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Standards

Which standard governs what, and the point in a programme at which each one starts to constrain the design. The standards themselves are sold by ISO and IEC, and none is reproduced here.

What's included
ISO 14971 for risk management. IEC 62366-1 for usability engineering. IEC 62304 for the software life cycle. IEC 60601-1 for basic safety and essential performance of medical electrical equipment, with IEC 60601-1-2 for electromagnetic disturbances. ISO 10993 for biological evaluation of materials that contact the body. ISO 13485 for the quality system itself.
Where it fits
Each one starts to constrain the design well before testing. IEC 60601-1 fixes creepage and clearance distances, so it shapes the board and the enclosure before either is drawn. ISO 10993 decides which materials may touch the patient. IEC 62304 asks for a software plan before the first line is written. ISO 14971 runs from the first hazard analysis through to post-market.
What you get
Where the standards sit against the rules. In India the Medical Device Rules, 2017 set the risk class, the licence route and the Device Master File that goes with the application. The standards named here are what the evidence inside that file is produced against.

When each standard starts to shape the design

A timeline across eight stages from concept to post-market, showing when six standards start to shape a design. ISO 14971 runs through every stage. IEC 62366-1 runs from inputs to the summative test at validation. IEC 60601-1 fixes spacings at architecture. IEC 60601-1-2 applies from architecture to verification. IEC 62304 needs its plan at the inputs stage and runs to post-market. ISO 10993 decides materials at architecture. ISO 13485 holds the records of every stage.ConceptInputsArchitectureDetaileddesignVerificationValidationProductionPost-marketISO 14971Risk managementIEC 62366-1UsabilitySummative testIEC 60601-1Electrical safetySpacings fixedIEC 60601-1-2EMCIEC 62304Software life cyclePlan firstISO 10993Biological evaluationMaterials chosenISO 13485 quality system: holds the records of every stageISO 13485Where the standard starts to shape the designA point where it fixes a decision
Typical, not fixed. The article Six standards that shape a device before testing starts explains each one.

The rules set the duty, the standards set the method

The rulesClass and licenceWhat must be shownThe standardsHow to show itMethods and limitsYour evidenceTests and reportsIn the master fileThis library

In India the Medical Devices Rules, 2017 decide the class, the licence and what the application must show. The standards describe how to produce that evidence. The results go into the Device Master File that supports the application.

Questions about standards

Which standards does India expect?

The Medical Devices Rules, 2017 look first to standards set by the Bureau of Indian Standards. Where none exists, ISO and IEC standards apply, and then other recognised or validated standards.

Which edition should we use?

The edition is set in the device's regulatory plan, for each market. Check it before testing starts, because an edition change can change the tests.

Do all these standards apply to every device?

No. ISO 14971 and ISO 13485 apply to every programme. The others depend on the device: software, electrical power, patient contact and use by patients.

See where your device stands

Three free tools that run in your browser and send us nothing: a readiness check, an intended use builder and your likely class and licence.