compliance news
Scientists Invent a Paper Battery— Just Add Water
In the quest for battery power that’s also environmentally friendly, a group of Swiss researchers has proposed a novel packaging approach that could help reduce metal and plastic waste associated with battery end-of-life processes.

According to a recent article posted on the website of Scientific American, researchers working at the Federal Laboratories for Materials Science and Technology in Switzerland have published a paper describing a water-activated paper battery made from environmentally friendly materials. The battery reportedly consists of the same key components as standard batteries, but the anode and cathode elements consist of inks that have been printed on the front and the back of a piece of paper.

The paper, which is infused with salt, is exposed to water and the resulting salt solution acts as the battery’s electrolyte, producing approximately 1.2 volts of electricity until the paper dries out. Subsequently, rewetting the paper produces about 0.5 volts of electricity for over an hour.

The researchers believe that the greatest potential opportunity for using this water-activated paper battery is to embed them in low-power devices such as diagnostic tests and environmental sensors.

FDA Updates Recognized Standards List
The U.S. Food and Drug Administration (FDA) has updated its list of recognized international and national standards that can be used to demonstrate compliance with certain requirements for premarket review and authorization of medical devices.

In a Notice published in the Federal Register in mid-August, the agency announced more than 40 additions and modifications to the list of FDA Recognized Consensus Standards. Notable among the new standards added to the list is the addition of ISO 80601-2-87, which details safety and essential performance requirements for high-frequency ventilators, and IEC 62563-2, which addresses acceptance and constancy tests for medical image displays. Also newly added to the list of recognized standards is ISO 17664-2, which covers information to be provided by medical device manufacturers for the sterilization of non-critical medical devices.

EU Updates Standards Under Safety Regulation
The Commission of the European Union (EU) has amended its list of standards that can be used to demonstrate compliance with the essential requirements of its Directive on General Product Safety (2001/95/EC, also known as the GPSD).

According to an Implementing Decision (EU) 2022/1401 published in mid-August in the Official Journal of the European Union, the Commission has amended Annex 1 of the GPSD to add or replace 13 individual standards covering a wide range of products, including children’s furniture and child use and care items, and gymnastic equipment.

The Implementing Decision also updates EN IEC 62368-1, which covers audio, video, information, and communications technology equipment, to reflect the 2020 amended version of the standard.

FCC Fines Electronics Marketer for Selling Non-Compliant Wireless Devices
The U.S. Federal Communications Commission (FCC) has levied a nearly $700k financial penalty against a New York-based electronics marketer for selling non-compliant wireless devices.

In a Forfeiture Order, the Commission cited the company Sound Around, a Brooklyn, NY seller of audio and video electronics and accessories, for marketing 32 non-compliant wireless microphones.

According to the Forfeiture Order, Sound Around had been receiving directives from the FCC since as far back as 2011, advising the company of the need to ensure that the devices it marketed have been properly authorized under Commission rules. Following ongoing complaints of non-compliance, the Commission issued a formal Letter of Inquiry in 2016, and a second Letter of Inquiry in 2019. However, in both cases, Sound Around never provided complete answers to the Commission’s inquiry regarding the authorization of the wireless microphones it was marketing.

Ultimately, the Commission issued a Notice of Apparent Liability in April 2020 proposing a forfeiture of $685,338 for marketing 32 noncompliant models of wireless microphones within the prior 12 months. In response, Sound Around claimed that the Commission failed to prove that unlicensed wireless microphones were actually purchased and that the Commission’s proposed fine was “excessive and unwarranted” and should be lowered.

In its Forfeiture Order, the Commission upheld its earlier assessment regarding Sound Around’s practices in marketing unlicensed wireless microphones, laying out in exacting detail the basis for its rejection of the company’s arguments against the proposed forfeiture, and even noting that the company “appears to be continuing to market some of the same noncompliant radio frequency devices issued in this Forfeiture Order.”

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