Name: UNI EN ISO 17664 : 2005
Brand: UNI

UNI EN ISO 17664 : 2005

Superseded

STERILIZATION OF MEDICAL DEVICES - INFORMATION TO BE PROVIDED BY THE MANUFACTURER FOR THE PROCESSING OF RESTERILIZABLE MEDICAL DEVICES

Superseded date

09-05-2022

Published date

01-01-2005

Publisher

Ente Nazionale Italiano di Unificazione (UNI)

PREMESSA
INTRODUZIONE
1 SCOPO E CAMPO DI APPLICAZIONE
2 TERMINI E DEFINIZIONI
3 INFORMAZIONI CHE DEVONO ESSERE FORNITE DAL
  FABBRICANTE DEL DISPOSITIVO MEDICO
4 PRESENTAZIONE DELLE INFORMAZIONI
5 VALIDAZIONE DELLE INFORMAZIONI FORNITE SUI PROCESSI RIPETUTI
6 ANALISI DEL RISCHIO
APPENDICE A (informativa) - METODI DI UTILIZZO COMUNE PER I
  PROCESSI RIPETUTI
APPENDICE B (informativa) - ESEMPIO DI ISTRUZIONI SUI PROCESSI
  RIPETUTI PER DISPOSITIVI MEDICI RIUTILIZZABILI
APPENDICE ZA (informativa) - PUNTI DELLA PRESENTE NORMA EUROPEA
  RIGUARDANTI REQUISITI ESSENZIALI O ALTRE DISPOSIZIONI DELLE
  DIRETTIVE UE
BIBLIOGRAFIA

Describes the information to be provided by the medical device manufacturer on the processing of medical devices claimed to be re-sterilizable and medical devices intended to be sterilized by the processor.

DocumentType	Standard
PublisherName	Ente Nazionale Italiano di Unificazione (UNI)
Status	Superseded
SupersededBy	UNI EN ISO 17664:2018

Standards	Relationship
UNE-EN ISO 17664:2004	Identical
NBN EN ISO 17664 : 2004	Identical
I.S. EN ISO 17664:2004	Identical
DIN EN ISO 17664:2016-06 (Draft)	Identical
ISO 17664:2017	Identical
BS EN ISO 17664:2004	Identical
EN ISO 17664:2017	Identical
NS EN ISO 17664 : 2017	Identical
BS EN ISO 17664:2017	Identical
NEN EN ISO 17664 : 2018	Identical
NF EN ISO 17664 : 2017	Identical
SN EN ISO 17664 : 2018	Identical
I.S. EN ISO 17664:2017	Identical
ONORM EN ISO 17664 : 2018	Identical

EN ISO 14937:2009	Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)
ISO 11135:2014	Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
EN 285:2015	Sterilization - Steam sterilizers - Large sterilizers
ISO 14937:2009	Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
ISO 11607:2003	Packaging for terminally sterilized medical devices
ISO 11134:1994	Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization
ISO 7000:2014	Graphical symbols for use on equipment Registered symbols
ISO 15223:2000	Medical devices Symbols to be used with medical device labels, labelling and information to be supplied