Projects

Evaluation and routine testing in medical imaging departments - Part 3-4: Acceptance tests - Imaging performance of dental X-ray equipment

60.60   Standard published

Medical electrical equipment - Part 2-52: Particular requirements for basic safety and essential performance of medical beds (IEC 60601-2-52:2009)

60.60   Standard published

Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use

60.60   Standard published

Dentistry - Corrosion test methods for metallic materials (ISO 10271:2020)

60.60   Standard published

Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328:2016)

60.60   Standard published

Information supplied by the manufacturer of medical devices

90.92   Standard to be revised

Dentistry - Contents of technical file for dental implant systems (ISO 10451:2010)

60.60   Standard published

Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (ISO 10524-4:2008)

60.60   Standard published

Intravascular catheters - Sterile and single-use catheters - Part 3: Central venous catheters (ISO 10555-3:2013)

60.60   Standard published

Intravascular catheters - Sterile and single-use catheters - Part 5: Over-needle peripheral catheters (ISO 10555-5:2013)

60.60   Standard published

Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports (ISO 10555-6:2015)

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 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 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