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European Standards & Certification

Dinesh Chand Sharma (Director – Standardization, Policy and Regulation), Project SESEI (FIEO, 26th July 2016)

FIEO Delhi, 26th July 2016 Slide 2

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Content

Project SESEI

Standards and Why Standards

Standardization & Certification in Europe

FIEO Delhi, 26th July 2016 Slide 3

Project SESEI

FIEO Delhi, 26th July 2016 Slide 4

Project SESEI in brief

Seconded European Standardization Expert in India

local representative and a connect-between standardizers’ communities in EU/EFTA and India

EU-India dialogue and cooperation on standards, R&D, Innovation, and policy/regulation around standardization

Phase 3: March’16 to June’19

Project Owners

EU Standards Organizations (ETSI, CENELEC and CEN), European Commission and EFTA -European Free Trade Association

Project is managed by ETSI

Priority Sector for this phase of the project (3 Year)

Information & Communication Technologies (equipment and services)

Electrical equipment including Consumer Electronics – Smart Energy

Automotive - ITS

Smart City

Energy Efficiency in ICT, Manufacturing policy, WTO-TBT, IPR, R&D & Innovation

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What is a Standard

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What is a standard?

It is a document that define

technical or quality requirements

with which current or future

products, production processes,

services or methods may comply

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Always voluntary

Consensus based

Established by all interested parties

Driven mainly by business

Drafted by technical experts

Approved by a recognized, independent standardization body

Standard are :

FIEO Delhi, 26th July 2016 Slide 8

Why Standardization

© CEN-CENELEC 2014 - 9

Standards are Business tools

Comply with national legislation Eg. EN 30 Domestic cooking Appliances burning gas

Increase confidence of consumers &

social communities in products & services

Eg. EN 71-1: 2014 Safety of toys - Part 1: Mechanical and & physical properties

© CEN-CENELEC 2014 - 10

Improve safety of workers

Eg. Series EN 13087 –

Protective helmets – Test methods

Boost innovation: vehicle for transferring technical knowledge and provide market validation of research projects

Eg. CWA 16379 - Fuels and

biofuels – Pure plant oil

fuel for diesel engine concepts

Standards are Business tools

© CEN-CENELEC 2014 - 11

Increase effectiveness, efficiency & allow

companies to save money

Eg. EN ISO 50001 - Energy management systems –

Requirements with guidance for use

Standards are Business tools

© CEN-CENELEC 2014 - 12

Enhance accessibility

Eg. EN 81-70 - Rules for the improvement

of the accessibility of existing lifts

for persons including persons with disability

Improve quality of services

and comparability

Eg. EN 16224 - Healthcare provision

by chiropractors

Standards are Business tools

© CEN-CENELEC 2014 - 13

Environmental protection & sustainability

EN 13432 – Requirements for packaging

recoverable through composting and biodegradation

Promote understanding - common

terminology

EN ISO 18513 Tourism services - Hotels and other types of tourism - accommodation - Terminology

Standards are Business tools

© CEN-CENELEC 2014 - 14

Promote interoperability of products

& servicesEg. EN ISO 12855- Electronic fee

collection – Information exchange

between service provision

and toll charging

Eg. Telecommunication Standards GSM/WCDMA (2G,3G,4G) etc.

Standards are Business tools

EaS I Hyderabad, 16 Dec. 2015 Slide 15

Standardization in Europe

© CEN-CENELEC 2015 - 16

Standardization in Europe

Regulation 1025/2012 on European Standardization

• Sets legal framework for standardization in Europe

• Confirms importance of development of voluntary European Standards for services

• Recognises 3 European Standards Organizations (ESO) – CEN, CENELEC and ETSI

© CEN-CENELEC 2015 - 17

Expertise

ESOs cover standardization in all fields at European level

CEN: Chemistry, Material, Energy, Environment, Transport, Construction, Services, eMobility etc.

CENELEC: Electricity, Electro-technical

ETSI: Information & Communication Technologies (ICT)

Agreements at the international level with

ISO, IEC and ITU

© CEN-CENELEC 2015 - 18

European standardisation today

• Consumer protection

• Safe products

• Worker protection

• Health services

• Accessibility

• Economies of scale

• Interoperability of

products and services

• Competitiveness

• Facilitate trade

• Ecological

safety

• Environmental

management

• Energy efficiency

• Carbon footprint

• Air, soil & water

quality

EconomicGrowth

SocietalProgress

EnvironmentalIntegrity

© CEN-CENELEC 2015 - 19

European Standards by sector: CEN CENELEC

3040

24242374 2331

1835

1235 1202 1197 11921085

1026959

787

467 458353

287

103

0

500

1000

1500

2000

2500

3000

3500

~ 22355 standards

EaS I Hyderabad, 16 Dec. 2015 Slide 20

ETSI publishes between 2,000 and 2,500 standards every year.

Since their establishment in 1988, they have produced over 30,000.

— include the standards that enable key global technologies such as GSM™, 3G, 4G, DECT™, smart cards and many more standards success stories.

