Surgical instruments - Definition of immatriculation specifications for tracability purposes

1 Domaine d'application 4

2 Termes et définitions 4

3 Exigences 4

3.1 Généralités sur la traçabilité 4

3.2 Responsabilités et mises à jour 6

3.3 Architecture et codifications 6

3.4 Modalités d'opération et interopérabilité 6

3.5 Conditions environnementales et cycles de stérilisation 6

Annexe A (informative) Système EAN-UCC :Codification, structure et représentation des données 8

A.1 Codification : structure du GTIN 8

A.2 La structure et représentation des données 9

A.3 Démarche pratique pour marquer les informations complémentaires 9

Annexe B (informative) Exemple d'identifiants EAN-UCC 128 10

Annexe C (informative) Exemple de préparation stérile des instruments chirurgicaux 11

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