ISO Medical Device Work Day Grid ISO 13485

Transcription

1 1. Medical Device Classification ISO Page 1 of Medical devices are categorized based upon their potential risk. The extent of compulsory regulation is proportional to the inherent risk involved with the device. Moreover, it is the intended use of the device which determines the device s classification. 1.2 Highest potential risk - It is possible that a device could fall into more than one of the rules. For example a device could be both n-invasive and active etc. In the event that a device can be described by more than one rule, the highest degree risk classification is assigned to the device. 1.3 Factors - When quoting a medical device manufacturer there are four factors which shall be considered: Degree of invasiveness Duration of contact Body system affected Local versus universal effects 1.4 Invasiveness - The first rules to consider are rules These are special rules and if the device does t fall into these categories, than it should be determined whether the device is: Invasive Non-invasive Active Any device which either partially or minimally penetrates the body through an artificial opening, is considered invasive. It makes difference how big the opening may be; it could be a tiny hole from a syringe or a surgical incision. of such devices would be surgical gloves, or needles on syringes. The exceptions to this rule would be a surgically created stoma (used in colostomy and ileostomy). When considering classification, the aforementioned would be considered natural openings. As a consequence, devices utilized in conjunction with such orifices would t be surgically invasive. Devices which administer energy to the body are t considered invasive if the energy, in question, delivers energy only to the body and t through the device itself. Inasmuch as energy is t a device, it cant be classified as such. Indeed, only the device creating the energy can be classified. On the other hand, if a device administers a substance, whether this substance is a medicine or a medical device, such substances are to be assessed accordingly. 1.5 Active Devices - It is important to remember that in order for a device to be classified as active, the device must induce a significant change on the patient. If there is significant change the device is t active. A device that relies on electricity (such as a drill) would be considered active. However, a device that relies on the power of either gravity (such as intraveus drainage units) or a human hand (such a syringe) would t be considered active. 1.6 Rules Governing Medical Device Classification - The following table and flowcharts contain 16 Rules whereby medical devices are classified. These rules provide guidance for medical devices based upon their intended use. Here are some things to consider when classifying medical devices: Should a device be classified according to multiple rules, the highest rule applies Classification should be consistent with the claims that appear on the labeling and other information disseminated with the device If the intended use of the device is t clearly specified in the information accompanying the device,

2 Page 2 of 11 the intended use will that of general medical practices Printers, cameras and other multi-use equipment is t considered a medical device unless it is used only with medical devices If a medical device consists of component parts the manufacturer has the option of classifying the device as a system or classifying each part separately. For example a drainage device will have an invasive tube and a n-invasive collection device.

3 Table 1 Page 3 of 11 Rule Device Description Class 1.1 Subject to 1.2 and 1.3, all surgically invasive devices - Short term, intravascular catheters - X-ray detectable, n-absorbable internal sponges Surgically invasive devices that are intended to diagse, monitor, control or correct a defect 1.2 of the central cardiovascular system, the central nervous system or of a fetus in utero. - Aneurysm clips - HIS bundle detectors - Implanted spinal cord stimulators for pain relief - Fetal blood sampling endoscope and accessories - Transabdominal amnioscope (fetoscope and accessories) Any surgically invasive device that is absorbed by the body, or that is rmally 1.3 intended to remain in the body for at least 30 consecutive days. - Peritoneal, long term indwelling catheters - Internal saline inflatable breast prosthesis I - Shoulder prosthesis - Absorbable, synthetic, polyglycolic acid sutures - Amalgam alloy - Tooth shade resin material Subject to 2.2 and 2.3, all invasive devices that penetrate the body through a body orifice or 2.1 that comes into contact with the surface of the eye. - Laryngoscope - Balloon, retention type catheter - Daily wear, soft contact lenses A device described in 2.1, that is placed in oral or nasal cavities as far as the 2.2 pharynx or ear canal up to the ear drum. - Oropharyngeal airway (anesthesiology) - Tympascope - Intra-nasal, septal splint A device described in 2.1 that is rmally intended to remain in the body or in contact with the 2.3 surface of the eye for at least 30 consecutive days. I - Intrauterine contraceptive device - Tracheal stent A device that is described in 2.1 that is represented as preventing the 2.4 transmission of infectious agents during sexual activities or reducing the risk thereof. I - Female condom 3a All denture materials and orthodontic appliances, and their accessories. - Plastic Teeth 3b All surgical or dental instruments. 3c All latex condoms. Subject to 4.2, all n-invasive devices that are intended to come into contact with injured 4.1 skin. - Chemical cold pack - Antimicrobial catheter cuff - Hydrogel dressing, wound and burn A device described in 4.1 that is used as a mechanical barrier, for compression - Orthodontic brackets - Over-the-counter denture repair kits - Preformed dentures

