CEN/TS 15277:2006
(Main)Non-active surgical implants - Injectable implants
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
- 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
Overview
CEN/TS 15277:2006 - Non‑active surgical implants: Injectable implants - is a European Technical Specification that sets out the characteristic requirements and evaluation principles for medical devices intended to be introduced by injection and remain in the body. The document addresses safety and performance aspects including lifetime, migration, displacement, unintended degradation, impurity, infection, bio‑compatibility and clinical compatibility. Pharmaceuticals (e.g. botulinum toxin) are explicitly excluded.
Key topics and requirements
Definitions and scope
Clear terms are provided for injectable implant, temporary vs permanent implants, migration, resorption, degradation, biocompatibility and clinical compatibility.General requirements
Injectable implants must meet general non‑active implant requirements (EN ISO 14630) and biocompatibility testing (EN ISO 10993). Risk management should follow EN ISO 14971.Lifetime and performance data
Manufacturers must state expected duration of performance. Where applicable, implant survivorship should be reported using appropriate statistical methods (e.g., Kaplan–Meier) and factors that influence individual implant lifetime must be identified.Clinical compatibility and evaluation
Clinical evaluation must estimate rates of device‑related adverse events such as infections, granulomatous reactions and other adverse device effects. Clinical investigations must comply with EN ISO 14155‑1/‑2. Use of literature or external clinical data requires demonstrated equivalence and high‑quality evidence.Post‑market surveillance
Prospective monitoring of long‑term performance and complication rates (including infection and granulomatous reactions) is required, with follow‑up periods aligned to expected implant lifetime. Manufacturers must provide a patient card including patient name, clinician, implant name, lot number, injection date, injected volume and injection site(s).Material examples and hazards (informative Annex A)
The Technical Specification lists common temporary and permanent implant materials (animal‑derived and non‑animal‑derived) and associated hazards (migration, displacement, degradation, impurity, infection, bio‑ and clinical incompatibility).
Applications and users
This standard is intended for:
- Manufacturers and R&D teams developing injectable implants and associated labeling/instructions for use
- Regulatory affairs and quality managers preparing conformity documentation and risk files
- Clinical investigators and clinicians assessing safety, follow‑up protocols and patient information
- Notified bodies and conformity assessment organizations reviewing pre‑market and post‑market evidence
Keywords: CEN/TS 15277:2006, injectable implants standard, non‑active surgical implants, biocompatibility, risk management, post‑market surveillance, patient card.
Related standards
- EN ISO 10993 (Biological evaluation of medical devices)
- EN ISO 14630 (Non‑active surgical implants - General requirements)
- EN ISO 14971 (Risk management for medical devices)
- EN ISO 14155‑1 / ‑2 (Clinical investigations of medical devices)
Frequently Asked Questions
CEN/TS 15277:2006 is a technical specification published by the European Committee for Standardization (CEN). Its full title is "Non-active surgical implants - Injectable implants". This standard covers: 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.
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.
CEN/TS 15277:2006 is classified under the following ICS (International Classification for Standards) categories: 11.040.40 - Implants for surgery, prosthetics and orthotics. The ICS classification helps identify the subject area and facilitates finding related standards.
You can purchase CEN/TS 15277:2006 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CEN standards.
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
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
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 patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to announce this Technical Specification: 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.
Introduction
This Technical Specification has been written because injectable implants are not covered by any standard.
1 Scope
This Technical Specification 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.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
EN ISO 10993, Biological evaluation of medical devices (all parts)
EN ISO 14155-1, Clinical investigation of medical devices for human subjects – Part 1: General requirements
(ISO 14155-1:2003)
EN ISO 14155-2, Clinical investigation of medical devices for human subjects – Part 2: Clinical investigation
plans (ISO 14155-2:2003)
EN ISO 14630:1997, Non-active surgical implants – General requirements (ISO 14630:1997)
EN ISO 14971 Medical devices - Application of risk management to medical devices (ISO 14971:2000)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
biocompatibility
ability of a material to perform with an appropriate host response in a specific application.
NOTE This would be restricted to in vitro tests etc.]
3.2
clinical compatibility
Absence of unacceptable risk due to the implant as documented during pre-market and post-market
evaluation
NOTE For acceptability of risk see EN ISO 14971
3.3
degradation
decomposition of an injectable implant in vivo into smaller chemical or physical components
3.4
displacement
undesired dislocation of the implant due to mechanical forces or gravity
3.5
impurity
unacceptable levels of substances from the production process and/or of other substances in injectable
implants
3.6
injectable implant
implant material which is intended to be introduced by injection into the human body and which is supposed to
remain in place after the procedure
3.7
harm
physical injury or damage to the health of people, or damage to property or environment
[ISO/IEC Guide 51:1999, definition 3.1]
3.8
hazard
potential source of harm
[ISO/IEC Guide 51:1999, definition 3.5]
3.10
migration
active or passive transport of the implant material from the intended place of administration
3.11
permanent injectable implants
injectable implants which are not intended to be totally degraded or resorbed
NOTE There are injectable implants composed of both temporary and permanent materials.
3.12
resorption
elimination and excretion of an injectable implant by the body
3.13
risk
combination of the probability of occurrence of harm and the severity of that harm
[ISO/IEC Guide 51:1999, definition 3.2]
3.14
temporary injectable implants
injectable implants which are intended to be totally degraded or resorbed
NOTE There are injectable implants composed of both temporary and permanent materials.
4 Characteristics of injectable implants
4.1 General
General requirements for non-active surgical implants are given in EN ISO 14630.
Requirements for the biocompatibility of injectable implants are given in the EN ISO 10993 series of standards.
Requirements for the risk management of injectable implants are given in EN ISO 14971.
All injectable implants shall be used in accordance with the instructions for use.
Once the implant is in place it is usually difficult to retrieve the implant completely.
4.2 Lifetime
4.2.1 General
The lifetime of injectable implants can vary depending on the type of material us
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.
Loading comments...