BS EN 45502-1:2015 – TC:2020 Edition
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Tracked Changes. Implants for surgery. Active implantable medical devices – General requirements for safety, marking and for information to be provided by the manufacturer
| Published By | Publication Date | Number of Pages |
| BSI | 2020 | 145 |
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 89 | 1 Scope 2 Normative references |
| 90 | 3 Terms and definitions |
| 95 | 4 Symbols and abbreviations (optional) 5 General requirements for active implantable medical devices 5.1 General requirements for non-implantable parts 5.2 General requirements for software |
| 96 | 5.3 Usability of non-implantable parts 5.3.1 Usability of non-implantable parts of an active implantable medical device connected to or equipped with an electrical power source 5.3.2 Usability of non-implantable parts of an active implantable medical device not connected to or equipped with an electrical power source 5.4 Data security and protection from harm caused by unauthorized information tampering 5.5 General requirements for risk management 5.5.1 Risk management policy 5.5.2 Risk management file 5.5.3 Risk management plan |
| 97 | 5.5.4 Risk management process 5.6 Misconnection of parts of the active implantable medical device 6 Requirements for particular active implantable medical devices 7 General arrangement of the packaging 7.1 Implantable parts of active implantable medical devices shall be supplied in a non-reusable pack (see 14.1). 7.2 The non-reusable pack shall be enclosed in the sales packaging. 8 General markings for active implantable medical devices 8.1 Any warnings required by this part of EN 45502 shall be prominently displayed. |
| 98 | 8.2 Implanted parts of active implantable medical devices and components of those parts shall be identified in such a way as to allow any necessary measure to be taken following the discovery of an unacceptable risk in connection with any implanted part. 9 Markings on the sales packaging 9.1 If the sales packaging contains any radioactive substance, it shall have markings that state the type and activity of the radioactive substance. 9.2 The sales packaging shall bear the name and full address of the manufacturer. 9.3 The sales packaging shall bear a description of the active implantable medical device (e.g. cardiac pulse generator), the model designation and, if applicable, the batch number or the serial number of the active implantable medical device. 9.4 The sales packaging of implantable parts of an active implantable medical device shall bear relevant characteristics for its use. 9.5 The sales packaging of implantable parts of an active implantable medical device shall bear a statement that the contents of the package have been sterilized. 9.6 The sales packaging of implantable parts of an active implantable medical device shall bear the year and month of manufacture, expressed in numerals as specified by ISO 8601:2004. 9.7 The sales packaging of implantable parts of an active implantable medical device shall bear the ‘use by’ date, expressed as year and month, and, if appropriate, day, in numerals as specified in ISO 8601:2004. 9.8 The markings on the sales packaging of implantable parts of an active implantable medical device shall identify the accessories within the packaging or, if there is insufficient space on the sales packaging, the contents shall be identified within… |
| 99 | 9.9 If the intended use of an implantable part of an active implantable medical device enclosed within the sales packaging requires that it be connected to another device or accessory not included in the pack, the sales packaging shall identify the co… 9.10 The sales packaging of implantable parts of an active implantable medical device shall carry a clear description of the intended use of the device, if this is not obvious from the device description as required by 9.3 and 9.4. 9.11 The sales packaging shall bear information about any special environmental or handling constraints (for example, protection from impact, vibration, temperature, pressure, or humidity) necessary to allow the active implantable medical device to be… 9.12 The sales packaging shall, if applicable, bear an indication that the active implantable medical device contains a medicinal substance derived from human blood or human plasma. 9.13 The sales packaging of an active implantable medical device that is intended for a special purpose shall bear an indication of the special purpose (e.g. “custom-made device” or “exclusively for clinical investigations”). 9.14 In cases where the manufacturer is required to designate an authorized representative, the sales packaging shall bear the name and address of the authorized representative. 10 Construction of the sales packaging 10.1 The sales packaging of an active implantable medical device shall be constructed to protect the device and to withstand the dropping (shock), stacking (compression), vibration and temperature that can occur during storage or handling as specified… 10.2 The sales packaging of an active implantable medical device shall be sufficiently protected against the effects of humidity during storage or handling to prevent visible deterioration of the packaging, markings, labels. or accompanying documentat… |
| 100 | 10.3 The markings on the sales packaging of an active implantable medical device shall be indelible. 10.4 The sales packaging shall ensure association between the active implantable medical device and the accompanying documentation that defines the purposes and functions of the device and the conditions qualified and specified for its implantation. 11 Markings on the sterile pack 11.1 The sterile pack shall bear the name or trade name of the manufacturer, and the address (city and country) of the manufacturer. 11.2 The sterile pack shall bear a prominent indication that the contents of the package have been sterilized and the method of sterilization. 11.3 The sterile pack of an active implantable medical device that is intended for a special purpose shall bear an indication of the special purpose as required by 9.13. 11.4 The sterile pack shall bear the year and month when the packaged device was manufactured, as required by 9.6. 11.5 The sterile pack shall bear the ‘use by’ date, as required by 9.7. 11.6 The sterile pack shall bear a description of the device, as required by 9.3. |
