LPRA MEMBER FEEDBACK REQUEST: EN 300 328 v1.9.1: backward Compatibility Clauses

Dear Member,

The current version of EN 300 328 v1.9.1 includes backward compatibility clauses that allow medical equipment manufacturers to continue to offer external instruments that periodically communicates with implantable devices that were placed on the market in 2008 in accordance with the then “state-of-the-art” EN 300 328 v1.7.1


This standard is currently being updated as 
EN 300 328 v2.0.20, to bring it in line with the Radio Equipment Directive and the LPRA seeks your views on the continued inclusion of these clauses, as medical equipment, including implants have very long lifespans.  The matter was highlighted by new LPRA Member St. Jude Medical  (please see below). 

** Please submit your comments to The LPRA Secretariat by Thursday 14th April 2016 ** 

"St. Jude Medical wants to bring back into EN 300 328 V2.0.20 a backwards compatibility clause that was part of the previous version of the standard. Below you will find the text I submitted to update the standard via ITS (Swedish Information and Telecommunications Standards Institute) in Sweden. This backwards compatibility clause allows St. Jude Medical to continue to use an external instrument that periodically communicates with implantable devices that was placed in the market in 2008 by the then “state-of-the-art” EN 300 328 V1.7.1.

Implantable devices have very long lifespans, and we have a need to continue to use this type of equipment to help support our patients.

I want to use our LPRA membership to help bring back into the standard the backwards compatibility clause we need to keep using this equipment in Europe."

Jorge Amely - Senior Principal Engineer, RF H/W Development

St. Jude Medical, Implantable Electronic Systems Division, U.S.A

Email : jamely-velez@sjm.com

 

National Committee

Clause/ Subclause

Paragraph Figure/ Table

Type of comment (General/ Technical/Editorial)

COMMENTS

Proposed change

Observations

ITS

EN 300 328 V2.0.20

4.3.1.3.1

 

 

Editorial

Medical Devices Requiring Reverse Compatibility Clause is not present in EN 300 328 V2.0.20

Insert the following paragraph at the end of the clause indicated:

Medical instruments supporting medical implants are allowed to have a legacy operating mode in which they do not have to comply with requirements for Adaptivity or Medium Utilisation (including Duty Cycle, Tx-sequence and Tx-gap) only when communicating to medical implants already placed on the market when previous versions of this standard not containing these requirements did apply. When not operating in this legacy mode, these devices shall comply with all applicable requirements of the present document.

 

 

EN 300 328 V2.0.20, 4.3.1.4.3.1

 

 

 

Insert the following paragraph after the first paragraph of the indicated clause:

Medical instruments supporting medical implants are allowed to have a legacy operating mode in which the maximum Accumulated Transit Time is 400 ms within any observation period of 400 ms multiplied by the minimum number of hopping frequencies (N) that have to be used, only when communicating to these legacy devices already placed on the market. When not operating in this legacy mode, these devices shall comply with all applicable requirements of the present document.

 

 

EN 300 328 V2.0.20, 4.3.1.6.1

 

 

 

Insert the following paragraph after the 2nd paragraph of the clause:

Medical instruments supporting medical implants are allowed to have a legacy operating mode in which they have a Medium Utilization above the limit defined in clause 4.3.1.6.3 only when communicating to medical implants already placed on the market when previous versions of this standard not containing these requirements did apply. When not operating in this legacy mode, these devices shall comply with all applicable requirements of the present document.

 

 

EN 300 328 V2.0.20, 4.3.2.4.1

 

 

 

Insert the following paragraph after the second paragraph of the clause:

Medical instruments supporting medical implants are allowed to have a legacy operating mode in which they do not have to comply with requirements for Adaptivity or Medium Utilisation (including Duty Cycle, Tx-sequence and Tx-gap) only when communicating to medical implants already placed on the market when previous versions of this standard not containing these requirements did apply. When not operating in this legacy mode, these devices shall comply with all applicable requirements of the present document.

 

 

EN 300 328 V2.0.20, 4.3.2.5.1

 

 

 

Insert the following paragraph after the second paragraph of the clause:

Medical instruments supporting medical implants are allowed to have a legacy operating mode in which they have a Medium Utilization above the limit defined in clause 4.3.2.5.3 only when communicating to medical implants already placed on the market when previous versions of this standard not containing these requirements did apply. When not operating in this legacy mode, these devices shall comply with all applicable requirements of the present document.