4 4.2 or for absorption of exudations. - Dressing - Adhesive strip - Surgical drape All n-invasive devices intended for channeling or storing gases, liquids, tissues or body 5.1 fluids for the purpose of introduction into the body by means of infusion or other means of administration. - Ventilator, tubing and support set - Piston syringe - Enteral feed bag - Medicine spoon - Ocular emergency irrigator - Portable air compressor - Flowmeter, (anesthesia) Subject to 6.2 and 6.3, a n-invasive device intended for modifying the biological or chemical 6.1 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. - Automatic delivery peritoneal dialysis system - Hollow fiber capillary dialyser - Parallel flow dialyser A device described in 6.1 whose characteristics are such that the modification process may 6.2 introduce a foreign substance into the body that is potentially hazardous, taking into account the nature and quantity of the substance. - Stem cell separators - Ex vivo photodynamic cell processors A device described in 6.1 whose modification is accomplished by centrifugation, gravity 6.3 filtration or the exchange of gas or heat. - 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 n-invasive devices. - Thoracic drainage system, water seal - Manual, adjustable, hospital bed A device described in 7.1, that is intended to act as a calibrator, tester or quality control 7.2 support to ather medical device, or to be connected to an active device that is classified as, III, or IV. - Pacemaker, generator function analyzer - Anesthesia unit, calibrator - Gas pressure transducer - Transcutaneous, oxygen electrode - Heart sound transducer - Tens cable/lead - Ultrasonic, diagstic transducer Subject to 8.2 and 8.3, an active device intended to emit ionizing radiation, including any 8.1 device or software intended to control or monitor such a device or directly influence its performance. - Gold, titanium or platinum isotope seed - Angiographic system x-ray - Bone densitometer - Fixed radiographic/fluoroscopic unit Page 4 of 11 I I

5 Page 5 of 11 - of devices that are used in the radiographic mode and are - Digital dental imaging system - filmless - Radiographic unit, diagstic dental (x-ray) - Tomographic x-ray system 8.2 A device described in 8.1 that is used in radiographic mode. 8.3 Despite 8.2, an active device that is used for mammographies. I Subject to rules 9.2 and 9.3, an active therapeutic device, including any dedicated software 9.1 used to administer or withdraw energy to or from the body. - 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 If the administration or withdrawal by a device described in 9.1 is potentially hazardous, taking 9.2 into account the nature of the administration or withdrawal, the intensity of the energy and the I part of the body concerned. - 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 A device described in 9.2 that is intended to control the treatment of a patient s condition 9.3 through a closed loop system. - External, pacemaker, pulse generator - Automatic implantable cardioverter defibrillator - Implantable, rate responsive pacemaker - Implanted vagus nerve stimulator (epilepsy) Subject to 10.2, an active diagstic device including any dedicated software that supplies 10.1 energy for the purpose of imaging or monitoring physiological processes. - Phocardiograph - Recorder, long-term, ECG, Portable (Holter Monitor) - Enuresis alarm (conditioned response) - Infrared thermometer - Audiometer A device described in 10.1 that is used to monitor, assess or diagse disease, 10.2 a disorder, an abrmal physical state, or pregnancy, where erroneous readings could result I in immediate danger. - Gas analyzer - nitrous-oxide, gaseous phase - Gas analyzer - oxygen, gaseous phase - Monitor, pulse rate - Monitor, ventilation - Monitor, blood pressure, neonatal, ultrasonic/doppler of devices that would rmally be I by Rule ten but are by Rule 1: - Intracardiac oximeters - Cerebral blood flow monitors

