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Engineering Design

AMI4900: Engineering Design

Unit 3: Regulatory Requirements

Section 1:

Overview of health and safety issues, focussing on electronic based products and components


Contents

Introduction

The Health & Safety (H&S) side of the course is to be split into four sections. Each of these sections will cover different aspects relating to design and its impact upon H&S.

The four sections are briefly described below:

1) The Law
- 1974 Health and Safety at Work Act
- 1993 'Six Pack'
- Duty of care

2) Risks and Hazards
- What are they?
- Definitions
- Examples

3) Regulations affecting Electronic Design
- How regulations work, i.e., a skeleton
- Electrical Equipment (Safety) Regulations 1994
- CE marking

4) Regulations Overseas
- Europe
- America
- Japan

Each of these sections will be supported by examples and references.

When specifying Regulatory Requirements a structural approach is desirable to effectively ascertain what is required for a particular product. This approach is defined as follows:


 

3.1.1 Types of Regulation

The types of regulations that are applied to the UK are as follows:

Purpose of Regulations

Regulations, at any level, exist to ensure that products and processes are manufactured and operate in a sensible, safe manner. They exist to protect individuals, organisations, the state and the environment. They have grown in number due to an increase in the awareness of social responsibility, in Health and Safety Law this is known as the Duty of Care.

Everyone at every level from an individual level to the European Union has a Duty of Care. It is due to this Duty of Care that most legislation in the UK now originates from the European Union in the form of directives.

European Directives

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

Development

The justification for a directive has to be the need for harmonisation to reduce market barriers and help to create a European single market. Through a process of multiple treaties, most policy areas are now decided under the Codecision procedure. The European Commission has the task, after consulting member states, to submit a proposal, which may then be adopted by the Council (of responsible Ministers) and, where required by Treaty, Parliament. Depending on the policy area one of three different legislative procedures applies.

Implementation

A directive fixes the agreed objectives to be pursued by the EU member states, but leaves freedom of choice for the ways of obtaining them (maintaining an obligation to achieve the result): "A directive shall be binding, as to the result to be achieved, upon each Member State to which it is addressed, but shall leave to the national authorities the choice of form and methods."

How each country puts the directive into effect depends on their legal structure, and may vary. For example, in the UK most directives are brought in via statutory instruments but some directives create such major changes to the law that Parliament passes a separate Act to incorporate the changes.

In areas covered by the EEA (European Economic Area) Agreement, directives are also binding for Norway, Iceland and Liechtenstein and are integrated into the EEA Agreement through an EEA Joint Committee decision and subsequently becomes part of the national legislation of the EEA EFTA States.

Enforcement

In practice, with the exception of directives related to the common agricultural policy, the Union 'addresses' directives to all member states, and specifies a date by which the states must have put the directive into effect. (These dates are either determined by the Council of Ministers at the time of the main agreement, or the twentieth day following that of publication). Individual states often miss these deadlines, and when the deadlines slip badly, the European Commission can and does commence proceedings in the European Court of Justice against the countries involved.

Through its case law, the European Court of Justice has provided guidelines for member state judges on how to deal with cases where directives have not been transposed into national law, or have been transposed incorrectly.

Example

The Electrical Equipment (Safety), the Low Voltage Directive has been published by EU and has caused the low voltage regulations in the UK to be examined. 

Acts of Parliament

In Westminster System parliaments , an Act of Parliament is a part of the law passed by the Parliament. It can also be a private bil.

For example, the Consumer Protection Act 1987 came into place because the previous Acts needed updating to reflect contemporary views and legal precedence's. The 1987 Consumer Protection Act superseded the 1961 Consumer Protection Act and the 1965 Consumer Protection Act ( Northern Ireland ) but included many of their parts.

British Acts of Parliament can be found online at http://www.opsi.gov.uk. This is the website of HMSO and details all parliamentary publications.

Regulations

Regulations come into place following an Act of Parliament or the issue of a European Directive. An Act of Parliament can be quite general. Regulations define and specify the detail required.

For example, the Electrical Equipment (Safety) Regulations 1994 came into force following the Consumer Protection Act 1987 and the Electrical Equipment (Safety), the Low Voltage Directive. The Act of Parliament was a general Act which determined that consumers needed to be protected. The Directive was equally non-specific, relying upon individual member states to apply it. The regulations which followed the Act and Directive defined how consumers were to be protected.

