YY/T 1759-2020 Guide for design and evaluation of primary flexible packaging for medical devices

GB/T 16886.10-2024 Biological evaluation of medical devices—Part 10:Tests for skin sensitization GB/T 16886.11-1997 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity GB/T 16886.11-2011 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity GB/T 16886.11-2021 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity GB/T 16886.12-2000 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.12-2005 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.12-2017 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.12-2023 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.13-2001 Biological evaluation of medical devices—Part 13:Identification and quantification of degradation products from polymeric medical devices GB/T 16886.13-2017 Biological evaluation of medical devices—Part 13:Identification and quantification of degradation products from polymeric medical devices GB/T 16886.14-2003 Biological evaluation of medical devices—Part 14:Identification and quantification of degradation products from ceramics GB/T 16886.15-2003 Biological eveluation of medical devices—Part 15:Identification and quantification of degradation products from metals and alloys GB/T 16886.15-2022 Biological evaluation of medical devices—Part 15:Identification and quantification of degradation products from metals and alloys GB/T 16886.16-2003 Biological evaluation of medical devices—Part 16:Toxicokinetic study design for degradation products and leachables GB/T 16886.16-2013 Biological evaluation of medical devices—Part 16:Toxicokinetic study design for degradation products and leachables GB/T 16886.16-2021 Biological evaluation of medical devices—Part 16:Toxicokinetic study design for degradation products and leachables GB/T 16886.17-2005 Biological evaluation of medical devices—Part 17:Establishment of allowable limits for leachable substances GB/T 16886.17-2025 Biological evaluation of medical devices—Part 17:Toxicological risk assessment of medical device constituents GB/T 16886.18-2011 Biological evaluation of medical devices—Part 18:Chemical characterization of materials GB/T 16886.18-2022 Biological evaluation of medical devices—Part 18:Chemical characterization of medical device materials within a risk management process GB/T 16886.19-2011 Biological evaluation of medical devices—Part 19:Physico-chemical,morphological and topographical characterization of materials GB/T 16886.19-2022 Biological evaluation of medical devices—Part 19:Physico-chemical,morphological and topographical characterization of materials GB/T 16886.20-2015 Biological evaluation of medical devices—Part 20:Principles and methods for immunotoxicology testing of medical devices GB/Z 16886.22-2022 Biological evaluation of medical devices—Part 22:Guidance on nanomaterials GB/T 16886.23-2023 Biological evaluation of medical devices—Part 23:Tests for irritation GB/T 17593-1998 Textiles—Test method of heavy metal ions—Atomic absorption spectrophotometry GB/T 17593.1-2006 Textiles—Determination of heavy metals—Part 1:Atomic absorption spectrophotometry GB/T 17593.2-2007 Textiles—Determination of heavy metals—Part 2:Inductively coupled plasma atomic emission spectrometry GB/T 17593.2-2025 Textile—Determination of heavy metals—Part 2:Inductively coupled plasma-optical emission spectrometry(ICP-OES) and inductively coupled plasma-mass spectrometry(ICP-MS) GB/T 17593.3-2006 Textiles—Determination of heavy metals—Part 3:Chromium(Ⅵ)—Spectrophotometry GB/T 17593.4-2006 Textiles—Determination of heavy metals—Part 4:Arsenic and mercury—Atomic fluorescence spectrophotometry 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 19789-2005 Packaging material—Test method for oxygen gas permeability characteristics of plastic film and sheeting—Coulometric sensor GB/T 19789-2021 Packaging material—Test method for oxygen gas permeability characteristics of plastic film and sheeting—Coulometric sensor GB/T 21529-2008 Determination of water vapour transmission rate for plastic film and sheeting—Electrolytic detection sensor method GB/T 22819-2008 Determination of air permeability of high permeable paper GB/T 22895-2008 Paper and board—Determination of the static and kinetic coefficients of friction—Horizontal plane method GB/T 22898-2008 Paper and board—Determination of tensile properties—Constant rate of elongation method (100 mm/min) GB/T 22901-2008 Paper and board—Determination of air permeance(medium range)—General method GB/T 22921-2008 Paper and board—Determination of water vapour transmission rate of sheet materials—Dynamic sweep and static gas methods GB/T 24218.1-2009 Textiles—Test methods for nonwovens—Part 1:Determination of mass per unit area GB/T 24218.2-2009 Textiles—Test methods for nonwovens—Part 2:Determination of thickness GB/T 24218.3-2010 Textiles—Test methods for nonwovens—Part 3:Determination of tensile strength and elongation(strip method) GB/T 24218.18-2014 Textiles—Test methods for nonwovens—Part 18:Determination of breaking strength and elongation (grab method) GB/T 26253-2010 Determination of water vapour transmission rate for plastics-film and sheeting—Infrared detection sensor method GB/T 30412-2013 Determination of water vapour transmission rate for plastic film and sheeting—Humidity detection sensor method GB/T 31729-2015 Test method for mass per unit area of plastic film GB/T 31354-2014 Determination of oxygen gas transmission rate through dry packages—Coulometric sensor GB/T 31355-2014 Determination of water vapor transmission rate through dry