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AMI4900: Engineering Design

Unit 3: Regulatory Requirements

Section 2:

Overview of regulatory requirements in the European Community and other major world markets, such as the USA, Japan, and the Far East

Content

• 3.2.1 Introduction
• 3.2.2 European Directives
• 3.2.3 USA
• 3.2.4 Japan

3.2.1 Introduction

The aim of the section on Overseas Regulatory Requirements is not to specify what all the regulations are but to identify who designs them. If there are any specific regulations which implicitly affect the way in which products need to be manufactured they will be mentioned.

It is important to remember that by satisfying and working to British Standards and the associated regulations, such as, CE marking, a product will be compatible for sale and use in the EU and also around the rest of the world.

Regulations specified by other countries are important and should be noted and adhered to if wishing to export products to them. This section will provide information as to the source of regulations and also where they can be found.

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3.2.2 European Directives

3.2.2.1 European Union

The legislative acts of the European Union (EU) can have different forms: regulations , directives, decisions , recommendations and opinions .

A European Union Directive is the (mutually binding) collective decision made by the member states, acting through their national Government Ministers in the Council of the European Union and the Parliament . It is not an "order from Brussels ".

Directives can be found online at: http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/reflist.html

European Directives apply to all member states of the EU, that is:

Austria Belgium Cyprus Czech Republic Denmark Estonia Finland France Germany Greece Hungary Ireland Italy Latvia Lithuania Luxembourg Malta Netherlands Poland Portugal Slovakia Slovenia Spain Sweden United Kingdom

and are also directly used by and accepted in and from:

Iceland Norway Liechtenstein  

3.2.2.2 Protocols to the Europe Agreements on Conformity Assessment and Acceptance of Industrial Products (PECAs)

The Europe Agreements are the basic accords governing bilateral relations between the European Communities and their Member States . They also cover candidate countries. Candidate countries for EU membership should approximate their legislation to that of the Community. In the field of industrial standards and conformity assessment, the Europe Agreements aim to achieve the candidate countries' full conformity with Community technical regulations and European standardisation and conformity assessment procedures.

PECAs are the major instrument of the pre-accession strategy in the field of the free movement of goods. They represent recognition of progress made in adopting and implementing the relevant EC legislation on industrial products, and in creating the necessary administrative infrastructure.

Basically this means that Electrical Equipment complying with European directives, as interpreted by individual member countries, can enjoy free movement to countries with a PECA in force.

Information on the status of each individual country in relation to PECAs can be found at:

http://europa.eu.int/comm/enterprise/regulation/pecas/pecas.htm

3.2.2.3 Customs Agreement with Turkey

A Customs agreement has been agreed to set up a free trade agreement between the EU and Turkey . This essentially allows for a stepped harmonisation of Turkish and EU laws. That is, to export to Turkey European goods must satisfy all relevant legislation and have CE marks attached where applicable. It also means that Turkish goods being exported to the EU must begin to approach the requirements required for CE marking.

One of the key factors is that when considering EU states and EU legislation Turkey should be though of as one of the EU member states.

Full information on the treaty between Turkey and the EU can be found at:

http://europa.eu.int/comm/enlargement/turkey/pdf/ec_tk_ass_council_1_95_en.pdf

3.2.2.4 Mutual Recognition Agreements (MRAs)

Mutual Recognition Agreements (MRAs) are established between the EU and the Government of countries, which are on a comparable level of technical development and have a compatible approach concerning conformity assessment. These agreements are based on the mutual acceptance of test reports, certificates and marks of conformity issued by the conformity assessment bodies of one of the Parties of the Agreement in conformity with the legislation of the other Party.

Generally MRAs require more than just compliance with the Regulations.

Switzerland has its own MRA in place; the details can be found at:

http://trade-info.cec.eu.int/tbt/mra.cfm?id=46

Other information on MRAs can be found at:

http://europa.eu.int/comm/enterprise/international/indexb1.htm

 3.3.2.5 Individual Member States

Although EU legislation governs the overall legislation that member countries must adhere to and also controls imports to the EU individual member states also have their own legislative bodies in the same way that British Standards supply legislation in the UK .

