ISO 16971:2015
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 instruments — Optical coherence tomograph for the posterior segment of the human eye
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
08-11-2024
English, French
15-04-2015
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ISO 16971:2015 is applicable to optical coherence tomography (OCT) instruments, systems, and methods that are intended to image and measure the biological tissue of the posterior segment of the human eye.
ISO 16971:2015 defines certain terms that are specific to this diagnostic procedure.
ISO 16971:2015 specifies minimum requirements for OCT instruments and systems. It specifies tests and procedures that will verify that a system or instrument complies with ISO 16971:2015 and so qualifies as an OCT in the meaning of this International Standard. It specifies type test methods and procedures that will allow the verification of capabilities of systems that are beyond the minimum required for OCTs.
| Committee |
ISO/TC 172/SC 7
|
| DevelopmentNote |
Supersedes ISO/DIS 16971. (04/2015)
|
| DocumentType |
Standard
|
| Pages |
9
|
| PublisherName |
International Organization for Standardization
|
| Status |
Superseded
|
| SupersededBy | |
| UnderRevision |
| Standards | Relationship |
| NF ISO 16971 : 2015 | Identical |
| NEN ISO 16971 : 2015 | Identical |
| DS ISO 16971 : 2015 | Identical |
| ISO 15004-1:2006 | Ophthalmic instruments Fundamental requirements and test methods Part 1: General requirements applicable to all ophthalmic instruments |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| IEC 60825-1:2014 | Safety of laser products - Part 1: Equipment classification and requirements |
| ISO 12052:2017 | Health informatics — Digital imaging and communication in medicine (DICOM) including workflow and data management |
| IEC 62304:2006+AMD1:2015 CSV | Medical device software - Software life cycle processes |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 15004-2:2007 | Ophthalmic instruments — Fundamental requirements and test methods — Part 2: Light hazard protection |
| ISO 32000-1:2008 | Document management — Portable document format — Part 1: PDF 1.7 |
| ISO 10940:2009 | Ophthalmic instruments — Fundus cameras |
| ISO 14155:2011 | Clinical investigation of medical devices for human subjects Good clinical practice |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
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