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Стандарт и/или проект Этап ТК
ISO 594-1:1986
Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 1: General requirements
95.99 ISO/TC 210
ISO 594-2:1991
Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 2: Lock fittings
95.99 ISO/TC 84
ISO 594-2:1998
Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 2: Lock fittings
95.99 ISO/TC 210
ISO/R 594:1967
Conical fittings for syringes, needles and other medical equipment — Definition and dimensional characteristics for conical fittings with a 6 % and a 10 % taper
95.99 ISO/TC 84
ISO 595-1:1986
Reusable all-glass or metal-and-glass syringes for medical use — Part 1: Dimensions
95.99 ISO/TC 84
ISO 595-2:1987
Reusable all-glass or metal-and-glass syringes for medical use — Part 2: Design, performance requirements and tests
95.99 ISO/TC 84
ISO 6009:1992
Hypodermic needles for single use — Colour coding for identification
95.99 ISO/TC 84
ISO 6009:1992/Cor 1:2008
Hypodermic needles for single use — Colour coding for identification — Technical Corrigendum 1
95.99 ISO/TC 84
ISO 6009:2016
Hypodermic needles for single use — Colour coding for identification
60.60 ISO/TC 84
ISO 7864:1993
Sterile hypodermic needles for single use
95.99 ISO/TC 84
ISO 7864:2016
Sterile hypodermic needles for single use — Requirements and test methods
60.60 ISO/TC 84
ISO 7885:2000
Sterile dental injection needles for single use
95.99 ISO/TC 106/SC 4
ISO 7885:2010
Dentistry — Sterile injection needles for single use
90.93 ISO/TC 106/SC 4
ISO 7886-1:1993
Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
95.99 ISO/TC 84
ISO 7886-1:1993/Cor 1:1995
Sterile hypodermic syringes for single use — Part 1: Syringes for manual use — Technical Corrigendum 1
95.99 ISO/TC 84
ISO 7886-1:2017
Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
60.60 ISO/TC 84
ISO 7886-2:1996
Sterile hypodermic syringes for single use — Part 2: Syringes for use with power-driven syringe pumps
90.92 ISO/TC 84
ISO 7886-3:2005
Sterile hypodermic syringes for single use — Part 3: Auto-disable syringes for fixed-dose immunization
90.92 ISO/TC 84
ISO 7886-4:2006
Sterile hypodermic syringes for single use — Part 4: Syringes with re-use prevention feature
95.99 ISO/TC 84
ISO 7886-4:2018
Sterile hypodermic syringes for single use — Part 4: Syringes with re-use prevention feature
60.60 ISO/TC 84
ISO/DIS 7886-2
Sterile hypodermic syringes for single use — Part 2: Syringes for use with power-driven syringe pumps
40.60 ISO/TC 84
ISO/DIS 7886-3
Sterile hypodermic syringes for single use — Part 3: Auto-disabled syringes for fixed-dose immunization
40.60 ISO/TC 84
ISO 8537:1991
Sterile single-use syringes, with or without needle, for insulin
95.99 ISO/TC 84
ISO 8537:1991/Amd 1:2000
Sterile single-use syringes, with or without needle, for insulin — Amendment 1
95.99 ISO/TC 84
ISO 8537:2007
Sterile single-use syringes, with or without needle, for insulin
95.99 ISO/TC 84
ISO 8537:2016
Sterile single-use syringes, with or without needle, for insulin
60.60 ISO/TC 84
ISO 8836
Suction catheters for use in the respiratory tract
60.00 ISO/TC 121/SC 2
ISO 8836:2007
Suction catheters for use in the respiratory tract
95.99 ISO/TC 121/SC 2
ISO 8836:2014
Suction catheters for use in the respiratory tract
90.92 ISO/TC 121/SC 2
ISO 9626:1991
Stainless steel needle tubing for the manufacture of medical devices
95.99 ISO/TC 84
ISO 9626:1991/Amd 1:2001
Stainless steel needle tubing for the manufacture of medical devices — Amendment 1
95.99 ISO/TC 84
ISO 9626:2016
Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
60.60 ISO/TC 84
ISO 9997:1999
Dental cartridge syringes
90.92 ISO/TC 106/SC 4
ISO/FDIS 9997
Dentistry — Cartridge syringes
