IEC 60601-1-2 Edition 4.1

September 2020, the EMC Standard for medical devices, IEC 60601-1-2 edition 4.1, has been published. Added to the FDA recognized consensus standards on December 21, 2020 with partial recognition. 

The FDA has designated a 3 year transition period, after which the previous version will not be accepted- REC#19-8 (IEC 60601-1-2:ed4.0 + ANSI AAMI IEC 60601-1-2:2014).

New testing requirements include 

• Testing at minimum and maximum input voltage levels for conducted emissions and voltage dips and short interruptions
• Power frequency magnetic field at either 50 or 60 Hz so long as the frequency is the same as that used to power the equipment
• A new technical reference standard has been added IEC 61000-4-39:2017 
• Magnetic field immunity testing requirements from 9 kHz to 13.56 MHz 

Some of the normative references have been updated to reflect new versions of older base standards updating requirements for emissions and surge and voltage dips. Removal of ISO 7137:1995 procedures for airborne equipment.

The standard includes guidance on the determination of immunity levels and adjustments according to implemented mitigations and intended use. Identification of pass/fail and guidance on risk management for basic safety and essential performance related to electromagnetic compatibility. 

REF:

FDA FR Recognition Number 19-36  http://bit.ly/60601-1-2ed4-1

UKCA Guidance Designated standards: EMC

 The UK has published a list of designated standards for EMC

https://www.gov.uk/government/publications/designated-standards-emc

Additional information regarding UK EMC regulations can be found at https://celectronics.com/training/learning/authorization/UK-EMC-Regulations.html

Canada ICES-003 update

Innovation, Science, and Economic Development Canada (ISED) has published issue 7 of ICES-003. Following are the main changes as published in the standard.

1. Changed title of the standard from Information Technology Equipment (Including Digital Apparatus) — Limits and Methods of Measurement to Information Technology Equipment (including Digital Apparatus) 

2. Added requirements for devices with wireless power transfer functionality (section 1.3) 

3. Removed requirements that are specified in ICES-Gen and referred to ICES-Gen for all general requirements (section 2.2) 

4. Removed the alternative limits (ICES-003 now has only one set of limits), while continuing to allow either the CISPR or ANSI test methods (section 3) 

A copy of the standard can be obtained via the ISED page at ic.gc.ca;

Link - https://www.ic.gc.ca/eic/site/smt-gst.nsf/vwapj/ICES-003-i7-2020-10EN.pdf/$file/ICES-003-i7-2020-10EN.pdf

FCC Publishes Addendum to draft for U-NII 6 GHz devices

The FCC has published an addendum to the draft U-NII 6 GHz certification guidance. The purpose of this document is to provide clarifications and updates to 987594 U-NII 6 GHz devices 5.925-7.125 GHz DR01-44057 during the commenting period. This addendum will evolve as the draft period continues, adding new items to the existing ones and incrementing the version.

A link to this addendum is here: http://bit.ly/6GHz-FCC-KDB-Addendum

In a related post, in August 2020 the FCC published guidance for certification of 6GHz devices, see posting "FCC publishes guidance on certification of 6 GHz devices operating in the 5.925 - 7.125 GHz U-NII band" for a link to that guidance document.

These documents are in support of the the newly published, May 2020, FCC rules, effective July 27, 2020, opening more spectrum for unlicensed use in the 5 to 7 GHz range.  See "FCC Adopts Rules for Unlicensed Use of the 6 GHz Band"

REF:

A link to the FCC Draft Knowledge Database (KDB)

https://apps.fcc.gov/oetcf/kdb/reports/PublishedDocumentList.cfm

FCC KDB Home page

https://apps.fcc.gov/oetcf/kdb/index.cfm

FCC publishes guidance on certification of 6 GHz devices operating in the 5.925 - 7.125 GHz U-NII band

Following the adoption of new rules published in May, 2020 allowing use of new spectrum for emerging "6 GHz" devices, the Federal Communication Commission (FCC)  Office of Engineering and Technology (OET) Laboratory Division has published a draft guidance document for public review covering certification of U-NII 6 GHz devices operating in the 5.925-7.125 GHz band.

The document can be found on the FCC OET Page, a shortcut provided here - 

http://bit.ly/6GHz-FCC-KDB 

Other links;

FCC KDB document home;
https://apps.fcc.gov/oetcf/kdb/index.cfm

Archive copy of publication available at;
https://celectronics.com/pdf/FCC-6GHz-KDB.pdf

FCC Adopts Rules for Unlicensed Use of the 6 GHz Band

FCC publishes new rules in the Federal Register designed to optimize unlicensed access by authorizing two types of unlicensed operations in the 6 GHz band.

The Commission is authorizing standard-power access points that operate under the control of an automated frequency coordination system in portions of the 6 GHz band, additionally opening the entire 6 GHz band for unlicensed indoor low power access points. The Commission will also permit unlicensed client devices to communicate with both the standard-power and low-power access points. These new rules provide use of up to 320-megahertz channels to expand capacity and increase performance.

These new rules have an effective date of July 27, 2020.

REF:

https://www.govinfo.gov/content/pkg/FR-2020-05-26/pdf/2020-11236.pdf

 

European Union postpones new requirements for medical devices

On Friday, April 17, 2020 The European Parliament has adopted the Commission proposal to postpone the implementation of new approval rules for medical devices,

 

New regulations for medical devices, expected to be fully applicable on May 26, 2020, proposed to be postponed for 1 year (new effective date May 26, 2021).

 

In a press release by the European Parliament they note;

 

“The European Parliament is therefore supporting the proposal to postpone the application of this Regulation by one year to allow authorities and manufacturers alike to prioritise the fight against the coronavirus pandemic by continuing under current procedures.”

 

The European Member States will need to approve the proposal and publish in the Official Journal of the European Union. Expectations are this will happen prior to May 26, 2020.

 

The In Vitro Diagnostics Medical Devices Regulation is not affected by the new proposal, and its applicability date remains, effective May 26, 2022.

 

Ref:

 

EU Parliament press release

 

New regulations on medical devices