YY/T 0492-2017 Implantable cardiac pacing lead

YY/T 0492-2004 Implantable pacing lead

GB/T 2423.22-2012 Environmental testing—Part 2:Test methods—Test N:Change of temperature GB/T 7408-2005 Data elements and interchange formats—Information interchange—Representation of dates and times GB/T 16175-2008 Biological evaluation test methods for medical organic silicon materials GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.18-2001 GB 16174.2-2015 Implants for surgery—Active implantable medical devices—Part 2:Cardiac pacemakers YY/T 0491-2004 Cardiac pacemakers—Low-profile connectors(IS-1) for implantable pacemakers YY/T 0972-2016 Active implantable medical devices—Four-pole connector system for implantable cardiac rhythm management devices—Dimensional and test requirements GB/T 601-2002 Chemical reagent Preparations of standard volumetric solutions GB/T 601-2016 Chemical reagent—Preparations of reference titration solutions GB/T 16886.7-2001 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals GB/T 16886.7-2015 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals GB 18279-2000 Medical devices—Validation and routine control of ethylene oxide sterilization GB 18279-2023 Sterilization of health-care products—Ethylene oxide—Requirements for the development,validation and routine control of a sterilization process for medical devices GB 18279.1-2015 Sterilization of health care products—Ethylene oxide—Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices GB/T 18279.2-2015 Sterilization of health care products—Part 2:Guidance on the application of GB 18279.1 GB/T 19633-2005 Packaging for terminally sterilized medical devices GB/T 19633.1-2015 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials, sterile barrier systems and packaging systems GB/T 19633.1-2024 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials,sterile barrier systems and packaging systems GB/T 19633.2-2015 Packaging for terminally sterilized medical devices—Part 2:Validation requirements for forming,sealing and assembly processes GB/T 19633.2-2024 Packaging for terminally sterilized medical devices—Part 2:Validation requirements for forming,sealing and assembly processes YY/T 0466.1-2009 Medical devices—Symbols to be used with medical device labels, labelling and information to be supplied—Part 1:General requirements YY/T 0466.1-2016 Medical devices—Symbols to be used with medical device labels,labelling and information to be supplied—Part 1:General requirements YY/T 0466.1-2023 Medical devices—Symbols to be used with information to be supplied by the manufacturer—Part 1:General requirements