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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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slide1

Brazilian Approvals

Electrical Equipments

slide2

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
slide3

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
slide4

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)
slide5

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)

slide6

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)
slide7

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.
slide8

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
slide9

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
slide10

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
slide11

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.
slide12

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.