Environmental Aspects Pretext: A product must be designed in accordance with all the environmental conditions that it may see including those while in operation and those while being shipped or stored. Key Requirements/Questions to Consider for the Product: Do the Std Requirements reflect the Operating Temp Range with margin? Operating Humidity Range? If so what is your margin? Can your product be subject to extreme Solar heat (eg; automotive) Do the Std Requirements reflect the Non-Operating (storage, shipment, etc) Temp Range, Humidity Range adquately Operating and Non-Operating Max Shock, Max Vibration Levels Max Audible Noise Emission Level Electromagnetic Compatibility Forms part of the environment Ventilation or other airflow restriction concerns, air filters, cleaning Will the product be subjected to dirt, cleaning fluids or processes

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?)

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 <= 40oC 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?

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

ISO 9000 Quality The ISO 9000 Family of Standards via ISO web site : http://www.iso.ch/iso/en/iso9000-14000/iso9000/selection_use/iso9000family.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

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 fulfil: - 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.

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.

Safety Standard Organizations: Safety Aspects Safety Standard Organizations: AAMI - American Association of Medical Instrumentation ANSI - American National Standards Institute ASTM - American Society for Testing and Materials CSA - Canadian Standards Association IEC - International Electrotechnical Commission ISO - International Standards Organization NFPA - National Fire Protection Association SCC - Standards Council of Canada UL - Underwriters Laboratories, Inc.   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

Battery Chargers for Charging Engine-Starter Batteries UL Std Example: UL1236 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 StandardsInfoNet | Underwriters Laboratories Inc. Copyright © 2003 Underwriters Laboratories Inc.

UL1950 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 C22.1; CSA C22.2 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

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.

Project Aspects: Safety Lasers and Products Containing Lasers US/FDA: 21 CFR 1040.10 - Laser Products  IEC: 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 Z136.3 - Safe use of lasers in health care facilities Imaging and Display Including CRT Type Video Monitors US/FDA: 21 CFR 1020.10 - Television Receivers (x-ray emissions) Other: 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