In the last few years new medical device standards have been developed for Risk Analysis. EN1441 and EN60601-1-4 have been Harmonized under the Medical Device Directive (MDD) and may apply if you are selling product in Europe. These standards may also be used for meeting requirements in other countries including the USA, Australia, the Far East and Canada:

• EN1441 (1997) Medical devices – Risk analysis
• EN60601-1-4 (1996) Medical electrical equipment Part1: General requirements for safety 4: Collateral Standard: Programmable electrical medical systems

The Risk Analysis should be a living document throughout the design cycle and into production. The steps of risk analysis are:

• Identify the potential hazards using cross functional teams that might include engineering, R&D, clinicians, marketing, users, regulatory, product safety engineers, manufacturing, etc.
• Define the probability and risk of each hazard using either a bottom-up Failure Mode and Effect Analysis or a top-down Fault Tree Analysis.
• Determine which hazards have risk levels that require mitigation.
• Mitigate the hazards. Check to ensure no new hazards are generated. Continue to mitigate hazards until the risk level is low enough to be acceptable.

EN1441 applies to all medical devices from a tongue depressor to an implanted insulin pump, etc. It covers risk analysis procedures, which includes identifying hazards and estimating risks, associated with the device. This standard does not stipulate levels of acceptability and isn’t intended to give detailed guidance on risk management.

EN60601-1-4 applies to Medical electrical equipment (EN60601-1) and systems (EN60601-1-1) incorporating one or more Central Processing Units (CPU’s) or computer processor chips. The standard includes hardware, software, firmware, and interfaces. The bad news is if you have a medical piece of equipment that meets the definition of the EN60601-1 or EN60601-1-1 and it has software, firmware, a CPU, etc. you may need to go through the risk analysis for EN60601-1-4 as well as the risk analysis under EN1441. The good news is that EN60601-1-4 does follow some of EN1441 concepts so you won’t have to recreate the wheel if you have done an EN1441 risk analysis. The second piece of good news is that FDA has recognized EN60601-1-4 compliant documentation as part of 510(k) review, and risk analysis as part of Design Control requirements under 21 CFR820.30.