| 101 | 11.7 The markings on the sterile pack shall identify the contents, unless the sterile pack is transparent and the contents are visible. 11.8 If the intended use of an active implantable medical device enclosed in a sterile pack requires that it be connected to other devices or accessories not included in the sterile pack, the sterile pack shall identify the connector types or configur… 11.9 The sterile pack shall bear instructions for opening the package. 12 Construction of the non-reusable pack 12.1 The non-reusable pack shall comply with EN ISO 11607-1. 12.2 The non-reusable pack shall be so designed that once it has been opened, this is readily apparent and, if it has been opened and resealed, it shall remain thereafter apparent that it has been previously opened. 12.3 The markings on the non-reusable pack shall be indelible. 13 Markings on the active implantable medical device 13.1 As far as practicable and appropriate, the active implantable medical device shall legibly and indelibly bear at least, the following particulars, where appropriate in the form of generally recognized/harmonized symbols: 13.2 Implantable parts of the active implantable medical device shall contain markings with sufficient information to allow for positive identification at the time of implantation. |
| 102 | 13.3 The implantable parts of an active implantable medical device shall bear, if feasible, a code by which they and their manufacturer can be unequivocally identified (particularly with regard to the model of device and year of manufacture). It shall… 13.4 When an active implantable medical device or its parts bear instructions required for the correct operation or indicate operating or adjustment parameters, by means of a visual system, such information shall be understandable to the user with ref… 14 Protection from unintentional biological effects being caused by the active implantable medical device 14.1 Any implantable part of an active implantable medical device or other parts enclosed in the non-reusable pack (see 7.1) and not contained within an implantable, hermetically-sealed, impermeable container shall be terminally-sterilized. The steril… 14.2 Any part of the active implantable medical device, intended in normal use to be in contact with body fluids, shall cause no unacceptable release of particulate matter at time of implantation. |
| 103 | 14.3 Parts of active implantable medical devices intended to penetrate the body or intended to come into contact with biological tissues, cells or body fluids shall be assessed and documented according to the guidance and principles given in EN ISO 10… |
| 104 | 14.4 If the active implantable medical device incorporates a medicinal substance or a medicinal substance derived from human blood or human plasma, that substance shall be both safe and beneficial to a declared function of the active implantable medic… 15 Protection from harm to the patient or user caused by external physical features of the active implantable medical device 15.1 External surfaces of non-implantable parts of an active implantable medical device shall comply with 9.3 of EN 60601-1:2006 and its A1:2013. 15.2 Implantable parts of an active implantable medical device shall have no surface features, such as sharp corners or edges that could cause excessive reaction or inflammation beyond that caused by the implanting procedure, or rough surfaces which a… 16 Protection from harm to the patient caused by electricity 16.1 External parts of an active implantable medical device shall comply with 8.7 of EN 60601-1:2006 and its A1:2013. 16.2 Except for its intended function, implantable parts of an active implantable medical device shall be electrically neutral when in contact with the body. 16.3 Insulating parts of implanted leads or of catheters that incorporate electrical conductors and are subject to electrical potential differences shall withstand a dielectric strength test in which the applied voltage shall be not less than twice th… |
| 105 | 17 Protection from harm to the patient caused by heat 17.1 Protection from harm to the patient caused by heat 17.2 Active implantable medical device intended to supply heat 18 Protection from ionizing radiation released or emitted from the active implantable medical device 18.1 If an active implantable medical device contains any radioactive substance, it shall be in the form of a sealed source. 18.2 If an active implantable medical device contains any radioactive substances, consequent exposure to ionizing radiation shall be justified by the advantages which the radioactive substances provide. 18.3 If an active implantable medical device contains any radioactive substances, consequent exposure to ionizing radiation shall be kept as low as reasonably achievable. |
| 106 | 19 Protection from unintended effects caused by the active implantable medical device 19.1 During the lifetime of the implanted parts of the active implantable medical device as specified by the manufacturer, any gradual, long-term changes in the materials chosen shall not result in an unacceptable risk. 19.2 If the implantable part of an active implantable medical device contains within it a non-rechargeable source of power, such as a primary battery or pressure reservoir, the active implantable medical device shall include an ‘elective replacement i… 19.3 An active implantable medical device shall be designed so that the failure of any single component, part, software of the active implantable medical device, or software that falls within the definition of an active implantable medical device shal… 19.4 Possible side effects arising from the intended use of an active implantable medical device shall not result in an unacceptable risk. |
