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Syringes, needles & catheters

Parent Category: Medical equipment

Standards in development (119)
Published standards (73)
Committees (9)

Standards in development (119)

Standard Title	Status
BS EN 13014 REV Connections for gas sampling tubes to anaesthetic and respiratory equipment	Approval
BS EN 13496 Thermal insulation products for building applications - Determination of the mechanical properties of glass fibre meshes	Technical Review
BS EN 15732 Light weight fill and thermal insulation products for civil engineering applications (CEA) - Expanded clay lightweight aggregate products (LWA)	Approval
BS EN 1607 Thermal insulating products for building applications - Determination of tensile strength perpendicular to faces	Approval
BS EN 16382 Thermal insulation products for building applications - Determination of the pull-through resistance of anchors through thermal insulation products external thermal insulation composite systems with renders (ETICS)	Public Comment
BS EN 16383 Thermal insulation products for building applications - Determination of the hygrothermal behaviour of external thermal insulation composite systems with renders (ETICS)	Public Comment
BS EN 16491 Thermal insulation products for buildings - Factory made composite products - Specification	Public Comment
BS EN 45502-1 Active implantable medical devices Part 1: General requirements for safety, marking and information to be provided by the manufacturer	Public Comment
BS EN 60601-2-10 Medical electrical equipment Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators	Approval
BS EN 60601-2-16 Medical electrical equipment Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment	Publication
BS EN 60601-2-24 ED. 2.0 Medical electrical equipment Part 2-24: Particular requirements for basic safety and essential performance of infusion pumps and controllers	Approval
BS EN 60601-2-26 Medical electrical equipment Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs	Approval
BS EN 60601-2-27 Medical electrical equipment Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment	Approval
BS EN 60601-2-3 Medical electrical equipment Part 2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment	Approval
BS EN 60601-2-36 Medical electrical equipment Part 2-36: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy	Public Comment
BS EN 60601-2-41 ED 2.0/A1/A1 Medical electrical equipment Part 2-41: Particular requirements for basic safety and essential performance of surgical luminaires and luminaires for diagnosis	Technical Review
BS EN 60601-2-47 ED.2 Medical electrical equipment Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems	Approval
BS EN 60601-2-52:2009/A1 Medical electrical equipment Part 2-52: Particular requirements for the basic safety and essential performance of medical beds	Public Comment
BS EN 60601-2-6 Medical electrical equipment Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment	Approval
BS EN 60601-2-62 ED 1.0 Medical electrical equipment Part 2-62: Particular requirements for basic safety and essential performance of high intensity therapeutic ultrasound (HITU) system	Approval
BS EN 80601-2-30/A1 Medical electrical equipment Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers	Publication
BS EN 80601-2-58 Medical electrical equipment Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery	Public Comment
BS EN 80601-2-60 Medical electrical equipment Particular requirements for basic safety and essential performance of dental equipment	Approval
BS EN 80601-2-71 Medical electrical equipment Part 2-71: Particular requirements for basic safety and essential performance of functional NIRS equipment	Accepted
BS EN EN ISO 11499 Dentistry - Single-use cartridges for local anaesthetics	Public Comment
BS EN ISO 80601-2-67 Medical electrical equipment Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment	Approval
BS EN ISO 9173-3 Dentistry - Extraction forceps Part 3: Design and dimensions	Public Comment
BS EN ISO 9680 Dentistry - Operating lights	Public Comment
