Saturday, May 2, 2009

Overview of ISO 14971

It has 9 clauses.
Clause -1 - Scope
It covers all medical devices including IVDs.
It applies to all phases of product life cycle.
It does not
-define acceptable risk
-Apply to clinical decision making
-Does not require quality system
Clause -2 - Definition
- Clause provides definitions of terms
- there are new terms and definitions
- To provide uniformity among standards many definitions are harmonized with other standards and also with Guide 51 which is used by ISO and IEC for common definitions
- Clause also contains updated definitions from ISO 9000:2005
Definition changes

-in vitro diagnostic medical device– “medical device intended by the manufacturer for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes”

- life-cycle– “all phases in the life of a medical device, from the initial conception to final decommissioning and disposal”
- Post-production – new term – “part of the life-cycle of the product after the design has been completed and the medical device has been manufactured”
- Use error – “act or omission of an act that results in a different medical device response than intended by the manufacturer or expected by the user” – from IEC 62366
Clause -3 -General Requirements
- Sub-clause 3.2 “Management responsibilities” expands description of requirements and indicates that documentation created in the process and the risk management review can be part of the quality system documentation.
-Sub-clause 3.3 indicates in a Note that risk management activities can be performed by “representative of several functions, each contributing their specialist knowledge”
-Does not require a single individual be assigned the total responsibility for risk management
-Personnel assigned these activities must have proper training, background, education and experience
- Sub-clause 3.4 describes the Risk management plan
- Requirements unchanged
-In response to many comments in ISO 14971 voting process, extensive notes added to provide explanations and references to additional information in Annex D and Annex F

- Sub-clause 3.5 has been revised to include the traceability requirement removed from Clause 8 Risk management report
- Risk management report for complex devices was getting unwieldy
- Note indicates the Risk management file can be in any form or medium (such as electronic files)
Clause -4 - Risk Analysis
- Clause 4 covers Risk Analysis and Risk Estimation
- Sub-clause 4.1 re-titled to “Risk analysis process” from “Risk analysis procedure”
- New Notes point to informative annexes with additional information
- Sub-clause 4.2 Note 1 indicates “misuse is intended to mean incorrect or improper use of the medical device”
- Sub-clause 4.3 title changed to “Identification of hazards”
- Note points to E.2 and H.2.4 for guidance in hazard identification
- Sub-clause 4.4 title changed to “Estimation of the risk(s) for each hazardous situation”
- This is a new emphasis in Second Edition, from idea that harm cannot occur unless a Hazardous Situation leads to an exposure to a hazard
- Extensive notes used to explain this Subclause
Clause -5 - Risk Evaluation
- Evaluation requirement is in reference to “Hazardous situation” instead of “Hazard”
- Evaluation is comparison of Risk to Acceptability Criteria established in Risk Management Plan
Clause -6 - Risk Control
Sub-clause 6.1 removed requirement to reduce residual risk associated with each hazard to acceptable
- Addressed under “Residual Risk”
Sub-clause 6.2 Title changed to “Risk Control Option Analysis”
- Extensive Notes provide information and reference including use of other standards as part of option analysis
- Sub-clause 6.3 Implementation of risk control measure(s)
- Indicates that verification of effectiveness of risk control measures may include validation activities
- Sub-clause 6.4 Residual risk evaluation
- adds Note to Annex J for information on disclosing residual risk
- Sub-clause 6.5 Risk/benefit analysis
-Adds note referring to Annex D.6 for more information on Risk/benefit analysis
- Sub-clause 6.6 title changed to “Risks arising from risk control measures”
- Includes introduction of new hazards or hazardous situations
- Adds requirement that these new risks or increased risks be managed with process in sub-clauses 4.4 to 6.5
- Sub-clause 6.7 Completeness of risk control
- Changes “hazard” to “hazardous situation”
- Changes “The results of this assessment…” to “The results of this activity…”

Clause -7 - Evaluation of overall Residual risk acceptability
Clause 7 title changed to “Evaluation of overall residual risk acceptability”
- Adds requirement for deciding what information to disclose on overall residual risk
- Add reference to Annex D.7 on Overall residual risk
-Adds reference to Annex J on disclosure of residual risk
Clause -8 - Risk Management report
- Clause 8, removed the traceability requirement from the Risk management report to the Risk Management File (see Sub-clause 3.5)
- Adds requirements for responsibility for review and documentation of review that demonstrates
-“the risk management plan has been appropriately implemented;
-the overall residual risk is acceptable;
-appropriate methods are in place to obtain relevant production and post-production information.”

Clause - 9 - Production and post production process

- The Title was changed to “Production and post-production information” to emphasize that there is information available during production which is important to Risk Management
- Adds a requirements for systems collecting and reviewing device information

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