Document ID: chunk:federal_register_of_legislation:F2025C00021:front:0:p8
Version: federal_register_of_legislation:F2025C00021
Segment Type: other
Provision Reference: 
Character Range: 21915–25094

source
12.1 Programmed or programmable medical device or software that is a medical device
12.2 Safety dependent on internal power supply
12.3 Safety dependent on external power supply
12.4 Medical devices intended to monitor clinical parameters
12.5 Minimisation of risk of electromagnetic fields
12.6 Protection against electrical risks
12.7 Protection against mechanical risks
12.8 Protection against risks associated with vibration
12.9 Protection against risks associated with noise
12.10 Protection against risks associated with terminals and connectors
12.11 Protection against risks associated with heat
12.12 Protection against risks associated with administration of energy or substances
12.13 Active implantable medical devices
13 Information to be provided with medical devices
13.1 Information to be provided with medical devices—general
13.2 Information to be provided with medical devices—location
13.3 Information to be provided with medical devices—particular requirements
13.4 Instructions for use
13A Patient information about implantable medical devices or active implantable medical devices to be made available
13A.1 Scope of clauses 13A.2 to 13A.4
13A.2 Patient implant cards etc. for implantable devices
13A.3 Patient information leaflets etc. for implantable devices
13A.4 General requirements for information to be made available for patients
13B Software—version numbers and build numbers
14 Clinical evidence
15 Principles applying to IVD medical devices only
Schedule 2—Classification rules for medical devices other than IVD medical devices
Part 1—Interpretation
1.1 Transient, short‑term and long‑term use
Part 2—Rules for non‑invasive medical devices
2.1 Non‑invasive medical devices—general
2.2 Non‑invasive medical devices intended to channel or store blood, etc
2.3 Non‑invasive medical devices intended to modify the biological or chemical composition of blood, etc
2.4 Non‑invasive medical devices intended to have contact with injured skin or mucous membrane
Part 3—Rules for invasive medical devices and implantable medical devices
3.1 Invasive medical devices intended to be used by penetration of body orifices
3.2 Surgically invasive medical devices intended for transient use
3.3 Surgically invasive medical devices intended for short‑term use
3.4 Surgically invasive medical devices intended for long‑term use and implantable medical devices
Part 4—Special rules for active medical devices
4.1 Active medical devices—general
4.2 Active medical devices for therapy
4.3 Active medical devices for diagnosis
4.4 Active medical devices intended to administer or remove medicines, etc from a patient's body
4.5 Programmed or programmable medical device or software that is a medical device for use in relation to diagnosing or screening for a disease or condition
4.6 Programmed or programmable medical device or software that is a medical device for use for monitoring the state or progression of a disease or condition etc.
4.7 Programmed or programmable medical device or software that is a medical device for use in specifying or recommending treatment or intervention
4.8 Programmed or programmable medical device or software that is a