Health Care Technology Standards
BS EN ISO 10993-12:2021
Biological evaluation of medical devices - Sample preparation and reference materials...
BS EN ISO 10993-13:2010
Biological evaluation of medical devices - Identification and quantification of degradation products from polymeric medi...
BS EN ISO 10993-14:2009
Biological evaluation of medical devices - Identification and quantification of degradation products from ceramics...
BS EN ISO 10993-15:2009
Biological evaluation of medical devices - Identification and quantification of degradation products from metals and all...
BS EN ISO 10993-16:2017
Biological evaluation of medical devices - Toxicokinetic study design for degradation products and leachables...
BS EN ISO 10993-17:2009
Biological evaluation of medical devices - Establishment of allowable limits for leachable substances...
BS EN ISO 10993-1:2020
Biological evaluation of medical devices - Evaluation and testing within a risk management process...
BS EN ISO 10993-2:2006
Biological evaluation of medical devices - Animal welfare requirements...
BS EN ISO 10993-3:2014
Biological evaluation of medical devices - Tests for genotoxicity, carcinogenicity and reproductive toxicity...
BS EN ISO 10993-6:2016
Biological evaluation of medical devices - Tests for local effects after implantation...
BS EN ISO 10993-9:December 2009
Biological evaluation of medical devices - Framework for identification and quantification of potential degradation prod...
BS EN ISO 11070:2014+A1:2018
Sterile single-use intravascular introducers, dilators and guidewires...
BS EN ISO 11073-00103:2017
Health informatics. Personal health device communication - Overview...
BS EN ISO 11073-10441:2017
Health informatics. Personal health device communication - Device specialization. Cardiovascular fitness and activity mo...
BS EN ISO 11117:2019
Gas cylinders. Valve protection caps and guards. Design, construction and tests...
BS EN ISO 11135:2014+A1:2019
Sterilization of health-care products. Ethylene oxide. Requirements for the development, validation and routine control ...
BS EN ISO 11137-1:2015+A2:2019
Sterilization of health care products. Radiation - Requirements for development, validation and routine control of a ste...
BS EN ISO 11137-2:2015
Sterilization of health care products. Radiation - Establishing the sterilization dose...
BS EN ISO 11137-3:2017
Sterilization of health care products. Radiation - Guidance on dosimetric aspects of development, validation and routine...