3.2.2.5.1 EU Wide

Electrical legislation is prepared on an EU wide basis by CENELEC. CENELEC is the European Committee for Electrotechnical Standardization . This is the body which advises the EU directly.

CENELEC supplies the standards for the following EU countries and is the originator of the EN standards. The countries which CENELEC operates for are:

Belgium Italy The Netherlands Austria Denmark Norway Portugal Sweden Switzerland Finland Denmark Ireland Spain Luxembourg Greece Iceland Czech Republic Malta Hungary Slovakia Lithuania Estonia Latvia Poland Slovenia Cyprus

The affiliate members of CENELEC who adhere to its standards are:

Turkey Albania Macedonia Croatia Bulgaria Romania Bosnia-Herzegovina

Ukraine

Information pertaining to CENELEC can be found at:

http://www.cenelec.org/

3.3.2.5.2 Germany

The German organization that compiles the standards is the "Deutscher Industrie Normenausschuss " or DIN. DIN has been recognized since 1975 by the German government as the national standards body and represents Germany 's interests internationally and in the EU.

Information relating to German Standards can be found on the DIN website:

http://www.din.de

DIN aims to promote rationalization, quality assurance, safety, and environmental protection as well as improving communication between industry, technology, science, government, and the public domain.

3.2.2.5.3 France

The "Association Française de Normalisation" AFNOR is the French authority in charge of coordinating the establishment of standards for the French ma rket in full compliance with European Union standards. AFNOR prepares new and revised standards, subjects them to French public inquiry, and finally submits them to the relevant French ministry for approval.

Information on AFNOR can be found at:

http://www.afnor.fr

3.2.2.5.4 Other EU Standards

The main regulations in Europe are BS, DIN, AFNOR and CENELEC. Adherence to BS, DIN, AFNOR or CENELEC will ensure compliance across the rest of the EU.

It must be remembered, though, that conformance to EU regulations and the ability to affix CE marks will enable free movement of good across the EU, Switzerland , Turkey , Iceland , Norway and Liechtenstein .

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3.2.3 USA

3.2.3.1 Standardisation Body

The American National Standards Institute (ANSI) is a private, non-profit standards organization that serves as a facilitator for the standardization work of its members in the United States .

ANSI has its own website where full details can be found. It is:

http://www.ansi.org/

In the same way that British Standards are marked and goods that satisfy EU regulations are CE marked; ANSI has its own mark. This mark denotes products which have satisfied all ANSI regulations. The mark must be in specific dimensions and colours. An example of an approved ANSI mark is:

Figure 3.2.1

ANSI Mark

3.2.3.2 Standard Setting

ANSI facilitates the development of American National Standards (ANS) by accrediting the procedures of standards developing organizations (Sods). The SDO for electrical regulations in the USA is the Institute of Electronics and Electrical Engineers (IEEE). Its website is: http://www.ieee.org/portal/site

Accreditation by ANSI signifies that the procedures used by the standards body in connection with the development of American National Standards meet the Institute's essential requirements for openness, balance, consensus and due process.

Before Ana's are developed and applied IEEE lays out guidelines. These are then taken further by ANSI which, if the guidelines are acceptable, applies them to create standards. For example:

IEEE C57.12.22 1993 PAD-MOUNTED, COMPARTMENTAL-TYPE, SELF COOLED THREE PHASE DISTRIBUTION TRANSFORMERS WITH HIGH-VOLTAGE BUSHINGS, 2500 KVA AND SMALLER HIGH VOLTAGE, 34 500 GRDY/19 920 VOLTS AND BELOW LOW VOLTAGE, 480 VOLTS AND BELOW

Became

ANSI C57.12.22 1998 TRANSFORMERS- PAD-MOUNTED, COMPARTMENTAL-TYPE, SELF-COOLED, THREE-PHASE DISTRIBUTION TRANSFORMERS WITH HIGH-VOLTAGE BUSHINGS, 2500 KVA AND SMALLER: HIGH VOLTAGE, 34 500 GRD Y/19 920 VOLTS AND BELOW; LOW VOLTAGE, 480 VOLTS AND BELOW

Some of the examples of regulations applied by ANSI after the information has been supplied by IEEE are:

• ANSI C37.17 TRIP DEVICES FOR AC AND GENERAL PURPOSE DC LOW VOLTAGE POWER CIRCUIT BREAKERS

• ANSI Y32.9 GRAPHIC SYMBOLS FOR ELECTRICAL WIRING & LAYOUT DIA

3.2.3.3 International Standardisation

ANSI promotes the use of U.S. standards internationally, advocates U.S. policy and technical positions in international and regional standards organizations, and encourages the adoption of international standards as national standards where they meet the needs of the user community.

