UNI EN ISO 17664 : 2005
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
STERILIZATION OF MEDICAL DEVICES - INFORMATION TO BE PROVIDED BY THE MANUFACTURER FOR THE PROCESSING OF RESTERILIZABLE MEDICAL DEVICES
05-09-2022
01-01-2005
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Superseded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 |
| 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 |
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