NF ISO 19227
Implants for surgery - Cleanliness of orthopedic implants - General Requirements
ISO 19227:2018 specifies requirements for the cleanliness of orthopaedic implants, hereafter referred to as implants, and test methods for the cleaning process validation and controls, which are based on a risk management process.ISO 19227:2018 does not specify requirements for packaging or sterilization which are covered by other International Standards.ISO 19227:2018 applies to in-process cleaning and final cleaning.ISO 19227:2018 does not apply to liquid or gaseous implants.ISO 19227:2018 does not apply to cleaning processes performed by the user or under the responsibility of the user.
ISO 19227:2018 specifies requirements for the cleanliness of orthopaedic implants, hereafter referred to as implants, and test methods for the cleaning process validation and controls, which are based on a risk management process.
ISO 19227:2018 does not specify requirements for packaging or sterilization which are covered by other International Standards.
ISO 19227:2018 applies to in-process cleaning and final cleaning.
ISO 19227:2018 does not apply to liquid or gaseous implants.
ISO 19227:2018 does not apply to cleaning processes performed by the user or under the responsibility of the user.
Le présent document établit les principes directeurs des procédures de validation recommandées pour le nettoyage des implants orthopédiques avant conditionnement final qui permettront de garantir leurs propretés physico-chimique et microbiologique. Il est applicable aux implants orthopédiques (les prothèses articulaires, les implants du rachis et le matériel d'ostéosynthèse) qui peuvent être des implants métalliques revêtus ou non, des implants céramiques, polymères, multi-matériaux, composites, destinés à être stérilisés.
- Avant-propos
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1 Domaine d'application
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2 Références normatives
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3 Termes et définitions
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4 Exigences générales
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5 Évaluation de la propreté: méthodes d'essai et critères d'acceptation de propreté après le nettoyage final
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6 Vérification continue du procédé
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7 Documentation
- Annexe A (informative) Sources potentielles de dommages au cours du procédé de nettoyage
- Annexe B (informative) Relation entre la conception du procédé de nettoyage, sa validation et la gestion des risques
- Annexe C (informative) Relation entre la validation du nettoyage, l'évaluation biologique et la validation de la stérilisation
- Bibliographie
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