NF ISO 19227

NF ISO 19227

August 2018
Standard Current

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.

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Main informations

Collections

National standards and national normative documents

Publication date

August 2018

Number of pages

23 p.

Reference

NF ISO 19227

ICS Codes

11.040.40   Implants for surgery, prosthetics and orthotics

Classification index

S94-091

Print number

1

International kinship

ISO 19227:2018
Sumary
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.

Replaced standards (1)
NF S94-091
August 2013
Standard Cancelled
Implants for surgery - Validation requirements for cleaning process of orthopaedic implants before final packaging

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.

Table of contents
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  • Avant-propos
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Exigences générales
  • 5 Évaluation de la propreté: méthodes d'essai et critères d'acceptation de propreté après le nettoyage final
  • 6 Vérification continue du procédé
  • 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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