PLATE 14 OF 20
Standards, specifications and notified bodies.
Harmonised standards, common specifications, and the role of notified bodies.
Pillar guide
Harmonised standards, overview: What a harmonised standard is, what presumption it gives, and what it does not prove about a machine.
Supporting guides
| Guide | What it covers |
|---|---|
| Presumption of conformity | How presumption works, when it is lost, and why a presumption is not a conformity finding. |
| Common specifications | Specifications adopted where harmonised standards are absent or insufficient, and how they are used in assessment. |
| Checking standards coverage | A per requirement coverage check, so a standard is not listed for requirements it does not address. |
| Notified bodies, role and limits | What a notified body does in each route, and what it does not do for the manufacturer. |
| Selecting a notified body | Scope, procedure, product type, and timing checked before engagement, and recorded in the file. |
| Withdrawn and superseded standards | What happens when a standard reference is withdrawn or superseded, and how a file responds. |
| Using several standards together | How multiple standards combine to cover requirements, and where overlaps and gaps hide. |
| Standards versus the law itself | The legal text governs, standards support it, and a conflict is resolved in favour of the text. |