BS EN WI 00088331 Thermal insulation products for buildings - Factory made reflective insulation products (RI) - Specification	Idea
BS ENISO 10555-1 Sterile, single-use intravascular catheters Part 1: General requirements	Approval
BS ENISO 10555-3 Sterile, single-use intravascular catheters Part 3: Central venous catheters	Approval
BS ENISO 10555-4 Sterile, single-use intravascular catheters Part 4: Balloon dilatation catheters	Approval
BS ENISO 10555-5 Sterile, single-use intravascular catheters Part 5: Over-needle peripheral catheters	Approval
BS ENISO 12570:2000/A1 Hygrothermal performance of building materials and products - Determination of moisture content by drying at elevated temperature	Approval
BS ENISO 12571 Hygrothermal performance of building materials and products - Determination of hygroscopic sorption properties	Approval
BS ENISO 14408 - Requirements for marking and accompanying information	Idea
BS ENISO 14457:2012/C 1 BS EN ISO 14457:2012 Dentistry - Handpieces and motors	Publication
BS ENISO 15197 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus	Publication
BS ENISO 15758 'Hygrothermal performance of building equipment and industrial installations - Calculation of water vapour diffusion - Cold pipe insulation systems	Public Comment
BS ENISO 16635-2 Dentistry - Rubber dam technique Part 2: Rubber dam clamp forceps	Public Comment
BS ENISO 19001:2013/C 1 In vitro diagnostic medical devices - Information supplied by themanufacturer with in vitro diagnostic reagents for staining in biology	Publication
BS ENISO 3630-3 Dental root-canal instruments Part 3: Condensers, pluggers and spreaders	Accepted
BS ENISO 3826-1 Plastics collapsible containers for human blood and blood components Part 1: Conventional containers	Publication
BS ENISO 5356-1 Anaesthetic and respiratory equipment - Conical connectors Part 1: Cones and sockets (ISO/NP 5356-1)	Public Comment
BS ENISO 5361:2012/CORR equipment - Tracheal tubes and connectors (ISO 5361:2012)	Idea
BS ENISO 5364 Oropharyngeal airways	Idea
BS ENISO 5366-1 Anaesthetic and respiratory equipment - Tracheostomy tubes Part : Tubes and connectors for use in adults	Accepted
BS ENISO 5366-1 Anaesthetic and respiratory equipment - Tracheostomy tubes Part 1: Tubes and connectors for use in adults	Approval
BS ENISO 5366-3 Anaesthetic and respiratory equipment - Tracheostomy tubes Part 3: Paediatric tracheostomy tubes	Approval
BS ENISO 5367 Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO/DIS 5367:2012)	Public Comment
BS ENISO 6781-3 Performance of buildings - Detection of heat, air and moisture irregularities in buildings by infrared methods Part 3: Qualifications of Equipment Operators, Data Analysts and Report Writers	Public Comment
BS ENISO 7345:1995/A1 Thermal insulation - Physical quantities and definitions (ISO 7345:1987)	Accepted
BS ENISO 7494-2 Dentistry -- Dental units Part 2: Water and air supply	Public Comment
BS ENISO 80601-2-12:2011/CORR @:2011 Medical electrical equipment Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators	Publication
BS ENISO 8536-4:2010/A1 Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed - Amendment 1	Publication
BS ENISO 8836 Suction catheters for use in the respiratory tract	Public Comment
BS ENISO 9687 Dental equipment - Graphical symbols	Public Comment
BS ENISO 9972 Thermal performance of buildings - Determination of air permeability of buildings - Fan pressurization method	Public Comment
BS ISO 10555-6 Intravascular catheters - Sterile and single-use catheters Part 6: Subcutaneous implanted ports	Accepted
BS ISO 11040-4 Prefilled syringes Part 4: Glass barrels for injectables and ready-to-use prefillable syringes	Accepted
BS ISO 11040-7 Prefilled syringes Part 7: packaging system for disposable ready-to-use syringes	Accepted
BS ISO 11070 Sterile, single-use intravascular catheter introducers	Public Comment
BS ISO 1135-4 Transfusion equipment for medical use Part 4: Transfusion sets for single use	Accepted
BS ISO 1135-5 Transfusion equipment for medical use Part 5: Transfusion sets for single use with pressure infusion apparatus	Accepted