| 107 | 19.5 If the implantable part of an active implantable medical device is intended to administer a medicinal substance, then the parts of the active implantable medical device intended to come in contact with the medicinal substance shall be designed an… 19.6 If an active implantable medical device is intended to use a transcutaneous energy transfer system such a system shall not result in an unacceptable risk. 20 Protection of the active implantable medical device from damage caused by external defibrillators 20.1 The function of non-implantable parts of active implantable medical devices connected to electrodes shall be designed so that defibrillation of the patient will not permanently affect the active implantable medical device, provided that the defib… 20.2 Parts of an active implantable medical device with leads and electrodes and intended to be implanted in the torso shall be designed so that defibrillation of the patient will not permanently affect the implanted part, provided that the defibrilla… |
| 110 | 21 Protection of the active implantable medical device from changes caused by electrical fields applied directly to the patient 21.1 Implanted electrically-conductive parts (of an active implantable medical device) in contact with the body shall be constructed so that effects caused by known electrical treatment applied directly to the patient will not damage the active implan… |
| 111 | 21.2 Requirements for protection of particular active implantable medical devices susceptible to electrical fields applied directly to the patient are not detailed in this part of EN 45502, but they can be specified in subsequent parts of EN 45502. 22 Protection of the active implantable medical device from changes caused by miscellaneous medical treatments 22.1 The implantable parts of an active implantable medical device, other than leads and catheters, shall be designed and constructed so that no irreversible change will be caused by exposure to diagnostic levels of ultrasonic energy. |
| 112 | 22.2 The manufacturer shall declare and provide information if and under which conditions a patient wearing an active implantable medical device can undergo MRI procedure without exposing the patient to unacceptable risk (see 28.12 and 28.13). 23 Protection of the active implantable medical device from mechanical forces 23.1 Non-implantable parts of an active implantable medical device that are either hand held in normal use or portable shall be constructed so that shocks caused by mishandling or dropping while in use do not damage the active implantable medical device. 23.2 Implantable parts of the active implantable medical device or patient-carried part of an active implantable medical device, other than leads or catheters, shall be constructed to withstand the mechanical forces which might occur during normal co… 23.3 Implantable leads or catheters shall withstand the tensile forces that might occur during or after implantation or replacement of the device to which they are connected, without fracture of any conductor or cracking of either any functional elect… 23.4 Implantable leads having a junction of two or more conductive components shall be designed such that the junctions are relieved from strain caused by the flexural stresses that might occur during or after implantation. |
| 113 | 23.5 Implantable leads or catheters shall withstand the flexural stresses that might occur during or after implantation without fracture of any conductor or cracking either of any functional electrical insulation or of the body of the lead or catheter. 23.6 Implantable connectors, intended for use by physicians to connect implantable parts of the active implantable medical device, shall be identified. The manufacturer shall declare (see 28.4) the intended performance as implanted. The quality of con… 23.7 The implantable part of the active implantable medical device, other than leads or catheters, shall be constructed so that minor mechanical shocks caused by mishandling during the implant procedure do not damage the implantable parts of the activ… 24 Protection of the active implantable medical device from damage caused by electrostatic discharge 24.1 The active implantable medical device shall be designed and constructed so that no irreversible change will be caused by an electrostatic discharge applied to the electrically-powered non-implantable parts. |
| 114 | 24.2 Requirements for protection of particular active implantable medical devices susceptible to damage caused by electrostatic discharge are not detailed in this part of EN 45502, but they may be specified in subsequent parts of EN 45502. 25 Protection of the active implantable medical device from damage caused by atmospheric pressure changes 25.1 Implantable parts of an active implantable medical device shall be constructed to withstand the changes of pressure which can occur during transit or normal conditions of use. 25.2 Requirements for protection of particular active implantable medical devices susceptible to damage caused by atmospheric pressure changes are not detailed in this part of EN 45502, but they may be specified in subsequent parts of EN 45502. 26 Protection of the active implantable medical device from damage caused by temperature changes 26.1 For electrically-powered non-implantable parts of an active implantable medical device, see 5.1. 26.2 Implantable parts of an active implantable medical device shall be designed and constructed so that no irreversible change will be caused by the changes in temperature to which they can be subjected during transportation or storage. 27 Protection of the active implantable medical device from electromagnetic non-ionizing radiation 27.1 Implantable parts of an active implantable medical device shall not result in an unacceptable risk because of susceptibility to electrical influences due to external electro-magnetic fields, whether through: |
| 115 | 27.2 Requirements for protection of particular active implantable medical devices from electromagnetic non-ionizing radiation are not detailed in this part of EN 45502, but they may be specified in subsequent parts of EN 45502. 28 Accompanying documentation 28.1 The accompanying documentation shall include the name and full address of the manufacturer. 28.2 If the package contains any radioactive substance, the accompanying documentation shall include information about the type and activity of the radioactive substance (see also Clause 18). |