3.2.3.4 Health and Safety

Health and Safety Law in the United States is controlled by the Occupational Safety & Health Administration (OSHA) which is part of the US Department of Labor. OSHA standards determine how products need to be treated so that they are safe to work with. Whilst not specifying control regulations they do identify what is needed to make products safe for use.

OSHA has its own website at: http://www.osha.gov/

And electrical information can be found at: http://www.osha.gov/SLTC/electrical/standards.html

An example of what is contained within an OSHA standard is:

OSHA Reg. 1910.303 , General requirements - This specifies, as it suggests, the general requirements for working with electricity. It is not for use on its own but in coordination with ANSI regulations. Using the two together should ensure that all legislative requirements are satisfied.

3.2.3.5 Further Investigations

To become familiar with the intricacies of American standards it is worthwhile spending time exploring the IEEE, OSHA and ANSI websites. By doing this greater familiarity with the system and the demands it has for any product which needs to be sold-on the United States will be gained.

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3.2.4 Japan

3.2.4.1 Introduction

Japanese standards operate in much the same way as European standards. That is, a standardisation body sets the standards to which products must adhere. This section will give some information and sources for where to find that information.

3.24.2 Standardisation Body

The standardisation body for Japan is the Japanese Standards Association (JSA). The aim of JSA is to:

JSA operates for Japan in the same way as BS does in Britain or DIN in Germany . That is, it works with recognised bodies to establish safe ways of work and good procedures which then become embedded practice.

JSA has its own website with a default to English to make understanding of it more straightforward. It can be found at:

http://www.jsa.or.jp/default_english.asp

3.2.4.3 Markings

JSA has its own mark. This is after the fashion of the kitemark. The carrying of the JIS mark

The JIS mark is illustrated below.

Figure 3.2.2

JIS Mark

3.2.4.4 Regulations

The main regulation which affects electrical goods is the Electrical Appliance and Material Safety Law (Law No. 234 of 1961). This law has the purpose of regulating manufacture, sale, etc. of electrical appliances and materials. It also has the aim of promoting voluntary activities by private businesses to ensure the safety of electrical appliances and materials so as to prevent hazards and interference.

This law, in common with European laws does not specify the actual standards which must be adhered to but lays out a framework to work to. The law may be classed as a skeleton to which JSA supplies the flesh. This, again, is in the same fashion as European legislation.

JSA standards can be found online at their website. A Japanese standard is known as a JIS standard. For example, one JIS standard is:

JIS B 9960-1:1999 - Safety of machinery -- Electrical equipment of machines -- Part 1: General requirements. The JSA website helpfully gives an abstract from the standard and in this case the abstract is:

http://www.webstore.jsa.or.jp/webstore/Com/FlowControl.jsp?lang=en&bunsyoId=JIS+B+9960-1%3A1999&dantaiCd=JIS&status=1&pageNo=0

Another standard with its abstract is:

JIS C 4901:2000 - Low-voltage power capacitors

"This Japanese Industrial Standard specifies phase advance metallized capacitors to be used indoors in a circuit at an a.c. voltage not exceeding 600V and at power frequency being connected in parallel to the load, for the purpose of power factor improvement."

http://www.webstore.jsa.or.jp/webstore/Com/FlowControl.jsp?lang=en&bunsyoId=JIS+C+4901%3A2000&dantaiCd=JIS&status=1&pageNo=1

To become familiar with Japanese regulations it is worthwhile spending time exploring the JSA website and clarifying which specific standards affect the work you intend to do. The Japanese system is effective and is simple to operate within as it is set-up in a European fashion.

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