GOST R ISO 11137-3-2008
ГОСТ Р ИСО 11137-3-2008
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Sterilization of health care products. Radiation. Part 3. Guidance on dosimetric aspects
Стерилизация медицинской продукции. Радиационная стерилизация. Часть 3. Руководство по вопросам дозиметрии
Status: Effective - Introduced for the first time
This standard provides guidance on the implementation of the requirements of ISO 11137-1 and ISO 11137-2 concerning dosimetry, and also describes the dosimetry procedures for the development, validation and routine control of the radiation sterilization process
В настоящем стандарте содержится руководство по реализации требований ИСО 11137-1 и ИСО 11137-2, касающихся дозиметрии, а также описаны процедуры дозиметрии при разработке, валидации и текущем контроле процесса радиационной стерилизации
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Format: Electronic (pdf/doc)
Approved: Federal Agency for Technical Regulation and Metrology,
12/18/2008
SKU: RUSS67893
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 »
National standards »
11 HEALTH »
11.080 Sterilization and disinfection »
ISO classifier »
11 HEALTH »
11.080 Sterilization and disinfection »
11.080.01 Sterilization and disinfection in general »
National standards »
11 HEALTH »
11.080 Sterilization and disinfection »
11.080.01 Sterilization and disinfection in general »
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 »
The Document is Referenced By:
GOST 8.651-2016: State system for ensuring the uniformity of measurements. Medical devices. Radiation sterilization. Dosimetric techniques
GOST R 50325-2011: Medical products. Radiation sterilization. Dosimetric techniques
GOST R 52249-2009: Good manufacturing practice for medicinal products (GMP)
GOST R ISO 16061-2011: Instrumentation for use in association with non-active surgical implants. General requirements
GOST R ISO 25539-1-2012: Cardiovascular implants. Endovascular devices. Part 1. Endovascular prostheses
RMG 135-2016: State system for ensuring the uniformity of measurements. Radiation-technological facilities with electron accelerators for medical products sterilization. Certificationtechniques
RMG 137-2016: State system for ensuring the uniformity of measurements. Photon and electron radiation absorbed doses at determination of sterilizing and maximum permissible dose for medical products undergoing radiation sterilization. Measurement technique
RMG 138-2016: State system for ensuring the uniformity of measurements. Radiation-technological facilities with radionuclide sources of radiation for medical products sterilization. Certification techniques
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