Compliance of WirelessUSB transceivers for medical field

Question: Achieving Class 1 compliance with Cypress WirelessUSB transceivers and meeting European EN 300 440 class 1-receiver requirements for medical field applications.

 

Answer:

The European norm EN 300 440 includes the following:

[12/300440a] ETSI EN 300 440-1 v1.3.1 (2001-09)
Electromagnetic compatibility and Radio spectrum Matters (ERM): Short range devices; Radio equipment to be used in the 1 GHz to 40 GHz frequency range; Part 1: Technical characteristics and test methods


[12/300440b] ETSI EN 300 440-2 v1.1.1 (2001-09)
Electromagnetic compatibility and Radio spectrum Matters (ERM); Short range devices; Radio equipment to be used in the 1 GHz to 40 GHz frequency range; Part 2: Harmonized EN under article 3.2 of the R&TTE Directive


[12/300440c] ETSI EN 300 440-2 v1.1.2 (2004-07)
Electromagnetic compatibility and Radio spectrum Matters (ERM); Short range devices; Radio equipment to be used in the 1 GHz to 40 GHz frequency range; Part 2: Harmonized EN under article 3.2 of the R&TTE Directive.

 

EN 300 440, clause 4.1.1, divides receivers into three classes "based upon the impact on persons in case the equipment does not operate above the specified minimum performance level", with class 1 imposing the most stringent requirements in terms of in-band channel selectivity (clause 8.1), adjacent band selectivity (8.2) and blocking/desensitization (8.3). You can download the standard from http://www.etsi.org/services_products/freestandard/home.htm

 

Cypress device is a wideband data transceiver operating in the 2.4 GHz ISM band using DSSS modulation techniques. Only EN 300 328 applies for this type of radio. EN 300 440 does not apply because it is a generic product family standard that is superseded by the specific standard (EN 300 328) covering a specific application ( 2.4 GHz data transmission using wide-band modulation).

 

EN 300 440-2, subclause 1 states, "It is a product family standard which may be completely or partially superseded by specific standards covering specific applications. The present document applies to generic SRDs.."

 

EN 300 328, clause 1 states, "The present document applies to the following transceivers, transmitters and receivers including IEEE 802.11, HomeRF? and Bluetooth? wireless technologies.

 

Fixed, mobile or portable applications, e.g.: 


* stand-alone radio equipment with or without their own control provisions;
* plug-in radio devices intended for use with or within a variety of host systems, e.g. personal computers, hand-held terminals, etc.; 
* plug-in radio devices intended for use within combined equipment, e.g. cable modems, set-top boxes, access points, etc.;
* combined equipment or a combination of a plug-in radio device and a specific type of host equipment.

The present document applies to equipment which utilizes wideband radio modulation techniques and which has an effective radiated power of up to -10 dBW (100 mW) and a power density of up to -10 dBW (100 mW) e.i.r.p . per 100 kHz for frequency hopping spread spectrum modulation or a power density of up to -20 dBW (10 mW) e.i.r.p. per 1 MHz for other forms of modulation."