50.00 ISO/TC 106/SC 4
ISO 10555-1:1995
Sterile, single-use intravascular catheters — Part 1: General requirements
95.99 ISO/TC 84
ISO 10555-1:1995/Amd 1:1999
Sterile, single-use intravascular catheters — Part 1: General requirements — Amendment 1
95.99 ISO/TC 84
ISO 10555-1:1995/Amd 2:2004
Sterile, single-use intravascular catheters — Part 1: General requirements — Amendment 2
95.99 ISO/TC 84
ISO 10555-1:2013
Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements
90.93 ISO/TC 84
ISO 10555-1:2013/Amd 1:2017
Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements — Amendment 1
60.60 ISO/TC 84
ISO 10555-2:1996
Sterile, single-use intravascular catheters — Part 2: Angiographic catheters
95.99 ISO/TC 84
ISO 10555-2:1996/Cor 1:2002
Sterile, single-use intravascular catheters — Part 2: Angiographic catheters — Technical Corrigendum 1
95.99 ISO/TC 84
ISO 10555-3:1996
Sterile, single-use intravascular catheters — Part 3: Central venous catheters
95.99 ISO/TC 84
ISO 10555-3:1996/Cor 1:2002
Sterile, single-use intravascular catheters — Part 3: Central venous catheters — Technical Corrigendum 1
95.99 ISO/TC 84
ISO 10555-3:2013
Intravascular catheters — Sterile and single-use catheters — Part 3: Central venous catheters
90.93 ISO/TC 84
ISO 10555-4:1996
Sterile, single-use intravascular catheters — Part 4: Balloon dilatation catheters
95.99 ISO/TC 84
ISO 10555-4:1996/Cor 1:2002
Sterile, single-use intravascular catheters — Part 4: Balloon dilatation catheters — Technical Corrigendum 1
95.99 ISO/TC 84
ISO 10555-4:2013
Intravascular catheters — Sterile and single-use catheters — Part 4: Balloon dilatation catheters
90.93 ISO/TC 84
ISO 10555-5:1996
Sterile, single-use intravascular catheters — Part 5: Over-needle peripheral catheters
95.99 ISO/TC 84
ISO 10555-5:1996/Amd 1:1999
Sterile, single-use intravascular catheters — Part 5: Over-needle peripheral catheters — Amendment 1
95.99 ISO/TC 84
ISO 10555-5:1996/Cor 1:2002
Sterile, single-use intravascular catheters — Part 5: Over-needle peripheral catheters — Technical Corrigendum 1
95.99 ISO/TC 84
ISO 10555-5:2013
Intravascular catheters — Sterile and single-use catheters — Part 5: Over-needle peripheral catheters
90.93 ISO/TC 84
ISO 10555-6:2015
Intravascular catheters — Sterile and single-use catheters — Part 6: Subcutaneous implanted ports
60.60 ISO/TC 84
ISO 10555-6:2015/Amd 1:2019
Intravascular catheters — Sterile and single-use catheters — Part 6: Subcutaneous implanted ports — Amendment 1
60.60 ISO/TC 84
ISO 11040-1:1992
Prefilled syringes — Part 1: Glass cylinders for dental local anaesthetic cartridges
95.99 ISO/TC 76
ISO 11040-1:2015
Prefilled syringes — Part 1: Glass cylinders for dental local anaesthetic cartridges
60.60 ISO/TC 76
ISO 11040-2:1994
Prefilled syringes — Part 2: Plungers and discs for dental local anaesthetic cartridges
95.99 ISO/TC 76
ISO 11040-2:2011
Prefilled syringes — Part 2: Plunger stoppers for dental local anaesthetic cartridges
90.93 ISO/TC 76
ISO 11040-3:1993
Prefilled syringes — Part 3: Aluminium caps for dental local anaesthetic cartridges
95.99 ISO/TC 76
ISO 11040-3:2012
Prefilled syringes — Part 3: Seals for dental local anaesthetic cartridges
90.93 ISO/TC 76
ISO 11040-4:1996
Prefilled syringes — Part 4: Glass barrels for injectables
95.99 ISO/TC 76
ISO 11040-4:2007
Prefilled syringes — Part 4: Glass barrels for injectables
95.99 ISO/TC 76
ISO 11040-4:2015
Prefilled syringes — Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling
60.60 ISO/TC 76
ISO 11040-4:2015/DAmd 1
Prefilled syringes — Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling — Amendment 1
40.60 ISO/TC 76
ISO 11040-5:1996
Prefilled syringes — Part 5: Plungers for injectables
95.99 ISO/TC 76
ISO 11040-5:2001
