1 / 12

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

wes
Download Presentation

Brazilian Approvals

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript


  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.

More Related