【国外标准】 Standard Terminology Relating to Radiation Processing: Dosimetry and Applications

3.1 The purpose of this standard is to facilitate communication and promote common understanding within the professionals in radiation processing research and industry.3.2 Unambiguous communication of concepts is crucial taking into account the relevant implications that may arise from misunderstandings with regard to equipment and materials involved in the standards dealing with any subject regarding radiation processing activities. Concepts dealing with dosimetry related to radiation processing and procedures for preparation, testing, and using dosimetry systems to determine the absorbed dose are present in all standards developed by E61 and ISO/TC85/WG3 and need to be designated by common terms and described by harmonized definitions in order to avoid misunderstandings.1.1 This terminology standard lists terms and definitions related to radiation processing concepts, especially radiation dose measurements. Use of this standard, and the common terminology, will foster clearer communication, and remove ambiguity.1.2 The use of ionizing radiation for the treatment of commercial products such as the sterilization of medical devices, the reduction of microbial contamination in food or the modification of polymers is referred to as radiation processing. The types of radiation used may be gamma radiation (typically from cobalt-60 sources), X-radiation or accelerated electrons.1.3 This standard provides terms and definitions for dosimetry for radiation processing concepts dealing with procedures related to operational qualification, performance qualification, and routine processing that may influence absorbed dose in the products, and types of dosimetry systems that may be used during calibration or on a routine basis as part of quality assurance in commercial radiation processing of products.1.4 When selecting terms and definitions, special care has been taken to include the terms that need to be defined, that is to say, either because the definitions are essential to the correct understanding of the corresponding concepts or because some specific ambiguities need to be addressed.1.5 The “Discussion” appended to certain definitions offers clarification or examples to facilitate understanding of the concepts described. In certain cases, miscellaneous information is also included, for example, the units in which a quantity is normally measured, recommended parameter values, references, etc.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.