Prefilled syringes — Part 5: Plungers for injectables
95.99 ISO/TC 76
ISO 11040-5:2012
Prefilled syringes — Part 5: Plunger stoppers for injectables
90.93 ISO/TC 76
ISO 11040-6:2012
Prefilled syringes — Part 6: Plastic barrels for injectables
95.99 ISO/TC 76
ISO 11040-6:2019
Prefilled syringes — Part 6: Plastic barrels for injectables and sterilized subassembled syringes ready for filling
60.60 ISO/TC 76
ISO 11040-7:2015
Prefilled syringes — Part 7: Packaging systems for sterilized subassembled syringes ready for filling
60.60 ISO/TC 76
ISO 11040-8:2016
Prefilled syringes — Part 8: Requirements and test methods for finished prefilled syringes
60.60 ISO/TC 76
ISO 11070:1998
Sterile, single-use intravascular catheter introducers
95.99 ISO/TC 84
ISO 11070:2014
Sterile single-use intravascular introducers, dilators and guidewires
90.20 ISO/TC 84
ISO 11070:2014/Amd 1:2018
Sterile single-use intravascular introducers, dilators and guidewires — Amendment 1
60.60 ISO/TC 84
ISO 11608-1:2000
Pen-injectors for medical use — Part 1: Pen-injectors — Requirements and test methods
95.99 ISO/TC 84
ISO 11608-1:2012
Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems
95.99 ISO/TC 84
ISO 11608-1:2014
Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems
90.92 ISO/TC 84
ISO 11608-2:2000
Pen-injectors for medical use — Part 2: Needles — Requirements and test methods
95.99 ISO/TC 84
ISO 11608-2:2012
Needle-based injection systems for medical use — Requirements and test methods — Part 2: Needles
90.92 ISO/TC 84
ISO 11608-3:2000
Pen-injectors for medical use — Part 3: Finished cartridges — Requirements and test methods
95.99 ISO/TC 84
ISO 11608-3:2012
Needle-based injection systems for medical use — Requirements and test methods — Part 3: Finished containers
90.92 ISO/TC 84
ISO 11608-4:2006
Pen-injectors for medical use — Part 4: Requirements and test methods for electronic and electromechanical pen-injectors
90.92 ISO/TC 84
ISO 11608-5:2012
Needle-based injection systems for medical use — Requirements and test methods — Part 5: Automated functions
90.92 ISO/TC 84
ISO 11608-7:2016
Needle-based injection systems for medical use — Requirements and test methods — Part 7: Accessibility for persons with visual impairment
60.60 ISO/TC 84
ISO/CD 11608-1
Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems
30.60 ISO/TC 84
ISO/CD 11608-2
Needle-based injection systems for medical use — Requirements and test methods — Part 2: Needles
30.60 ISO/TC 84
ISO/CD 11608-3
Needle-based injection systems for medical use — Requirements and test methods — Part 3: Finished containers
30.60 ISO/TC 84
ISO/CD 11608-4
Needle-based injection systems for medical use — Requirements and test methods — Part 4: Needle-based injection systems containing electronics
30.60 ISO/TC 84
ISO/CD 11608-5
Needle-based injection systems for medical use — Requirements and test methods — Part 5: Automated or device-driven features
30.60 ISO/TC 84
ISO/CD 11608-6
Needle-based injection systems for medical use — Requirements and test methods — Part 6: On-body delivery systems
30.60 ISO/TC 84
ISO 13926-1:1996
Pen systems — Part 1: Glass cylinders for insulin pen-injectors
95.99 ISO/TC 76
ISO 13926-1:1998
Pen systems — Part 1: Glass cylinders for pen-injectors for medical use
95.99 ISO/TC 76
ISO 13926-1:2004
Pen systems — Part 1: Glass cylinders for pen-injectors for medical use
95.99 ISO/TC 76
ISO 13926-1:2018
Pen systems — Part 1: Glass cylinders for pen-injectors for medical use
60.60 ISO/TC 76
ISO 13926-2:1999
Pen systems — Part 2: Plungers and discs for pen-injectors for medical use
95.99 ISO/TC 76
ISO 13926-2:2011
Pen systems — Part 2: Plunger stoppers for pen-injectors for medical use
95.99 ISO/TC 76