Codes of Practice

Codes of Practice (CoP's) are guidance notes for how tasks should be carried out. For example, the most widely known CoP is the Highway Code. It defines what should be done to make the roads safe for all users. CoP's can be quoted in legal cases and are regarded as best practice.

Codes of Practice can be found at http://www.hse.gov.uk. This is the website of the Health & Safety Executive and details Health and Safety literature and legislation.

British Standards 

British Standards are specific and relate to individual products or processes.

For example, BS 1363-4:1995 is the British Standard which contains all the detail relating to 13 A fused connection units switched and unswitched. It is important to identify which British Standards are applicable to the design being considered and then adhered to.

A standard will be used to support a Regulation. That is, BS 1363-4:1995 specifies how 13A fused connection units should be used. This forms part of the Electrical Equipment (Safety) Regulations 1994.

British Standards can be found on-line at http://www.bsi-global.com. From this site a brief description of all standards can be viewed and purchased.

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3.1.2 Health and Safety Law - Overview

Health and Safety Law in the UK is concerned with the protection of individuals in the workplace and in public. The regulations applied by Health and Safety law dictate what employers have to do to reduce the risk of hazards.

The definitions of risk and hazard are important in Health and Safety Law. This is because they are quite different. A hazard is defined as:

Quote

 

"A Hazard is a thing or condition that may expose a person to a risk of injury harm."

 

Meanwhile a risk is defined as:

Quote

 

"A risk is a chance that injury or harm could happen."

 

Health and Safety Law needs to take risks and hazards into account and as far as reasonably practicable ensure that no one, either in the manufacturing process or in the use of an item, be exposed to either hazard or risk.

Design needs to take Health and Safety into account. This is mainly done by adhering to Directives, Regulations, Codes of Practice (CoP's) and British Standards.

A brief overview of Health and Safety Law as it applies to employers and users of equipment is set out below.

The UK has one of the lowest accident rates in the world. In part this is because of the pioneering Health and Safety at Work Act, and the various regulations made under this Act. These regulations have the same status as other laws.

If all the legislation on health and safety were fully enforced, then the United Kingdom would be a very safe place to work.

Ignorance is not a defence, and you cannot delegate your responsibilities. However remember, compliance is not enough. Designers should aim to go above simply complying with the law and try to be a good designer, with health and safety built into the device.

The following Acts and Regulations are those that are likely to be used in the workplace and those which should be considered if designing for domestic use. They apply to all parts of the UK , although the name of the legislation is different in the case of Northern Ireland .

Health and Safety at Work Act

The Health and Safety at Work Act (1974) (HaSaWA) is the main piece of health and safety legislation. It puts a duty on employers to ensure the safety, health and welfare at work of their employees and to ensure their activities do not endanger others. It says that you must have a safety policy and you must consult with your workforce. The Act also allows the Secretary of State to make regulations on health and safety. This power has been used to introduce most subsequent health and safety legislation.

The Six Pack

The six pack is a set of six regulations all introduced at the end of 1992 following a European directive. Some have since been updated. The regulations are:

CHIP's

The Chemicals (Hazard Information and Packaging for Supply) Regulations, commonly known has CHIP's, cover the classification and labelling of chemicals. They say you must keep safety datasheets on all chemicals where there is a possible hazard, including those used for cleaning.

 COSHH

The Control of Substances Hazardous to Health Regulations covers all dangerous substances, not just chemicals. They say that employers must conduct a risk assessment, control the hazard, and give information and training.

RIDDOR

The Reporting of Injuries Diseases and Dangerous Occurrences Regulations state employers must report and keep a record of, certain accidents and incidents.

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3.1.3 The Electrical Equipment (Safety) Regulations 1994

3.1.3.1 Origins

The Electrical Equipment (Safety) Regulations 1994 have their origins in European Council Directive 73/23/EEC - the Low Voltage Directive. This Directive aimed to harmonise the laws of EEC member states. This Directive was adopted on 19 February 1973 - making it one of the first directives taken up by the UK after joining the EEC.

The 1994 regulations replace the Low Voltage Electrical Equipment (Safety) Regulations 1989. These regulations implemented the Low Voltage Directive.

The Low Voltage Directive is classed as "an old approach Directive". This means that it does not provide for the use of CE marking. More recent Directives do make allowances for CE Marking. Most specifically, Directive 93/68/EEC - the CE Marking Directive, from July 1993. This Directive aimed to harmonise all rules relating to CE Marking. The CE Marking Directive required that amendments be made to the Low Voltage Directive.

