Garry Lee, P.Eng. Engineering Manager Global Advantage International CSA, UL, CB and CE Certification & Approvals WELCOME Ontario PDMA Date: May 27, 2008 Garry Lee, P.Eng. Engineering Manager Global Advantage International

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Standards and Certification Standards affect nearly every electrical product and service you encounter They may deal with safety and quality requirements, efficiency, compatibility, reliability, environmental issues, etc. www.globaladvantage.ca

Standards and Certification (cont’d) The ability to sell products in a particular marketplace often depends on the manufacturer’s ability to design their product to comply with applicable standards and obtain the certifications and approvals necessary to satisfy regulatory requirements Certification is the process for verifying compliance with the requirements or standards www.globaladvantage.ca

Standards Most standards are voluntary Since standards organizations are not government bodies, they don’t have the power to make standards mandatory A standard only becomes law if a federal, state, regional, provincial, or municipal government references it in legislation www.globaladvantage.ca

Standards (cont’d) There are many different Standards organizations including: CSA, UL, VDE, American National Standards Institute (ANSI) International Organization for Standardization (ISO) – A worldwide federation of national standards bodies representing approx 140 countries International Electrotechnical Commission (IEC) – a worldwide body focusing on international harmonization of standards for electrical, electronic and telecommunications products and systems www.globaladvantage.ca

Standards (cont’d) European Committee for Electrotechnical Standardization (CENELEC) – Responsible for European Standards (EN Standards) International Telecommunications Union (ITU) www.globaladvantage.ca

Why Do Products Need To Be Certified or Approved ? For liability purposes and to satisfy regulatory requirements, manufacturer’s are often required to obtain independent, third party certification or approval of their products www.globaladvantage.ca

Why Do Products Need To Be Certified or Approved ? (cont’d) Certification may be mandated by trade or industry associations To demonstrate to purchasers a commitment to safety and quality www.globaladvantage.ca

Certification and Approval Marks Different marks offered by a number of Certification Bodies in countries throughout the world Certification or Approval marks indicate that the product has been independently tested and certified to meet the applicable recognized standards for safety or performance Acceptance of various marks depends on regulatory authorities www.globaladvantage.ca

Who Certifies and Approves ? There are a number of organizations throughout the world who certify and approve products to a wide variety of standards Within North America, the major Certification and Testing organizations include CSA, UL, TUV and ITS www.globaladvantage.ca

Who Certifies and Approves ? (cont’d) These certification and testing organizations are accredited by various government agencies (such as SCC and OSHA) Accreditation involves the verification that an organization has the competence to carry out a specific function www.globaladvantage.ca

SCC The Standards Council of Canada (SCC) is a federal Crown Corporation with the mandate to promote efficient and effective standardization Oversees Canada’s National Standards System Represents Canada’s interests in standards-related matters in foreign and international forums www.globaladvantage.ca

OSHA Occupational Safety & Health Administration (OSHA) falls under the U.S. Department of Labor Administers the Nationally Recognized Testing Laboratory (NRTL) Program NRTL’s are third-party organizations recognized by OSHA as having the capability to provide product safety testing and certification services to the manufacturers of a wide range of products for use in the American workplace www.globaladvantage.ca

SCC and OSHA SCC has accredited a number of Certification Organizations and Testing Organizations in Canada, including CSA, UL, TÜV America and ITS OSHA currently recognizes 18 NRTL’s, including CSA International, UL, TÜV America and ITS who test to applicable US Standards (including ANSI, UL, CSA, NSF and others) www.globaladvantage.ca

CSA CSA Group is an independent, not-for-profit membership-based association serving consumers, business and government Founded in Canada in 1919 Presently consists of three divisions (CSA, CSA International and QMI) Canadian Standards Association – responsible for standards development, information products, sale of publications, training and membership services www.globaladvantage.ca

CSA (cont’d) CSA International – responsible for product testing and certification Quality Management Institute (QMI) – responsible for management systems registration Worldwide network of offices and partners www.globaladvantage.ca

UL Underwriters Laboratories Inc. (UL) is an independent, not-for-profit product-safety testing and certification organization Founded in the United States in 1894 Leader in product-safety testing and certification in the United States Developed and maintains more than 800 Standards UL has customers in 96 countries www.globaladvantage.ca

UL (cont’d) More than 66,000 manufacturers produce UL-certified products, and each year, more than 17 billion UL Marks appear on products Conducts more than 500,000 follow-up visits annually to audit compliance with product certification requirements Laboratory, testing and certification facilities located around the world www.globaladvantage.ca