packages—Modulated infrared sensor GB/T 31556.1-2015 Packaging sacks—Description and method of measurement for dimension—Part 1:Paper sacks GB/T 31556.2-2015 Packaging sacks—Description and method of measurement for dimension—Part 2:Sacks made from thermoplastic flexible film GB/T 34444-2017 Paper and board—Determination of the layer peel strength YY/T 0506.4-2005 Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment—Part 4: Test method for linting in the dry state YY/T 0506.4-2016 Surgical drapes,gowns and clean air suits for patients,clinical staff and equipment—Part 4:Test method for linting in the dry state YY/T 0506.5-2009 Surgical drapes,gowns and clean air suits for patients,clinical staff and equipment—Part 5:Test method for resistance to dry microbial penetration YY/T 0681.1-2009 Test methods for sterile medical device package—Part 1:Test guide for accelerated aging YY/T 0681.2-2010 Test methods for sterile medical device package—Part 2:Seal strength of flexible battier materials YY/T 0681.3-2010 Test methods for sterile medical device package—Part 3:Internal pressurization failure resistance of unrestrained packages YY/T 0681.4-2010 Test methods for sterile medical device package—Part 4:Detecting seal leaks in porous packages by dye penetration YY/T 0681.5-2010 Test methods for sterile medical device package—Part 5:Detecting gross leaks in medical packaging by internal pressurization(bubble test) YY/T 0681.10-2011 Test methods for sterile medical device package—Part 10:Test for microbial barrier ranking of porous package material YY/T 0681.6-2011 Test methods for sterile medical device package—Part 6：Evaluation of chemical resistance of printed inks and coatings on flexible packaging materials YY/T 0681.7-2011 Test methods for sterile medical device package—Part 7:Evaluating inks or coating adhesion to flexible packaging materials using tape YY/T 0681.8-2011 Test methods for sterile medical device package—Part 8:Coating/adhesive weight determination YY/T 0681.9-2011 Test methods for sterile medical device package—Part 9:Burst testing of flexible package seals using internal air pressurization weight restraining plates YY/T 0681.11-2014 Test methods for sterile medical device package—Part 11:Determining integrity of seals for medical packaging by visual inspection YY/T 0681.12-2014 Test methods for sterile medical device package—Part 12:Flex durability of flexible barrier films YY/T 0681.13-2014 Test methods for sterile medical device package—Part 13:Slow rate penetration resistance of flexible barrier films and laminates YY/T 0681.14-2018 Test methods for sterile medical device package—Part 14:Testing the microbial barrier for porous packaging materials under moist conditions and with passage of air YY/T 0681.1-2018 Test methods for sterile medical device package—Part 1:Test guide for accelerated aging YY/T 0681.16-2019 Test methods for sterile medical device package—Part 16:Test for climatic stressing of packaging system YY/T 0681.15-2019 Test methods for sterile medical device package—Part 15:Performance testing of shipping containers and systems YY/T 0681.17-2019 Test methods for sterile medical device package—Part 17:Testing the microbial barrier performance of porous package materials using aerosol filtration method YY/T 0681.18-2020 Test methods for sterile medical device package—Part 18:Nondestructive detection of leaks in packages by vacuum decay method YY/T 0681.4-2021 Test methods for sterile medical device package—Part 4:Detecting seal leaks in porous packages by dye penetration YY/T 0681.12-2022 Test methods for sterile medical device package—Part 12:Flex durability of flexible barrier materials YY/T 0698.2-2009 Packaging materials for terminal sterilized medical devices—Part 2:Sterilization wrap—Requirements and test methods YY/T 0698.2-2022 Packaging materials for terminal sterilized medical devices—Part 2:Sterilization wrap—Requirements and test methods YY/T 0698.3-2009 Packaging materials for terminal sterilized medical devices—Part 3:Paper for use in the manufacture of paper bags(specified in YY/T 0698.4)and in the manufacture of pouches and reels(specified in YY/T 0698.5)—Requirements and test methods YY/T 0698.4-2009 Packaging materials for terminal sterilized medical devices—Part 4:Paper bags—Requirements and test methods YY/T 0698.5-2009 Packaging materials for terminal sterilized medical devices—Part 5:Heat and self-sealable pouches and reels of paper and plastic film construction—Requirements and test methods YY/T 0698.5-2023 Packaging materials for terminal sterilized medical devices—Part 5:Sealable pouches and reels of porous materials and plastic film construction—Requirements and test methods YY/T 0698.6-2009 Packaging materials for terminal sterilized medical devices—Part 6:Paper for manufacture of sterile barrier systems intended for sterilization by low temperature sterilization processes or irradiation—Requirements and test methods YY/T 0698.7-2009 Packaging materials for terminal sterilized medical devices—Part 7:Adhesive coated paper for the manufacture of sealable packs for medical use for sterilization by ethylene oxide or irradiation—Requirements and test methods YY/T 1286.1-2015 Platelets storage container performances—Part 1:Determination of gas permeability of the film—Differential-pressure method YY/T 1432-2016 Test method for determination of heatsealability of flexible webs of medical devices as measured by seal strength YY/T 1433-2016 Test method of hot seal strength(hot tack)of flexible webs of medical devices ISO 6588(所有部分) ISO 7765-1 ISO 9197 ISO 15105(所有部分)