Projects

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 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 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)

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 medical device materials within a risk management process (ISO 10993-18:2020)

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 10993-4:2002, including Amd 1:2006)

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

Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014)

60.60   Standard published

Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007, including Cor 1:2007)

60.60   Standard published

Medical supply units (ISO 11197:2016)

60.60   Standard published

Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)

60.60   Standard published

Lasers and laser-related equipment - Test method and classification for the laser resistance of surgical drapes and/or patient protective covers - Primary ignition, penetration, flame spread and secondary ignition (ISO 11810:2015)

60.60   Standard published

Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2017)

60.60   Standard published

Clinical thermometers - Part 1: Metallic liquid-in-glass thermometers with maximum device

90.93   Standard confirmed

Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers

90.93   Standard confirmed