Documentos (recomendações, normas, entre outros) de diversas entidades internacionais acerca dos limites de exposição à radiação eletromagnética.
Implants for surgery – Active implantable medical devices – Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
This part 1 of EN 45502 specifies requirements that are generally applicable to active implantable medical devices. For particular types of active implantable medical devices, these essential requirements are supplemented or modified by the requirements of particular standards which form additional parts of this European Standard. The tests that are specified in EN 45502 are type tests and are to be carried out on samples of a device to show compliance. This part of EN 45502 is applicable not only to active implantable medical devices that are electrically powered but also to those powered by other energy sources (for example by gas pressure or by springs). This part of EN 45502 is also applicable to some non-implantable parts and accessories of the devices. The device that is commonly referred to as an active implantable medical device may in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify some requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device. The terminology used in this European Standard is intended to be consistent with the terminology of Directive 90/385/EEC.
European Committee for Electrotechnical Standardization (CENELEC)
Medical electrical equipment: Part 1-2: General requirements for safety – Collateral standard: Electromagnetic disturbances – Requirements and tests
Specifies requirements and tests for electromagnetic compatibility of medical electrical equipment and medical electrical systems and serves as the basis of electromagnetic compatibility requirements and tests in Particular Standards. The existence of electromagnetic emission requirements is essential for the protection of: – safety services; – other medical electrical equipment and medical electrical systems; – non-medical electrical equipment (e.g. computers); – telecommunications (e.g. radio/TV, telephone, radio-navigation). The existence of electromagnetic immunity requirements is essential to assure safety of equipment and systems. The immunity test levels specified in this standard (EN 60601 test levels) represent the range found in the general medical use environment.
International Electrotechnical Commission (IEC) / International Organization for Standardization (isso)
Advice on Limiting Exposure to Electromagnetic Fields (0-300GHz)
The National Radiological Protection Board (NRPB) has the responsability for providing advice on exposure guidelines for electromagnetic fields (EMFs). As part of its policy of ongoing evaluation of scientific evidence and health risk assessment, NRPB has reviewed its advice on limiting exposure to EMFs and, at request of the Department of Health, has particulary addressed the issues of uncertainty in the science and aspects of precaution. As a result of this review, NRPB recommends the adoption of the guidelines of the International Commission on Non-Ionizing Radiation Protection (ICNIRP) for limiting exposure to EMFs.
Biological Effects and Exposure Criteria for Radiofrequency Electromagnetic Fields
NCRP Report No. 86 presents the result of a comprehensive evaluation of the available literature on the biological effects of radiofrequency electromagnetic fields. This Report begins with a discussion of studies of biological effects at the molecular level and continues to progressively larger scales of interaction, covering macromolecular and cellular effects, chromosomal and mutagenic effects and carcinogenic effects. The Report then goes on to treat systemic effects such as those relating to reproduction, growth and development, hematopoesis and immunology, endocrinology and the autonomic nerve function, cardiovascular and cerebrovascular effects, interaction of electromagnetic fields with the central nervous system and the special senses. The Report treats neurological effects and assesses studies relating to behavioral effects. The careful evaluation of the research studies forms the basis for the exposure criteria enunciated in the Report. These specify permissible levels, not only for individuals exposed occupationally, but for members of the general public exposed to radiofrequency electromagnetic radiation.
National Council on Radiation Protection and Measurements (NCRP)
Guidelines for Limiting Exposure to Time-Varying Electric, Magnetic, and Electromagnetic Fields (up to 300 GHz)
The main objective of this publication is to establish guidelines for limiting EMF exposure that will provide protection against known adverse health effects. An adverse health effect causes detectable impairment of the health of the exposed individual or of his or her offspring; a biological effect, on the other hand, may or may not result in an adverse health effect. Studies on both direct and indirect effects of EMF are described; direct effects result from direct interaction of fields with the body, indirect effects involve interactions with an object at a different electric potential from the body. Results of laboratory and epidemiological studies, basic exposure criteria, and reference levels for practical hazard assessment are discussed, and the guidelines presented apply to occupational and public exposure.
International Commission for Non-Ionizing Radiation Protection (ICNIRP)