BS ISO 11608-4 Pen-injectors for medical use Part 4: Requirements and test methods for electronic and electromechanical pen-injectors	Accepted
BS ISO 11608-6 Needle-based injection systems for medical use - Requirements and test methods Part 6: Bolus Injectors	Idea
BS ISO 11663 Quality of dialysis fluid for haemodialysis and related therapies	Public Comment
BS ISO 12417 Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products	Accepted
BS ISO 12574-2 Thermal insulation— Cellulose-fibre loose-fill for horizontal applications in ventilated roof spaces— Part 2 : Principal responsibilities of installers	Approval
BS ISO 13397-5 Dentistry - Periodontal curettes, dental scalers and excavators Part 5: Jacquette scalers	Idea
BS ISO 13959 Water for haemodialysis and related therapies	Public Comment
BS ISO 16782 Clinical laboratory testing - Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing	Idea
BS ISO 16954 Dentistry - Test methods for evaluating microbiological treatment methods for dental unit procedural water	Accepted
BS ISO 17217 Ginseng seeds and seedlings, Panax ginseng C.A. Meyer	Accepted
BS ISO 17217-1 Traditional Chinese medicine - Ginseng seeds and seedlings Part 1: Panax ginseng CA Meyer	Public Comment
BS ISO 17218 Sterile acupuncture needles for single use	Public Comment
BS ISO 17256 Anaesthetic and respiratory equipment - Respiratory therapy tubing and connectors	Public Comment
BS ISO 17509 Dentistry - Torque transmitter for handpieces	Idea
BS ISO 17518 Medical Laboratories - Guidance for users of reagents for staining in biology in medical laboratories	Idea
BS ISO 17822 Nucleic acid based in vitro diagnostics for detection and identification of microbial pathogens - General requirements and definitions	Idea
BS ISO 17937 Dentistry - Osteotomy	Accepted
BS ISO 18190 Anaesthetic and respiratory equipment - General requirements for airways and related equipment	Accepted
BS ISO 18241 Cardiovascular implants and extracorporeal systems - Cardiopulmonary bypass systems - Venous bubble traps	Idea
BS ISO 18242 Cardiovascular implants and extracorporeal systems - Centrifugal blood pumps	Idea
BS ISO 18397 Dentistry - Scaler handpieces and scaler tips	Accepted
BS ISO 18463 Needle-based injection devices for visually-impaired patients	Accepted
BS ISO 18556 Dentistry - Heidemann spatulas	Accepted
BS ISO 18562-1 Biocompatibility evaluation of respiratory gas pathways in healthcare applications Part 1: Evaluation and testing within a risk management process	Accepted
BS ISO 18562-2 Biocompatibility evaluation of respiratory gas pathways in healthcare applications Part 2: Tests for emissions of particulate matter	Accepted
BS ISO 18562-3 Biocompatibility evaluation of respiratory gas pathways in healthcare applications Part 3: Tests for emissions of volatile organic compounds (VOCs)	Accepted
BS ISO 18562-4 Biocompatibility evaluation of respiratory gas pathways in healthcare applications Part 4: Tests for leachables in condensate	Accepted
BS ISO 18586 Requirements for basic safety and essential performance for Electroacupuncture Stimulator	Idea
BS ISO 18615 General requirements of electric radial pulse tonometric devices	Idea
BS ISO 18662-1 Traditional Chinese medicine - Vocabulary Part 1: Chinese Materia Medica	Idea
BS ISO 18663 Electroacupuncture stimulator device for quality	Idea
BS ISO 18664 Heavy metals in natural materials of Traditional Chinese Medicine (TCM)	Idea
BS ISO 18665 Herbal decoction apparatus	Idea
BS ISO 18666 Moxibustion devices	Idea
BS ISO 18668-1 Coding System of Chinese Medicine Part 1: Coding Rules for Decoction Pieces	Idea
BS ISO 18746 Intradermal acupuncture needles	Idea
BS ISO 23500 Guidance for the preparation and quality management of fluids for haemodialysis and related therapies	Public Comment
BS ISO 26722 Water treatment equipment for haemodialysis applications and related therapies	Public Comment
BS ISO 27186:2010/AMD 1 Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements - Amendment 1	Accepted
BS ISO 27427 Anaesthetic and respiratory equipment - Nebulizing systems and components	Public Comment
