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Embedded Modules: Compliance and Compatibility Embedded Modules: Compliance and Compatibility Global electromagnetic field standards and regulatory requirements December 2011 Legal Notice The GSM Association (“Association”) makes no representation, warranty or undertaking (express or implied) with respect to and does not accept any responsibility for, and hereby disclaims liability for the accuracy or completeness or timeliness of the information contained in this document. The information contained in this document may be subject to change without prior notice. Copyright Notice Copyright © 2011 GSM Association Antitrust Notice The information contain herein is in full compliance with the GSM Association’s antitrust compliance policy. For further information about the content of this document please contact Dr Jack Rowley (Director Research & Sustainability): [email protected]. GSMA Member Use Only Contents Summary 1 Table of Abbreviations 2 Scope 4 Chapter One - EMF Compliance and Compatibility Standards 5 Overview 5 EMF Safety Standards 5 EMF Compatibility Standards 7 Immunity Standards in the Electro-Medical Area 8 Immunity Standards for Implanted Cardiac Pacemakers 11 Immunity Standards in the Automotive Area 12 Chapter Two – Low Power Exclusions and Compliance Assessment 13 Standards for Assessment of EMF Compliance 13 Chapter Three – Overview of Applicable Regulations 15 United States 15 Canada 17 Argentina 19 Brazil 19 China 19 Japan 20 South Korea 21 European Union 22 CIS Countries 22 Global Certification Forum (GCF) 23 PTCRB 24 Chapter Four – Design and Compliance Recommendations 26 Guidelines for Embedded Modules 26 Guidelines for Safety and EMC/EMI Design 26 Enclosures 29 A: China - Relevant Standards 29 B: USA – FCC RF Exposure Procedures and Equipment Authorization Policies 50 C: Canada - Certification of Radio Apparatus 60 D: Brazil - Certification and Authorization of Telecommunications Products 95 E: Japan – MIC Technical Regulations Conformity Certification System 132 F: South Korea - Limits and Conformity Evaluation 140 G: Russia – EMF Exposure Limits 295 GSMA Member Use Only Embedded Modules: Compliance and Compatibility EMF Standards and Regulatory Requirements Summary This report examines the requirements for compliance with human exposure standards for electromagnetic fields (EMFs) that may affect the use of embedded modules based on the GSM family of technologies generally operating at frequencies in the range 700 MHz to 3.5 GHz. The report also examines the electromagnetic compatibility (EMC) and electromagnetic immunity (EMI) standards relevant to automotive and hospital environments as these are areas of proposed application of embedded modules and where historically there have been issues raised in regard to the use of mobile phones. It does not address other restrictions that may apply to the use of mobile communications equipment in vehicles. The document provides outline information on the process for applying for certification in key national markets, however, it is not a substitute for examining the specific technical regulations applicable to each market. The GSMA has published Embedded Mobile Guidelines which lists a range of issues to be considered and incorporated into the design of the module. In addition to the existing guidelines this report identifies four variables that can be manipulated by the designer to achieve compliance with the relevant human exposure limits and the EMC/EMI limits for medical and automotive environments. The four variables are: Power reduction. Reduced duty cycle. Increased separation between the antenna and human contact. Alternative antenna selection. However, two key questions for the designer are: Will the device be used closer than 20 cm of the body? Different safety criteria apply when the device is used within 20 cm of the body. Will the device be used in the medical environment? There are several standards that address the immunity levels of electro-medical equipment in the bands of operation of cellular phones and these immunity standards are generally the most difficult with which to comply. Given that key decision points dictate the type of safety compliance measurements it is recommended that suitable experts are consulted during the design and prototype process. In addition, because the various national regulatory arrangements can be complex and subject to ongoing change it is further recommended that early in the design process consultation should take place with experts in the regulatory and compliance arrangements for the particular target markets. Legal information 1 GSMA Member Use Only Embedded Modules: Compliance and Compatibility EMF Standards and Regulatory Requirements Table of Abbreviations 3G 3rd Generation mobile telecommunications 3GPP 3rd Generation Partnership Project ANATEL Agência Nacional de Telecomunicações (Brazil) ANSI American National Standards Institute AQSIQ General Administration of Quality Supervision, Inspection & Quarantine BRA Bureau of Radio Administration (China) CCC China Compulsory Certification Certificate CDMA Code-Division Multiple Access CE (Mark) Conformité Européenne or European Conformity (Mark) CNC Comisión Nacional de Comunicaciones (Argentina) CNCA Certification and Accreditation Administration of China CIS Commonwealth of Independent States CTIA Cellular Telecommunications Industry Association (The Wireless Association) DECT Digital Enhanced Cordless Telecommunications EED Electro Explosive Device EMC Electro-Magnetic Compatibility EMF Electro-Magnetic Field EMI Electro-Magnetic Interference ESA Electronic Sub Assembly EU European Union E-UTRAN Evolved UMTS Terrestrial Radio Access Network FCC Federal Communications Commission (USA) FDA Food and Drug Administration (USA) GCF Global Certification Forum GERAN GSM EDGE Radio Access Network GPRS General Packet Radio Service GSM Global System for Mobile communications - originally Groupe Spécial Mobile HIPERLAN High Performance Radio LAN HSPA High Speed Packet Access IC Industry Canada ICNIRP International Commission for Non-Ionizing Radiation IEC International Electrotechnical Commission IEEE Institute of Electrical and Electronics Engineers ILO International Labour Organization ITU International Telecommunication Union KCC Korea Communications Commission KDB Knowledge Data Base (US FCC) LAN Local Area Network LMA Limited Modular Approval Legal information 2 GSMA Member Use Only Embedded Modules: Compliance and Compatibility EMF Standards and Regulatory Requirements LTE Long-Term Evolution ME Medical Equipment MHRA Medicines and Healthcare products Regulatory Agency (UK) MIC Ministry of Internal Affairs and Communications (Japan) MIIT Ministry of Industry and Information Technology (China) MRA Mutual Recognition Agreement NAL Network Access License (China) NCRP National Council on Radiation Protection & Measurements NGO Non-Governmental Organization NHS National Health Service (UK) OCD Designated Certification Organization (Brazil) OET Office of Engineering and Technology (FCC) PBA Permit But Ask Procedure (US FCC) PBR Private Business Radio PDA Personal Digital Assistant PTCRB PCS Type Certification Review Board RF Radio-Frequency RLAN Radio Local Area Network RRA Radio Research Agency (South Korea) RTA Radio Type Approval Certificate (China) R&TTE Radiocommunications Telecommunications Terminal Equipment (Directive) SAR Specific Absorption Rate (unit of W/kg) SDoC Suppliers’ Declaration of Conformity SEPA State Environmental Protection Administration (China) SIM Subscriber Identity Module TAB Telecom Administration Bureau (China) TAC Technical Acceptance Certificate (Canada) TCB Telecommunications Certification Body TCF Technical Construction File TETRA Terrestrial Trunked Radio System UMTS Universal Mobile Telecommunications System UN United Nations USB Universal Serial Bus UTRAN Universal Terrestrial Radio Access Network WCDMA Wideband Code-Division Multiple Access WHO World Health Organization Legal information 3 GSMA Member Use Only Embedded Modules: Compliance and Compatibility EMF Standards and Regulatory Requirements Scope This document applies only to the GSM family of technologies primarily GSM, GPRS, 3G (WCDMA), HSPA and LTE. The content examines requirements for compliance with human exposure standards for electromagnetic fields (EMFs) that may affect the use of embedded modules based on the GSM family of technologies generally operating at frequencies in the range 700 MHz to 3.5 GHz. It primarily addresses the standards that apply to exposures of the public. Many standards include specific restrictions (often allowing higher levels of exposure1) for professional users of radiofrequency (RF) transmitting equipment, however, it is assumed that embedded modules will be mostly intended for non-professional applications. This document also examines the electromagnetic compatibility (EMC) and electromagnetic immunity (EMI) standards relevant to automotive and hospital environments as these are areas of proposed application of embedded modules and where historically there have been issues raised in regard to the use of mobile phones. It does not address other restrictions that may apply to the use of mobile communications equipment in vehicles. The document provides outline information on the process for applying for certification in some markets. It is not a substitute for examining the specific technical regulations applicable to each market. Recommendations are provided for amendments to the GSMA Embedded Mobile Guidelines2 and areas of work identified in regard to compliance standards
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