Wednesday, September 18, 2013

Standards and Regulations Quick Reference

General Electrical Standards:
  • ANSI C84.1 - American National Standard for Electric Power Systems and Equipment - Voltage Ratings (60 Hertz)
    • Voltage Input Specifications for American supply mains operated equipment. A nice practical overview is provided by PowerQualityWorld
  • NFPA 70 - National Electric Code (US)
    • Comprehensive American electric code for building wiring
  • CAN/CSA C22.1-12 - Canadian Electrical Code
  • ANSI/NEMA WD 6 - Wiring Devices—Dimensional Specifications
    • Mechanical specifications for NEMA (home outlet) jacks and plugs
  • IEEE 1149.1 - Test Access Port and Boundary-Scan Architecture 
    • JTAG standard
  • IEC 60050 - International Electrotechnical Vocabulary
  • UL 1310 - Class 2 Power Units
    • Safety standard for "Class 2" (i.e. doubly insulated with no safety/chassis grounding) power supplies
  • IEEE 315 - Graphic Symbols for Electrical and Electronics Diagrams (Including Reference Designation Letters)
Printed Circuit Design:
  • IPC Standards Tree (PCB and Flex Circuit design/manufacturing/inspection standards)
    • Printed Circuit Design:
      • IPC 2221 - Generic Standard for Printed Circuit Design
      • IPC 7351 - Generic Requirements for Surface Mount Design (Land Patterns)
    • Printed Circuit Manufacturing/Performance
      • IPC 6012 - Qualification and Performance Specification for Rigid Printed Boards
      • MIL-PRF-31032 - General Performance Specification for Printed Circuit Board/Printed Wiring Board 
    • Printed Circuit Inspection (Bare Board)
      • IPC-A-600 - Acceptability of Printed Boards
    • Assembly/Soldering
      • J-STD-001 - Requirements for Soldered Electrical and Electronic Assemblies
    • Assembly Inspection
      • IPC-A-610 - Acceptability of Electronics Assemblies
    • Slash sheets exist for general specifications for laminates, copper foil, etc - see the standards tree link. Printed circuit drawing may define materials by specifying the IPC slash sheet requirements.

General Product Standards:
  • IEC 60529 - Degrees of protection provided by enclosures (IP Code)
    • Standard for degrees of protection from dust and fluid ingress
  • UL 94 - Tests for Flammability of Plastic Materials for Parts in Devices and Appliances
    • Standard for plastic material flammability ratings (self-extinguishing properties)
  • UL 746A - Polymeric Materials - Short Term Property Evaluations (Electrical Ignition)
    • Standard for plastic material flammability ratings (electrical ignition properties)
  • ISO 9001 - Quality management systems - Requirements
    • General standard for enterprise quality management systems
  • ISO 7000 - Graphical symbols for use on equipment -- Registered symbols
    • International standard for symbol graphics
  • ISO 8601 - Data elements and interchange formats – Information interchange – Representation of dates and times
    • International standard for representing dates and times
  • ASME Y14 - Engineering Drawings
    • Has many sub-parts/sub-standards for most aspects of technical drawings
    • ASME Y14.44 covers schematic reference designators

Military & US Government Standards:
  • Many defense and government standards are freely available at ASSIST
  • MIL spec standard microcircuit drawings (SMD) cross-reference available from DLA
  • MIL specs for parts also available from DLA
  • AS9100 - Quality Management Systems
Medical Device Standards:
Electrical Safety
  • IEC 60601-1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    • International standard for medical device safety. Many countries have their own nationalized version, e.g. AAMI/ANSI 60601-1 (for compliance with US electrical code). Has multiple associated collateral standards (sub-parts). 60601-1 is not technically a prerequisite for 510(k) clearance but in practice is near-necessity to help demonstrate electrical and use safety.  
  • IEC 60601-1-2 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
  • 47 CFR §15 - Radio Frequency Devices
    • FCC regulations covering intentional and unintentional EM radiators
  • FDA Recognized Consensus Standards are searchable from their website
Quality Systems and Risk Management
  • ISO 13485 - Medical devices - Quality management systems - Requirements for regulatory purposes
    • Similar to the American FDA quality system regulations 21 CFR §820
  • ISO 14971 - Medical devices - Application of risk management to medical devices
    • Risk = Probability of Harm for a given hazardous situation (P2) x Probability of Occurrence of given hazardous situation (P1)
Human Factors and Usability
  • AAMI HE75 - Human factors engineering - Design of medical devices
    • Comprehensive human factors standard for medical devices
  • IEC 62366 - Medical devices - Application of usability engineering to medical devices
Labelling
  • ISO 15223-1 - Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements
  • MIL-STD-130

Systems Engineering:
  • ISO/IEC 15288 - Systems and software engineering - System life cycle processes
    • High-level standard for a complete system lifecycle
  • ISO/IEC 19760 - A guide for the application of ISO/IEC 15288 (System life cycle processes)
  • IEEE 1220 - IEEE Standard for Application and Management of the Systems Engineering Process
    • A much more specific example of one way to implement IEC 15288
  • ISO/IEC/IEEE 42010 - Systems and software engineering. Architecture description
  • ISO 9241-210 - Ergonomics of human-system interaction -- Part 210: Human-centred design for interactive systems
  • IEC 15026 - Assurance Cases

Illumination Engineering:
  • IES HB-10 - The IES Lighting Handbook
    • Comprehensive guide to lighting engineering
Regulations:
General
  • 29 CFR §1910.399 - Inspection by a NRTL - see Certified and Acceptable
    • This regulation effectively requires NRTL safety marking for electronic installations in a workplace
  • 49 CFR §173.185 - LITHIUM CELLS AND BATTERIES
    • Hazardous materials regulation concerning the transportation of lithium cells and batteries (& products containing them)
  • Directive 2011/65/EU - (RoHS) restriction of the use of certain hazardous substances in electrical and electronic equipment
    • Restriction of hazardous materials in electronics (e.g. lead-free)
  • Directive 2006/121/EC - Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
    • Further restrictions of hazardous materials in electronics
Packaging and Transportation
  • NMF-100 - National Motor Freight Classification
  • IATA Lithium-Ion Packaging Instructions 965-970
    • Packing and labeling instructions for lithium-ion batteries
Medical Devices
United States:
Canada:
Europe: