Lesson 7.4 · 5 min
§ 13 Devices and medical products
Open in the coursewith narrated slides, a checklist to tick off and a quiz
At a glance
- Every rule, with proof. For devices and medical products: repair, maintenance, recurring safety checks and reprocessing, each with proof.
- Manuals and manufacturer information. Every device in use has its manual on hand; every medical product its manufacturer's information.
- When buying. Use only CE-marked products for their purpose, and ask for a statement on reprocessing.
In detail
What § 13 requires
- For the practice's medical-technical equipment and medical devices, you meet all legal rules with proof, in particular on repair, maintenance, recurring safety checks and inspection, and reprocessing § 13(1).
- Manuals for all medical-technical equipment in use are on hand § 13(2).
- The manufacturer's information supplied with all medical devices in use is on hand § 13(3).
Which checks apply at which intervals isn't set by the QS-VO itself: it's the rules that apply to each device, medical-device law above all, and the manufacturer's instructions. Whoever operates the devices is trained in their use, with proof (§ 16(1), lesson 8.2).
What works as proof
- a device register with the next check and service dates;
- check reports and service records per device;
- the manuals and manufacturer information, collected in one place, digital is fine.
Checklist
- A device register with check and service dates exists.
- Each device has proof of the required checks and servicing.
- Each device's manual is on hand.
- Each medical product's manufacturer information is on hand.
Quiz
What must be on hand for all medical-technical equipment under § 13(2)?
- A photo of the device
- The device manual
- The warranty card
- The invoice
Show the answer
The answer is B: The device manual. § 13(2): manuals for all medical-technical equipment in use; under (3), manufacturer information for all medical devices.
Sources
This lesson's statements rest on:
Not legal advice. What counts is the text of the QS-VO 2024 in the Federal Legal Information System (version of 3 October 2026) and the Austrian Medical Chamber's Hygiene Regulation 2014. Not an offer of ÖQMED, the BIQG or the Medical Chamber.