UNE-EN ISO 14160:2012
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2011)
Hardcopy , PDF
Spanish, Castilian, English
08-02-2012
01-09-2021
Definisce requisiti per in via di sviluppo, convalidare, comando di processo E monitoraggio della sterilizzazione, utilizzando sostanza chimica liquida sterilants, di singolo uso dispositivi medici consistente (lo : uno) o l'altro Completamente o parzialmente di materiali di origine dell'animale. Non applicabile a materiale di origine umana.
| Committee |
CTN 111
|
| DocumentType |
Standard
|
| Pages |
46
|
| PublisherName |
Asociación Española de Normalización
|
| Status |
Superseded
|
| Standards | Relationship |
| BS EN ISO 14160:2011 | Identical |
| NBN EN ISO 14160 : 2011 | Identical |
| I.S. EN ISO 14160:2011 | Identical |
| DIN EN ISO 14160:2011-10 | Identical |
| NS EN ISO 14160 : 2011 | Identical |
| NF EN ISO 14160 : 2011 | Identical |
| ONORM EN ISO 14160 : 2011 | Identical |
| NEN EN ISO 14160 : 2011 | Identical |
| EN ISO 14160:2011 | Identical |
| ISO 14160:2011 | Identical |
| ISO 11137-1:2006 | Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| ISO 11737-2:2009 | Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process |
| ISO 11737-1:2006 | Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products |
| ISO 13485:2016 | Medical devices — Quality management systems — Requirements for regulatory purposes |
| 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 22442-1:2015 | Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management |
| ISO 11135-1:2007 | Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| ISO 9004:2009 | Managing for the sustained success of an organization — A quality management approach |
| ISO/TS 11139:2006 | Sterilization of health care products — Vocabulary |
| ISO 10993-17:2002 | Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances |
| ISO 10993-1:2009 | Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process |
| ISO 10012:2003 | Measurement management systems — Requirements for measurement processes and measuring equipment |
| ISO 22442-2:2015 | Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling |
| ISO 11138-1:2017 | Sterilization of health care products — Biological indicators — Part 1: General requirements |
| ISO 22442-3:2007 | Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents |
| ISO/IEC 90003:2014 | Software engineering — Guidelines for the application of ISO 9001:2008 to computer software |
| ISO 14161:2009 | Sterilization of health care products — Biological indicators — Guidance for the selection, use and interpretation of results |
| ISO 17665-1:2006 | Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
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