The Consumer Protection Act 1987 also affects the Electrical Equipment (Safety) Regulations 1994. This is because the interests of the consumer are paramount under this act and protection is regarded as a proactive not a reactionary duty.

There are four key principles to the CE Marking Directives. They are:

3.1.3.2 Free Movement of Goods

Achieving the free movement of goods is one of the four basic freedoms of the European Community. Complying with the Electrical Equipment (Safety) Regulations 1994 demonstrates that products meet the 'Essential Requirements'. Products meeting these requirements carry CE marking , which means they can be sold anywhere in the European Union.

3.1.3.3 Products affected by the Regulations

The Regulations apply to all electrical equipment , with the exception of:

The equipment is designed or adapted for use between 50 and 1,000 volts (in the case of alternating current) or 75 and 1,500 volts (in the case of direct current). The Regulations cover domestic electrical equipment and equipment that is intended for use in the workplace.

The term 'electrical equipment' is not defined in the Low Voltage Directive and should therefore be given the ordinary dictionary meaning. 'Electrical' is defined as 'operated by means of electricity' or 'of or pertaining to electricity'. 'Equipment' is defined as 'apparatus' which is in turn defined as 'the things collectively necessary for the performance of some activity of function'. An item is only subject to the requirements of the Regulations if it is 'electrical equipment' as so defined.

Certain components of electrical equipment may in themselves be considered to be electrical equipment. If this is the case then they need to satisfy the requirements of the Regulations if it is intended that they are to be supplied as separate items. For example, a manufacturer of control devices will need to ensure that his product satisfies the Regulations' requirements if he supplies it, and this will include supplies for retail sales and to other manufacturers for incorporation into other electrical equipment. Manufacturers of small components which are in themselves electrical equipment may under the Regulations affix CE marking to the packaging, instruction sheet or guarantee certificate of such components. It is important that component (and indeed all) manufacturers ensure that the mark is present.

Further guidance with regard to components can be obtained from the following Com mission website link:

http://europa.eu.int/comm/enterprise/electr_equipment/lv/direct/text.htm

3.1.3.4 Suppliers Affected

The Regulations affect all persons who supply electrical equipment during the course of a business, whether or not the business is one of supplying electrical equipment. They affect:

All suppliers have a statutory duty to ensure that they supply only electrical equipment which satisfies the requirements of the Regulations. However, the Regulations require that certain suppliers have to fulfil particular obligations.

The manufacturer is the person, whether established in the EU or not, who is primarily responsible for designing and manufacturing equipment so that it complies with the safety requirements of the Regulations. The regulations go on to illustrate what constitutes a manufacturer and what, as a manufacturer, the responsibilities and requirements are.

3.1.3.5 The Safety Requirements

All electrical equipment must be:

3.1.3.6 How to comply with the safety requirements

Electrical equipment that is constructed to meet the safety provisions of one of the following in an accepted hierarchy of standards and requirements will be taken to satisfy the safety requirements of the Regulations, unless there are reasonable grounds for suspecting that it does not so comply .

3.1.3.6.1 Harmonised Standards

Electrical equipment which complies with the safety provisions of a harmonised standard, will be presumed to comply with the safety requirements of the Regulations.

Standards are regarded as being harmonised once they have been drawn up by common agreement between the National Standards Bodies notified to the European Commission by the Member States under Article 5 of the Low Voltage Directive. The United Kingdom National Standards Body is the British Standards Institution.

Harmonised standards and their amendments have equal validity in all Member States. However, they may include Special National Conditions for individual Member States that will require a departure from the general specifications, this can be due to climate or in the electrical supply system and wiring rules in various Member States.

BSI are responsible for publishing harmonised standards and any amendments as identically worded British Standards. A list of harmonised standards that have been drawn up by common agreement under the Low Voltage Directive is periodically published in the Official Journal of the European Communities ("the Official Journal"). The list of harmonised standards may also be viewed on the Commission website at :

http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/reflist.html

3.1.3.6.2 International Standards

Where no relevant harmonised standard exists, electrical equipment which complies with the specification of a standard published by the International Electrotechnical Commission (IEC) (details of which have been published by the European Commission in the Official Journal ) will be presumed to comply with the safety provisions of the Regulations.

3.1.3.6.3 National Standards

Where no relevant harmonised standard or international standard exists, electrical equipment will be presumed to comply with the safety provisions of the Regulations, if it is constructed to conform with the safety provisions of either:

3.1.3.6.4 Electrical Equipment that does not conform to any published standard

Electrical equipment that does not conform to any of the accepted hierarchy of standards, perhaps because it is an innovative product, must nevertheless comply with the basic requirement to be safe. Manufacturers and suppliers of such products will need to consider what steps to take to satisfy themselves as to the compliance of the electrical equipment with the requirements of the Regulations.

