New Medical Equipment Standards Impact Power Supply Selection and More

[berkeman]

Interesting article sent out by Digikey just now:

https://www.digikey.com/en/articles/techzone/2018/may/4th-edition-medical-equipment-standards-impact-power-supply-selection?utm_medium=email&utm_source=tnl&utm_campaign=35242_TNL1807A&utm_content=article2title_US&utm_cid=7628644&WT.v_sub=7628644&WT.mc_id=em_Email%20Batch%20Program-30380-send-email-campaign&WT.z_email=35242_TNL1807A0B0US_article2title&mkt_tok=eyJpIjoiTW1Wa09ESTBObUkwWkRsbCIsInQiOiJ1bGR1bUR6VjZxZFcxZE1uaTYyQUdaV29hekZpQ1h3WVA3RFRUamFGS1c5N1Y4UHAzUVJ6bFphZGVuNXNHQmFiM3lwZWM5RDlwYnFCSnZ3NlpURlBtMUV5Uk92WDRybUZueFVndml3WVJrdzFvOWRCeXdRVzUyM2s2WUtybU1rQyJ9

4th Edition Medical Equipment Standards Impact Power Supply Selection and More
By Jeff Schnabel VP of Marketing, CUI Inc.

2018-05-24

The IEC 60601-1 technical standards for medical electrical equipment are about to change, as new usage modes and expectations place more stringent demands on safety and effectiveness. The first territories to adopt the latest version of the standard – known as the 4th Edition – are North America and the EU. Products entering these markets must be compliant by January 2019, and other territories are expected to follow their lead.

For producers of medical equipment, the best response to this move is to understand the new standards straight away, and design new products accordingly. The 4th Edition introduces several changes, including stricter limits on electromagnetic compatibility (EMC), made necessary by generally increasing use of wireless equipment such as smartphones and wearables, and new contexts for the use of medical equipment – such as in the home. Overall, the amendments affect the product design process and documentation, as well as features and performance.

 

[dlgoff]

Does this mean that older equipment will have to be retired? If so, what will become of it? Just curious.

 

[anorlunda]

Ah yes, things do change and changes have unforeseen consequences. The FCC puts limits on max levels of EMI allowed. But some percentage of the devices in people's pockets must be presumed to be malfunctioning and in violation of the limits. That is one of the arguments used against use of passenger electronics on airplanes; it is the malfunctioning ones that count.

Whereas the 3rd Edition immunity specifications anticipated professional users’ ability to enforce a “quiet” electromagnetic environment in the vicinity of medical equipment, the new 4th Edition classes acknowledge that this is no longer feasible given the sheer ubiquity of wireless equipment, including consumer smartphones, wearables, and other devices, acting in any environment at any given time.

Does this mean that older equipment will have to be retired? If so, what will become of it? Just curious.

They discuss that:

The US and EU have harmonized the timeframe for mandatory compliance with the 4thEdition 60601-1 standard. After December 31, 2018, all new products submitted to the US Food & Drug Administration (FDA) must comply with the new standard, and the EU has set the same Date of Withdrawal (DoW) for its current 3.1-based EN 60601-1-2:2007 standard. However, while the US will continue to allow legacy equipment to be marketed in the US, the EU will make no such concession: all medical devices imported after the DoW must be compliant with the 4th Edition.

 

[dlgoff]

They discuss that:

Guess I missed that. Thanks.