Standards Update - Healthcare

Full list

Chemical technology

BS EN 17272:2020 Chemical disinfectants and antiseptics. Methods of airborne room disinfection by automated process. Determination of bactericidal, mycobactericidal, sporicidal, fungicidal, yeasticidal, virucidal and phagocidal activities
   
BS EN ISO 28399:2020 Dentistry. External tooth bleaching products

 

Information technology

BS EN ISO 11073-20701:2020 Health informatics. Device interoperability. Point-of-care medical device communication. Service oriented medical device exchange architecture and protocol binding

 

Medical equipment

BS EN 60601-2-43:2010+A2:2020 Medical electrical equipment. Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
   
BS EN 60601-2-65:2013+A1:2020 Medical electrical equipment. Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
   
BS EN IEC 60580:2020 Medical electrical equipment. Dose area product meters
   
BS EN IEC 60601-2-31:2020 Medical electrical equipment. Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
   
BS EN IEC 60601-2-66:2020 Medical electrical equipment. Particular requirements for the basic safety and essential performance of hearing aids and hearing aid systems
   
BS EN IEC 60601-2-83:2020 Medical electrical equipment. Particular requirements for the basic safety and essential performance of home light therapy equipment
   
BS EN IEC 61223-3-6:2020 Evaluation and routine testing in medical imaging departments. Acceptance and constancy tests. Imaging performance of mammographic X-ray equipment used in a mammographic tomosynthesis mode of operation
   
BS EN IEC 80601-2-60:2020 Medical electrical equipment. Particular requirements for the basic safety and essential performance of dental equipment
   
BS EN IEC 80601-2-78:2020 Medical electrical equipment. Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or  alleviation
   
BS EN ISO 11608-7:2017 Needle-based injection systems for medical use - Requirements and test methods. Part 7: Accessibility for persons with visual impairment
   
BS EN ISO 20695:2020 Enteral feeding systems. Design and testing
   
BS EN ISO 7199:2016+A1:2020 Cardiovascular implants and artificial organs. Blood-gas exchangers (oxygenators)
   
BS EN ISO 8637-1:2020 Extracorporeal systems for blood purification. Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
   
BS ISO 25841:2017+A1:2020 Female condoms. Requirements and test methods
   
BS ISO 8548-2:2020 Prosthetics and orthotics. Limb deficiencies. Method of describing lower limb amputation stumps
   
PD IEC TR 62653:2020 Guideline for safe operation of medical equipment used for haemodialysis treatments