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Crosswalk: ISO 14971:2007 Vs. ISO 14971:20XX

Executive Summary

Here's a table cross-referencing the current 2007 version of international risk management standard ISO 14971 and its revised draft version, which will likely be published by the International Organization for Standardization (ISO) later this year.

Below is a crosswalk for the clauses and subclauses in the current version of international risk management standard ISO 14971 and its revised draft version, which will likely be published by the International Organization for Standardization (ISO) in the third quarter of 2019. (Check out our story about the ISO 14971 redo here.)

ISO 14971:2007

ISO 14971:20XX

1  Scope

1  Scope

(New clause)

2  Normative references

2  Terms and definitions

3  Terms and definitions

2.1  accompanying document

3.1  accompanying document

(New definition)

3.2  benefit

2.2  harm

3.3  harm

2.3  hazard

3.4  hazard

2.4  hazardous situation

3.5  hazardous situation

2.5  intended use/intended purpose

3.6  intended use/intended purpose

2.6  in vitro diagnostic medical device/IVD medical device

3.7  in vitro diagnostic medical device/IVD medical device

2.7  life-cycle

3.8  life-cycle

2.8  manufacturer

3.9  manufacturer

2.9  medical device

3.10  medical device

2.10  objective evidence

3.11  objective evidence

2.11  post-production

3.12  post-production

2.12  procedure

3.13  procedure

2.13  process

3.14  process

(New definition)

3.15  reasonably foreseeable misuse

2.14  record

3.16  record

2.15  residual risk

3.17  residual risk

2.16  risk

3.18  risk

2.17  risk analysis

3.19  risk analysis

2.18  risk assessment

3.20  risk assessment

2.19  risk control

3.21  risk control

2.20  risk estimation

3.22  risk estimation

2.21  risk evaluation

3.23  risk evaluation

2.22  risk management

3.24  risk management

2.23  risk management file

3.25  risk management file

2.24  safety

3.26  safety

2.25  severity

3.27  severity

(New definition)

3.28  state of the art

2.26  top management

3.29  top management

2.27  use error

3.30  use error

2.28  verification

3.31  verification

3  General requirements for risk management

4  General requirements for risk management

3.1  Risk management process

4.1  Risk management process

3.2  Management responsibilities

4.2  Management responsibilities

3.3  Qualification of personnel

4.3  Qualification of personnel

3.4  Risk management plan

4.4  Risk management plan

3.5  Risk management file

4.5  Risk management file

4  Risk analysis

5  Risk analysis

4.1  Risk analysis process

5.1  Risk analysis process

4.2  Intended use and identification of characteristics related to the safety of the medical device

5.2  Intended use and reasonably foreseeable misuse

5.3  Identification of characteristics related to safety

4.3  Identification of hazards

5.4  Identification of hazards and hazardous situations

4.4  Estimation of the risk(s) for each hazardous situation

5.5  Risk estimation

5  Risk evaluation

6  Risk evaluation

6  Risk control

7  Risk control

6.1  Risk reduction

(Subclause deleted)

6.2  Risk control option analysis

7.1  Risk control option analysis

6.3  Implementation of risk control measure(s)

7.2  Implementation of risk control measures

6.4  Residual risk evaluation

7.3  Residual risk evaluation

6.5  Risk/benefit analysis

7.4  Benefit-risk analysis

6.6  Risks arising from risk control measures

7.5  Risks arising from risk control measures

6.7  Completeness of risk control

7.6  Completeness of risk control

7  Evaluation of overall residual risk acceptability

8  Evaluation of overall residual risk

8  Risk management report

9  Risk management review

9  Production and post-production information

10  Production and post-production activities

10.1  Information collection

10.2  Information review

10.3  Actions

Annex A  Rationale for requirements

Annex A  Rationale for requirements

Annex B  Overview of the risk management process for medical devices

Annex B  Overview of the risk management process for medical devices

Annex C  Questions that can be used to identify medical device characteristics that could impact on safety

Moved to ISO/TR 24971

Annex D  Risk concepts applied to medical devices

Moved to ISO/TR 24971

Annex E  Examples of hazards, foreseeable sequences of events and hazardous situations

Annex C  Fundamental risk concepts

Annex F  Risk management plan

Moved to ISO/TR 24971

Annex G  Information on risk management techniques

Moved to ISO/TR 24971

Annex H  Guidance on risk management for in vitro diagnostic medical devices

Moved to ISO/TR 24971

Annex I  Guidance on risk analysis process for biological hazards

Moved to ISO/TR 24971

Annex J  Information for safety and information about residual risk

Moved to ISO/TR 24971


Source: ISO 14971:20XX

 

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