On this page
- Published base with separately identified amendments
- General, collateral and particular documents
- Four decisions in a device assessment order
- Questions for a laboratory or equipment supplier
- Example: adding a powered accessory
- Order amendments without assuming consolidation
- Frequently asked buying questions
- Related guidance
- Explore more standards buying guides
Published base with separately identified amendments
General, collateral and particular documents
The public scope concerns basic safety and essential performance of medical electrical equipment. It explains that collateral or particular standards can supplement or modify the general requirements and that the general document should not be used alone where particular standards exist.
Describe the device's intended purpose, environment, users and configuration to the assessor. Ask it to propose a reasoned document set and identify information gaps. A quote naming only “60601 testing” needs more definition before it can be compared with another service offer.
Four decisions in a device assessment order
| Decision | Evidence to request |
|---|---|
| Device baseline | Model, accessories, software and construction represented by the service. |
| Document set | Exact general, amendment, collateral and particular references proposed. |
| Assessment scope | Included variants, technical inputs and stated limitations. |
| Final handover | Report identity and the configuration to which the conclusions relate. |
The table is an original procurement aid. It does not define essential performance, prescribe electrical test values or determine product acceptance. Those are device-specific decisions for the responsible technical team.
Questions for a laboratory or equipment supplier
- What information supports the proposed complete document package?
- Does existing evidence identify the exact device and accessories being offered?
- Which European amendments and corrections are included in the assessment basis?
- Who supplies technical input and resolves findings during the service?
- How are later power-source, accessory, component or software changes reviewed?
Compare quotations using the same device description and evidence register. A supplier's existing report may reduce remaining work, but ask the assessor to explain its relevance and limitations. Do not assume that a report for a similar model covers the offered configuration.
Example: adding a powered accessory
A medical equipment business buys an assessment service for a device with a new powered accessory. The supplier provides a base-device report and a separate accessory specification. The buyer asks the assessor to define the combined assignment and identify which evidence can be used.
The purchase order names the device and accessory versions, the proposed document set and the process for answering findings. Any unresolved information has a named owner before the sample is sent. This example shows purchasing preparation; it does not approve the combination or choose its technical tests.
Order amendments without assuming consolidation
Genorma provides separate records for A1:2013, A12:2014, A2:2021 and A13:2024. Ask the seller how the requested set is supplied and how correction information is included.
Keep international and European edition identities intact in reports. A new standard purchase does not rewrite historic evidence. Where a project needs a current regulatory conclusion, define that separate review and check official citations rather than inferring it from a publication title.
Frequently asked buying questions
Is the base button the complete assessment package?
It targets the base publication. Confirm the required amendments and companion documents with the assessor and seller.
Can this guide define essential performance?
No device-specific decision is made here. Provide the intended purpose and technical information to the responsible team.
Is a 2006 publication automatically obsolete?
The checked catalogue lists this base as published with later amendments. Use status and the agreed document set rather than age alone.
Related guidance
Continue with medical-device risk management buying and software lifecycle purchasing.
Explore more standards buying guides
Browse standards by reference and subject to compare related document choices.