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ONORM EN ISO 15798 : 2013 AMD 1 2018

ONORM EN ISO 15798 : 2013 AMD 1 2018

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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)

Superseded date

19-05-2022

Superseded by

ÖNORM EN ISO 15798:2022 05 15

Published date

12-01-2013

Publisher

Osterreichisches Normungsinstitut/Austrian Standards

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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Superseded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

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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