Standards · Regulatory context
Design requirements, examined in context.
We evaluate device performance against the design requirements, safety standards, and regulatory records that applied to the device at the relevant time.
Regulatory context
The right requirements for the relevant time period.
A regulatory record explains how a device reached the market. An investigation examines how that device actually behaved.
We review device classification, 510(k) clearance, De Novo classification, and PMA approval in the context of the allegation. Clearance, approval, and compliance evidence answer different questions; none of them independently establishes the cause of an incident.
We identify the requirements and standard editions that applied at the relevant time. FDA’s Quality Management System Regulation took effect on February 2, 2026 and incorporates ISO 13485:2016.
Sources: FDA device classification · FDA QMSR
Reference library
Standards that inform the investigation.
Our experience includes IEC 60601 and ISO 14971 analysis. The references below help frame questions about safety, software, materials, and processing. We determine which standards and editions apply, along with any specialist testing needs.
Safety and essential performance
| Standard | Technical focus |
|---|---|
| IEC 60601-1Official reference | Basic safety and essential performance of medical electrical equipment.Electrical, mechanical, thermal, and system-level safeguards. |
| IEC 60601-1-2Official reference | Electromagnetic compatibility and disturbances.Emissions, immunity, intended environment, and performance during disturbance. |
| IEC 60601-1-6Official reference | Usability of medical electrical equipment.Safety-related interaction with controls and interfaces. |
| IEC 60601-1-8Official reference | Medical electrical alarm systems.Alarm conditions, signals, priorities, and distributed alarm behavior. |
| IEC 60601-1-10Official reference | Physiologic closed-loop controllers.Performance and safeguards of physiologic feedback control. |
| IEC 60601-1-11Official reference | Medical electrical equipment in the home healthcare environment.Environmental and user conditions specific to intended use. |
| IEC 60601-1-12Official reference | Medical electrical equipment in emergency medical services.Environmental and operating requirements for emergency use. |
Design, software, and quality
| Standard | Technical focus |
|---|---|
| ISO 14971 / ISO/TR 24971ISO 14971 · ISO/TR 24971 | Medical device risk management and supporting guidance.Hazards, risk controls, residual risk, and production or postproduction information. |
| ISO 13485Official reference | Medical device quality management systems.Design and development, verification, validation, complaints, and corrective action records. |
| IEC 62304Official reference | Medical device software life-cycle processes.Software requirements, architecture, testing, change control, and problem resolution. |
| IEC 62366-1Official reference | Usability engineering for medical devices.Safety-related use scenarios, interface characteristics, and use errors. |
| IEC 81001-5-1Official reference | Security activities in the health-software life cycle.Security-related development and maintenance evidence where relevant. |
Device-specific standards
| Standard | Technical focus |
|---|---|
| ISO 80601-2-12Official reference | Critical-care ventilator safety and essential performance.Therapy delivery, alarms, and essential performance in the applicable environment. |
| ISO 80601-2-72Official reference | Home ventilators for ventilator-dependent patients.Therapy delivery, essential performance, and home-use conditions. |
| IEC 60601-2-35Official reference | Heating devices using blankets, pads, and mattresses.Temperature and heating safeguards. Replaced IEC 80601-2-35 in 2020; older editions may matter to historical devices. |
| IEC 80601-2-52Official reference | Medical beds for adults.Mechanical and electrical safety. The 2026 publication replaced IEC 60601-2-52; assess the historical edition separately. |
| IEC 60601-2-2Official reference | High-frequency surgical equipment and accessories.Electrosurgical performance and energy-related hazards; not a general standard for all surgical tools. |
| IEC 60601-2-24Official reference | Infusion pumps and controllers.Delivery performance and alarms. Its scope excludes extracorporeal blood-circulation devices. |
Materials, interfaces, and labeling
| Standard | Technical focus |
|---|---|
| ISO 10993 seriesOfficial reference | Biological evaluation of medical devices.Material-contact risks, chemical characterization, and biological-safety evidence. Part selection depends on contact type and duration. |
| ISO 18562 seriesOfficial reference | Biocompatibility of breathing-gas pathways.Emissions and pathway-material risks. Distinguish device emissions from contaminants entering from outside. |
| ISO 80369 seriesOfficial reference | Small-bore healthcare connectors.Connection performance and misconnection hazards; select the application-specific part. |
| ISO 5356 / ISO 5367ISO 5367 · ISO 5356-1 | Conical respiratory connectors and breathing sets.Interface geometry, circuit components, connection, and breathing-tube performance. |
| ISO 15223-1Official reference | Symbols used with manufacturer-supplied information.Interpretation and consistency of labels and accompanying symbols. |
| ISO 20417Official reference | Information supplied by the device manufacturer.Identification, labeling, instructions, and accompanying information; confirm the applicable edition. |
Processing and sterile barriers
| Standard | Technical focus |
|---|---|
| ISO 17664 seriesISO 17664-1 | Manufacturer information for device processing.Cleaning, disinfection, and sterilization instructions appropriate to device classification and use. |
| ISO 11135ISO 11135 | Ethylene-oxide sterilization.Development, validation, and routine process control. |
| ISO 11137 seriesISO 11137-1 | Radiation sterilization.Process validation, dose establishment, and routine controls. |
| ISO 17665Official reference | Moist-heat sterilization.Process definition, validation, and ongoing control. |
| ISO 11607-1 / -2ISO 11607-1 · ISO 11607-2 | Packaging for terminally sterilized devices.Sterile-barrier systems and validation of forming, sealing, and assembly processes. |
| ISO 11737 series / ISO 14937ISO 11737-1 · ISO 14937 | Microbiological methods and general sterilization-process requirements.Review of bioburden, sterilization studies, and process-validation evidence. |
We select standards based on intended use, recognition and transition dates, and the records available from the time of the incident. This reference describes investigation scope; it does not represent certification or accredited testing under every listed standard.
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