Name: UNI CEN/TS 15277 : 2007
Brand: UNI

UNI CEN/TS 15277 : 2007

Superseded

View Superseded by

NON-ACTIVE SURGICAL IMPLANTS - INJECTABLE IMPLANTS

Superseded date

26-07-2022

Published date

01-01-2007

Publisher

Ente Nazionale Italiano di Unificazione (UNI)

PREMESSA
INTRODUZIONE
1 SCOPO E CAMPO DI APPLICAZIONE
2 RIFERIMENTI NORMATIVI
3 TERMINI E DEFINIZIONI
4 CARATTERISTICHE DEGLI IMPIANTI INIETTABILI
  4.1 Generalità
  4.2 Durata di vita
      4.2.1 Generalità
      4.2.2 Impianti iniettabili temporanei
      4.2.3 Impianti iniettabili permanenti
      4.2.4 Impianti iniettabili composti da
            materiali sia temporanei che permanenti
  4.3 Compatibilità clinica
  4.4 Sorveglianza post-commercializzazione
APPENDICE A (informativa) - PANORAMICA DI ESEMPI
            DI IMPIANTI INIETTABILI
BIBLIOGRAFIA

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

DocumentType	Standard
PublisherName	Ente Nazionale Italiano di Unificazione (UNI)
Status	Superseded
SupersededBy	UNI EN 15560 : 2009

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)