ISO/TS 19218-1:2011 ( https://www.iso.org/obp/ui/#iso:std:iso:ts:19218:-1:ed-1:v1:en ) and ISO/TS 19218-2:2012 ( https://www.iso.org/obp/ui/#iso:std:iso:ts:19218:-2:ed-1:v1:en )
Medical Devices – Hierarchic coding structure for adverse events
Specifies requirements for a hierarchical coding structure for describing adverse events related to medical devices. These codes can be used for coding events that are not related to death or serious injury, or malfunctions that could lead to death or serious injury.
- Will provide testing and general requirements for implementing an emergency shutoff switch
- Both software switch and hardware switch will be included to avoid pain and burns from the heating elements
ISO 15223-1:2012(en) ( https://www.iso.org/obp/ui/#iso:std:iso:15223:-1:ed-2:v1:en )
Medical devices — Symbols to be used with medical device labels, labeling, and information to be supplied:
Specifies requirements for use of symbols used in medical device labeling that convey information on the safe and effective use of medical devices. It can be used on the medical device itself or on the packaging or in associated documents.
- Symbols should be used on the device to convey to the patient on how to use the device
- The symbols should be clear in where they are labeled and in what they mean
- The device should come with instructions for use for the patient to be able to use the device in the home
ISO 8301:1991(en) ( https://www.iso.org/obp/ui/#iso:std:iso:8301:ed-1:v1:en:sec:2.2.2 )
Thermal Insulation – Determination of steady-state thermal resistance and related properties
Specifies how heat transfer through a material should be measured in a slab model as well as physical parameter limits for the testing to be held valid. Testing apparatus and specimen parameters are also covered under this standard.
- It will allow us to determine how much heating and cooling we will need to apply for the device to act as intended
- It will provide a basis for testing on a pseudo-hand
ISO 13485:2016(en) ( https://www.iso.org/obp/ui/#iso:std:iso:13485:ed-3:v1:en )
Medical devices — Quality management systems — Requirements for regulatory purposes
Requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
- General requirement necessary for making a medical device and potentially bringing it to market
ISO 14971:2007(en) (https://www.iso.org/obp/ui/#iso:std:iso:14971:ed-2:v2:en )
Medical Devices – application of risk management to medical devices
Specifies a process for a manufacturer to identify the hazards associated with medical devices to estimate and evaluate the associated risks, control these risks, and monitor the effectiveness of the controls. Applicable to all stages of the life-cycle of a medical device. Will provide a risk management process and the identification of hazards during the designing of the device.
- Will allow us to assess the hazards and risks associated with our device during the design process, manufacturing, and testing
IEC TS 60479-1 ( https://www.sis.se/api/document/preview/8021445/ )
Effect of current on human beings and livestock – Part 1: General Aspects
Contains information about body impedance and body current thresholds for various physiological effects. Can be used to derive estimates of AC and DC though voltage thresholds for certain body current pathways, contact moisture conditions, and skin contact areas
- Will allow us to ensure that the user will not be harmed by the electrical components of the device including the battery
ANSI-IEC 60529 ( https://www.nema.org/Standards/ComplimentaryDocuments/ANSI-IEC-60529.pdf )
Degrees of Protection Provided by Enclosures
Classification of protection provided by enclosures for electrical equipment with a rated voltage not exceeding 72.5kV. To protect people against access to hazardous parts inside the enclosure, protection of equipment against ingress or solid foreign objects, protection of the equipment inside the enclosure against harmful effects due to the ingress of water.
- Will ensure that we do not exceed certain voltages in our electronic component
- We will have to make sure the electric parts are safely integrated into the design and enclosed against the outside environment
ANSI/AAMI HA60601-1-11:2015 (http://my.aami.org/aamiresources/previewfiles/HA6060101011_1508_preview.pdf )
Medical Electrical Equipment
Applies basic safety and essential performance of medical electrical equipment and medical electrical systems for use in the home healthcare environment. It specifies environmental operating conditions and environmental conditions of transport and storage that must be met. It provides general requirements for testing the equipment, classification of equipment, equipment identification, marking documents (including instructions for use), requirements of the electrical power source, and requirements for start-up procedure.
- Will ensure that the electrical components do not harm the user and are safe for use in the home
- Our device is intended to be used at home by the user so this standard sets basic safety and methods for performance testing.