Se aprobó la segunda edición de la norma :

ISO 14971:2007 Productos Sanitarios: Aplicación de la gestión de riesgos a los productos sanitarios

Esta norma cancela y reemplaza a las previas ISO 14971:2000 (UNE-EN ISO 14971:2003) e ISO 14971/Amd.1:2003.
No se ha fijado aún la fecha de retirada de la versión previa (dow).
En breve AENOR y todas las entidades de normalización publicaran la versión española UNE-EN ISO 14971:2007 y se armonizará con las directivas de producto sanitario dando un plazo de adaptación.

Indice / Contents Page

Foreword.......................................................................................................................................... iv
Introduction ...................................................................................................................................... v
1 Scope ............................................................................................................................................ 1
2 Terms and definitions...................................................................................................................... 1
3 General requirements for risk management ....................................................................................... 5
       3.1 Risk management process ......................................................................................................5
        3.2 Management responsibilities ..................................................................................................7
        3.3 Qualification of personnel .....................................................................................................7
        3.4 Risk management plan...........................................................................................................7
        3.5 Risk management file ........................................................................................................... 8
4 Risk analysis .................................................................................................................................. 8
          4.1 Risk analysis process .......................................................................................................... 8
           4.2 Intended use and identification of characteristics related to the safety of the medical device ........ 9
            4.3 Identification of hazards ...................................................................................................... 9
            4.4 Estimation of the risk(s) for each hazardous situation.............................................................. 9
5 Risk evaluation............................................................................................................................ 10
6 Risk control ................................................................................................................................ 11
        6.1 Risk reduction ..................................................................................................................... 11
        6.2 Risk control option analysis................................................................................................... 11
       6.3 Implementation of risk control measure(s).................................................................................11
      6.4 Residual risk evaluation............................................................................................................12
      6.5 Risk/benefit analysis ............................................................................................................... 12
      6.6 Risks arising from risk control measures................................................................................... 12
     6.7 Completeness of risk control ................................................................................................... 12
7 Evaluation of overall residual risk acceptability .............................................................................. 13
8 Risk management report.............................................................................................................. 13
9 Production and post-production information.................................................................................. 13
Annex A (informative) Rationale for requirements ........................................................................... 15
Annex B (informative) Overview of the risk management process for medical devices ........................ 23

Annex C (informative) Questions that can be used to identify medical device characteristics that                
could impact on safety................................................................................................................... 25
Annex D (informative) Risk concepts applied to medical devices....................................................... 32
Annex E (informative) Examples of hazards, foreseeable sequences of events and hazardous                   
situations ..................................................................................................................................... 49
Annex F (informative) Risk management plan ................................................................................. 54
Annex G (informative) Information on risk management techniques.................................................. 56
Annex H (informative) Guidance on risk management for in vitro diagnostic medical devices............... 60
Annex I (informative) Guidance on risk analysis process for biological hazards................................... 76
Annex J (informative) Information for safety and information about residual risk ............................... 78
Bibliography ................................................................................................................................ 80

Hemos preparado un curso de formación sobre la misma:

 CURSO ISO 14971:2007 GESTION DE RIESGOS