What IEC 62304?

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What IEC 62304?

IEC 62304 is a functional safety standard that covers safe design and maintenance of software. It provides processes, activities, and tasks to ensure safety. It applies to the development and maintenance of medical device software when: Or the software is an embedded or integral part of the final medical device.

Is IEC 62304 mandatory?

IES 62304/2006 may be employed in technical reports (technical dossiers). It is currently not mandatory to be certified on that standard. However, evidence of conformity to recognised standards can be submitted to demonstrate that specific requirements of the Medical Devices Regulations have been met.

What is the current version of IEC 62304?

The second version of IEC 62304 is still in draft. It has been in this state for five years, since the publication of the amendment 1. We already had a draft version in 2019. A new draft version is, again, in public review (or has been in public review in your country) under the name IEC CDV 62304:2021.

What is the current ISO 14971 standard?

EN ISO 14971:2012 applies only to manufacturers with devices intended for the European market; for the rest of the world, ISO 14971:2007 and the latest version, 14971:2019, remain the standard recommended for medical device risk management purposes.

What are the applicable life cycle process for IEC 62304?

Section 5 of IEC/EN 62304 describes the software development process as follows:

  • development planning.
  • requirements analysis.
  • architectural design.
  • detailed design.
  • unit implementation and verification.
  • integration and integration testing.
  • system testing.
  • release.

What is the difference between IEC and ISO?

The scope of ISO covers standardization in all fields except electrical and electronic engineering standards, which are the responsibility of the International Electrotechnical Commission (IEC). The work in the field of information technology is carried out by a joint ISO/IEC technical committee (JTC 1).

Does FDA require 62304?

– Recognized Consensus Standard: FDA evaluated and recommends using IEC 62304 to satisfy regulatory requirements and software development needs. – Requirement vs. Recommendation: IEC 62304 is voluntary, not prescriptive. However, most in the SaMD industry use and follow it to meet requirements.

What are the applicable life cycle processes for IEC 62304?

What is the difference between ISO 14971 2012 and ISO 14971 2019?

ISO 14971:2019 Impact in Europe In the EU, a regional version of the standard called EN ISO 14971:2019 was published on December 18, 2019. While the previous EN ISO 14971:2012 still exists, it is no longer “state of the art” as a risk management standard for medical devices, with the release of the 2019 edition.

What is the difference between ISO 14971 and EN ISO 14971?

If you have already purchased the ISO version, ISO 14971:2019, then there is no need to purchase the EN version, the reason being that there is absolutely no difference between the two versions of the standard. Normally EN standards are published with Z Annexes placed in front of the ISO version of the standard.

What are the safety classification for software systems as per IEC 62304?

IEC 62304 defines three safety classes for software: Class A: No injury or damage to health is possible. Class B: Non-SERIOUS INJURY is possible. Class C: Death or SERIOUS INJURY is possible.

What is the ISO 13485 / IEC 62304 / ISO 14971 package?

The ISO 13485 / IEC 62304 / ISO 14971 – Medical Devices Package consolidates the IT, quality, and risk management medical devices necessities. It includes: IEC 62304 Ed.

What is IEC 62304 for medical device software?

IEC 62304 provides a framework for processes, activities, and documentation associated with designing and maintaining medical device software. It applies to all SaMD and embedded software used in medical devices.

What is IEC 62366 and what does it mean?

IEC 62366 is about ergonomics and the interaction of the user with the device. Ergonomics shall be considered for every medical device (it is a “cousin” of ISO 60601-1-6, another standard for electrical devices). Implementing this standard for software requires the same method as other devices.

What kind of standard is IEC 60601-1?

IEC 60601-1 is a standard about electrical medical devices. Medical devices with software are included in this category, as chips containing the software are powered by electricity. They are called PEMS for “Programmable Electrical Medical Devices”.