CEN/TS 15277:2006

Non-active surgical implants - Injectable implants

This Technical Report gives characteristics of medical devices that are injectable implants, such as lifetime, migration, displacement, unintended degradation, impurity, infections, bio-incompatibility and clinical incompatibility.
Pharmaceuticals, e.g. Botulinum-toxin, are not covered by the present document.

Nichtaktive chirurgische Implantate - Injizierbare Implantate

Implants chirurgicaux non actifs - Implants injectables

La présente Spécification technique présente les caractéristiques des dispositifs médicaux que sont les implants injectables, telles que leur durée de vie, leur migration, leur déplacement, leur dégradation accidentelle, la présence d’impuretés, les infections, la bio-incompatibilité et l’incompatibilité clinique.
Les produits pharmaceutiques, par exemple la toxine botulinique, ne sont pas traités dans le présent document.

Neaktivni kirurški vsadki (implantati) - Vsadki za paranteralne farmacevtske oblike

General Information

• Status: Published
• Publication Date: 26-Sep-2006
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: CEN/TC 285 - Non-active surgical implants
• Drafting Committee: CEN/TC 285 - Non-active surgical implants
• Current Stage: 9093 - Decision to confirm - Review Enquiry
• Start Date: 25-Jan-2009
• Completion Date: 25-Jan-2009
• Ref Project: SIST-TS CEN/TS 15277:2006 - Non-active surgical implants - Injectable implants

Standards Content (Sample)

SLOVENSKI STANDARD
SIST-TS CEN/TS 15277:2006
01-december-2006
Neaktivni kirurški vsadki (implantati) - Vsadki za paranteralne farmacevtske oblike
Non-active surgical implants - Injectable implants
Nichtaktive chirurgische Implantate - Injizierbare Implantate
Implants chirurgicaux non actifs - Implants injectables
Ta slovenski standard je istoveten z: CEN/TS 15277:2006
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
SIST-TS CEN/TS 15277:2006 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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TECHNICAL SPECIFICATION
CEN/TS 15277
SPÉCIFICATION TECHNIQUE
TECHNISCHE SPEZIFIKATION
September 2006
ICS 11.040.40

English Version
Non-active surgical implants - Injectable implants
Nichtaktive chirurgische Implantate - Injizierbare Implantate
This Technical Specification (CEN/TS) was approved by CEN on 24 October 2005 for provisional application.
The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to submit their
comments, particularly on the question whether the CEN/TS can be converted into a European Standard.
CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS available
promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in parallel to the CEN/TS)
until the final decision about the possible conversion of the CEN/TS into an EN is reached.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,
Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TS 15277:2006: E
worldwide for CEN national Members.

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CEN/TS 15277:2006 (E)
Contents Page
Introduction .4
1 Scope.5
2 Normative references.5
3 Terms and definitions .5
4 Characteristics of injectable implants.6
4.1 General.6
4.2 Lifetime.7
4.2.1 General.7
4.2.2 Temporary injectable implants.7
4.2.3 Permanent injectable implants.7
4.2.4 Injectable implants composed of both temporary and permanent materials .7
4.3 Clinical Compatibility.7
4.4 Post-market surveillance.8
Annex A (informative) Overview of examples of injectable implants .9
Bibliography .13

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CEN/TS 15277:2006 (E)
Foreword
This document (CEN/TS 15277:2006) has been prepared by Technical Committee CEN/TC 285 “Non-active
surgical implants”, the secretariat of which is held by NEN.
Attention is drawn to the possibility that some of the elements of this document may be the subject of p
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