2. Regarding the Withdrawal of ISO/IEEE Projects from the TC 215 Program of Work

Transcription

1 Proposed Resolutions from the 8 May 2012 meeting of ISO/TC 215/WG 7, Devices, in Vancouver for consideration at the plenary meeting of ISO/TC 215 on 9 May Regarding IEEE Projects in TC 215 ISO/TC 215 thanks Mary-Lou Pelaprat (ISO Central Secretariat), Lisa Spellman, (ISO/TC 215 Secretary), Jodi Haasz (IEEE) and Kathryn Bennett (IEEE) for the hard work they have done to resolve the status of the shared ISO/TC 215 and IEEE work programme and to clarify the procedures for registering and progressing work under the ISO-IEEE Partner Standards Developer Organization Agreement. 2. Regarding the Withdrawal of ISO/IEEE Projects from the TC 215 Program of Work Noting that the following 14 shared IEEE-ISO/TC 215 work items have been removed from the work programme of work of IEEE: ISO/IEEE NP communication Part 10300: Device specializations Framework and overview ISO/IEEE NP communication Part 10301: Device specialization Infusion device ISO/IEEE NP communication Part 10302: Device specialization Vital signs monitor ISO/IEEE NP communication Part 10303: Device specialization Ventilator ISO/IEEE NP communication Part 10304: Device specialization Pulse oximeter ISO/IEEE NP communication Part 10305: Device specialization Defibrillator ISO/IEEE NP communication Part 10306: Device specialization ECG monitoring ISO/IEEE NP communication Part 10307: Device specialization Blood pressure

2 ISO/IEEE NP communication Part 10308: Device specialization Temperature ISO/IEEE NP communication Part 20301: Application profile Optional package, remote control ISO/IEEE NP communication Part 20201: Application profile Polling mode ISO/IEEE NP communications Part 20202: Application profile Baseline asynchronous mode ISO/IEEE NP Standard for Health informatics Point-of-care medical device communication Domain information model (DIM) XML schema format Part 10202: ISO/IEEE NP Health informatics Personal health device communication Device specialization Urine analyzer Part ISO/TC 215 agrees with the WG 7 recommendation that these work items should be removed from the ISO TC 215 Program of Work; and Instructs the TC 215 Secretary to inform the ISO Central Secretariat of this decision and request the removal of these projects from the TC 215 Program of Work. 3. Regarding the Revision of ISO/IEEE Projects Noting that IEEE has begun revision of the following five ISO-IEEE standards ISO/IEEE :2004 ISO/IEEE :2004 communication Part 10101: Nomenclature communication Part 10201: Domain information model ISO/IEEE :2010 Health informatics Personal health device communication Part 10404: Device specialization Pulse oximeter ISO/IEEE :2004 communication Part 20101: Application profiles Base standard ISO/IEEE :2010 Health informatics Personal health device communication Part 20601: Application profile Optimized exchange protocol

3 Agrees with the WG 7 recommendation that these revisions should be added to the TC 215 Program of Work; and Further resolves that, following their completion, IEEE be invited to submit these revised standards shall for Fast Track ballot and adoption by TC 215 in accordance with the ISO IEEE Partner 4. Regarding ISO/IEEE :2010, Health informatics Personal health device communication Part 10417: Device specialization Glucose meter Noting that a revision of this standard was completed in 2011; Agrees with the WG 7 recommendation that IEEE be invited to submit this revised standard for Fast Track ballot and adoption by ISO/TC 215 in accordance with the ISO IEEE Partner Further noting that an amendment to the 2011 edition of the IEEE standard is under development, TC 215 resolves that this amendment should be added to the work programme of the technical committee and that, upon completion, IEEE be invited to submit this amendment for Fast Track ballot and adoption by TC 215 in accordance with the ISO IEEE Partner 5. Regarding ISO/IEEE NP , Health informatics Personal health device communication Part Device specialization International Normalized Ratio (INR) monitor Noting that ISO/IEEE NP is on the work programme of TC 215: TC 215 agrees with the WG 7 recommendation that IEEE be invited to submit this document for Fast Track ballot and adoption by ISO/TC 215 in accordance with the ISO IEEE Partner Further noting that the limit date for completion of this document by ISO was 5 May 2012, TC 215 resolves that the ISO Central Secretariat should be asked to grant an extension of this work and instructs the TC 215 Secretary to submit an extension request to ISO Central Secretariat. 6. Regarding ISO/IEEE NP , Health informatics Point-of-care medical device communication Part 10103: Nomenclature Implantable device, cardiac Noting that IEEE expects to complete work on ISO/IEEE NP by the end of 2012

4 TC 215 agrees with the WG 7 recommendation that, upon the document s completion, IEEE be invited to submit the standard for Fast Track ballot and adoption by TC 215 in accordance with the ISO IEEE Partner 7. Regarding New Parts of IEEE Noting that IEEE is working on the following five new parts of the ISO series: IEEE NP Health informatics Personal health device communication Device specialization Respiration rate monitor IEEE NP Health informatics Personal health device communication Device specialization Insulin pump IEEE NP Health informatics Personal health device communication Device specialization Cardiovascular fitness and activity monitor IEEE NP Health informatics Personal health device communication Device specialization Strength fitness equipment IEEE NP Health informatics Personal health device communication Device specialization Physical activity monitor TC 215 agrees with the WG 7 recommendation that these items should be added to the work programme of the technical committee. TC 215 further resolves that, following their completions, IEEE be invited to submit these new standards for Fast Track ballot and adoption by TC 215 in accordance with the ISO IEEE Partner 8. Regarding ISO/AWI , Health informatics Medical waveform format Part 1: Encoding rules Noting that a revised draft of ISO/AWI has been prepared, TC 215 agrees with the WG 7 recommendation that the document should be circulated for Enquiry ballot. Instructs PL/WG Convener to submit the revised DIS text to the TC 215 Secretary no later than 1 September 2012; Instructs the TC 215 Secretariat to circulate ISO/CD/DIS to TC 215 for a three month CD ballot OR submit the text to ISO Central Secretariat for initiation of DIS balloting. 9. Regarding ISO/TR 21730:2007, Health informatics Use of mobile wireless communication and computing technology in healthcare facilities Recommendation for

5 electromagnetic compatibility (management of unintentional electromagnetic interference) with medical devices Noting WG 7 s concern that ISO/TR 21730:2007 should be reviewed to ensure that it is still current and is consistent with existing International Standards, TC 215 instructs the TC 215 Secretary to circulate this document to WG7, JWG 7 and the IEC/SC 62A Secretariat for review prior to the Vienna meeting planned for September 2012.