Transcript Health and Safety Aspects

318-595 Safety
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
318-595 Safety
Health and Safety Aspects
• Key Electrical Requirements/Questions to Consider for the
Product:
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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
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?
318-595 Safety
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
318-595 Safety
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
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 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.
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
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
318-595 Safety
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.
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Copyright © 2003 Underwriters Laboratories Inc.
318-595 Safety
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
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 Aspects: Safety
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 Z136.3 - 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