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ISO DIS 20031 - Radiological protection - Monitoring and dosimetry for internal exposures due to wound contamination with radionuclides
January 14, 2019 - ISO

This document specifies the requirements for personal contamination monitoring and dose assessment following wounds involving radioactive materials. It includes requirements for the direct monitoring at the wound site, monitoring of uptake of radionuclides into the body and assessment of...

ISO 20046 - Radiological protection — Performance criteria for laboratories using Fluorescence In Situ Hybridization (FISH) translocation assay for assessment of exposure to ionizing radiation
March 1, 2019 - ISO

The purpose of this document is to provide criteria for quality assurance (QA), quality control (QC) and evaluation of the performance of biological dosimetry by cytogenetic service laboratories. This document addresses: a) the responsibilities of both the customer and the laboratory; b) the...

Dose, Benefit, and Risk in Medical Imaging
October 29, 2018 - CRC

This timely overview of dose, benefit, and risk in medical imaging explains to readers how to apply this information for informed decision-making that improves patient outcomes. The chapters cover patient and physician perspectives, referral guidelines, appropriateness criteria, and...

AAMI TIR40 - Sterilization of health care products-Radiation- Guidance on dose setting utilizing a Modified Method 2
January 1, 2018 - AAMI

Inclusions This TIR describes a modification to Methods 2A and 2B of ANSI/AAMI/ISO 11137-2 that reduces the number of incremental doses needed to determine the minimum dose required to achieve a predetermined sterility assurance level (SAL). This method of sterilization dose...

DS/CEN ISO/TS 13004 - Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD
June 18, 2014 - DS

1.1 Inclusions This Technical Specification describes a method for substantiating a selected sterilization dose of 17,5, 20, 22,5, 27,5, 30, 32,5 or 35 kGy that achieves a sterility assurance level (SAL) of 10-6 or less for radiation sterilization of health care products. This Technical...

DS/EN ISO 17099 - Radiological protection – Performance criteria for laboratories using the cytokinesis block micronucleus (CBMN) assay in peripheral blood lymphocytes for biological dosimetry (ISO 17099:2014)
October 18, 2017 - DS

ISO 17099:2014 addresses the following: a) confidentiality of personal information for the customer and the laboratory; b) laboratory safety requirements; c) radiation sources, dose rates, and ranges used for establishing the calibration reference dose-effect curves allowing the...

ISO 11137-2 - Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
June 1, 2013 - ISO

This part of ISO 11137 specifies methods for determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10−6. This part of ISO...

AAMI TIR13004 - Sterilization of health care products-Radiation-Substantiation of a selected sterilization dose: Method VDmax SD
September 3, 2013 - AAMI

Inclusions This Technical Specification describes a method for substantiating a selected sterilization dose of 17.5, 20, 22.5, 27.5, 30, 32.5 or 35 kGy that achieves a sterility assurance level (SAL) of 10−6 or less for radiation sterilization of health care products. This Technical...

CEI EN 62387 - Radiation protection instrumentation - Passive integrating dosimetry systems for individual, workplace and environmental monitoring of photon and beta radiation
January 1, 2017 - CEI

This standard applies to all kinds of passive dosimetry systems that are used for measuring - the personal dose equivalent Hp(10) (for whole body dosimetry), - the personal dose equivalent Hp(3) (for eye lens dosimetry), - the personal dose equivalent Hp(0,07) (for both whole...

AAMI 11137-2 - Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
January 1, 2013 - AAMI

This part of ISO 11137 specifies methods for determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10-6. This part of ISO...

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