Standards

Qualitas Compliance can help keep you up-to-date with the latest medical industry standards. Qualitas Compliance can conduct gap analysis to the standards listed below to ensure your company is meeting all of the necessary requirements. In addition, we can assist with the implementation of the various standards / processes within your Quality Management System and device records. We can also help you conduct a design review specific to a particular standard.

Standard	Description
ISO 13485:2016	Medical Devices—Quality Management Systems Requirements—Requirements for Regulatory Purposes.
ISO 9001:2015	Quality Management Systems Requirements Standard
ISO 10993	Biological Evaluation of Medical Devices
ISO 14971:2012	Medical Devices-Application of Risk Management to Medical Devices (BSI Standards Publication)
ISO 15004:2007	Ophthalmic Instruments-Fundamental requirements and test methods
ISO 9022-2:2002	Optics and optical instruments-Environmental test methods
IEC60601-1: ED 3.1 2012	Medical Electrical Equipment-Part 1: General Requirements for the Basic Safety and Essential Performance
IEC60601-1-2 Ed. 3.0 2007	Medical Electrical Equipment-Part 1-2:  General Requirements for the Basic Safety and Essential Performance-Collateral Standard: Electromagnetic Compatibility-Requirements and Test
IEC62304:2006	Medical device software – Software life cycle processes
IEC60601-1-6: Ed. 3.0 2010	General Requirements for the Basic Safety and Essential Performance—Collateral Standard:  Usability
IEC60601-1-8: Ed. 2.0 2006	General Requirements, test, and guidance for alarm systems in medical electrical equipment and medical electrical systems.
IEC 60601-1-11 :2010	Medical 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.
IEC60601-2-10: Ed 2.0 2012	Particular Requirements for the Basic Safety and Essential Performance of Nerve and Muscle Stimulators
IEC60601-2-22: Ed. 3.0 2007	Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
IEC60601-2-24: Ed. 2.0 2012	Particular Requirements for the Basic Safety and Essential Performance of Infusion Pumps and Controllers
IEC 60601-2-50: Ed. 2.0 2009	Particular Requirements for the Basic Safety and Essential Performance of Infant Phototherapy Equipment.
IEC 60601-2-52:2009	Particular Requirement for the Basic Safety and Essential Performance of Medical Beds.
IEC 60601-2-57:2011	Particular requirements for the basic safety and essential performance of non laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/asesthetic use
IEC 62366:2007	Medical Device—Application of Usability Engineering to Medical Devices
IEC 62471:2006	Photobiological safety of lamps and lamp systems
IEC 61326-1 Ed 2.0 2012	Electrical equipment for measurement, control and laboratory use EMC requirements.
IEC 61326-2-6 Ed 2.0 2012	Electrical equipment for measurement, control and laboratory use – EMC requirements Part 2-6: Particular requirements- Invitro diagnostic (IVD) medical equipment
IEC 60695-2-10: 2013	Fire hazard testing Glowing hot wire based test methods
IEC 61010-2-81: 2001	Safety requirements for electrical equipment for measurement control and laboratory use Particular requirements for automatic and semiautomatic laboratory equipment for analysis and other purposes
IEC 62474: 2012	Material declaration for products of and for electrotechnical industry
IEC 62321: 2008	Electrotechnical products- Determination of level of six regulated substances (lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls, polybrominated diphenyl ethers)
EN50581: 2012	Technical documentation for the assessment of electrical and electronic products with respect to the restriction of hazardous substances

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Helpful Links:  FDA and Medical Device Industry