ISO 13485

Rule

Device Description

Class

1.1

Subject to 1.2 and 1.3, all surgically invasive devices

Class II

-         Short term, intravascular catheters

-         X-ray detectable, non-absorbable internal sponges

1.2

Surgically invasive devices that are intended to diagnose, monitor, control or correct a defect of the central cardiovascular system, the central nervous system or of a fetus in utero.

Class IV

Examples

-         Aneurysm clips

-         HIS bundle detectors

-         Implanted spinal cord stimulators for pain relief

-         Fetal blood sampling endoscope and accessories

-         Transabdominal amnioscope (fetoscope and accessories)

1.3

Any surgically invasive device that is intended to be absorbed by the body, or that is normally intended to remain in the body for at least 30 consecutive days.

Class III

Examples

-         Peritoneal, long term indwelling catheters

-         Internal saline inflatable breast prosthesis

-         Shoulder prosthesis

-         Absorbable, synthetic, polyglycolic acid sutures

-         Amalgam alloy

-         Tooth shade resin material

2.1

Subject to 2.2 and 2.3, all invasive devices that penetrate the body through a body orifice or that comes into contact with the surface of the eye.

Class II

Examples

-         Laryngoscope

-         Balloon, retention type catheter

-         Daily wear, soft contact lenses

2.2

A device described in 2.1, that is intended to be placed in oral or nasal cavities as far as the pharynx or ear canal up to the ear drum.

Class I

Examples

-         Oropharyngeal airway (anesthesiology)

-         Tympanoscope

-         Intra-nasal, septal splint

2.3

A device described in 2.1 that is normally intended to remain in the body or in contact with the surface of the eye for at least 30 consecutive days.

Class III

Examples

-         Intrauterine contraceptive device

-         Tracheal stent

2.4

A device that is described in 2.1 that is intended to be represented as preventing the transmission of infectious agents during sexual activities or reducing the risk thereof.

Class III

Examples

-         Female condom

3a

All denture materials and orthodontic appliances, and their accessories.

Class II

Examples

-         Orthodontic brackets

-         Over-the-counter denture repair kits

-         Preformed dentures

-         Plastic Teeth

3b

All surgical or dental instruments.

Class I

3c

All latex condoms.

Class II

4.1

Subject to 4.2, all non-invasive devices that are intended to come into contact with injured skin.

Class II

Examples

-         Chemical cold pack

-         Antimicrobial catheter cuff

-         Hydrogel dressing, wound and burn

4.2

A device described in 4.1 that is intended to be used as a mechanical barrier, for compression or for absorption of exudations.

Class I

Examples

-         Dressing

-         Adhesive strip

-         Surgical drape

5.1

All non-invasive devices intended for channeling or storing gases, liquids, tissues or body fluids for the purpose of introduction into the body by means of infusion or other means of administration.

Class II

Examples

-         Ventilator, tubing and support set

-         Piston syringe

-         Enteral feed bag

-         Medicine spoon

-         Ocular emergency irrigator

-         Portable air compressor

-         Flowmeter, (anesthesia)

6.1

Subject to 6.2 and 6.3, a non-invasive device intended for modifying the biological or chemical composition of the blood or other body fluids, or liquids, for the purpose of introduction into the body by means of infusion or other means of administration.

Class III

Examples

-         Automatic delivery peritoneal dialysis system

-         Hollow fiber capillary dialyser

-         Parallel flow dialyser

6.2

A device described in 6.1 whose characteristics are such that the modification process may introduce a foreign substance into the body that is potentially hazardous, taking into account the nature and quantity of the substance.

Class IV

Examples

-         Stem cell separators

-         Ex vivo photodynamic cell processors

6.3

A device described in 6.1 whose modification is accomplished by centrifugation, gravity filtration or the exchange of gas or heat.

Class II

Examples

-         Cardiotomy suction line blood filter

-         Cardiopulmonary bypass oxygenator

-         Cardiopulmonary bypass heat exchanger

-         Anesthetic conduction filter

7.1

A device described in rule 7.2, all other non-invasive devices.

Class I

Examples

-         Thoracic drainage system, water seal

-         Manual, adjustable, hospital bed

7.2

A device described in 7.1, that is intended to act as a calibrator, tester or quality control support to another medical device, or to be connected to an active device that is classified as Class II, III, or IV.

Class II

Examples

-         Pacemaker, generator function analyzer

-         Anesthesia unit, calibrator

-         Gas pressure transducer

-         Transcutaneous, oxygen electrode

-         Heart sound transducer

-         Tens cable/lead

-         Ultrasonic, diagnostic transducer

8.1

Subject to 8.2 and 8.3, an active device intended to emit ionizing radiation, including any device or software intended to control or monitor such a device or directly influence its performance.

Class III

Examples

-         Gold, titanium or platinum isotope seed

-         Angiographic system x-ray

-         Bone densitometer

-         Fixed radiographic/fluoroscopic unit

-         Examples of devices that are used in the radiographic mode and are Class II

-         Digital dental imaging system - filmless

-         Radiographic unit, diagnostic dental (x-ray)

-         Tomographic x-ray system

8.2

A device described in 8.1 that is intended to be used in radiographic mode.

