REGULATORY REQUIREMENTS FOR SOUTH AMERICA

COUNTRIESMARCO A. BUCCIARELLI ROQUE

June, 2018

INTRO: SOUTH AMERICA CERTIFICATION SCHEME

OCPs: ABNT (ISO/IEC 17065)

LABs: ABNT (ISO/IEC 17025)

OCSs: ABNT (ISO/IEC 17021)

CGCRE OAA

IRAN

ONAC

AVLIX

CNA

AVLIX

127-220V

60Hz

BR

220V

50Hz

Au/Nz

110V

60Hz

US

220V

50Hz

BR

BRASIL ARGETINA COLOMBIA CHILE

INTRO: SOUTH AMERICA CERTIFICATION – INITIAL PROCESS

Steps to Certificate a product in the main countries of South America

Client is ready to

sell/import the

product

1.) Document Analysis

2.) Laboratory Testing

3.) Factory Auditing

4.) Surveillance

ILAC MoU Local ILAC

Local

BRAZIL: INMETRO REQUIREMENTS FOR ELECTRICAL EQUIPMENT

1. OCP should be accredited by Inmetro

2. Follow the Certification Steps

Engineering Docs: Up to date

Type Test report: 3 years old

Audit report: 1 year old ???

ISO 9001: 2015

ISO 13485: 2016 / MDSAP

ISO 80079-34: 2018

3. Maintenance and Planning

Test Results Conducted Abroad

For products already certified abroad, the tests

performed by laboratories outside Brazil can be

accepted if these laboratories are accredited by

INMETRO or by some Accreditation Body that

is recognized by INMETRO and a MoU (Service

Agreement) is signed.

a) Interamerican Accreditation Cooperation -

IAAC

b) European Cooperation for Accreditation - EA

c) International Laboratory Accreditation

Cooperation - ILAC

BRAZIL: ISO 9001: 2015

BRAZIL: MEDICAL

Audit report: 1 year old ???

ISO 13485: 2016 / MDSAP

BRAZIL: MAINTENANCE AND PLANNING

BRAZIL: TYPE TESTS, QUALITY SYSTEM EVALUATION AND

SURVEILLANCE

Technical Evaluation of the Product - by IEx;

Definition of the Test Lab – by IEx with NEMKO Affiliates labs or ILAC Members;

Test plan - prepared by IEx and submitted to the Test Laboratory;

Initial Audit - performed by IEx or under NEMKO x IEx MoU (if the manufacturer is ISO 9001:2015 Registered, only the additional requirements are performed, Routine tests and the Brazilian law of consumer protection);

For products already certified by the IECEE / IECEx Schemes – CBTL and CIG 023+ / ExTR and QAR;

For products not certified by the IECEx Scheme – Test Results from Test Lab accredited by an ILAC.

Certificate Validity: from 2 years to 5 years.

BRAZIL: PRODUCT CATEGORY + ORDINANCES:

IT: Ordinance N# 170:2012; 407:2015; 048:2017

Digital Devices ICP Brasil: Ordinance N# 8:2013

Audio & Video: Self declaration N# 563:2014

Appliances: Ordinance N# 371:2009 ; 121:2015

Pressure Sound: Ordinance N# 268:2009

Pumps: Self declaration N# 455:2010

Washing Machines: Ordinance N# 553:2015; Self declaration N# 185:2015

Compressors: Ordinance N# 402:2012

Microwaves ovens: Ordinance N# 497:2011

Commercial ovens: Ordinance N# 446:2012

Freezer and Refrigerators: Self declaration N# 577:2015

Fans: Ordinance N# 20:2012; N# 113:2018

Air Conditioning: Ordinance N# 007: 2011

Ex: Ordinance N# 179:2010

Industrial Valves: Ordinance N# 272:2011

BRAZIL: PRODUCT CATEGORY + ORDINANCES:

Medical & Dental Devices: Ordinance N# 054:2016

Lite:

LED: Ordinance N# 144:2015 ; 076: 2016 ; 221: 2016

Lamps: Ordinance N# 498:2010; N# 483:2010

Ballast: Ordinance N# 20:2002; N# 267:2009

LV directive:

Circuit Breaker: Ordinance N# 348:2007 ; 102 : 209

Plugs and Outlets: Ordinance N# 85:2006

Wiring and Cables: Ordinance N# 640:2012

Switches: Ordinance N# 234:2008

Induction Motors: Self declaration N# 488:2010

Transformers: Self declaration N# 378:2010

Miscellaneous: Ordinance N# 355: 2011

LV installation: Ordinance N# 51:2014

PV: Self declaration N# 4:2011

BRAZIL: REQUIREMENTS

Safety: 90% harmonized with IEC standards

EMC: 60% harmonized with CISPR, IEC 60601 & IEC 60001, EN 55

Environmental: RoHS and WEEE only for wire and cables

Energy efficiency: similar with Energy Star (USA), tested in Brazil or accredited by Inmetro.

Acoustics: For appliances (vacuum cleaner, mixers and hair dryer). ISO 374X, IEC 60704-2.

Radio: ANATEL only local type tests for telecom and wireless applications

Other Requirements: water quality

Other South America Countries: Safety and Radio for telecom.

PARTNERSHIP BETWEEN NEMKO AND IEX

Full Service

Enable product safety + Access to Brazilian Market (invisible service):

Local company

Distributor

Importer

Forward

Customs

Bi-lingual certificate of conformity (CoC)

IEx means planning. By the end of the initial process:

2 - 5 years plan

Selection of samples (if needed) by local NEMKO

Maintenance confirmation – ATESTATE

NEXT STEPS

Regulatory Convergence (harmonized and accepted) in South America: 2019

Infra-Structure power certification (Based in ISO 37001 + Local Requirements)

ISO 9001:2015

ISO 13485:2016

ISO/IEC 80079-34: 2018