If you are working on a preexisting software not iec 62304 compliant, no panic. Notes the higher the class, the higher the amount of required documentation. Identifies requirements for what needs to be done and what needs to be documented. Iecen 62304 medical device software life cycle processes. The standard specifies a 3 class model consisting of safety classes a, b and c for this purpose. The standard does not prescribe a particular life cycle model or documentation structure, only that the activities and tasks be completed. Software description describe what the software will do at a high level. Feb 20, 20 the common sense systems iec 62304 checklist is a convenient and easytouse tool for medical device software engineering personnel who are involved in a software project for a class a, b or c medical device. While it makes it easier to segregate between classes a, b and c, it adds a quite bit of documentation work. The medical device software should be classified based on severity as follows.
In class c, all paragraphs of the iec 62304 shall be applied when developing the software inside the thermometer. Regulatory control increases from class i to class iii. Jan 04, 2021 iec 62304 is intended to be used together with other appropriate standards when developing a medical device. Iec en 62304 medical device software life cycle processes.
Implementation of ansiaamiiec 62304 medical device. Class a class b class c software development plan must contain contents to sections 5. Note the software safety classes assigned to each requirement are identified in the. Medical devices are classified into class i, ii, and iii. To accommodate this iec 62304 has three software safety classes class a, class b and class c, with class c being assigned to. Isoiec 17025 general requirements for the competence of testing and calibration laboratories is the main iso standard used by testing and calibration laboratories. Fdas introduction to its rules for medical device regulation states. Medical device software standards for safety and regulatory. How to achieve compliance with iec 62304 for medical device software development pdf. Clause 5 of iec 62304 details the software development process through eight stages ending in release. The course covers all aspects of the iec 62304 standard and the relationship between the iec 62304 and other standards such as iso 14971, iec 606011 and iec 823041. The iec 62304 defines three software safety classes.
Notice that the elements of clause 5 map to those in figure 1 and figure 5. Iec 62304 medical device software software life cycle. The safety classification is based on associated risk. Iec 62304 class a project elsmar quality forum and. Dependability is based on availability and reliability. Sw dev lifecycle iec 62304 safety plan, and development plan a.
The set of processes, activities, and tasks described in this standard establishes a common framework for medical device software life cycle processes that is similar to other safetycritical software development standards. Include programming language, hardware platform, os. Alignment of 62304 classes with level of concern alignment of 62304 with submission. Oct 30, 2020 three different classes of software are envisioned within the iec 62304. Introduction in iec 62304 terminology safety classes iec 62304 safety classes class a no injury or damage to health possible. Design assurance level, software integrity level, class same principle.
Until a safety class has been assigned, the requirements of class c apply to each software system. Pdf creation of an iec 62304 compliant software development plan. Aug 15, 2018 you will have to develop it per the class your customer requires. As the standard states, the manufacturer shall assign to each software system a software safety class a, b, or c according to the possible effects on the patient, operator, or other people resulting from a hazard being a potential source of harm to which the software system can contribute. An overview of the iec 62304 standard and software safety. Iec 62304 medical device software overview of the main. Iec 62304 2015 fill and sign printable template online. While i recommend using en 62304 also for a true class a software. Leveraging ptcs integrity platform for iec 62304 compliance.
Medical device compliance with iec 62304 and iso 14971. Iec 62304 fda software validation compliance qa systems. The international standard iec 62304 medical device software software life cycle processes is a standard which specifies life cycle requirements for the development of medical software and software within medical devices. The international standard iec 62304 medical device software software. C, with certain subsystems having a lower safety class a. The safety classes depend on the contribution of the software to a hazardous situation. Iec 62304 permits a reduction of the software safety class by means that are external to the software only. Generated a complete specification master technical file for the iso 485 compliant medical device. Because the standard is harmonised, medical device manufacturers adopting it will satisfy the essential requirements contained in medical devices directive 9342eec mdd with amendment m5 200747ec as related to software development. In class a, only a few paragraphs of the iec 62304 shall be applied. Developing medical device software to be compliant with iec 62304. Iec 62304 is a functional safety standard for medical device software. It is obvious that effort and cost is much higher for the development assigned to class c then for class b or class a. Classes section title fulfilled in document comment general 4.
Iec 62304 compliance checklist common sense systems. In most countries, isoiec 17025 is the standard for which most labs must hold accreditation in order to be deemed technically competent. If the risk has been reduced to an acceptable level with applying hardware related risk control measures, it is possible to adjust the safety class accordingly. It also intends to provide guidance on technical and. Safety class 62304 coverage measure a statement coverage.
Software requirements specification software requirements specification conforming to 5. Iec 62304 medical device software life cycle processes. Slgi, minnetonka, minnesota, usa abstract the quality of software is high in medical devices due to the. If the software can cause minor harm such as injuries. The plans content list increases as the class increases, but a plan is required for all classes.
Enhanced the quality system further to conform to the iec 62304 medical device software standard. Medical device software software life cycle processes pdf. Implementing iec 62304 for safe and effective medical device software part 1. Developing medical device software to be compliant with. This document aims to clarify questions that relate to the use of en 62304. Using a tool with an iec 62304 certification can help speed up the process. Medical device compliance with iec 62304 and iso 14971 youtube. This publication has been drafted in accordance with the isoiec directives, part 2. International standard iec 62304 has been prepared by a joint working group of subcommittee 62a.
