IEC 60601-1-4:1996 + A1:1999 | Medical Electrical Equipment - Part 1-4: Safety General Seeking – Parallel Standard: Programmable Medical Electrical System |
IEC 60601-1-6:2010 | Medical electrical equipment - Part 1-6: General requirements for
basic safety and practical performance - Parallel standard:
Availability |
ISO 14971:2007 | Medical Devices – Risk Management for Medical Devices |
ISO 15004-1:2006 | Ophthalmic instruments - Test methods for basic requirements - Part
1: General requirements for all ophthalmic instruments |
ISO 15004-2:2007 | Ophthalmic instruments - Test methods for basic requirements - Part
2: |
ISO 10940:2009 | Ophthalmic Instruments - Fundus Camera |
ISO 10993-1:2009 ISO 10993-5:2009 ISO 10993-10:2010 | Biological evaluation of medical devices |
IEC 62304:2006 | Medical Device Software - Software Lifecycle Process |
IEC 62366:2007 | Medical Devices – Usability Engineering for Medical Devices |
GB/T 191-2008 | Packaging storage and transportation icon |
GB 4824-2013 | Industrial, scientific and medical (ism) radio frequency equipment
disturbance characteristics limits and methods of measurement |
GB/T 14710-2009 | Medical electrical environment requirements and test methods |
GB/T 16886.1-2011 | Medical Device Biology Evaluation - Part 1: Evaluation and Testing
in Risk Management Process |
GB/T 16886.5-2003 | Biological evaluation of medical devices - Part 5: In vitro
cytotoxicity test |
GB/T 16886.10-2005 | Biological evaluation of medical devices - Part 10: Stimulation and
delayed hypersensitivity test |