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Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
60.60 Standard published
Information supplied by the manufacturer of medical devices
60.60 Standard published
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)
60.60 Standard published
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)
60.60 Standard published
Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)
60.60 Standard published
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)
60.60 Standard published
Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)
60.60 Standard published
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)
60.60 Standard published
Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)
60.60 Standard published
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
60.60 Standard published
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
60.60 Standard published
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
60.60 Standard published
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)
60.60 Standard published
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)
60.60 Standard published
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Technical Corrigendum 1 (ISO 10993-7:2008/Cor 1:2009)
60.60 Standard published
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)
60.60 Standard published
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)
60.60 Standard published
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)
60.60 Standard published
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