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318 -595 Safety Approval Agencies • National Electrical Code – Originally developed in 1897 by the NFPA – Revised every 3 years, Currently 9 chapters, >700 pages – Controls methods, systems and materials used in electrical wiring, and building power distributions – USA Specific but referenced outside US – Also See www. mikeholt. com
318 -595 Safety Approval Agencies • Underwriters Labs (www. ul. com) – Originally developed in 1894 – Mission is to certify the safety of industrial, commercial and consumer products. – Government Independent, Non-for-profit organization – 5 Locations including, Northbrook IL (HQ), Research Triangle NC, Melville NY, Santa Clara CA, Camas WA – Certifications of products, Certifications of Companies – Cross agreement with CSA – Product Certifications C • Listed: Ready to use complete products • Recognized: Certified as a component for use in other products
318 -595 Safety Approval Agencies • CSA International (Canadian Stds Association) – – – – See www. csa. ca Established in 1919 in Toronto, Canada Similar to UL, Independent, but growing Internationally Controls materials, processes, products, companies Cross certification agreements with UL Does NOT differentiate between products & components Local offices in Canada, US and Asia
318 -595 Safety What is the “CE” Mark? CE Marking is the symbol CE as shown on the top of this page. The letters "CE" are the abbreviation of French phrase "Conformité Européene" which literaturely means "European Conformity". The term initially used was "EC Mark" and it was officially replaced by "CE Marking" in the Directive 93/68/EEC in 1993. "CE Marking" is now used in all EU official documents. "CE Mark" is also in use, but it is NOT the official term. 1. CE Marking on a product is a manufacturer's declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislations, in practice by many of the so-called Product Directives “Product Directives” contains the "essential requirements" and/or "performance levels" and "Harmonized Standards" to which the products must conform. Harmonized Standards are the technical specifications (European Standards or Harmonization Documents) which are established by several European standards agencies (CEN, CENELEC, etc). CEN stands for European Committee for Standardization. CENELEC stands for European Committee for Electrotechnical Standardization. 1. CE Marking on a product indicates to governmental officials that the product may be legally placed on the market in their country. 2. CE Marking on a product ensures the free movement of the product within the EFTA & European Union (EU) single market (total 28 countries), and 3. CE Marking on a product permits the withdrawal of the non-conforming products by customs and enforcement/vigilance authorities.
318 -595 Safety CE • CE Approval (Certificate Europe) – 15 countries in original EU (European Union) established harmonized standards – EC (European Committee) is the body driving establishment of standards for any product sold in or entering into the EU. – Members may additional more stringent standards but may not contradict existing EC approved standards – Some of the EC Directives: • • • 88/106/EEC: Safety of Toys 89/106/EEC: Construction of Products 89/336/EEC, 92/31/EC: EMC 89/392/EEC, 91/368/EC, 3/44/EEC: Machinery 89/686/EEC, 93/95/EEC: Personal Protective Equipment 91/263/EEC, 93/97/EEC, 98/13/EEC: Telecommunications 93/42/EEC: Medical Devices 72/23/EEC: Low Voltage Products 95/94/EEC: Automotive Products 96/57/EC: Energy Efficiency for consumer refridgeration systems
318 -595 Safety ISO – International Organization for Standardization www. iso. org • ISO is a network of the national standards institutes of 148 countries, on the basis of one member per country. • Central Secretariat in Geneva, Switzerland, that coordinates the system • ISO is a non-governmental organization • ISO occupies a special position between the public and private sectors • Many of its member institutes are part of the governmental structure of their countries, or are mandated by their government. • Other members have their roots uniquely in the private sector, having been set up by national partnerships of industry associations.
