Search results with tag "Iec 60601 1 6"
PREVENA PLUS - Acelity
www.acelity.comunder IEC 60601-1. IP22 - Protection level against ingress of solid foreign objects and liquids. All alerts are classified as low priority according to IEC 60601-1-8. Conforms to: IEC 60601-1, IEC 60601-1-6, IEC 60601-1-11, IEC 60601-1-8 Electrical Equipment Interference Cell phones or other similar products could affect the therapy unit.
Medical Device Usability - BSI Group
www.bsigroup.com• EN 60601-1-6:2010 Collateral Standard: Usability (IEC 60601-1-6:2010) – reference EN 62366 • EN 62366:2008 Medical devices - Application of usability engineering to medical devices (IEC 62366:2007) • EN 60601-1-8: 2007 - Alarm systems
GHTF SG2 Guidance for Adverse Event Reporting for Medical ...
www.imdrf.orgDefinition taken from IEC 60601-1-6:2004. See also Annex A for examples of potential abnormal use. Immediate adverse event report: For purposes of adverse event reporting, immediately means as soon as possible, but not later than 10 elapsed calendar days following the date of awareness of the event.
IEC Webstore - International Electrotechnical Commission
webstore.iec.chthe second edition of IEC 60601‐1‐8, as well as the fourth edition of IEC 60601‐1‐2, the third edition of IEC 60601‐ 1‐6, the second edition of IEC 60601‐1‐11 and IEC 60601‐1‐12. The most significant changes are the following modifications: – updated rationale (Annex AA) and references related to advances in the ...
IEC/ISO 62366 医療機器のユーザビリティー
park.itc.u-tokyo.ac.jp• iec 60601-1-6医用電気機器のユーザビリ ティー規格が2005年に制定、isoより、これ は医用電気機器のみならずもっと広い医療 機器全体に重要な規格である。合同で新規 格とすべきと提案（jwg4を発足） • 2007年1月22日～25日jeitaにて東京会議 cdv