CEN/TS 15277:2006
Current
The latest, up-to-date edition.
Non-active surgical implants - Injectable implants
27-09-2006
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Characteristics of injectable implants
4.1 General
4.2 Lifetime
4.2.1 General
4.2.2 Temporary injectable implants
4.2.3 Permanent injectable implants
4.2.4 Injectable implants composed of both temporary
and permanent materials
4.3 Clinical Compatibility
4.4 Post-market surveillance
Annex A (informative) Overview of examples of injectable implants
Bibliography
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.
| Committee |
CEN/TC 285
|
| DocumentType |
Technical Specification
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Current
|
| Standards | Relationship |
| UNI CEN/TS 15277 : 2007 | Identical |
| DIN CEN/TS 15277:2006-12 | Identical |
| UNE-CEN/TS 15277:2007 EX | Identical |
| NEN NPR CEN/TS 15277 : 2006 | Identical |
| XP CEN/TS 15277 : 2007 XP | Identical |
| I.S. CEN TS 15277:2006 | Identical |
| I.S. EN 16844:2017 | AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES |
| I.S. EN 16844:2017+A2:2019 | Aesthetic medicine services - Non-surgical medical treatments |
| 13/30278952 DC : 0 | BS EN 16372 - AESTHETIC SURGERY AND AESTHETIC NON-SURGICAL MEDICAL SERVICES |
| 15/30317874 DC : 0 | BS EN 16844 - AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES |
| UNE-EN 16372:2015 | Aesthetic surgery services |
| I.S. EN 16372:2014 | AESTHETIC SURGERY SERVICES |
| EN 16844:2017 | Aesthetic medicine services - Non-surgical medical treatments |
| EN 16372:2014 | Aesthetic surgery services |
| BS EN 16372:2014 | Aesthetic surgery services |
| BS EN 16844 : 2017 | AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL TREATMENTS |
| EN 12442-3 : 2000 | ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE AGENTS |
| ISO 14155-2:2003 | Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans |
| ISO 14155-1:2003 | Clinical investigation of medical devices for human subjects Part 1: General requirements |
| ISO 15798:2013 | Ophthalmic implants Ophthalmic viscosurgical devices |
| ISO 14630:2012 | Non-active surgical implants — General requirements |
| ISO/IEC Guide 51:2014 | Safety aspects — Guidelines for their inclusion in standards |
| EN ISO 14971:2012 | Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
| EN 12442-1 : 2000 | ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| EN ISO 14155-2:2009 | Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003) |
| EN ISO 14155-1:2009 | Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003) |
| EN 12442-2 : 2000 | ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 2: CONTROLS ON SOURCING, COLLECTION AND HANDLING |
| EN ISO 14630:2012 | Non-active surgical implants - General requirements (ISO 14630:2012) |
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