FD ISO/TR 13121

FD ISO/TR 13121

October 2011
Published document Current

Nanotechnologies - Nanomaterial risk evaluation

ISO/TR 13121:2011 describes a process for identifying, evaluating, addressing, making decisions about, and communicating the potential risks of developing and using manufactured nanomaterials, in order to protect the health and safety of the public, consumers, workers and the environment. ISO/TR 13121:2011 offers guidance on the information needed to make sound risk evaluations and risk management decisions, as well as how to manage in the face of incomplete or uncertain information by using reasonable assumptions and appropriate risk management practices. Further, ISO/TR 13121:2011 includes methods to update assumptions, decisions, and practices as new information becomes available, and on how to communicate information and decisions to stakeholders. ISO/TR 13121:2011 suggests methods organizations can use to be transparent and accountable in how they manage nanomaterials. It describes a process of organizing, documenting, and communicating what information organizations have about nanomaterials.

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Main informations

Collections

National standards and national normative documents

Publication date

October 2011

Number of pages

69 p.

Reference

FD ISO/TR 13121

ICS Codes

07.120   Nanotechnologies

Classification index

T16-303

Print number

1 - 26/10/2011

International kinship

ISO/TR 13121:2011
Sumary
Nanotechnologies - Nanomaterial risk evaluation

ISO/TR 13121:2011 describes a process for identifying, evaluating, addressing, making decisions about, and communicating the potential risks of developing and using manufactured nanomaterials, in order to protect the health and safety of the public, consumers, workers and the environment.

ISO/TR 13121:2011 offers guidance on the information needed to make sound risk evaluations and risk management decisions, as well as how to manage in the face of incomplete or uncertain information by using reasonable assumptions and appropriate risk management practices. Further, ISO/TR 13121:2011 includes methods to update assumptions, decisions, and practices as new information becomes available, and on how to communicate information and decisions to stakeholders.

ISO/TR 13121:2011 suggests methods organizations can use to be transparent and accountable in how they manage nanomaterials. It describes a process of organizing, documenting, and communicating what information organizations have about nanomaterials.

Table of contents
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  • Avant-propos
    v
  • Introduction
    vi
  • 1 Domaine d'application
    1
  • 2 Symboles et termes abrégés
    1
  • 3 Résumé du processus décrit dans le Rapport technique
    3
  • 4 Description des matériaux et des applications
    5
  • 4.1 Généralités
    5
  • 4.2 Descriptions des matériaux
    6
  • 4.3 Approvisionnement en matériaux
    6
  • 4.4 Fabrication
    7
  • 4.5 Distribution
    7
  • 4.6 Utilisation/réutilisation/maintenance
    7
  • 4.7 Gestion de fin de vie/recyclage/déchets
    8
  • 4.8 Questions à poser concernant le nanomatériaux
    8
  • 5 Profils des propriétés, dangers et expositions des nanomatériaux
    9
  • 5.1 Généralités
    9
  • 5.2 Développement d'un profil de propriétés physiques/chimiques
    11
  • 5.3 Développement du profil de danger
    12
  • 5.4 Développement de profil d'exposition
    16
  • 6 Évaluation des risques
    22
  • 6.1 Généralités
    22
  • 6.2 Processus d'évaluation des risques
    22
  • 7 Évaluation des options de gestion des risques
    24
  • 8 Décision documentation et action
    26
  • 8.1 Généralités
    26
  • 8.2 Constitution d'une équipe de revue de prise de décision multifonctionnelle
    27
  • 8.3 Revue des informations
    28
  • 8.4 Considération des aspects commerciaux légaux et des parties prenantes
    28
  • 8.5 Détermination des responsabilités relatives à la mise en oeuvre des actions recommandées
    28
  • 8.6 Sur la base de ces entrées décision de poursuivre et si oui comment
    28
  • 8.7 Détermination des données additionnelles nécessaires et initiation de la collecte de données si nécessaire
    28
  • 8.8 Établissement et mise en oeuvre de processus appropriés de gestion surveillance conformité et communication des risques
    29
  • 9 Revue et adaptation
    30
  • 9.1 Généralités
    30
  • 9.2 Revues "au besoin"
    30
  • 9.3 Revues périodiques
    31
  • 9.4 Adaptation de la gestion des risques et collecte d'informations additionnelles le cas échéant
    31
  • 9.5 Documentation et communication de nouvelles décisions et actions
    32
  • Annexe A (informative) Ensemble de données de propriétés physiques et chimiques
    34
  • Annexe B (informative) Approche d'essai nivelé pour les données de danger pour la santé
    37
  • Annexe C (informative) Ensemble de données de danger pour la santé (autre approche)
    39
  • Annexe D (informative) Ensemble de données de danger pour l'environnement
    44
  • Annexe E (informative) Ensemble de données de devenir dans l'environnement
    46
  • Annexe F (informative) Feuille de calcul de résultats
    49
  • Annexe G (informative) Sources et références pour les ensembles de données
    61
  • Bibliographie
    63
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