定价： 0元 / 折扣价： 0 元

定价： 1911元 / 折扣价： 1625 元

4.1 This practice is applicable to the use of calorimetric dosimetry systems for the measurement of absorbed dose in electron beams, the qualification of electron irradiation facilities, periodic checks of operating parameters of electron irradiation facilities, and calibration of other dosimetry systems in electron beams. Calorimetric dosimetry systems are most suitable for dose measurement at electron irradiation facilities utilizing conveyor systems for transport of product during irradiation.NOTE 1: For additional information on calorimetric dosimetry system operation and use, see ICRU Report 80. For additional information on the use of dosimetry in electron accelerator facilities, see ISO/ASTM 51649, and ICRU Reports 34 and 35, and Refs (1-3).64.2 The calorimetric dosimetry systems described in this practice are not primary standard dosimetry systems. The calorimeters are classified as Type II dosimeters (ISO/ASTM 52628). They might be used as internal standards at an electron beam irradiation facility, including being used as transfer standard dosimetry systems for calibration of other dosimetry systems, or they might be used as routine dosimeters. The calorimetric dosimetry systems are calibrated by comparison with transfer standard dosimeters.4.3 The dose measurement is based on the measurement of the temperature rise (dosimeter response) in an absorber (calorimetric body) irradiated by an electron beam. Different absorbing materials are used, but the response is usually defined in terms of dose to water.NOTE 2: The calorimetric bodies of the calorimeters described in this practice are made from low atomic number materials. The electron fluences within these calorimetric bodies are almost independent of energy when irradiated with electron beams of 1.5 MeV or higher, and the mass collision stopping powers are approximately the same for these materials.4.4 The absorbed dose in other materials irradiated under equivalent conditions can be calculated. Procedures for making such calculations are given in ASTM Practices E666 and E668, and Ref (1).4.4.1 Calorimeters for use at industrial electron accelerators have been constructed using graphite, polystyrene or a Petri dish filled with water as the calorimetric body (4-10). The thickness of the calorimetric body should be less than the range of the incident electrons.4.4.2 Polymeric materials other than polystyrene might also be used for calorimetric measurements. Polystyrene is used because it is known to be resistant to radiation (11) and because almost no exo- or endothermic reactions take place (12).1.1 This practice covers the preparation and use of semi-adiabatic calorimetric dosimetry systems for measurement of absorbed dose and for calibration of routine dosimetry systems when irradiated with electrons for radiation processing applications. The calorimeters are either transported by a conveyor past a scanned electron beam or are stationary in a broadened beam.1.2 This document is one of a set of standards that provides recommendations for properly implementing dosimetry in radiation processing, and describes a means of achieving compliance with the requirements of ISO/ASTM Practice 52628 for a calorimetric dosimetry system. It is intended to be read in conjunction with ISO/ASTM Practice 52628.1.3 The calorimeters described in this practice are classified as Type II dosimeters on the basis of the complex effect of influence quantities. See ISO/ASTM Practice 52628.1.4 This practice applies to electron beams in the energy range from 1.5 to 12 MeV.1.5 The absorbed dose range depends on the calorimetric absorbing material and the irradiation and measurement conditions. Minimum dose is approximately 100 Gy and maximum dose is approximately 50 kGy.1.6 The average absorbed-dose rate range shall generally be greater than 10 Gy·s-1.1.7 The temperature range for use of these calorimetric dosimetry systems depends on the thermal resistance of the calorimetric materials, on the calibration range of the temperature sensor, and on the sensitivity of the measurement device.1.8 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.9 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

定价： 468元 / 折扣价： 398 元 加购物车

4.1 Ionizing radiation is used to produce various desired effects in products. Examples of applications include the sterilization of medical products, microbial reduction, modification of polymers and electronic devices, and curing of inks, coatings, and adhesives (4).4.2 Absorbed-dose measurements, with statistical controls and documentation, are necessary to ensure that products receive the desired absorbed dose. These controls include a program that addresses requirements for calibration of routine dosimetry system.4.3 A routine dosimetry system calibration procedure as described in this document provides the user with a dosimetry system whose dose measurements are traceable to national or international standards for the conditions of use (see Annex A4). The dosimetry system calibration is part of the user’s measurement management system.1.1 This practice specifies the requirements for calibrating routine dosimetry systems for use in radiation processing, including establishing measurement traceability and estimating uncertainty in the measured dose using the calibrated dosimetry system.NOTE 1: Regulations or other directives exist in many countries that govern certain radiation processing applications such as sterilization of healthcare products and radiation processing of food requiring that absorbed-dose measurements be traceable to national or international standards (ISO 11137-1, Refs (1-3)2).1.2 The absorbed-dose range covered is up to 1 MGy.1.3 The radiation types covered are photons and electrons with energies from 80 keV to 25 MeV.1.4 This document is one of a set of standards that provides recommendations for properly implementing dosimetry in radiation processing, and describes a means of achieving compliance with the requirements of ASTM E2628 “Practice for Dosimetry in Radiation Processing” for the calibration of routine dosimetry systems. It is intended to be read in conjunction with ASTM E2628 and the relevant ASTM or ISO/ASTM standard practice for the dosimetry system being calibrated referenced in Section 2.1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