Where electrical equipment has not been manufactured to comply with the specifications of one of the above standards, suppliers may consider it prudent to have the equipment assessed for safety by an independent third party, in particular, a notified body. Third party tests are not mandatory but if there are any doubts about the safety of the equipment such a report may help establish that it is safe.

3.1.3.7 Notified Bodies

Member States are required by the Low Voltage Directive to notify the European Commission and other Member States of those bodies that are capable of providing an authoritative test report on the safety of electrical equipment. It is not mandatory for such a report to be drawn up but suppliers may feel that in some circumstances it is in their best interests to consider the need for such a report, particularly where the electrical equipment has not been constructed to conform to the specifications of any of the recognised hierarchy of standards.

The notified bodies within the UK can be found at:

http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/reflist.html

3.1.3.8 Electrical Equipment intended for use by a Manufacturer in his own Premises

Electrical equipment that is intended for use by a manufacturer in his own premises is controlled by the Regulations. Such equipment must satisfy the safety requirements of the Regulations. This equipment does not need to satisfy the CE marking requirements unless the manufacturer wishes to supply the equipment.

3.1.3.9 Second Hand and Hired Electrical Equipment ETC

The safety of second hand equipment that is supplied in the course of business (including auctions) is controlled by the Regulations.

Second hand electrical equipment need not satisfy the CE marking requirement. Although there is no mandatory requirement for second-hand equipment to undergo any safety testing, there is a requirement to supply only equipment that is safe so as to avoid the committing of an offence under the Regulations.

The safety of electrical equipment that is supplied by way of hiring it out in the course of business is also controlled by the Regulations. Where such equipment is supplied it must satisfy the safety requirements.

 The Regulations apply to any person who supplies electrical equipment in the course of a business. Thus, the safety of any electrical equipment that is supplied as part of furnished accommodation that is hired or let in the course of a business is controlled by the Regulations.

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3.1.4 CE Markings and other markings

3.1.4.1 CE Marking Requirements

The CE marking requirements consist of three parts, all of which must be satisfied.

These are:

CE marking is a visible declaration by the manufacturer or his authorised representative that the electrical equipment to which it relates satisfies all the provisions of the Regulations. Equipment bearing the mark will be taken as meeting the requirements and thereby entitled to free circulation throughout the EU provided that the equipment does in fact satisfy those requirements. Full details of the requirements can be found at:

http://europa.eu.int/eur-lex/lex/LexUriServ/LexUriServ.do?uri=CELEX:31993L0068:EN:HTML

or

http://www.dti.gov.uk/strd/cemark.html

CE marking should be affixed to the electrical equipment, or to the packaging, the instruction sheet, or the guarantee certificate. The mark must be visible, particularly to the enforcement authorities, easily legible and in an indelible form.

By affixing CE marking to electrical equipment, the manufacturer is making a statement that his equipment meets the requirements of all relevant Directives. It is for the manufacturer to decide which Directives are relevant to his equipment. The manufacturer must show, though, which Directive(s) have been applied, this information must be given in the documents, notices or instructions that accompany the electrical equipment.

The presence of CE marking does not mean that the electrical equipment cannot be challenged by an enforcement authority if they have reasonable grounds for suspecting an infringement of the Regulations.

It is important to note that CE marking is not a European safety mark or quality symbol. It is not intended for consumers and should not be presented as such. The purpose of CE marking is to indicate to enforcement authorities that the electrical equipment to which it relates is intended for sale in the EU.

CE marking is specific only to a range of Directives. It can only be applied to products covered by such Directives and under the conditions contained in them.

Below is an example of the CE Mark

Figure 4.1

Example of CE Mark

If the mark is reduced or enlarged the proportions given in the graduated drawing must be respected. The two letters of the CE marking must have substantially the same vertical dimension, which must not be less than 5mm. The grid does not form part of the mark and is for information only.

3.1.4.2 Marks other than CE Marking

Other marks, for example, an approval mark from a Certification Body, may appear on or with the equipment but they cannot be used to declare compliance with the Regulations, only CE marking can be used for this purpose. Any other marks that are present must not reduce the visibility or legibility of CE marking.

The most common and well known of the other markings is the kitemark. This signifies that a product complies with specific British Standards. It can be found on a wide range of products and demonstrated compliance. An example of the kitemark is shown below.