Class II

8.3

Despite 8.2, an active device that is intended to be used for mammographies.

Class III

9.1

Subject to rules 9.2 and 9.3, an active therapeutic device, including any dedicated software intended to be used to administer or withdraw energy to or from the body.

Class II

Examples

-         Air pressure tourniquet

-         Phototherapy timer

-         Biofeedback device

-         Powered traction unit

-         Scoliosis stimulator (Orthosis)

-         Air-powered, dental hand pieces

-         Thermal infusion fluid warmer

-         Non-invasive bone growth stimulator

9.2

If the administration or withdrawal by a device described in 9.1 is potentially hazardous, taking into account the nature of the administration or withdrawal, the intensity of the energy and the part of the body concerned.

Class III

Examples

-         Electro anesthesia apparatus

-         High energy DC defibrillator

-         External counter-pulsating device

-         Electroconvulsive therapy device

-         Neurosurgical, fragmentation and aspiration device

-         Cyclodestructive ultrasound device

-         Surgical neodymium, YAG laser

-         Cranial drill

9.3

A device described in 9.2 that is intended to control the treatment of a patient’s condition through a closed loop system.

Class IV

Examples

-         External, pacemaker, pulse generator

-         Automatic implantable cardioverter defibrillator

-         Implantable, rate responsive pacemaker

-         Implanted vagus nerve stimulator (epilepsy)

10.1

Subject to 10.2, an active diagnostic device including any dedicated software that supplies energy for the purpose of imaging or monitoring physiological processes.

Class II

-         Phonocardiograph

-         Recorder, long-term, ECG, Portable (Holter Monitor)

-         Enuresis alarm (conditioned response)

-         Infrared thermometer

-         Audiometer

10.2

A device described in 10.1 that is intended to be used to monitor, assess or diagnose disease, a disorder, an abnormal physical state, or pregnancy, where erroneous readings could result in immediate danger.

Class III

-         Gas analyzer - nitrous-oxide, gaseous phase

-         Gas analyzer - oxygen, gaseous phase

-         Monitor, pulse rate

-         Monitor, ventilation

-         Monitor, blood pressure, neonatal, ultrasonic/Doppler

Examples of devices that would normally be Class III by Rule ten but are Class IV by Rule 1:

-         Intracardiac oximeters

-         Cerebral blood flow monitors

-         Fetal PH monitors

Class IV

11.1

Subject to 11.2 and 11.3, an active device, including any dedicated software, intended to administer or withdraw drugs, body fluids or other substances to or from the body.

Class II

Examples

-         Nebulizer, direct patient interface

-         Biopsy instrument (suction)

-         Infant aspirator

-         Jet lavage

-         Hysteroscopic insufflator

-         Operatory suction unit

11.2

If the administration or withdrawal by a device described in 11.1 is potentially hazardous, taking into account the nature of the administration or withdrawal, the nature of the substance involved and the part of the body concerned.

Class III

Examples

-         Anti-choke suction device

-         Hemoperfusion sorbent apparatus

-         Negative pressure, external body ventilator

-         Volume ventilator (critical care)

-         Semi-automatic, peritoneal dialysate delivery system

-         Infusion pump

11.3

A device described in 11.2 that is intended to control the treatment of a patient’s condition through a closed loop system.

Class IV

Examples

-         Closed loop blood glucose controller

-         Closed loop blood pressure controller

12.1

Any other active medical devices

Class I

Examples

-         Intraoral dental light

-         Surgical television camera without audio

-         Endoscopic still camera

-         Surgical microscope system

-         AC-powered keratoscope

-         External limb component, powered hand

-         Fiber optic illuminator for an endoscope

13a

Any medical device that is intended to be used for disinfecting or sterilizing blood, tissues or organs that are intended for transfusion or transplantation.

Class IV

13b

Andy medical device that is intended to be used for disinfecting or sterilizing a medical device.

Class II

Examples

-         Steam sterilizer

-         Dry heat sterilizer

-         Ultraviolet sterilizer

14.1

Subject to 14.2, any medical device manufactured from or incorporating nonviable or viable, animal or human tissue or their derivatives, or a product produced through the use of recombinant deoxyribonucleic acid (DNA) technology.

Class IV

Examples

-         Corneal shield, collagen

-         Tissue heart valve

-         Human lyophilized dura matter

-         Skin grafts

14.2

A device described in 14.1 that is only intended to come into contact with intact skin

Class I

15

Any device that is a material that is intended to be sold to a health care professional or dispenser for the specific purpose of configuration or arrangement in a mold or shape to meet the needs of an individual is classified in the class that applies to the finished medical device.

Examples

-         Polymeric blocks used in the formation of dentures

-         Silicone blocked to be used in reconstructive surgery

-         Amalgams to be used in dentistry

-         Glass used in the formation of lenses

-         Polymeric blocks used to produce embolic devices

16

Despite rules 1 through 15, breast implants and tissue expanders for breast reconstruction & augmentation.

Class IV