318 -595 Safety ISO – International Organization for Standardization ISO 9000 Quality The ISO 9000 Family of Standards via ISO web site : http: //www. iso. ch/iso/en/iso 9000 -14000/iso 9000/selection_use/iso 9000 family. html ISO: 9000: 2000, Quality management systems - Fundamentals and vocabulary 9001: 2000, Quality management systems - Requirements (replaces 1994 versions of 9001, 9002 & 9003) 9004: 2000, Quality management systems - Guidelines for performance improvements 10005: 1995, Quality management - Guidelines for quality plans 10006: 1997, Quality management - Guidelines to quality in project management 10007: 1995, Quality management - Guidelines for configuration management
318 -595 Safety • The ISO 9000 and ISO 14000 families are among ISO's most widely known standards ever. • ISO 9000 and ISO 14000 standards are implemented by some 610, 000 organizations (companies & corporations) in 160 countries. • The ISO 9000 family is primarily concerned with "quality management“ • This means what the organization does to fulfill: - the customer's quality requirements, and - applicable regulatory requirements, while aiming to - enhance customer satisfaction, and - achieve continual improvement of its performance in pursuit of these objectives.
318 -595 Safety • The ISO 14000 family is primarily concerned with "environmental management". • This means what the organization does to: - minimize harmful effects on the environment caused by its activities, and to - achieve continual improvement of its environmental performance.
318 -595 Safety IEC – International Electrotechnical Commission www. iec. ch IEC Mission • The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes international standards for all electrical, electronic and related technologies. These serve as a basis for national standardization and as references when drafting international tenders and contracts. • Through its members, the IEC promotes international cooperation on all questions of electrotechnical standardization and related matters, such as the assessment of conformity to standards, in the fields of electricity, electronics and related technologies. • The IEC charter embraces all electrotechnologies including electronics, magnetics and electromagnetics, electroacoustics, multimedia, telecommunication, and energy production and distribution, as well as associated general disciplines such as terminology and symbols, electromagnetic compatibility, measurement and performance, dependability, design and development, safety and the environment. The Commission's objectives are to: • Meet the requirements of the global market efficiently • Ensure primacy and maximum world-wide use of its standards and conformity assessment schemes • Assess and improve the quality of products and services covered by its standards • Establish the conditions for the interoperability of complex systems • Increase the efficiency of industrial processes • Contribute to the improvement of human health and safety • Contribute to the protection of the environment.
318 -595 Safety Aspects Other Safety Standard Organizations: • AAMI - American Association of Medical Instrumentation • ANSI - American National Standards Institute • ASTM - American Society for Testing and Materials • NFPA - National Fire Protection Association • SCC - Standards Council of Canada See: http: //ulstandardsinfonet. ul. com/catalog/stdscatframe. html For an exhaustive list of potentially applicable safety standards (> 200 stds) Mexico: NOM-024 -SCFI-1994 Electronic, Electrical, and Home Electronic Products
318 -595 Safety UL Std Example: UL 1236 Battery Chargers for Charging Engine-Starter Batteries UL 1236 Scope 1. 1 These requirements cover battery chargers rated 600 volts or less and intended for household or commercial use to charge engine-starter batteries, in accordance with the National Electrical Code, ANSI/NFPA 70. 1. 2 A battery charger for use with an internal combustion engine driving a centrifugal fire pump is to be investigated under the requirements of this standard and the applicable requirements for the end product. 1. 3 These requirements do not cover a battery charger for use in a marina or boatyard, or other marine application excepting a battery charger intended to be permanently installed on a boat; for fire protection signaling service; or an appliance or system in which a battery charger is used. UL Standards. Info. Net | Underwriters Laboratories Inc. Copyright © 2003 Underwriters Laboratories Inc.
