Working documents for ISO/TC 2102015 年 1 月 23 日現在	 
文書 No.
ISO/IEC Guide 63ISO/DIS 13485ISO/DIS 15223-1ISO/CD 15225ISO/DIS 16142-1ISO/NP 16142-2ISO/DIS 18250-3ISO/DIS 18250-8ISO/NP 19081

タイトルCurrent Stage andregistration dateGuide to the development and inclusion of safety aspects in CD (committee draft)International Standards for medical devicesapproved for registration asDIS (Draft internationalstandard)2014-11Medical devices -- Quality management systems -- Report circulated (decisionRequirements for regulatory purposesfor new DIS ballot)2014-09（注：本文を参照のこと）Medical devices -- Symbols to be used with medical device DIS approved for registrationlabels, labelling and information to be supplied -- Part 1: General as FDIS (Final DIS)requirements2014-11Medical devices -- Quality management -- Medical device CD ballot initiatednomenclature data structure2014-11Medical devices -- Recognized essential principles of safety and DIS approved for registrationperformance of medical devices -- Part 1: General essential as FDIS (Final DIS)principles and additional specific essential principles for all 2014-11non-IVD medical devices and guidance on the selection ofstandardsMedical devices -- Recognized essential principles of safety and New project approvedperformance of medical devices -- Part 2: General essential 2013-05principles and additional specific essential principles for all IVDmedical devices and guidance on the selection of standardsConnectors for reservoir delivery systems for healthcare Close of DIS votingapplications -- Part 3: Enteral applications2014-12Connectors for reservoir delivery systems for healthcare DIS ballot initiatedapplications -- Part 8: Citrate-based anticoagulant solution for 2014-10apheresis applicationsConnectors for citrate-based anticoagulant solution reservoirs for New project approvedapheresis2013-08IECApplication of risk management for IT-networks incorporating Close of DIS voting62304:2006/DAmd medical devices Part 2-8: Application guidance - Guidance on 2014-071standards for establishing the security capabilities identified in IEC80001-2-2IEC/FDIS 62366-1ISO/AWI TR80002-2Medical devices -- Part 1: Application of usability engineering tomedical devicesMedical device software - Part 2: Validation of software forregulated processesFDIS ballot initiated2014-12New project registered inwork programme2013-02ISO/CD 80369-1Small-bore connectors for liquids and gases in healthcare Close of CD votingapplications -- Part 1: General requirements2014-12ISO/CD 80369-2Small bore connectors for liquids and gases in healthcare Close of CD votingapplications -- Part 2: Connectors for breathing systems and 2012-06driving gases applicationsISO/DIS 80369-3.2 Small-bore connectors for liquids and gases in healthcare Close of 2nd DIS votingapplications -- Part 3: Connectors for enteral applications2014-11IEC/DIS 80369-5Small-bore connectors for liquids and gases in healthcare Close of DIS votingapplications -- Part 5: Connectors for limb cuff inflation 2014-04applicationsISO/DIS 80369-6Small bore connectors for liquids and gases in healthcare DIS ballot initiatedapplications -- Part 6: Connectors for neuraxial applications2014-09ISO/DIS 80369-7Small-bore connectors for liquids and gases in healthcare DIS approved for registrationapplications -- Part 7: Connectors with 6% (Luer) taper for as FDISintravascular or hypodermic applications2014-11ISO/FDIS80369-20Small-bore connectors for liquids and gases in healthcare FDIS ballot initiatedapplications -- Part 20: Common test methods2014-12