CE Marking and UKCA Marking Guide

CE Marking and

Introduction

IES offer a CE marking service for equipment and products. We provide assessments and testing for compliance to specific directives and standards to enable self-declaration by the customer at our facility, the manufacturing facility or the end-user site.

We can advise and assist with preparation for the Technical File and support some Notified Body requirements.

General

The following provides some guidance on the requirements of CE marking:  In general, all products to be sold in the EC have to be CE marked.

 Every CE mark must have a Declaration of Conformity document that defines the directives and standards to which the product conforms.

 The Declaration of Conformity can be issued by the manufacturer or a representative economic operator of the goods as self-declaration, depending on the directive.

 If the self-declaration route is used, the manufacturer is obligated to be able to support its claim with proof that the product meets the essential health and safety requirements of the directive. This information can be supported from a third party, or manufacturers can provide it by themselves.

 The supporting data must be compiled into a “Technical File” which defines the product and contains the assembled data to support the Declaration. This Technical File must be maintained throughout the life of the product in line with design changes, any customer feedback that affects safety or durability, etc.

 When the manufacturer (or importer) is satisfied that the product meets the necessary requirements, the CE mark must be applied to the product. Normally this is to the product itself, on a label; for some products it is acceptable to have the mark on its packaging.

 A copy of the Declaration of Conformity must normally be supplied with the product. Depending on the product it can be permissible to include this as part of the instructions.

Checks for Conformity with the Low Voltage Directive

Any high power, direct current or radio frequency power supplies present in the equipment will need to be energised at various points in the testing process.

For site work, complex equipment should already have been commissioned by vendor engineers and be ready for normal operation.

Simple systems such as bench top metrology tools should be installed in a position and have power and any other required services connected to the tool ready for power up and operation of the tool.

In all cases an engineer familiar with the operation of the equipment will need to be available throughout the testing process. The IES test engineer will not operate the equipment but will liaise with the customer (or vendor) engineer when operation of the equipment under test is required.

An inspection will be completed using a checklist derived from the appropiate standard, similar to the following:

A short sample of items from the checklist is reproduced below:

Incoming Supply EN60204 Yes No

1 Are mains cables terminated close to the point of entry to the machine? 2 Does the isolator disconnect all power supplies?

3 Following point of disconnection, are circuits supplied through protective devices?

Earthing EN60204 Yes No

1 Is the main earth terminated near the main isolation point and marked PE?

2 Where the earth conductor is terminated to equipment frame, is all paint removed? 3 Is earth bonding connected to the panel and back plate of the power terminal

enclosure?

Checks for Conformity with The EMC Directive

The equipment will be set up either in a test facility, which is fit for purpose, provided by IES or in the intended operation position at the customer site. IES can arrange to have equipment tested at the manufacturer site where this is preferable.

The tool will need to be fully facilitised so that it can be operated in a normal production mode, with handling or transport functioning.

Any process-related direct current or radio frequency power supplied will need to be energised as requested by the test engineer during the course of the EMC measurement procedure.

The Electromagnetic Compatibility Directive requires tests to be completed,

to include:

 Emission tests

 Conducted and radiated immunity tests  Static discharge and fast transient burst tests.

The Conducted Emissions may be measured by probes or may require the connection of a Line Impedance Stabilisation Network (LISN) to be connected between the electrical supply to the equipment and the power input terminals to the EuT. A sensitive and calibrated receiver is connected to the output of the probe or LISN and measures output signals over a wide range of frequencies between 150 Khz. and 30 mhz. A trace is prepared by operating the receiver from a computer running a special software application.

The Radiated Emission tests require the use of a sensitive and calibrated receiver used with a highly directional receiving antenna. readings are taken over a wide range of frequencies under the control of a computer program, while the EuT is being cycled as in normal use.

The Static Discharge tests are carried out by means of a high voltage injection probe, which is used to inject high voltage pulses simulating static discharge to selected parts of the EuT ground wiring, panels and control elements.

Checks for Conformity with the Machinery Directive

Any equipment or production tool with moving parts or assemblies which are moved by appropriate actuators under the control of the machine must be tested for conformity with the Machinery Directive.

Harmonised Standards are selected as appropriate for the machine functions, to be used as a basis for the audit. These standards can cover many disciplines, from ergonomic principles to light curtains.

A checklist based on the requirements of the standards will be completed and form the basis of the technical report and any recommendations for conformity.

