ISO 14971:2007 -- "Medical devices -- Application of risk management to medical devices"
Newly revised. Although designed for medical devices, its principles
are useful for any regulated product.
1 Scope
2 Terms and definitions
3 General requirements for risk management
3.1 Risk management process
3.2 Management responsibilities
3.3 Qualification of personnel
3.4 Risk management plan
3.5 Risk management file
4 Risk Analysis
4.1 Risk analysis process
4.2 Intended use and identification of characteristics
related to the safety of the medical device
4.3 Identification of hazards
4.4 Estimation of the risk(s) for each hazard hazardous situation
5 Risk evaluation
6 Risk control
6.1 Risk reduction
6.2 Risk control option analysis
6.3 Implementation of risk control measure(s)
6.4 Residual risk evaluation
6.5 Risk / benefit analysis
6.6 Risks arising from risk control measures
6.7 Completeness of risk control
7 Evaluation of overall residual risk acceptability
8 Risk management report
9 Production and post-production information
Annexes
A Rationale for requirements
B Overview of the risk management process for medical devices
C Questions that can be used to identify medical device
characteristics that could impact on safety
D Risk concepts applied to medical devices
E Examples of hazards, foreseeable sequences of events, and
hazardous situations
F Risk management plan
G Information on risk management techniques (PHA, FTA, FMEA,
HAZOP, HACCP)
H Guidance on risk management for in vitro diagnostic medical
devices
I Guidance on risk analysis process for biological hazards
J Information for safety and information about residual risk
ISO 14971, a harmonized standard, is not mandatory, but regulatory agencies
(US FDA / EU Notified Bodies) will expect to see manufacturers conducting
risk analysis for devices under the CGMPs / ISO 13485. As the harmonized
standard, ISO 14971 is the model that represents current "state of the art"
thinking, and increasingly regulatory agencies will be expecting manufacturers
to use it as a basis for risk management of medical devices.
For aid in identifying device-specific hazards / risks, review similar product
families at the US FDA's Manufacturer and User Facility Device Experience
MAUDE) database, www.fda.gov/cdrh/maude, select "on-line search" link
in para. 2, then enter company or product desired, and select time
period, then "Search".