Figure 4.2

Example of Kite Mark

3.1.4.3 EC Declaration of Conformity

An EC Declaration of Conformity is a written declaration by the manufacturer or his authorised representative that the equipment to which the CE marking has been affixed complies with the requirements of the Regulations. For the purposes of the Regulations the Declaration must:

A copy of the EC Declaration of Conformity is not required to accompany each product but a copy must be retained within the territory of the EU by the manufacturer, the authorised representative or the importer who first places the equipment on the market in the EU.

3.1.4.4 Technical Documentation

The Technical Documentation provides the enforcement authorities with the means of assessing the conformity of the electrical equipment to the requirements of the Regulations. For the purposes of the Regulations the Documentation must:

It is the manufacturer's responsibility to compile the relevant Documentation whether he is established in the EU or not. However, the information must be kept within the EU for inspection purposes and this responsibility will fall on either:

The Documentation does not have to be assessed by an approved body but it must be possible to assemble it whether or not the equipment has undergone any independent testing, certification or approval. It must also be kept for a period of not less than 10 years after manufacture of the equipment to which it relates has ceased.

3.1.4.5 Internal Production Controls

The manufacturer is responsible for ensuring that his manufacturing process is such that the production of the electrical equipment conforms to that described in the Technical Documentation that relates to it.

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3.1.5 Waste from Electrical and Electronic Equipment

The Waste Electrical and Electronic Equipment (WEEE) Directive ( Directive 2002/96/EC on waste electrical and electronic equipment) aims to minimise the impacts of electrical and electronic equipment on the environment by designing products with recycling in mind and encouraging reuse, recycling, and recovery of WEEE. It affects manufacturers, retailers, businesses and consumers. Further information can be found at:

http://www.dti.gov.uk/sustainability/weee/WEEEguidance_draft.pdf

The WEEE Directive sets criteria for the collection, treatment, recycling and recovery of WEEE. It makes producers responsible for financing most of these activities (producer responsibility). The term 'producers' includes manufacturers, sellers and resellers of own-brand equipment, and importers and exporters of electrical and electronic equipment into the UK . Private householders are able to return WEEE without charge.

The WEEE Directive applies to a huge range of electrical equipment and has been enforced by UK Law since the 13 th August 2005. However, some specific actions, e.g. producer registration and reporting of data on equipment placed on the market, have been from January 2005 onwards.

A collection target of 4 kg per head of population per annum is to be achieved by 31 st December 2006.

Alongside the WEEE Directive is the related Directive on Restrictions of the use of certain Hazardous Substances in electrical and electronic equipment (RoHS). It seeks to reduce the environmental impact of WEEE by restricting the use of certain hazardous substances during manufacture.

The ROHS Directive requires the substitution of lead, cadmium, hexavalent chromium, polybrominated biphenyls (PBBs) and polybrominated diphenylethers (PDBEs) by 1st July 2006.

Manufacturers will need to ensure that their products and components comply. If they do not, they will need to redesign their products.

The WEEE Directive applies to the following categories of electrical and electronic equipment:

The WEEE regulations are considered extremely important and as a result the RSA was commissioned to produce a statue to demonstrate how much electrical rubbish the average person will dispose of in their lifetime. It is constructed of 3.3 tonnes of electrical rubbish.

Figure 4.3

A person life time electrical rubish

http://www.weeeman.org/ is the home site of WEEE Man and gives more information.

Products which comply to WEEE regulations must carry the WEEE mark. This denotes that compliance has been gained and also serves as a reminder to consumers that this type of product should be returned for re-use. The WEEE Mark is shown below.

Figure 4.4

The WEEE Mark

WWW Research

Sources of Information

http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/reflist.html

http://www.opsi.gov.uk

http://www.hse.gov.uk

http://www.bsi-global.com

http://www.hse.gov.uk/

http://europa.eu.int/comm/enterprise/electr_equipment/lv/direct/text.htm

http://www.dti.gov.uk/publications

http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/reflist.html

http://europa.eu.int/eur-lex/lex/LexUriServ/LexUriServ.do?uri=CELEX:31993L0068:EN:HTML

http://www.dti.gov.uk/strd/cemark.html

http://www.weeedirectory.com/Portals/0/Reports/finalweee_directive.pdf

http://www.dti.gov.uk/sustainability/weee/WEEEguidance_draft.pdf

http://www.weeedirectory.com/Portals/0/Reports/finalrohs_directive.pdf

http://www.weeeman.org/

 

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