Big News!!!

IEC published ahead of schedule 6 of the 8 standards from the IEC 60601 Amendments Project. These standards are in Consolidated format meaning the latest edition plus amendments are all consolidated together. IEC notes this as a CSV. On 22 July 5 standards that published were: IEC 60601-1-6 Ed. 3.2, IEC 60601-1-9 Ed. 1.2, IEC 60601-1-10 Ed. 1.2, IEC 60601-1-11 Ed. 2.1, IEC 60601-1-12 Ed. 1.1. On 23 July 2020 IEC 60601-1-8 Ed. 2.2 was also published https://bit.ly/2Bui5mK
The other IEC 60601 Amendments (2 standards) still to be published include — IEC 60601-1 (ed. 3.2), IEC 60601-1-2 (Ed. 4.1) and maybe published as early as the end of this month (rumor has it but looking more likely) but it could be til Sept time range too.

Join us for a webinar on July 29, 9AM PT (Noon ET) for a live Zoom conversation on the IEC 60601 Amendments Updates (the 8 standards being published now & soon) with Leo Eisner the “IEC 60601 Guy” of Eisner Safety Consultants and Rob Packard of Medical Device Academy.

To sign up for this Zoom conversation click here. This Zoom Conversation is being hosted by Rob Packard of Medical Device Academy.

Learn about some of the major changes from the IEC 60601 Amendments coming during this Zoom conversation. Read the below infographic to get an understanding of which standards are being updated, when the updates are estimated, how long the proposed transition period is, what are some of the concerns to consider, and what ways can we help you prepare and train your staff up for these changes.

In the Federal Register Notice the background information (the first few paragraphs of Section 3 [Overview] of the Guidance document) is interesting as follows:

“To understand use-related hazards, it is necessary to have an accurate and complete understanding of how a device will be used.  Understanding and optimizing how people interact with technology is the subject of human factors engineering (HFE) and usability engineering (UE). HFE/UE considerations that are important to the development of medical devices include three major components of the device-user system: (1) Device users, (2) device use environments, and (3) device user interfaces. This interaction and its possible results are depicted graphically in Figure 1.

For safety-critical technologies such as medical devices, the process of eliminating or reducing design-related use problems that contribute to or cause unsafe or ineffective medical treatment is part of a process for controlling overall risk. For devices where harm could result from “use errors,” the dynamics of user interaction are safety-related and should be components of risk analysis and risk management. By incorporating these considerations into the device development process, manufacturers can reduce the overall risk level posed by their devices, thus decreasing adverse events associated with the device, and avoid potential device recalls.

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To submit comments follow these instructions: Submit written requests for single copies of the draft guidance document entitled “Draft Guidance for Industry and Food and Drug Administration Staff: Applying Human Factors and Usability Engineering to Optimize Medical Device Design” to the Division of Small Manufacturers, International, and Consumer Assistance, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301-847-8149. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance.

Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Identify comments with the docket number found in brackets in the heading of this document.