BS ISO 3826-4 Plastics collapsible containers for human blood and blood components Part 4: Aphaeresis blood bag systems with integrated features	Accepted
BS ISO 5359 Low-pressure hose assemblies for use with medical gases	Public Comment
BS ISO 5361 Anaesthetic and respiratory equipment - Tracheal tubes and connectors	Idea
BS ISO 5840-1 Cardiovascular implants - Cardiac valve prostheses Part 1: General requirements	Accepted
BS ISO 5840-2 Cardiovascular implants - Cardiac valve prostheses Part 2: Surgically implanted valve substitutes	Accepted
BS ISO 5841-2 Implants for surgery - Cardiac pacemakers Part 2: Reporting of clinical performance of populations of pulse generators or leads	Accepted
BS ISO 7198 Cardiovascular implants - Tubular vascular prostheses	Accepted
BS ISO 80601-2-69 Medical Electrical Equipment Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment	Public Comment
BS ISO 80601-2-70 Medical Electrical Equipment Part 2-70: Particular requirements for basic safety and essential performance of sleep apneoa breathing therapy equipment	Public Comment
BS ISO 80601-2-72 Medical electrical equipment Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients	Accepted
BS ISO 8536-12:2007/AMD 1 Infusion equipment for medical use Part 12: Check valves - Amendment 1	Publication
BS ISO 8536-13 Infusion equipment for medical use Part 13: Clamps, restrictors and flow regulators for transfusion and infusion sets	Accepted
BS ISO/IEC 80600 Medical electrical equipment - Deployment, implementation and operationa l guidelines for identifying febrile humans using a screening thermograph	null
PD CEN/TS WI 00140088 Molecular in-vitro diagnostic examinations - Specifications for pre-examination processes for selected types of sample	Idea
PD ISO/TS 17137 Cardiovascular absorbable implants	Accepted

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Published standards (73)

Sort by: Reference | Title | Status

Standard reference	Name	Status
BS ISO 26825:2008	Anaesthetic and respiratory equipment. User-applied labels for syringes containing drugs used during anaesthesia. Colours, design and performance	Current
BS EN 1618:1997	Catheters other than intravascular catheters. Test methods for common properties	Current
BS EN 13868:2002	Catheters. Test methods for kinking of single lumen catheters and medical tubing	Current
BS EN 1707:1997	Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment. Lock fittings	Current
BS EN 20594-1:1994	Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - General requirements	Current
BS 3930-2:1991	Conical fittings with a 6% (Luer) taper for syringes, needles and other medical equipment - Specification for lock fittings	Withdrawn
BS EN ISO 7885:2010	Dentistry. Sterile injection needles for single use	Current
BS 7174-2:1990	Determination of hydraulic fluid power motor characteristics - Specification for angiographic catheters	Withdrawn
BS EN 1615:2000	Enteral feeding catheters and enteral giving sets for single use and their connectors. Design and testing	Current
BS EN ISO 6009:1994	Hypodermic needles for single use. Colour coding for identification	Current
PD CR 13825:2000	Luer connectors. A report to CEN CHeF from the CEN forum task group 'Luer fittings'	Current
BS EN ISO 11608-3:2012	Needle-based injection systems for medical use. Requirements and test methods - Finished containers	Current
BS EN ISO 11608-1:2012	Needle-based injection systems for medical use. Requirements and test methods - Needle-based injection systems	Current
BS EN ISO 11608-2:2012	Needle-based injection systems for medical use. Requirements and test methods - Needles	Current
BS EN ISO 11608-5:2012	Needle-based injection systems for medical use. Requirements and test methods - Automated functions	Current
BS ISO 13926-2:2011	Pen systems - Plunger stoppers for pen-injectors for medical use	Current
BS ISO 13926-3:2012	Pen systems - Seals for pen-injectors for medical use	Current
BS EN ISO 11608-4:2007	Pen-injectors for medical use - Requirements and test methods for electronic and electromechanical pen-injectors	Current
BS EN ISO 11608-2:2001	Pen-injectors for medical use - Needles. Requirements and test methods	Withdrawn
