This year will see the introduction of many new or revised harmonised standards relating to medical devices. Harmonised standards are used by medical device and IVD manufacturers to demonstrate compliance with Regulations and Directives. They provide a guide for manufacturers to demonstrate compliance and take the guess work out of the selecting suitable testing, materials, design features, etc. Many of the updates related to a large group of electromedical standards and sterilization standards which are currently awaiting final vote. Additionally, there are five standards for equipment used in ambulances pending approval. The table below summarises new and revised standards likely to become available over the next 18 months which have been listed in the latest standards update. Table 1: List of EU standards and availability of definitive texts Categories of standards Definitive text available STERILIZATION STANDARDS FprEN 13060 Small steam sterilizers 15.1.2015 FprEN ISO 11140-1 revSterilization of health care products – Chemical indicators – Part 1: General requirements (ISO/FDIS 11140-1:2014)* 22.10.2014 EN ISO -1:2009/FprA1Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2009/FDAM 1:2014)* 14.8.2014 EN ISO 11607-2:2006/FprA1Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006/FDAM 1:2014) 14.8.2014 EN ISO 15883-1:2009/prA1Washer-disinfectors – Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006/FDAM 1:2014) 21.8.2014 FprEN ISO 11135 revSterilization of health-care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/FDIS 11135:2014)* 28.8.2014 STANDARDS FOR AMBULANCES FprEN 13718-2Medical vehicles and their equipment – Air ambulances – Part 2: Operational and technical requirements for air ambulances 12.8.2014 FprEN 13718-1Medical vehicles and their equipment – Air ambulances – Part 1: Requirements for medical devices used in air ambulances 24.9.2014 EN 1789:2007+A1:2010/FprA2Medical … Continue reading Updated Standards to Keep Manufacturer’s Busy