What are the key requirements for “critical components”​?

In an earlier post, I answered and provided basic examples to the question, What are “critical components”?

But, before moving-on to answering the question in this post, let me ask this…Is it mandatory for “critical components” to have certification mark(s)?

When specifying components for your product to meet applicable product safety requirements, I recommend the following:

  • Verify existing component certification marks – Certification marks are country/region and standard specific. For example, an agency in the U.S. accredited by OSHA as a NRTL to certify products under specific standards. Please note that not all certification marks are agency owned. Let’s take the CE Mark as an example. No agency owns the CE Mark. It is a self-declaration mark intended for the EU market (I will discuss the details of the CE Mark in future posts).
  • Use within intended specifications – Integrate components in your product based on the certified specifications (i.e., flammability rating, electrical rating, pressure rating, etc.).
  • Verify conditions of use or acceptability – Some components are certified with conditions of use or acceptability. For example, component mounting orientation, ambient temperature, additional protective devices at installation, etc.
  • Ask your agency for acceptable certification marks – Ideally, a certification mark from a competitor’s certification mark should be acceptable. However, check with your agency and ask what additional information and/or testing they require for them to accept a competitor’s component certification marks. An agency may have an internal component acceptance program that covers acceptance of a competitor’s certification marks.

Quiz: Is it acceptable to use a CE marked switching power supply in a medical device for U.S. market? Let’s make the assumption that we are only concerned with MOOP and a CB report exists with “national deviations” included.

#MDD #IEC60601 #ISO13485 #ISO14971 #Medicaldevicedirective #CEmarking#productsafety #productcertification #REACH #ROHS #Californiaprop65

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