Electrical Equipments Brazilian Approvals Electrical Equipments

Conformity Assessment Programs GOVERNMENT AGENCIES INVOLVED: INMETRO (The National Institute of Metrology, Standardization and Industrial Quality) www.inmetro.gov.br Conformity assessments programs in general Certification and Energy Efficiency Labelling Program ANATEL (National Telecommunication Agency) www.anatel.gov.br All Telecom products have special requirements in Brazil ANVISA (National Health Surveillance Agency ) http://www.anvisa.gov.br/eng/index.htm Medical devices in general IBAMA (Brazilian Institute of Environment and Natural Resources) http://www.ibama.gov.br/ Noise Level Labelling Program

Mandatory/Voluntary Certifications: Brazilian Certification Structure Brazilian Certification Process: INMETRO (All kinds of products, except Telecom products) ANATEL (Telecommunication products) Brazilian Registration Process (usually it is done by the local representative): ANVISA (Medical devices) IBAMA (Noise Level Labelling Program) Brazilian Standards: ABNT/NBR (All kinds of product, most of them are translated from IEC standards) Lab Accreditation (17025 audit): INMETRO

INMETRO Certification Process Initial Process Product Documents by Customer Tests (Test reports can be accepted by accredited laboratories – accreditation body is member of ILAC) Factory Inspection (items from ISO 9001:2008) Tests Reports and Documents Analysis Technical Report Conformity Certificate Maintenance Process (1 or 2 times / year) Partial tests required for mandatory or voluntary processes Factory Inspection (routine tests are verified)

INMETRO: Mandatory List - Examples Components: Plugs and Socket-Outlets (ABNT NBR NM 60884-1 and NBR 14136) Switches for fixed installations (NBR NM 60669-1) Circuit Breakers (NBR IEC 60947-02 and NBR NM 60898) Wires and cables (NBR NM 247, NBR 13249 and others) Plug and Socket-Outlets Adapters (NBR 14936) Magnetic Ballasts (NBR 5114 and NBR 5172) Electronic Ballasts (NBR 14417 and NBR 14418) House Appliances: Drinking Fountains (NBR 335-1 and IEC 60730-2-8) Water filters (NBR 14908 and NBR 15176) (new INMETRO rule for all house appliances after July 2011)

INMETRO: Mandatory List - Examples IT Equipments: Voltage Stabilizer (NBR 14373) Areas: Eletro-medical devices (ABNT NBR NM 60601 series) Electric Equipments for use in Explosive Atmospheres, under inflammable gases and steam conditions (IEC 60079 series, IEC 60529 and IEC 60034-5)

INMETRO Process – New Mandatory Certification INMETRO Decree number 371 from December 29th 2009 After July 2011: all house appliances with mandatory certification Mandatory list: IEC 60335-2-X family Main differences Maintenance process performed every 1 year; Samples for maintenance tests collected in the market or Brazilian importer warehouse; Customer complaint service to be checked in the Brazilian Distributor or Importer.

INMETRO Energy Efficiency Labelling Program ENERGY EFFICIENCY LABELLING PROGRAM (PROCEL) Partial Mandatory List: Air conditioners; Refrigerators; Gas Stoves; Washing Machines; Ceiling Fans; LCD TV’s. General Characteristics Certification Bodies not involved; Applied directly to INMETRO by the Brazilian Legal Representer or Importer; Tests performed in Brazilian accredited laboratories or manufacturer laboratories after INMETRO evaluation

ANATEL – Telecom Products Rules: ANATEL Resolutions: Examples: 242 - Certification and homologation rules 323 - Product Certification Standard 529 - Electric Safety Tests Technical Requirements: ANATEL specific rules for product classification Basic Steps: Product classification under ANATEL Requirements => applicable tests and procedures Certification => product tests and technical analysis Homologation => document verification done by ANATEL Maintenance => recurring events based on Product Category

ANVISA: Medical Products Certification Process: INMETRO => mandatory certification of eletro-medical devices Certification Bodies => certification process Registration Process: ANVISA: Health Surveillance Brazilian Agency Registration Offices and/or Legal Representers or Importers Basic Steps: Product classification under applicable Brazilian standards Verification if standards are under mandatory certification Certification => product tests and technical analysis Registration => document verification and ANVISA Requirements Maintenance => yearly document verification or factory inspection

ANVISA: Medical Products Main Rules: Directive Resolution (RDC) number 032 from 2007 Defines Registration Process as mandatory; Basic procedure for registration process; The certification is required for the registration process; Normative Instruction (IN) number 08 from 2009 List of applicable standards under mandatory registration process; The IEC 60601-1 Applicable Medical Devices shall be certified according to INMETRO rules.

IBAMA: Noise Level Labelling Program Also known as SELO RUIDO Mandatory List: Vacuum cleaners; Blenders; Hair Dryers. General Characteristics Certification Bodies partially involved; Tests: only Brazilian accredited laboratories; Samples: collected in Brazilian local distributor; Noise Level Declaration: issued by Certification Bodies; Declaration applied directly to IBAMA Agency by the Brazilian Legal Representer or Importer to get authorization to use the Selo Ruido Label.