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I.S. CEN TS 15277:2006

Current
Current

The latest, up-to-date edition.

NON-ACTIVE SURGICAL IMPLANTS - INJECTABLE IMPLANTS
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2006

Preview

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

Presents characteristics of medical devices that are injectable implants, such as lifetime, migration, displacement, unintended degradation, impurity, infections, bio-incompatibility and clinical incompatibility.

DocumentType
Standard
Pages
15
PublisherName
National Standards Authority of Ireland
Status
Current

Standards Relationship
CEN/TS 15277:2006 Identical

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
EN ISO 15798:2013/A1:2017 OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES (ISO 15798:2013/AMD 1:2017)
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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