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
- Online searchable technical glossary with traceable definitions
- 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)
- 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.
- 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:
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
- 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
- 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
- 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
- NMF-100 - National Motor Freight Classification
- IATA Lithium-Ion Packaging Instructions 965-970
- Packing and labeling instructions for lithium-ion batteries
United States:
- 21 CFR §820 - Quality System Regulation
- 21 CFR §801 - Labeling
- 21 CFR §807 - Premarket Notification
- 21 CFR §803 - Medical Device Reporting
- SOR/98-282 - Medical Device Regulations
Europe:
- Directive 93/42/EEC