Electrical Installations in Canada Requirements contained in C22.1, Canadian Electrical Code, Part 1 - Safety Standard for Electrical Installations Developed and maintained by CSA Covers installation and maintenance of electrical equipment. Concerned with prevention of fire and shock hazards and proper operation and maintenance of electrical installations and electrical equipment Revised every four years www.globaladvantage.ca

Electrical Installation in the US Requirements contained in NFPA 70, National Electrical Code (NEC) NEC developed and maintained by the National Fire Protection Agency (NFPA) NEC focuses on the proper installation of electrical systems and equipment to protect people and property from the potential dangers of electricity Revised every three years www.globaladvantage.ca

Electrical Installations (cont’d) CEC and NEC are not harmonized, but contain similar requirements Contain requirements for wiring, wiring methods, materials, grounding, protection, installation requirements for different types of equipment, etc. CEC and NEC Handbooks exist which explain intent and rationale of requirements www.globaladvantage.ca

Electrical Installations (cont’d) CEC and NEC may be subject to additional requirements contained in local codes Subject to local regulatory authorities or Authority Having Jurisdiction (AHJ) Electrical equipment and components used in installations must also be approved Special requirements for different types of locations (such as hospitals, hazardous locations, outdoor locations, etc.) www.globaladvantage.ca

Product Certification Process (CSA, UL) Identify applicable requirements Obtain quotation from agency Make Application Provide representative samples, information, schematics, supporting documentation, installation instructions, etc. Preliminary Review Similar process involved with other Certification/Approval bodies. www.globaladvantage.ca

Product Certification Process (cont’d) Preparation of test plan Testing to appropriate requirements (testing may be done in-house or as witness testing at the manufacturer’s site or at another qualified facility) Construction review and draft report preparation Inform manufacturer of Findings and Alterations required (may require modified sample for evaluation and additional testing or re-testing) www.globaladvantage.ca

Product Certification Process (cont’d) Review responses to Findings and finalize report Report to be reviewed and approved Certification / Approval Documents issued (Certificate of Compliance / Notice of Authorization, Certification / Listing Records, Report) Follow-up Service Agreement signed with the Certification agency www.globaladvantage.ca

Ongoing Compliance Once a product is certified or approved, the process isn’t finished … Manufacturer is responsible for ongoing compliance of the product Subject to annual inspections at each manufacturing location (# of inspection visits may vary) Non-conformances must be addressed. Production may be stopped and products may have to be recalled (depending on nature of deficiency). www.globaladvantage.ca

Ongoing Compliance (cont’d) Some products are subject to re-examination Modifications to products after approval need to be addressed (updates to reports to cover alternate construction) Certified or Approved products may need to comply with new, revised or updated requirements (grandfathering period is often allowed) www.globaladvantage.ca

Europe and CE Marking Regulatory situation is different in Europe European Union (EU) consists of 15 Member States: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden and the United Kingdom 10 new Member States joined EU in 2004: Cyprus, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, Slovakia and Slovenia www.globaladvantage.ca

Europe and CE Marking (cont’d) European Economic Area (EEA) includes the 15 EU Member States and the three European Free Trade Association (EFTA) States (Iceland, Liechtenstein and Norway) Creation of single market in Europe eliminated barriers to trade between member states and provides for free movement of goods Developed New Approach to technical harmonization and standardization Establishment of various Directives and determination of essential requirements www.globaladvantage.ca

Europe and CE Marking (cont’d) The CE mark is a European marking of conformity indicating that a product complies with the essential requirements of the applicable European laws or Directives with respect to safety, health, environment and consumer protection Other marks may appear on products but the CE Marking is the only marking symbolizing conformity to all the legal obligations relating to manufacturers for a given product as required by the applicable New Approach Directives www.globaladvantage.ca

Directives www.globaladvantage.ca

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Manufacturer Responsibilities Manufacturer is the person who is responsible for designing and manufacturing a product with a view to placing it on the European Community market on his own behalf Manufacturer is obliged to ensure that a product intended to be placed on the market is designed, manufactured and conformity assessed to the essential requirements in accordance with the provisions of the applicable Directives www.globaladvantage.ca

Manufacturer Responsibilities (cont’d) Manufacturer needs to identify all Directives that are applicable to their product For example, some products may require both the Low Voltage Directive and the EMC Directive, other products may require both the Medical Devices Directive and the EMC Directive, etc. www.globaladvantage.ca

Conformity Assessment Conformity Assessment is process by which compliance with the essential requirements set by the Directives is determined Process may be carried out with or without the use of standards May use harmonized European Standards (EN Standards). Products meeting harmonized EN Standards are granted presumption of conformity with essential requirements www.globaladvantage.ca

Conformity Assessment (cont’d) Conformity Assessment may vary in levels of complexity depending on the level of risk associated with the products being assessed Conformity Assessment is subdivided into modules which relate to the design phase of products, their production phase or both. The eight basic modules and their eight possible variants can be combined with each other in a variety of ways to establish complete conformity assessment procedures www.globaladvantage.ca

Conformity Assessment (cont’d) Each New Approach Directive describes the range and contents of possible conformity assessment procedures Can vary from self-declaration to involvement of a third party (Notified Body) www.globaladvantage.ca

Notified Bodies Notified Bodies are independent test houses or certification bodies that carry out the conformity assessment procedures referred to in the applicable Directives when a third party is required. Notified Bodies are designated and notified by Member states www.globaladvantage.ca

Technical Documentation Manufacturer must prepare a Technical File which is intended to provide information on the design, manufacture and operation of the product The Technical File includes the information that proves the technical basis for conformity of the product to the requirements stated by the Directive(s) Technical File must be kept for 10 years after the last unit of the product has been placed on the market, unless otherwise stated www.globaladvantage.ca

CE Marking The CE conformity marking consists of the initials "CE" taking the form shown CE in the term CE Marking stands for Conformité Européenne (European Conformity) www.globaladvantage.ca

CE Marking (cont’d) CE Marking is affixed by manufacturer or his Authorized Representative , established in the European Union Must be affixed visibly, legibly and indelibly to the product, its data plate or, where this is not possible, to its packaging Where a Notified Body is involved in the production control phase according to the applicable directives, its identification number must also follow the CE Marking www.globaladvantage.ca

CB Scheme An international system for acceptance of test reports dealing with safety of electrical and electronic products A multilateral agreement among participating countries and certification organizations based on principle of mutual recognition by members of test results for obtaining certification or approval at national level Based on use of International (IEC) Standards and declared National Differences www.globaladvantage.ca

CB Scheme (cont’d) Currently 43 countries in the CB Scheme with 54 National Certification Bodies (NCB’s) and and 129 CB Testing Laboratories (CBTL’s) List of NCB’s and their scope of recognition published in the CB Bulletin Manufacturer applies to an NCB for testing of their product to relevant IEC Standard(s) and National Differences of countries where product will be marketed www.globaladvantage.ca

CB Scheme (cont’d) NCB conducts testing and evaluation through CBTL and issues CB Test Report and CB Test Certificate To obtain product certification in target markets, manufacturer makes application to an NCB in the target country and submits CB Test Certificate, CB Test Report (with national differences) and sample of product for verification. Usually, no additional testing will be required. NCB issues certification based on use of the CB Test Report www.globaladvantage.ca

Other Requirements Depending on the type of equipment manufacturers and products may also have to comply with other standards and requirements such as: EMC requirements (CISPR, FCC, Industry Canada) Requirements for products incorporating lasers (FDA and CDRH requirements) Requirements for Medical Equipment (FDA) Quality System Registration (ISO 9000, ISO 14000 Series requirements) CISPR – The International Special Committee on Radio Interference (integrated into IEC) CDRH – Center for Devices and Radiological Health FDA – Food and Drug Administration ISO 9000 Series – concerned with Quality Management ISO 14000 Series – concerned with Environmental Management www.globaladvantage.ca

Useful Options For limited production quantities – Special Inspection / Field Evaluation (conducted by TÜV America, CSA, UL) Technical Information Service (TIS) Export / Import Assistance Multiple Listing Use of Agents / Consultants – they are familiar with requirements and procedures www.globaladvantage.ca

Who We Are Independent Test Lab Product Safety Consultant Agent acting on behalf of manufacturers in dealing with various Certification Bodies Experienced personnel in Medical Equipment, Information Technology Equipment, Laboratory Equipment and EMC/EMI www.globaladvantage.ca

Global Advantage - Consultants Strong working relationship with various Certification Bodies Certification process: Witness testing program with UL, CSA, etc. Provide solutions to clients if there are product non-compliance issues GAI has the greatest amount of different product categories of any ULC agent www.globaladvantage.ca

Global Advantage - Consultants (cont’d) Provide technical regulatory evaluation of the product in the design stage Provide performance testing Large client list including JDSU, IBM, Sunrise Medical, GE Healthcare, Welch Allyn, Ciena Manage all regulatory approvals- (UL, CSA, EMC, FDA, Health Canada, CE, etc.) www.globaladvantage.ca

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If you require assistance: Please feel free to contact us at: Tel: (905) 883-3919 Fax: (905) 883-7995 Cell: (416) 722‑0925 E‑mail: garry@globaladvantage.ca Global Advantage International 180 Brodie Dr – Unit 2 Toronto, Ontario L3B 3K8 www.globaladvantage.ca