.05.05-84: Processing equipment and process pipelines
SNiP 3.05.07-85: Automated systems
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