Relatórios técnicos do FAQtos

302, 2021
Título Implants for surgery – Active implantable medical devices – Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
Resumo This Part 1 of EN 45502 specifies requirements that are generally applicable to ACTIVE IMPLANTABLE MEDICAL DEVICES. NOTE 1 For particular types of ACTIVE IMPLANTABLE MEDICAL DEVICES, these general 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 an ACTIVE IMPLANTABLE MEDICAL DEVICE to show compliance. This Part 1 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 1 of EN 45502 is also applicable to some non-implantable parts and accessories of the ACTIVE IMPLANTABLE MEDICAL DEVICES. NOTE 2 The terminology used in this European Standard is intended to be consistent with the terminology of Directive 90/385/EEC. NOTE 3 In this European Standard, terms printed in small capital letters are used as defined in Clause 3. Where a defined term is used as a qualifier in another term, it is not printed in small capital letters unless the concept thus qualified is also defined.
Fonte European Committee for Electrotechnical Standardization (CENELEC)
Origem Internacional
Autor/Editor CEN/CLC/JWG AIMD
Disponibilidade Disponível por encomenda
Endereço https://www.iso.org/standard/52804.html
Referência EN 45502-1:2015
Data Maio 2015
302, 2021
Título Maximum Exposure Levels to Radiofrequency Fields – 3 kHz to 300 GHz
Resumo This Radiation Protection Standard (hereafter referred to as ‘the Standard’) sets limits for human exposure to radiofrequency (RF) fields in the frequency range 3 kHz to 300 GHz. The Standard includes: • mandatory basic restrictions for both occupational and general public exposure involving all or part of the human body; • indicative reference levels for measurable quantities derived from the basic restrictions; • approaches for verification of compliance with the Standard; • requirements for management of risk in occupational exposure and measures for protection of the general public.
Fonte Australian Radiation Protection and Nuclear Safety Agency (ARPANSA)
Origem Austrália
Autor/Editor ARPANSA
Disponibilidade Disponível online
Endereço https://www.arpansa.gov.au/
sites/default/files/legacy/pubs/rps/rps3.pdf
Referência Radiation Protection Series Publication No. 3
Data Maio 2016
302, 2021
Título Limits of Human Exposure to Radiofrequency Electromagnetic Energy in the Frequency Range from 3 kHz to 300 GHz
Resumo The purpose of this code is to establish safety limits for human exposure to radiofrequency (RF) fields in the frequency range from 3 kHz to 300 GHz. The safety limits in this code apply to all individuals working at, or visiting, federally regulated sites. These guidelines may also be adopted by the provinces, industry or other interested parties. The Department of National Defence shall conform to the requirements of this safety code, except in such cases where it considers such compliance to have a detrimental effect on its activities in support of training and operations of the Canadian Forces. This code has been adopted as the scientific basis for equipment certification and RF field exposure compliance specifications outlined in Industry Canada’s regulatory documents (1–3), that govern the use of wireless devices in Canada, such as cell phones, cell towers (base stations) and broadcast antennas. Safety Code 6 does not apply to the deliberate exposure for treatment of patients by, or under the direction of, medical practitioners. Safety Code 6 is not intended for use as a product performance specification document, as the limits in this safety code are for controlling human exposure and are independent of the source of RF energy.
Fonte Healthy Environments and Consumer Safety (HECS)
Origem Canadá
Autor/Editor Consumer and Clinical Radiation Protection Bureau
Disponibilidade Disponível online
Endereço https://www.canada.ca/
content/dam/hc-sc/migration/hc-sc/ewh-semt/alt_formats/pdf/consult/_2014/safety_code_6-code_securite_6/final-finale-eng.pdf
Referência Safety Code 6 (2015)
Data Junho 2015
302, 2021
Título Microwave ovens
Resumo This Information Sheet discusses the operation and safety aspects of microwave ovens used in the home. More details about the nature of electromagnetic fields and health effects of radiofrequency and microwave fields are available in WHO Fact Sheets 182 and 183.
Fonte World Health Organization (WHO)
Origem Internacional
Autor/Editor World Health Organization (WHO)
Disponibilidade Disponível online
Endereço https://www.who.int
/news-room/questions-and-answers/item/radiation-microwave-ovens
Referência
Data Junho 2005
302, 2021
Título Diretiva 2013/35/UE do Parlamento Europeu e do Conselho relativa às prescrições mínimas de segurança e saúde em matéria de exposição dos trabalhadores aos riscos devidos aos agentes físicos (campos eletromagnéticos)
Resumo A presente diretiva estabelece as prescrições mínimas em matéria de proteção dos trabalhadores contra os riscos para a segurança e a saúde a que estão, ou podem vir a estar, sujeitos devido à exposição a campos eletromagnéticos durante o trabalho.
Fonte Parlamento Europeu e Conselho da União Europeia
Origem Internacional
Autor/Editor M. Schulz and A. Shatter
Disponibilidade Disponível online
Endereço https://eur-lex.europa.eu/
LexUriServ/LexUriServ.do?uri=OJ:L:2013:179:0001:0021:PT:PDF
Referência Jornal Oficial da União Europeias, L179/1, 2013/35/EU
Data Junho 2013
2020-03-18T10:56:47+00:00
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