Therefore, the software system as a whole is treated as safety class. Compliance is critical for medical device developers, and there are different requirements based on three iec 62304 software safety classifications. Overview of medical device cybersecurity standards. Published in 2006, it covers software, both embedded in medical devices and as a medical device. Common aspects of electrical equipment used in medical practice, of iec technical committee 62. Aim of the faq 62304 the international standard iec 62304 medical device software software lifecycle processes provides requirements for the development and maintenance of medical software. One such standard iec 62304, medical device softwaresoftware life. To accommodate this iec 62304 has three software safety classes class a, class b and class c, with class c being assigned to software systems where death or serious injury is possible. Legacy software not applicable not applicable unless you have legacy software. Implementing iec 62304 for safe and effective medical.
If the software can cause major harm such as severe injuries or even death. Creation of an iec 62304 compliant software development plan. This publication has been drafted in accordance with the iso iec directives, part 2. Implementing iec 62304 for safe and effective medical device.
Medical device software challenges qadvis rmd, october. The iec 62304 introduces the software safety classes to determine the extent. Iec 62304 defines the life cycle requirements for medical device software. When to do detailed design of software medical devices. In this standard the following print types are used.
A framework processes, activities and tasks process is the top level, a process has activities and an activity has tasks. Implementation of ansiaamiiec 62304 medical device software. Developing medical device software to be compliant with iec. A b a influences b level of concern usability iec 62366 as a driver of design as a guide to evaluate your design. Jun 29, 2020 the processes put forth by iec 62304 are really established best practices in the software industry, most of which can be followed for both medical and nonmedical projects. En 62304 version is a harmonized standard under all three medical devices directives.
Safety class 62304 coverage measure a statement coverage b branch coverage c modified condition decision coverage mcdc 1. Other component containing hardware electronics and even software e. International iec standard 62304 first edition 200605 medical device software software life cycle processes this englishlanguage version is derived from the original bilingual publication by leaving out all frenchlanguage pages. Based on the device risk classification, iec 62304 provides guidance for risk control measures that must occur throughout the life cycle of that particular device. Online software for medical devices and iec 62304 course. Oct 30, 2020 classes section title fulfilled in document comment general 4. Is it possible to reduce the documentation of detailed design of software medical devices. Ansiaami iec 62304 identifies three classes of medical device software in accordance with the possible effects on patient, operator, or any other people affected by softwarerelated hazards. There are three safety classes according to iec 62304.
Alignment of 62304 classes with level of concern alignment of 62304 with submission deliverables. The iec 62304 standard calls out certain cautions on using software, particularly soup software of unknown pedigree or provenance. The manufacturer shall assign to each software system a software safety class a, b, or c according to the possible effects on the patient, operator, or other. The device classification regulation defines the regulatory requirements for a general device type. Software development process section 5 of iec en 62304 describes the software development process as follows. Software level of concern establish the risk level of the system software and the software class as i, ii, or iii or associated a,b,c for iec 62304.
Specific requirements in iec 62304 are generally at the task level. The iec 62304 standard expects the manufacturer to assign a safety class to the software system as a whole, based on its potential to create a hazard that could result in an injury to the user, the patient, or other people. At a certain level, there is an interaction of other standards with the iec 62304. Situational factors in safety critical software development core.
Functional safety and safety certification ultimate. Iec 62304 requires the manufacturers of medical devices to assign a safety class to the software system as a whole based on the potential to create a hazard that could result in an injury. The first part of that is establishing the safety class of the software being created for the device. Iec 62304 medical device software development life cycle. Medical device class a, b, c under iec 62304, medical devices are classified based on the amount of injury that could be caused to a patient, an operator or an onlooker.
The international standard iec 62304 medical device software software life cycle processes. Through contact with software development organisations, the first element causing a major difficulty was the creation of a software development plan as described in section 5 of iec 62304. The international standard iec 62304 medical device software. Pdf fda uses grammatech to analyze recalled medical devices. Software safety classes iec 62304 versus levels of. Leveraging integrity for iec 62304 spk and associates. The effort for the development of medical devices depends on these security classes. It is harmonized by the european union eu and the united states us, and therefore can be used as a benchmark to comply with regulatory requirements from both. Electrical equipment in medical practice and iso technical committee 210, quality management and corresponding general aspects for medical devices. There are three software safety classifications, as follows. The higher the class the slower the process but the higher the reward. Iec 62304 also requires manufacturers to classify the risks of their medical software.
In previous work, an iec 62304 implementation roadmap has been developed 8 and is currently being prepared for validation by industry experts. Sinan baltacioglu senior technical advisor csps digital. The device classification regulation defines the regulatory requirements. With increasing market pressure to develop complex, high quality medical products as fast as possible, compliance with medical devices regulations and standa.
The safety class for each software system must be documented in the risk management file. Roadmaps, iec 62304, medical device software development plan. Make sure that you obtained this publication from an authorized distributor. Iec 62304 is a harmonised standard for software design in medical products adopted by the european union and the united states. A system to which iec 62304 is applicable often has varying levels of risk to the user or different safety requirements. Creation of an iec 62304 compliant software development. How software safety classifications changed in iec 62304. The standard spells out a riskbased decision model on when the use of soup is acceptable, and defines testing requirements for soup to support a rationale on why such software should be u.
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