| 116 | 28.3 The accompanying documentation shall include a description of the active implantable medical device (e.g. cardiac pulse generator) and the model designation. 28.4 If the package contains an implantable part of an active implantable medical device intended to be connected to another implantable device or accessory, the accompanying documentation shall provide information on the connector specifications, ass… 28.5 The accompanying documentation shall include information listing the accessories that might be required with the active implantable medical device and their essential functions. 28.6 The accompanying documentation shall include an explanation of the method of interpreting the identification code required by 13.3. 28.7 If applicable, the accompanying documentation shall include information regarding the medicinal substances which the active implantable medical device is designed to administer. 28.8 The accompanying documentation shall describe the intended use of the active implantable medical device, give its specifications and characteristics, and provide any information about significant side effects (see 19.4). 28.9 The accompanying documentation shall provide information allowing the physician to select a suitable active implantable medical device, related devices and accessories (e. g. a programmer). 28.10 The accompanying documentation shall include instructions for using the active implantable medical device, so that physicians and, where appropriate, the patient are able to use the active implantable medical device correctly. 28.11 The accompanying documentation shall include information on avoidable hazards at implantation. 28.12 The accompanying documentation shall contain warnings regarding the known hazards caused by reciprocal interference between the active implantable medical device and other medical equipment Iikely to be used in the course of other clinical proce… |
| 117 | 28.13 The accompanying documentation shall contain warnings of known medical treatments where an electrical current conducted or induced into the body from an external source that are contraindicated for patients with an active implantable medical dev… 28.14 The accompanying documentation shall contain a warning that implanted parts of an active implantable medical device should not be exposed to therapeutic levels of ultrasound energy, as the implantable part of the active implantable medical devic… 28.15 If appropriate, the accompanying documentation shall contain a warning that electronic components in an active implantable medical device can be damaged by therapeutic ionizing radiation, and warn that any damage to the implantable part of the a… 28.16 The accompanying documentation shall include a declaration that the implantable parts of the active implantable medical device have been sterilized and method of sterilization. 28.17 If appropriate, instructions shall be included on the method of sterilization for accessories that are delivered non-sterile and on dealing with the contents of the sterile pack in the event that it has been damaged or has been previously opened. 28.18 If appropriate, the accompanying documentation shall contain a warning that implantable parts are not to be reused if they have previously been implanted in another patient. Otherwise, the accompanying documentation provided with implantable par… 28.19 If the implantable part of the active implantable medical device contains an energy source, the accompanying documentation shall include: |
| 118 | 28.20 The accompanying documentation shall warn of recommended precautions to prevent adverse effects due to performance changes in the active implantable medical device. 28.21 The accompanying documentation shall include information about any special environmental or handling constraints (for example, protection from impact, vibration, temperature, pressure or humidity) necessary to allow the active implantable medica… 28.22 The accompanying documentation shall declare exceptions from the requirements of 27.1 and warn of precautions to be taken to prevent adverse effects to the patient due to specific adverse environmental conditions (for example, electromagnetic in… 28.23 The accompanying documentation shall include advice that the patient bearing an active implantable medical device should be warned to seek medical guidance before entering environments which could adversely affect the operation of the active imp… 28.24 If appropriate, the instructions for use shall provide warnings and instructions how to prevent misconnections. 28.25 The instructions for use shall contain the date of issue or an indication of the latest revision. 28.26 The manufacturer shall declare and provide information if a patient wearing an active implantable medical device is contraindicated for a medical procedure using effects caused by electrical fields (for example, application of diathermy). 28.27 The accompanying documentation of an active implantable medical device that is intended for a special purpose shall include an indication of the special purpose (e.g. “custom-made device” or “exclusively for clinical investigations”). 28.28 If applicable, the accompanying documentation of an active implantable medical device shall include an indication that the device contains a medicinal substance derived from human blood or human plasma. 28.29 If applicable, the accompanying documentation shall include instructions for the proper removal and disposal for the active implantable medical device. |
| 119 | 28.30 In cases where the manufacturer is required to designate an authorized representative the accompanying documentation shall include the name and address of the authorized representative. |
| 120 | Annex A (informative) General guidance and rationale A.1 General A.2 Rationale for specific subclauses |
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