ISO 13926-2:2011/Amd 1:2015
Pen systems — Part 2: Plunger stoppers for pen-injectors for medical use — Amendment 1
95.99 ISO/TC 76
ISO 13926-2:2017
Pen systems — Part 2: Plunger stoppers for pen-injectors for medical use
60.60 ISO/TC 76
ISO 13926-3:2012
Pen systems — Part 3: Seals for pen-injectors for medical use
95.99 ISO/TC 76
ISO 13926-3:2019
Pen systems — Part 3: Seals for pen-injectors for medical use
60.60 ISO/TC 76
ISO 14972:1998
Sterile obturators for single use with over-needle peripheral intravascular catheters
90.60 ISO/TC 84
ISO 17218:2014
Sterile acupuncture needles for single use
90.93 ISO/TC 249
ISO 18250-1:2018
Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 1: General requirements and common test methods
60.60 ISO/TC 210
ISO 18250-3:2018
Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 3: Enteral applications
60.60 ISO/TC 210
ISO 18250-6:2019
Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 6: Neural applications
60.60 ISO/TC 210
ISO 18250-7:2018
Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 7: Connectors for intravascular infusion
60.60 ISO/TC 210
ISO 18250-8:2018
Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 8: Citrate-based anticoagulant solution for apheresis applications
60.60 ISO/TC 210
ISO 18746:2016
Traditional Chinese medicine — Sterile intradermal acupuncture needles for single use
60.60 ISO/TC 249
ISO 20487:2019
Traditional Chinese medicine — Test method of single-use acupuncture needles for electrical stimulation
60.60 ISO/TC 249
ISO/FDIS 20695
Enteral feeding systems — Design and testing
50.20 ISO/TC 84
ISO 20696:2018
Sterile urethral catheters for single use
60.60 ISO/TC 84
ISO 20697:2018
Sterile drainage catheters and accessory devices for single use
60.60 ISO/TC 84
ISO 20698:2018
Catheter systems for neuraxial application — Sterile and single-use catheters and accessories
60.60 ISO/TC 84
ISO/DIS 22236
Traditional Chinese medicine —Thread embedding acupuncture needle for single use
40.20 ISO/TC 249
ISO 23908:2011
Sharps injury protection — Requirements and test methods — Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
90.93 ISO/TC 84
ISO 26825:2008
Anaesthetic and respiratory equipment — User-applied labels for syringes containing drugs used during anaesthesia — Colours, design and performance
90.92 ISO/TC 121/SC 1
ISO/DIS 26825
Anaesthetic and respiratory equipment — User-applied labels for syringes containing drugs used during anaesthesia — Colours, design and performance
40.00 ISO/TC 121/SC 1
IEC 80369-5:2016
Small-bore connectors for liquids and gases in healthcare applications — Part 5: Connectors for limb cuff inflation applications
60.60 ISO/TC 210
IEC 80369-5:2016/Cor 1:2017
Small-bore connectors for liquids and gases in healthcare applications — Part 5: Connectors for limb cuff inflation applications — Technical Corrigendum 1
60.60 ISO/TC 210
ISO 80369-20:2015
Small-bore connectors for liquids and gases in healthcare applications — Part 20: Common test methods
60.60 ISO/TC 210
ISO 80369-3:2016
Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors for enteral applications
90.92 ISO/TC 210
ISO 80369-3:2016/Amd 1:2019
Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors for enteral applications — Amendment 1
60.60 ISO/TC 210
ISO 80369-6:2016
Small bore connectors for liquids and gases in healthcare applications — Part 6: Connectors for neuraxial applications
60.60 ISO/TC 210
ISO 80369-7:2016
Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications
90.92 ISO/TC 210
ISO/DIS 80369-7
Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors with 6 % (Luer) taper for intravascular or hypodermic applications
40.20 ISO/TC 210

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