ONORM EN ISO 15798 : 2013 AMD 1 2018
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES (ISO 15798:2013)
05-19-2022
01-12-2013
Diese ÖNORM befasst sich mit ophthalmischen viskoelastischen Substanzen, einer Klasse nicht-aktiver chirurgischer Implantate mit viskosen und/oder viskoelastischen Eigenschaften, die für den Einsatz bei chirurgischen Eingriffen im Vorderabschnitt des menschlichen Auges bestimmt sind. Mit Bezug auf die Sicherheit legt diese ÖNORM Anforderungen für die beabsichtigte Funktion, Konstruktionsmerkmale, vorklinische und klinische Auswertungen, Sterilisation, Verpackung, Kennzeichnung und die Bereitstellung von Informationen durch den Hersteller dieser Produkte sowie für Prüfverfahren fest.
| Committee |
TC 047
|
| DocumentType |
Standard
|
| PublisherName |
Osterreichisches Normungsinstitut/Austrian Standards
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| ISO 15798:2013 | Identical |
| UNE-EN ISO 15798:2014 | Identical |
| I.S. EN ISO 15798:2013 | Identical |
| NEN EN ISO 15798 : 2013 AMD 1 2017 | Identical |
| SN EN ISO 15798:2013 | Identical |
| NBN EN ISO 15798 : 2013 | Identical |
| UNI EN ISO 15798 : 2013 | Identical |
| DIN EN ISO 15798:2014-02 | Identical |
| ONORM EN 1041 : 2013 | INFORMATION SUPPLIED BY THE MANUFACTURER WITH MEDICAL DEVICES |
| 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 10993-16:2017 | Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables |
| ISO 15223-2:2010 | Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation |
| ISO 10993-2:2006 | Biological evaluation of medical devices — Part 2: Animal welfare requirements |
| 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 14630:2012 | Non-active surgical implants — General requirements |
| ISO 13408-1:2008 | Aseptic processing of health care products — Part 1: General requirements |
| ISO 11137-3:2017 | Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 22442-2:2015 | Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling |
| ISO 10993-9:2009 | Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products |
| ISO 14155:2011 | Clinical investigation of medical devices for human subjects Good clinical practice |
| 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 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 11607-1:2006 | Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| ISO 15223-1:2016 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
| ISO 10993-6:2016 | Biological evaluation of medical devices Part 6: Tests for local effects after implantation |
| 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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