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Brazilian Approvals

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

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Brazilian Approvals

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  1. Brazilian Approvals Electrical Equipments

  2. 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

  3. 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) • ANATEL (Telecommunication products) • IBAMA (Noise Level Labelling Program) • Brazilian Standards: • ABNT/NBR (All kinds of product, most of them are translated from IEC standards) • ANATEL (Telecommunication products) • Lab Accreditation (17025 audit): • INMETRO

  4. 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)

  5. 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)

  6. 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)

  7. 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.

  8. 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

  9. 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

  10. 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

  11. 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.

  12. 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.

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