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Medical devices - Post-market surveillance for manufacturers (ISO/TR 20416:2020)
60.60 Standard published
Ergonomics data and guidelines for the application of ISO/IEC Guide 71 to products and services to address the needs of older persons and persons with disabilities (ISO/TR 22411:2008)
60.60 Standard published
Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)
60.60 Standard published
Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO/TS 13004:2013)
60.60 Standard published
Washer-disinfectors - Part 5: Test soils and methods for demonstrating cleaning efficacy (ISO/TS 15883-5:2005)
60.60 Standard published
Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 (ISO/TS 17665-2:2009)
60.60 Standard published
Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
60.60 Standard published
Ophthalmic optics - Reference method for the testing of spectacle frames and sunglasses for nickel release
60.60 Standard published
General guidance on the equipment used for inhaled nitric oxide therapy
60.60 Standard published
Mechanical vibration - Guide to the health effects of vibration on the human body
60.60 Standard published
Crisis and disaster management - Semantic and syntactic interoperability
60.60 Standard published
Guide to the development and inclusion of safety aspects in International Standards for medical devices
60.60 Standard published
Medical devices utilizing animal tissues and their derivatives — Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes
60.60 Standard published
Medical devices - Guidance on the application of ISO 14971
60.60 Standard published
Medical device software — Part 2: Validation of software for medical device quality systems
60.60 Standard published
Medical devices — Hierarchical coding structure for adverse events — Part 1: Event-type codes
60.60 Standard published
Medical devices — Hierarchical coding structure for adverse events — Part 1: Event-type codes — Amendment 1
60.60 Standard published
Medical devices — Hierarchical coding structure for adverse events — Part 2: Evaluation codes
60.60 Standard published
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