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Brazilian Approvals PowerPoint PPT Presentation


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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 - PowerPoint PPT Presentation

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Brazilian Approvals

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Integration process

Brazilian Approvals

Electrical Equipments


Integration process

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


Integration process

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


Integration process

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)


Integration process

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)


Integration process

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)


Integration process

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.


Integration process

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


Integration process

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


Integration process

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


Integration process

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.


Integration process

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.