REGULATORY COMPLIANCE

Standards and regulations

Following is a list of regulatory standards that we have expertise in:

Mains Safety
  • AS3100 - Approval and test specification - General requirements for electrical equipment: This is the primary specification governing the approval and test specification of electrical equipment. As such any electronic product must adhere to these basic rules governing safety. 

  • IEC 60730-1 - Automatic electrical controls - Part 1: General requirements: Most devices we design include elements of a control system including the use of relays. 

  • IEC 60335-1 - Safety for household and similar electrical appliances: This is for both battery operated appliances and mains connected.

  • AS/NZS 61558 - Safety of transformers, reactors, power supply units: This covers a specific aspect around power supply used in most product designs

  • UL60950 - Safety of Information Technology Equipment: Any products classified as information technology must adhere to this standard.

  • AS3000 - Wiring Rules: Many electronic products are hard wired into a building environment. As such the design and installation instructions must adhere to general wiring rules for electrical installations.

Product & Software Safety
  • IEC 60730

  • IEC 60335

  • IEC 62304

  • MISRA

  • UL924

Medical devices
  • ISO 13485:2016 certified (MD647437) (quality)

  • ISO 14971 (risk management)

  • IEC 60601-1 (product)

  • IEC 62304 - Software life cycle processes for medical devices: For medical devices, it is not enough to design good software. Developers must manage all the processes throughout the product life cycle including controlled modification, management of risks, configuration management, and problem resolution. 

Aerospace & Military
  • RTCA DO-160

  • RTCA DO-178

  • RTCA DO-254

  • MIL-STD-810

Materials Safety
  • RoHS

  • WEEE

EMC Emissions (C-Tick, CE, FCC)
  • CISPR11 (ISM)

  • CISPR12 (vehicles)

  • CISPR14 (household)

  • CISPR22 (IT)

  • EN61000-1 (general)

  • EN61000-2-1 (conducted)

  • EN61000-2-3 (radiated)

  • EN61000-3-2 (harmonics)

  • EN61000-3-5 (flicker)

ESD
  • EN61000-4-2 ESD

EMC Immunity (CE and Safety Critical)
  • EN61000-4-3 (radiated)

  • EN61000-4-4 (transient)

  • EN61000-4-5 (surge)

  • EN61000-4-6 (conducted)

  • EN61000-4-7 (harmonics)

  • EN61000-4-8 (magnetic)

  • EN61000-4-9 (pulse)

  • EN61000-4-11 (dips)

Hazardous Areas & Ingress Protection
  • IPxx

  • Intrinsic Safety

  • Safety Integrity Level (SIL)

 

Why compliance systems are needed

Companies developing products or devices must set up compliance systems for two core reasons:

 

  • Demonstrating compliance with technical standards

  • Gaining certification with regulatory authorities

 

It is easy to identify WHAT you need to do to comply. HOW to comply is much harder – particularly with complex technical standards. 

 

Medical Device Compliance 

Genesys can provide support for any standard. However, we primarily work in areas related to quality, risk, software development and electrical safety. Key headline standards we have expertise in are:

  • ISO 13485 - Medical devices -- Quality management systems

  • ISO 14971 -Medical devices -- Application of risk management

  • IEC 60601-1 - Medical electrical equipment

  • IEC 60601-1-2 - Electromagnetic Compatibility

  • IEC 62034 - Medical Device Software Life Cycle


Many of the industrial standards in the next panel also apply to medical devices.

For more information view our page on Medical Device Development or download our Whitepaper on What you Need to Know Before Developing Electronic Medical Devices. 

View the full list of standards we have experience addressing.

 

Industrial Device Compliance

Genesys can provide support for any standard. However, we primarily work in areas related to quality, risk, software development and electrical safety. Key headline standards we have expertise in are:


ISO 13485 - Medical devices -- Quality management systems
ISO 14971 -Medical devices -- Application of risk management
IEC 60601-1 - Medical electrical equipment
IEC 60601-1-2 - Electromagnetic Compatibility
IEC 62034 - Medical Device Software Life Cycle
AS 3100 - General requirements for electrical equipment
IEC 60950 - Information technology equipment safety


See the full list of standards we have expertise in.

 

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