A comprehensive risk analysis for all identifiable risks is carried out and assessed by the testing engineer. A short sample from the Machinery Directive checklist is shown below:

For every hazard identified, a risk assessment should be completed. The hazard will be described and the risk graded according to criteria described and an analysis of the measures taken to reduce or eliminate the risk will be carried out.

Based on the result of the checklist and individual risk assessments, a technical report will be created which may include recommendations to ensure equipment conformity with the Machinery Directive.

1. Principles of Safety Interrogation Yes No N/A Support Documentation

Is machine fit for function and can be operated and maintained without putting persons at risk?

Have risk assessments been carried out on the completed

machine? Individual riskassessment sheets.

Is essential equipment and accessories to allow use, adjustment and maintenance without risk supplied?

2. Controls Yes No N/A Support Documentation

Will the controls withstand the rigours of normal use?

Onsite Testing Procedure

The equipment will need to be facilitised to the point where it can be operated in a mode equivalent to normal production operation.

Any electrical sub-system included in the normal operation of the equipment must be capable of being operated at the request of the testing engineer.

The equipment should be in its normal production environment and position with any adjacent production equipment in standby or idle mode, to allow the testing engineer to conduct the EMC testing with a low ambient level.

The testing engineer will need to erect the test equipment close to the equipment and make connections to its electrical supply. An engineer from the facilities department should be available to assist in this connection and disconnection when testing is complete.

For the radiated emission tests, the engineer will require a directional antenna to be situated at various points around the equipment, typically with a 3m separation from the equipment under test.

Technical Report

Reports of tests and assessments are provided for inclusion in the Technical File.

These reports will include detailed summaries of test procedures and copies of test printouts and analysis of the Conducted Emissions and Radiated Emissions readings for conformance to the EMC Directive.

A summary of all the test equipment used and calibration data for each instrument is included.

The file will also include photographs of the equipment layout during testing to allow accurate repeatability of all the tests should this be required.

A summary of the results of the checklists for conformity to the Low Voltage Directive and the Machinery Directive will be included.

Additional Information

1. CE marking is a general heading which covers aspects of legal requirements for the sales of, installation of, use of etc of products.

2. This can be broken down into:  EMC Directive 2014/30/EU

 Low Voltage Directive 2014/35/EU plus amendments  Machinery Directive 2006/42/EC plus amendments  Pressure Equipment Directive 2014/68/EU

 Equipment Explosive Atmospheres (ATEX) Directive 2014/34/EU  Medical Devices Directive 98/79/EC

 Safety of Toys Directive 2009/48/FC

 Radio and Telecommunications Equipment (RTTE) Directive 2014/53/EU

Other Directives may be applicable, although not specifically requiring a CE mark, such as:  RoHS

 Packaging Directive

This list is an example of what may be applicable. There are other directives that could be necessary depending on the product.

3. In order to comply with the law ALL relevant directives MUST be properly addressed before a product can be sold. Each directive has requirements and a list of appropriate standards to which an assessment has to be made and recorded. This documentation forms the evidence that the importer requires to prove to interested authorities that the imported equipment is compliant with the law. Other information such as operation manuals, circuits, etc is also required.

Machinery Directive

The EC Machinery Directive (2006/42/EC) and its first amendment were implemented in the UK by the supply of Machinery (Safety) Regulations.

Notified Body

When CE marking a product, the majority of products can be self-declared as compliant by the manufacturer or importer on the basis of adequate test data and the compilation of a suitable Technical File for the product. In some cases, for example pressure vessels, products used in explosive atmospheres, specific radio devices and others, the assessment of the product must be made by a Notified Body.

IES, by acting on a consultancy basis, can recommend solutions and retest as appropriate - an efficient route for the client. The test data supplied can then be used by the client to support a self-declaration for the product without recourse to the additional expense of a Notified Body.

Technical File

Information needs to be available to comply with the requirements for CE Marking. The following list provides a guide to some of the requirements.

Technical File Contents List

Section Number Yes

Table of contents

Section 1 Copy of a signed declaration of conformity Section 2 Purpose & objective of the technical document

Section 3 Description of the device, its function, intended use and any variants or variants that are planned

Section 4 Copies of the marketing literature

Section 5 Essential requirements checklist – Machinery Directive Section 6 Essential Requirements checklist – Low Voltage Directive Section 7 Essential requirements checklist – EMC Directive

Section 8 Risk analysis data (using EN954 and EN1050)

Section 9 Design calculations – e.g. wire sizes for design current, material stress calculations for intended pressure applications, etc.

Section 10 Electrical safety inspection reports Section 11 EMC Reports and certificates

Section 12 FMEA’s, fault trees, etc. (Failure Mode Effect Analysis – if appropriate)

Section 13 User manuals, maintenance manuals, installation manuals – these can be included or referred to by part number and location.

EXAMPLE

EC Declaration of Conformity

Address:

Declares, in sole responsibility, that the following assembly Model:

Identification tag:

Conforms to the Essential Requirements of the following Directives:  EC Low Voltage Directive 2014/35/EU

 EMC Directive 2014/30/EU

by comparison against the Essential Requirements of the above Directives and the Harmonised Standards listed below:

 BSEN 12100 2010 (Safety of machinery - Principles for risk assessment)

 EN 60204 2013 “Safety of machinery – Electrical equipment of machines, part 1: Specification for general requirements”

 EN 60335-2:2016 “Household and similar electrical appliances – Safety – General Requirements”  EN 61000 series for Electromagnetic Compatibility

The manufacturer named above will keep the Technical Files required by EC Directives for review by authorised persons. This Declaration becomes invalid if modifications are introduced without the manufacturer’s specific approval.

Authorised signature: (Name)

Introduction

UKCA marking applies to products, production tools and equipment being supplied or sold in Great Britain. The UK Conformity Assessed (UKCA) marking is in effect from 1st January, 2021 onwards, and replaces the EU’s CE marking as the necessary certification for the Great Britain market, covering many of the same goods. The UK will continue to accept the CE mark for most products until the end of 2021.

IES provide assessments and testing for compliance with the relevant directives and standards required for self declaration and the achievement of the UKCA marking. Assessments and testing can be carried out at our own facility, at a manufacturing facility, or the end user site.

General

Here are some key points relating to UKCA marking requirements:

 The compilation of a Technical File will be needed to meet UK electrical equipment safety, machinery safety, and EMC regulations.

 Your Technical File will typically contain information such as detailed design drawings of components, safety inspection reports and test certificates.

 The UKCA marking process is completed by a signed Declaration of Conformity document, that details the directives and standards to which the product confirms

 This Declaration of Conformity can be issued by a Notified Body or made as a self-declaration, by the manufacturer or importer of the goods.

 In addition to assessments and testing, IES guides you through the compilation of the Technical File, providing the information and advice necessary to comply with the legislation.

 CE marking will still be required for goods sold in the EU.

 Goods sold in both Great Britain and the EU will require both UKCA marking and CE marking.

Checks for Conformity

IES testing can ensure conformity with the requirements of the UK Electrical Equipment (Safety) Regulations, the UK Supply of Machinery (Safety) Regulations, and the UK Electromagnetic Compatibility Regulations; which can be critical in achieving UKCA compliance. These regulations mirror the EU directives which are applicable in achieving conformity for CE marking.

Assessments can be conducted at your own site or an IES facility. We are accustomed to carrying out remedial work; identifying non-conforming products, and advising on the most suitable, cost-effective solution.

UK Electrical Equipment (Safety) Regulations

IES consultant engineers provide low voltage testing, helping manufacturers to gain product compliance, using conformity assessment procedures established under the UK Electrical Equipment (Safety) Regulations. Testing requires an engineer familiar with the operation of the equipment to be available throughout the process. An IES test engineer will liaise with the customer (or vendor) engineer when the operation of the equipment under test is required. Inspections are completed using a checklist which reflects the requirements of the UK Electrical Equipment (Safety) Regulations.

UK Supply of Machinery (Safety) Regulations

IES testing and assessments allow you to meet UK Supply of Machinery (Safety) Regulations requirements and demonstrate UKCA conformity. Many of these examinations concern the safety of machinery, risk assessment and reduction, and general principles for design.

The harmonised standards in the regulations are used as a basis for the audit, and a checklist based on relevant requirements will be completed during an inspection, forming the basis for the Technical File and any recommendations for conformity.

We also help companies and individuals meet their responsibilities in relations to PUWER (Provision and Use of Work Equipment Regulations 1998) guidelines, which are applicable in the UK.

UK Electromagnetic Compatibility Regulations