318 -595 Safety UL 1950 Safety of Information Technology Equipment This standard is applicable to mains-powered or battery-powered information technology equipment, including electrical business equipment and associated equipment, with a RATED VOLTAGE not exceeding 600 V and designed to be installed in accordance with the Canadian Electrical Code, Part I, CSA C 22. 1; CSA C 22. 2 No. 0 National Electrical Code, NFPA 70 The standard is also applicable to equipment, unless otherwise identified by a marking or instructions, designed to be installed in accordance with Article 645 of the National Electrical Code, NFPA 70 Standard for the Protection of Electronic Computer Data-Processing Equipment, NFPA 75
318 -595 Safety 1. 1. 1 Examples of equipment which is in the scope of this standard are: accounting machines, motor operated files, bookkeeping machines, PABX's, calculators, paper jogging machines, cash registers, paper trimmers (punchers cutting machines, separators), copying machines, pencil sharpeners data circuit terminatingequipment, personal computers, data preparation equipment, photoprinting equipment, data processing equipment, plotters, data terminal equipment, point of sale terminals including associated electronic scales, dictation equipment, postage machines, document shredding machines, public information terminals, duplicators, staplers, electrically operated drawingmachines, telephone answering machines, erasers, telephone sets, facsimile equipment, text processing equipment, key telephone systems, typewriters, magnetic tape handlers, visual display units, mail processing machines, micrographic office equipment, modems, monetary processing machines including automated teller (cash dispensing) machines 1. 1. 1 This list is not intended to be comprehensive, and equipment that is not listed is not necessarily excluded from the scope.
318 -595 Safety Project Safety Std Examples Lasers and Products Containing Lasers US/FDA: IEC: 21 CFR 1040. 10 - Laser Products 60820 - Electrical Safety of Laser Equipment and Installations 60825 - Radiation Safety of Laser Products, Equipment Classification, Requirements and User's Guide 60601 -2 -22 Diagnostic and Therapeutic Laser Equipment Other: ANSI Z 136. 3 - Safe use of lasers in health care facilities Imaging and Display Including CRT Type Video Monitors US/FDA: Other: 21 CFR 1020. 10 - Television Receivers (x-ray emissions) SMPTE Standards and Publications (test paterns) Broadcast TV Standards by Country (NTSC, PAL, SECAM etc. ) Video Recording Formats & Standards (VHS, Beta, Hi 8 etc. ) Imaging Systems: Range of Factors Affecting Image Quality Telephone Terminal and Communications Equipment US/FCC: 47 CFR 68 Connection of terminal equipment to the telephone network IEC: 60617 -9 Graphical symbols for diagrams part 9: telecommunications: switching and peripheral equipment EC: 1999/5/EC R&TTE - Radio & Telecommunications Terminal Equipment Directive
318 -595 Safety Project Health and Safety Aspects • Key Electrical Requirements/Questions to Consider for the Product: – – – – Over current or short circuit protection on output signals Over current protection on all power supplies Isolation from AC power line to electronic circuits Proper wire gauge/tracewidth vs. current Insulation and creepage distance versus voltage between conductors Proper derating of usable wattage in components versus ambient temp Diagnostic Tests or Failure Mode Indicators for Operator/Service Failure Modes and Effects Analysis (what happens if any one of the semiconductor parts fails in a way that shorts inputs to outputs? )
318 -595 Safety Project Health and Safety Aspects • Key Mechanical, Materials & Physics Requirements/Questions to Consider for the Product: – Edges of packaging are smooth and benign – Are electronics/mechanics susceptible to dirt, fluids, etc? Do they need to be sealed from the environment? (potted) – If the product is portable, have you considered handles, carrying, ergonomics, etc – If the product is > 40 lbs, have you considered handles, fixtures, etc for the user including OSHA mfg issues? – Maximum surface temperature of product (must be <= 40 o. C on any surface that can be touched by a user) – Does the product emit other energy output such light, sound, heat, etc and is there a safe level which can be related to a Safety Standard?
318 -595 Safety Project Health and Safety Aspects • Key Safety Requirements/Questions to Consider for the Product: – Are there any hazardous materials or components used in the product? If so, what are they? – In the US, the EHS laws require that companies keep Material Safety Data Sheets (MSDS) for most raw materials. What raw materials and MSDS’s are needed for your product manufacturing? – Does the Operator Manual include specific labeling of usage – Does the Operator/Service Manuals include proper warnings