Quality Systems
ISO 16142-1: Essential Principles of Safety and Performance
ISO 16142-1 sets out the generally recognized essential principles of safety and performance for medical devices other than IVDs, and gives guidance on selecting standards that help show those principles are met. A companion part, ISO 16142-2, addresses IVD medical devices.
At a Glance
- Standard
- ISO 16142-1
- Subject
- Essential Principles of Safety and Performance
- Group
- Quality Systems
A plain-language summary of scope, not the standard itself. Buy the current edition from the publisher and check which edition your auditor or market expects.
What It Covers
Essential principles are high-level safety and performance requirements that apply across devices. They cover topics such as chemical, physical and biological properties, infection and microbial contamination, interaction with the environment, devices with a measuring function, protection against radiation, software, electrical and mechanical risks, and information supplied by the manufacturer. General principles apply to every device, and further principles apply depending on its characteristics.
The guidance on standards helps a manufacturer choose standards that address each principle and use them sensibly, including how to handle a standard that only partly addresses a principle. That mirrors how regulators expect conformity to be shown: principle by principle, with evidence.
In practice, the standard is most useful for building an essential principles checklist that ties each requirement to the standards applied and the evidence in the technical documentation. The EU MDR's general safety and performance requirements and the IMDRF essential principles follow similar logic, so one well-built checklist can be adapted to serve several markets.
Who It Applies To
- Manufacturers of non-IVD medical devices preparing technical documentation
- Regulatory teams building essential principles or GSPR checklists
- Firms selecting which standards to apply to a new device
- Companies preparing submissions for more than one market
What Auditors Check
Applicability Decisions
Each principle marked applicable or not, with a stated reason for every one marked not applicable.
Standards Selection
The standards chosen for each principle, the version applied, and an explanation wherever a standard is only partly applied.
Evidence References
Specific references to the reports and records that show conformity, not just document titles.
Keeping the Checklist Current
A process for reassessing the checklist when standards are revised or the device changes.
Related Services
Submission Readiness (510(k), De Novo, PMA, Pre-Sub, 513(g))
The design, risk and V&V evidence behind a 510(k), De Novo or PMA, organized and gap-checked.
EU MDR and IVDR Readiness
Prepare your QMS and technical documentation for notified body audits under the EU MDR or IVDR.
MDSAP Readiness
Prepare for one audit covering ISO 13485 and the country-specific requirements of participating regulators.
ISO 16142-1
Check Your Quality System Against ISO 16142-1
An AI-assisted first pass maps your existing documents against the requirements in scope, and an advisor reviews every result. Please don't send confidential documents yet: secure upload is set up after onboarding.
