This standard specifies the definition, basic requirements and corresponding test methods of portable electric infusion pumps (hereinafter referred to as portable infusion pumps). This standard applies to portable electric infusion pumps used in medical monitoring environments; the intended use of this product is intravenous or epidural analgesic delivery. The portable infusion pump is mainly composed of a driving device, a liquid storage device and an infusion pipeline; the liquid storage device and the infusion pipeline are disposable parts. This standard does not apply to the following equipment:
——Equipment specifically used for diagnosis or similar purposes (such as high-pressure syringes);
——Gastrointestinal feeding pumps;
——Equipment used for extracorporeal circulation of blood;
——Insulin pumps and similar clinical applications Pump;
——Portable infusion pump with special requirements for infusion accuracy.
YY/T 1469-2016 Referenced Document
GB 9706.1-2007 Medical electrical equipment.Part 1:General requirements for safety
GB 9706.27-2005 Medical electrical equipments.Part 2-24: Particular requirements for the safety of infusion pumps and controllers
GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments for medical use.Part 1:Chemical analysis methods
GB/T 14233.2-2005 Test methods for infusion,transfusion,injection equipment for medical use.Part 2:Biological test methods
GB/T 14710-2009 Enviromental requirement and test methods for medical electrical equipment
GB/T 16886.1 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process*， 2022-04-15 Update
GB/T 16886.10 Biological evaluation of medical devices—Part 10: Tests for irritation and skin sensitization*， 2017-12-29 Update
GB/T 16886.11 Biological evaluation of medical devices—Part 11: Tests for systemic toxicity*， 2021-11-26 Update
GB/T 16886.12 Biological Evaluation of Medical Devices Part 12: Sample Preparation and Reference Materials*， 2023-11-27 Update
GB/T 16886.13 Biological evaluation of medical devices—Part 13: Identification and quantification of degradation products from polymeric medical devices*， 2017-12-29 Update
GB/T 16886.14 Biological evaluation of medical devices--Part 14: Identification and quantification of degradation products from ceramics
GB/T 16886.15 Biological evaluation of medical devices—Part 15: Identification and quantification of degradation products from metals and alloys*， 2022-12-30 Update
GB/T 16886.16 Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables*， 2021-11-26 Update
GB/T 16886.17 Biological evaluation of medical devices.Part 17:Establishment of allowable limits for leachable substances
GB/T 16886.18 Biological evaluation of medical devices—Part 18: Chemical characterization of medical device materials within a risk management process*， 2022-12-30 Update
GB/T 16886.19 Biological evaluation of medical devices—Part 19: Physico-chemical, morphological and topographical characterization of materials*， 2022-12-30 Update
GB/T 16886.2 Biological evaluation of medical devices.Part 2: Animal welfare requirements
GB/T 16886.20 Biological evaluation of medical devices.Part 20:Principles and methods for immunotoxicology testing of medical devices
GB/T 16886.3 Biological evaluation of medical devices—Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity*， 2019-06-04 Update
GB/T 16886.4 Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood*， 2022-04-15 Update
GB/T 16886.5 Biological Evaluation of Medical Devices Part 5: In Vitro Cytotoxicity Tests*， 2018-07-01 Update
GB/T 16886.6 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation*， 2022-04-15 Update
GB/T 16886.7 Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals
GB/T 16886.9 Biological Evaluation of Medical Devices Part 9: Qualitative and Quantitative Framework for Potential Degradation Products*， 2022-12-30 Update
GB/T 1962.1-2015 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment.Part 1:General requirement
GB/T 1962.2-2001 Conical fittings with a 6%(Luer)taper for syringes,needles and certain other medical equipment Part 2: Lock fittings
YY 0286.1-2007 Special infusion sets.Part 1:Infusion sets with precision filteers for single use
YY 0451-2010 Portable infusion devices for single use.Non electrically driven
YY 0505-2012 Medical electrical equipment.Part 1-2:General requirements for safety.Collateral standard:Electromagnetic compatibility.Requirements and tests
YY 0709-2009 Medical electrical equipment.Part 1-8:General requirements for safety.Collateral standard:General requirements,tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
YY 0770.1-2009 Filter material for medical infusion equipments.Part 1:Fluid filter material
YY/T 1469-2016 history
2016YY/T 1469-2016 Electrical infusion pump for ambulatory use