European Standards by sector: ETSI

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Standardization & CE Marking

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Standards vs Législation

Standards :

1. Voluntary

2. Consensual

3. Developed by independent organisations

4. Revised every 5 years

5. Provide specifications and test methods (interoperability, safety, quality, etc.)

Legislation :

1. Mandatory

2. Imposed by Law

3. Established by public authorities

4. Revised when legislators decide

5. Gives requirements to protect public interests

EaS I Hyderabad, 16 Dec. 2015 Slide 23

EU Council Directives

There are 40+ enacted Directives, and several more in-draft

The EU Directives are intended to:— Protect all EU Citizens from harm— Improve Citizens’ well-being— Provide essential Safety in Workplace, Home Life, and Leisure Activities. — Now also to address Environmental Protection

Eg. and Senior of the Directives: The Low Voltage Directive 73/23/EEC (LVD)Created in 1973 to assure a degree of Electrical Safety.

— Home and Business’ have 230 Volts, 50 Hz, 1Ǿ. — Heavy Industry uses 400 Volts, 50 Hz, 3Ǿ— Objective: To prevent Electric Shock, Burns, Injuries, Fires and Property Damage— There are several Product Specific Test and Evaluation Standards covering every type of electrically

powered product.

— Latest version is designated 2006/95/EC

Two Directives were enacted to provide Environmental Protection:

— RoHS- Restrictions of Hazardous Substances used in manufacture Controls Levels of Lead, Mercury, Cadmium, Hexavalent Chromium etc, used in products in

order to minimize seepage in land fills

— WEEE - Electronic Waste Disposal is being controlled.

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CE MARKING

Facilitate free movement of goods

in the Internal Market whilst ensuring a

high level of protection for consumers

Elimination of barriers to trade through technical harmonisation

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CE MARK Concept

The CE Mark with a Declaration of Conformity is analogous to a passport for products exported to the EU. Its intent is to IDENTIFY CompliantProducts so they are not delayed or held in Customs.

The CE MARK protocol is essentially an honor system accepted by EU member countries. Manufacturers can Self-Declare Compliance by adding CE MARKS and signing a Declaration of Conformity. It is also required that a Technical File be created.

The Technical File is the backup document for the CE MARK and Declaration of Conformity. The Technical File is NOT typically included with the product shipment. The Technical File is intended to:— Identify the Importer or Purchaser who is resident within the EU

— Describe the Product

— List Safety and Compliance Critical Parts

— Cite the applicable EU Directives

— List all Safety, EMC and Other Tests performed to Validate Compliance

— List Tests related to I.D. Number of each Test Standard used

EaS I Hyderabad, 16 Dec. 2015 Slide 26

CE MARK DeliverablesDetailed Findings Report is the first document generated. It is generated after the 1st safety review of the product. It is specific to the Clients Product. It includes viable suggestions for Corrections

The Findings Report notes any discrepancy in the product’s construction and offers suggestions

for making corrections. When appropriate we even suggest sources for key components and

alternatives.

The Declaration of Conformity provided as a draft

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CE Compliant Products Technical Report

EMC Test Report : EMC = ElectroMagnetic Compatibility

The “Technical File” or CE Mark Test Report

1. Includes a Declaration of Conformity (D.o.C). A separate D.o.C is also provided as a Certificate to accompany the shipping documents to an EU Port-of-Entry. Only one D.o.C. is required per shipment. This is regardless of the number of units in a single shipment.

2. The CE Mark Report is provided in pdf format and is known as a Technical File (TF). It is a detailed Report describing the product in detail and all of its testing. It bears the written opinion of a Competent and Independent 3rd Test Lab that the CE Marked Product has been evaluated and tested. It cites all of the Directives and Test Standards used in making the decision. The TF is used to set aside any challenges that a manufacturer may get as to the validity of the CE Mark.

4. If a customs official or a customer questions the validity of the CE Mark, a review of the TF should quickly set aside any concerns. Typically, one hard copy is kept at the main office and one sent to each Importer/Agent.

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All About CE Marking, NANDO, MRA & Market Surveillance

All About CE Marking NANDO

— Nando (New Approach Notified and Designated Organisations)

MRA

— Mutual recognition agreements

MS

— Market surveillance

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1. Identify Applicable Directive(s) and Harmonized Standards

2. Verify Requirements

3. Need for notified body?

4. Check Conformity

5. Technical Document [ report ]

6. Affix CE Marking

6 Steps Summary for Manufacturer

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Conclusions

Standards are Business Tools

Standards ensure interoperability of devices

Standardization is a tool to create markets as large and homogenous as possible to allow for economies of scale

Compliance with standards in support of regulation/legislation implies the right to place a device on the market, that is to offer it for sale

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Contact Details:

Dinesh Chand Sharma(Seconded European Standardization Expert in India)

Director – Standardization, Policy and Regulation

European Business Technology Centre, DLTA Complex, South Block, 1st Floor, 1, Africa Avenue, New Delhi

110029

Mobile: +91 9810079461, Tel: +91 11 3352 1500, dinesh.chand.sharma@eustandards.in

Thank you!