6 Page 6 of 11 - Fetal PH monitors Subject to 11.2 and 11.3, an active device, including any dedicated software, intended to 11.1 administer or withdraw drugs, body fluids or other substances to or from the body. - Nebulizer, direct patient interface - Biopsy instrument (suction) - Infant aspirator - Jet lavage - Hysteroscopic insufflator - Operatory suction unit If the administration or withdrawal by a device described in 11.1 is potentially hazardous, 11.2 taking into account the nature of the administration or withdrawal, the nature of the substance I involved and the part of the body concerned. - Anti-choke suction device - Hemoperfusion sorbent apparatus - Negative pressure, external body ventilator - Volume ventilator (critical care) - Semi-automatic, peritoneal dialysate delivery system - Infusion pump A device described in 11.2 that is intended to control the treatment of a patient s condition 11.3 through a closed loop system. - Closed loop blood glucose controller - Closed loop blood pressure controller 12.1 Any other active medical devices - 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 Any medical device that is used for disinfecting or sterilizing blood, tissues or 13a organs that are intended for transfusion or transplantation. 13b Andy medical device that is used for disinfecting or sterilizing a medical device. - Steam sterilizer - Dry heat sterilizer - Ultraviolet sterilizer Subject to 14.2, any medical device manufactured from or incorporating nviable or viable, 14.1 animal or human tissue or their derivatives, or a product produced through the use of recombinant deoxyribonucleic acid (DNA) techlogy. - 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 Any device that is a material that is sold to a health care professional or 15 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. - 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

7 16 - Polymeric blocks used to produce embolic devices Despite rules 1 through 15, breast implants and tissue expanders for breast reconstruction & augmentation. Page 7 of 11 Rule 1 Rule 2 Rule 3 Is this a surgically invasive device? Is this invasive device intended to penetrate through a body orifice or does it come into contact with the surface of the eye? Regardless of Rules 1 and 2 Is the intent of this device to diagse, monitor, control or correct a defect of the cvs, cns system, or of a fetus in utero? Will the device be absorbed by the body, or stay in the body for more that 30 days? Is the device longterm surgically invasive? I I placed in the oral or nasal cavity as far as the pharynx or in the ear canal up to the ear drum? intended to remain in the body or in contact with the surface of the eye for at least 30 consecutive days? I denture material or an orthodontic appliance or an accessory? a surgical or dental instrument? Is this a latex condom?

8 Page 8 of 11 Rule 4 Rule 5 Rule 6 intended to come into contact with injured skin? intended to act as a mechanical barrier, for compression or for the absorption of exudates? intended for the channeling or storing of gases, liquids, tissues or body fluids for the purpose of introduction into the body by means of infusion or other means? a n-invasive device intended for modifying the biological or chemical composition of the blood or other body fluids, or liquids, or for the purpose of introduction into body by means of infusion? Is this such a device which has characteristics 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? I Is this a device where modification is accomplished by centrifugation, gravity filtration or the exchange of gas or heat?

9 Page 9 of 11 Rule 7 Rule 8 Rule 9 connected to a, III, or IV medical device? intended to act as a calibrator, tester, quality control support to ather medical device? device intended to emit ionizing radiation, including any device or software intended to control or monitor such a device or directly influence its performance? used in radiographic mode? I therapeutic device, including any dedicated software sued to administer or withdraw energy to or from the body? therapeutic device by which the administration or withdrawal is potentially hazardous? Is this a device that is intended to be used for mammographies? therapeutic device by which the administration or withdrawal is potentially hazardous and is intended to control the treatment of a patient's condition through a closed loop system?

10 Page 10 of 11 Rule 10 Rule 11 Rule 12 is this an active diagstic device (including any dedicated software) that supplies energy for the purpose of imaging or monitoring physiological processes? device, including any software, intended to administer or withdraw drugs, body fluids, or other substances to or from the body? Is this a device to which ne of the aforementioned rules (regarding active devices) apply? Is the device used to monitor, assess or diagse disease, a disorder, an abrmal physical state, or pregnancy, where erroneous readings could result in immediate danger? I device whereby, the administration or withdrawal 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? I device intended to control the treatment of a patient's condition through a closed loop-system?

11 Page 11 of 11 Rule 13 Rule 14 Rule 15 Ru Is this a medical device that is used for disinfecting or sterilizing blood, tissues or organs that are intended for transfusion or transplantation? Is the device manufactured from or incorporating nviable or viable, animal or human tissue or their derivatives, or a product produced through the use of DNA techlogy? Is the device made of a material that is 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 the breast i tissue for recons augm Is this medical device that is used for disinfecting or sterilizing a medical device? Is the device intended only to come into contact with intact skin? Same class as finished device Cla