定价： 543元 / 折扣价： 462 元 加购物车

5.1 Microbiological water testing procedures using membrane filtration are based on the premise that all bacteria within a specific size range will be retained by the membrane filter used. If the membrane filter does not retain these bacteria, false negative results or lowered density estimates may occur that could have serious repercussions due to the presence of unrecognized potential health hazards in the water being tested, especially in drinking water.5.1.1 This procedure as devised will enable the user to test each membrane filter lot number for its ability to retain all bacterial equal to, or larger than, the stated membrane pore size.5.2 Since this membrane is often used to sterilize nonautoclavable liquids, it is essential that the retention characteristics of this membrane are stable.1.1 This test method covers a procedure to test membrane filters for their ability to retain bacteria whose diameter is equal to or slightly larger than the 0.2-µm pore size of the membrane filter.1.2 The procedures described are for the use of user laboratories as differentiated from manufacturers’ laboratories.1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

定价： 515元 / 折扣价： 438 元 加购物车

5.1 Microbiological water testing procedures using membrane filtration are based on the premise that all bacteria within a specific size range will be retained by the membrane filter used. If the membrane filter does not retain these bacteria, false negative results or lowered density estimates may occur that could have serious repercussions due to the presence of unrecognized potential health hazards in the water being tested, especially in drinking water.5.2 This procedure as devised will enable the user to test each membrane filter lot number for its ability to retain all bacteria equal to, or larger than, the stated membrane pore size.1.1 This test method covers a procedure to test membrane filters for their ability to retain bacteria whose diameter is equal to or slightly larger than membrane filters with pore size rated at 0.40 to 0.45 μm.1.2 The procedures described are for the use of user laboratories as differentiated from manufacturers’ laboratories.1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

定价： 515元 / 折扣价： 438 元 加购物车

1 Scope This International Standard specifies requirements for the use of moist heat in sterilization process development, validation of the sterilization process and control of routine sterilization. It covers all moist heat processes, including sa

定价： 774元 / 折扣价： 658 元

1 Scope 1.1 This International Standard establishes requirements and guidance for validation and routine control of ethylene oxide sterilization processes for medical devices. Particular attention is drawn to the need for specific testing for safe

定价： 819元 / 折扣价： 697 元

1 Scope This International Standard specifies requirements for validation, process control and routine monitoring in the r adiation sterilization of health care products. It applies to continuous and batch type gamma irradiators using the radionuclide

定价： 1274元 / 折扣价： 1083 元

4.1 Control charts are the primary process monitoring tool in SPC for radiation processing. The general objectives of implementing a SPC program with control charts are to:4.1.1 Increase knowledge of the process,4.1.2 Control the process to provide a targeted or required process output,4.1.3 Reduce variation of the process output or in other ways improve the performance of a process, and4.1.4 Identify single process run results that are outside of established control limits but may be within the USL and LSL limits.4.2 These objectives when achieved:4.2.1 Reduce costs through reduction of losses due to scrap, rework, and investigation time,4.2.2 Improve consistency of the process output,4.2.3 Facilitate preventive process adjustments, and4.2.4 Provide evidence of accurate process targeting and process performance; state of statistical control.1.1 This document provides guidance for the statistical analysis of the irradiation process from dosimetric data.1.2 This document is one of a set of guides and practices that provide recommendations for properly implementing dosimetry in radiation processing. It is intended to be read in conjunction with ISO/ASTM 52628 and ISO/ASTM 52303.1.3 This document employs a set of standard statistical methods and is intended to be read in conjunction with Practice E2586, Practice E2281, Practice E2587, and ASTM Manual MNL72.1.4 This guide is applicable to high-energy electron beam, X-ray and gamma-ray irradiation processes.1.5 This document assumes user knowledge of statistics, radiation processing, and radiation dosimetry. (See Annex A6)1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

定价： 843元 / 折扣价： 717 元 加购物车

定价： 1183元 / 折扣价： 1006 元

定价： 1274元 / 折扣价： 1083 元

1 Scope 1.1 This International Standard specifies general requirements for the characterization of a sterilizing agent, and for the development, validation and routing control of a sterilization process for medical devices. 1.2 This International

定价： 910元 / 折扣价： 774 元

定价： 1274元 / 折扣价： 1083 元