Updated Standards to Keep Manufacturer’s Busy

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 vehicles and their equipment – Road ambulances	15.9.2014
EN 1865-2:2010/FprA1Patient handling equipment used in road ambulances – Part 2: Power assisted stretcher	19.2.2015
EN 1865-3:2012/FprA1Patient handling equipment used in road ambulances – Part 3: Heavy duty stretcher	19.2.2015
MEDICAL ELECTRICAL EQUIPMENT STANDARDS
FprEN ISO 80601-2-69Medical Electrical Equipment – Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment (ISO/FDIS 80601-2-69:2014)	28.7.2014
FprEN 60601-2-27:2011Medical electrical equipment – Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment	4.7.2014
FprEN 60601-2-34:2011Medical electrical equipment – Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment	4.7.2014
FprEN 60601-1-12:2014Medical electrical equipment – Part 1-12: General requirements for basic safety and essential performance – Collateral standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment*	1.9.2014
EN 60601-1-2:2014Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests	4.7.2014
EN 60601-2-45:2011/FprA1:2013Medical electrical equipment – Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices	9.3.2015
EN 60601-2-36:2014Medical electrical equipment – Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy	4.7.2014
FprEN 80601-2-58:2014Medical electrical equipment – Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery	3.11.2014
FprEN 60601-2-64:2014Medical electrical equipment – Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical equipment	3.11.2014
FprEN 62220-1-1:2013Medical electrical equipment – Characteristics of digital x-ray imaging devices – Part 1-1: Determination of the detective quantum efficiency – Detectors used in radiographic imaging	14.10.2014
EN 60601-2-54:2009/FprA1:2014Medical electrical equipment – Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy	1.9.2015
FprEN 60601-1-11:2014Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment	20.10.2015
EN 62304:2006/FprA1:2014Medical device software – Software life-cycle processes	7.12.2015
FprEN 80601-2-71:2014Medical electrical equipment – Part 2-71: Particular requirements for the basic safety and essential performance of functional Near-Infrared Spectroscopy (NIRS) equipment	7.12.2015
ADDITIONAL STANDARDS – Small bore, respiratory, contraceptive etc
prEN ISO/IEC 80369-20Small-bore connectors for liquids and gases in healthcare applications – Part 20: Common test methods (ISO/DIS 80369-20:2013)	13.1.2015
prEN ISO/IEC 80369-5Small-bore connectors for liquids and gases in healthcare applications – Part 5: Connectors for limb cuff inflation applications	1.9.2015
FprEN ISO 8836 revSuction catheters for use in the respiratory tract (ISO/FDIS 8836:2014)	24.9.2014
FprEN ISO 5359 revAnaesthetic and respiratory equipment – Low-pressure hose assemblies for use with medical gases (ISO/FDIS 5359:2014)	22.10.2014
FprEN ISO 4074Natural rubber latex male condoms – Requirements and test methods (ISO/FDIS 4074:2014)	21.8.2014
FprEN ISO 7439 revCopper-bearing contraceptive intrauterine devices – Requirements and tests	12.11.2014
FprEN ISO 11608-1 revNeedle-based injection systems for medical use – Requirements and test methods – Part 1: Needle-based injection systems	12.1.2015
FprEN ISO rev 10993-3 revBiological evaluation of medical devices – Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO/FDIS10993-3:2014)*	5.11.2014
prEN ISO 11197Medical supply units (ISO/DIS 11197:2013)	28.4.2014
FprEN ISO 12870Ophthalmic optics – Spectacle frames – Requirements and test methods (ISO 12870:2012)	3.12.2014

For a full list of harmonised standards, visit http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/medical-devices/index_en.htm.

For further information on standards and demonstrating compliance with medical device regulation, contact KD&A.