GOST R 50325-2011
ГОСТ Р 50325-2011
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Medical products. Radiation sterilization. Dosimetric techniques
Изделия медицинского назначения. Радиационная стерилизация. Методика дозиметрии
Status: Not effective - Canceled. Registration information 1471-st dated 10/21/2016 (the official website of Rosstandart); IUS 2-2017
This standard applies to single-use medical devices sterilized by radiation and establishes general requirements for dosimetry at the stages of preparing and conducting the process of radiation sterilization of these products in radiation-technological installations with electron accelerators (bremsstrahlung and electron radiation), radionuclide sources of ionizing radiation, radiation circuits and spent fuel elements of nuclear reactors
Настоящий стандарт распространяется на изделия медицинского назначения однократного применения, стерилизуемые радиационным способом, и устанавливает общие требования к дозиметрии на этапах подготовки и проведения процесса радиационной стерилизации этих изделий на радиационно-технологических установках с ускорителями электронов (тормозное и электронное излучения), радионуклидными источниками ионизирующих излучений, радиационными контурами и отработанными тепловыделяющими элементами ядерных реакторов
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Format: Electronic (pdf/doc)
Approved: Federal Agency for Technical Regulation and Metrology,
9/22/2011
SKU: RUSS67404
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 »
As a Replacement Of:
GOST R 50325-92: Medical products. Dosimetric techniques for radiation sterilization
The Document References:
GOST 27451-87: Ionizing radiation measurement instruments
GOST 8.035-82: State system for ensuring the uniformity of measurements. State primary standard and all-union verification schedule for means measuring absorbed dose and absorbed dose rate of beta-radiation
GOST 8.070-96: State system for ensuring uniformity of measurements. State verification schedule for means measuring absorbed and equivalent doses and rate of absorbed and equivalent doses of photon and electron radiations
GOST R 8.563-2009: State system for ensuring the uniformity of measurements. Procedures of measurements
GOST R 8.594-2002: State system for ensuring the uniformity of measurements. The metrological ensuring of radiation control. General principles
GOST R ISO 11137-1-2008: Sterilization of health care products. Radiation. Part 1. Requirements for development, validation and routine control of a sterilization process for medical devices
GOST R ISO 11137-2-2008: Sterilization of health care products. Radiation. Part 2. Establishing the sterilization dose
GOST R ISO 11137-3-2008: Sterilization of health care products. Radiation. Part 3. Guidance on dosimetric aspects
GOST R ISO 11140-1-2009: Sterilization of health care products. Chemical indicators. Part 1. General requirements
GOST R ISO 13485-2004: Medical devices. Quality management systems. System requirements for regulatory purposes
GOST R ISO 22005-2009: Traceability in the feed and food chain. General principles and basic requirements for system design and implementation
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