Hello, 1. Yes. One of the main goals of the second amendment of IEC/EN 60601-1 was to bring it closer to the Essential Requirements of the Medical Device Directive. That is why 60601-1 also references requirements for biocompatibility and risk analysis.
Also, the EN version of 61010-1 has a requirement for compliance to the EMC directive. 2. According to my records, A2 to EN 60601-1 was published in the OJ (for the MDD) in C 307 on 18 November 1995. EN 60601-1-2 was published in the OJ (for the MDD) in C 204 on 09 August 1995. I thought that the effective date of the second amendment for IEC 60601-1 was the date of publication (1995). I would assume that the effective date for the EN version would also be the date of publication (1995). There was a lot of complaints about this, because A2 also required the remote end of patient leads to be touch proof. But, the FDA also required it, so manufactures gave up. FYI - The history behind that requirement, was that a nurse in a Chicago hospital, plugged in the remote ends of an apnea monitor cable, for an infant, into a IEC 320 detachable power cord. Seems the lead were colored Black, White and Green. If the USA, hospital grade power cords have clear ends. The nurse saw the Black, White and Green wires in the IEC 320 connector and plugged in the leads. The infant died. I believe that the FDA had reports of 8 similar incidences. Ned Devine Entela, Inc. Program Manager III Phone 616 248 9671 Fax 616 574 9752 e-mail [email protected] -----Original Message----- From: [email protected] [mailto:[email protected]] Sent: Tuesday, February 29, 2000 5:45 PM To: EMC-PSTC Subject: Medical safety & EMC standards tied together? I recently found out something interesting, and wanted to verify it. IEC 60601-1 is a standard dealing with electrical safety of medical equipment, and has two amendments. IEC 60601-1-2 is a standard dealing with EMC aspects of safety of medical equipment. IEC 60601-1 Amendment 2 specifies that paragraph 36 ('Protection against hazards from unwanted or excessive radiation - Electromagnetic compatibility') be changed From 'Under consideration' To 'See IEC 601-1-2' 1) Does this hold for the EN versions as well? Do statements of compliance with the basic electrical safety standard automatically include EMC testing as well? 2) The EN versions were published in the OJ in June 1999. What is the DOW of these specifications (if there is one)? --------- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. To cancel your subscription, send mail to: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list adminstrators: Jim Bacher: [email protected], or Michael Garretson: [email protected] For policy questions, send mail to: Richard Nute: [email protected] --------- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. To cancel your subscription, send mail to: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list adminstrators: Jim Bacher: [email protected], or Michael Garretson: [email protected] For policy questions, send mail to: Richard Nute: [email protected]