BS EN ISO 11608-3:2001	Pen-injectors for medical use - Finished cartridges. Requirements and test methods	Withdrawn
BS EN ISO 11608-1:2001	Pen-injectors for medical use - Pen-injectors. Requirements and test methods	Withdrawn
BS ISO 11040-4:2007	Prefilled syringes - Glass barrels for injectables	Current
BS ISO 11040-5:2012	Prefilled syringes - Plunger stoppers for injectables	Current
BS ISO 11040-2:2011	Prefilled syringes - Plunger stoppers for dental local anaesthetic cartridges	Current
BS ISO 11040-3:2012	Prefilled syringes - Seals for dental local anaesthetic cartridges	Current
BS ISO 11040-6:2012	Prefilled syringes - Plastic barrels for injectables	Current
BS 7652-2:1995	Prefilled syringes - Specification for plungers and discs for dental local anaesthetic cartridges	Withdrawn
BS 7652-1:1993	Prefilled syringes. - Specification for glass cylinders for dental local anaesthetic cartridges	Current
BS 1619-1:1962	Re-usable hypodermic syringes for insulin injection - Specification for syringes for use with insulin of strengths 20, 40 and 80 units per millilitre	Withdrawn
BS 1619-2:1988	Re-usable hypodermic syringes for insulin injection - Specification for syringes for use with insulin of strength 100 units per millilitre	Obsolescent
BS EN ISO 595-2:1995	Reusable all-glass or metal-and-glass syringes for medical use - Design, performance requirements and tests	Current
BS 1263-1:1989	Reusable hypodermic syringes for medical use. - Specification for dimensions of all-glass and metal-and-glass syringes	Current
BS EN ISO 23908:2013	Sharps injury protection. Requirements and test methods. Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling	Current
BS EN 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	Withdrawn
BS 7432:1991	Specification for dental cartridge syringes	Withdrawn
BS 3522:1962	Specification for hypodermic surgical mounted needles (Luer fitting)	Obsolescent
BS 6196:1989	Specification for sterile epidural catheters and introducer needles for single use	Current
BS 6314:1990	Specification for sterile, single-use, naso-enteric feeding tubes and ancillary equipment	Withdrawn
BS 7213:1989	Specification for suction catheters for use in the respiratory tract	Withdrawn
BS EN ISO 9626:1995	Stainless steel needle tubing for the manufacture of medical devices	Current
BS EN ISO 7885:2001	Sterile dental injection needles for single use	Withdrawn
BS EN 1617:1997	Sterile drainage catheters and accessory devices for single use	Current
BS EN 1615:1997	Sterile enteral feeding catheters and giving sets for single use	Withdrawn
BS EN ISO 7864:1996	Sterile hypodermic needles for single use	Current
BS 5081-1:1994	Sterile hypodermic syringes and needles - Specification for sterile, single-use hypodermic syringes for manual use	Withdrawn
BS EN ISO 7886-1:1997	Sterile hypodermic syringes for single use - Syringes for manual use	Current
BS EN ISO 7886-2:1997	Sterile hypodermic syringes for single use - Syringes for use with power-driven syringe pumps	Current
BS EN ISO 7886-4:2006	Sterile hypodermic syringes for single use - Syringes with re-use prevention feature	Withdrawn
BS EN ISO 7886-3:2005	Sterile hypodermic syringes for single use - Auto-disable syringes for fixed dose immunization	Withdrawn
BS EN ISO 7886-4:2009	Sterile hypodermic syringes for single use - Syringes with re-use prevention feature	Current
BS EN ISO 7886-3:2009	Sterile hypodermic syringes for single use - Auto-disable syringes for fixed-dose immunization	Current
BS 7174-4:1990	Sterile intravascular catheters and ancillary devices for single use - Specification for introducer needles, introducer cannulae, guide wires, dilators, valves and connectors	Withdrawn
BS 7174-1:1990	Sterile intravascular catheters and ancillary devices for single use - Specification for general requirements	Withdrawn
BS 7174-5:1990	Sterile intravascular catheters and ancillary devices for single use - Specification for balloon dilatation catheters	Withdrawn
BS 7174-3:1990	Sterile intravascular catheters and ancillary devices for single use - Specification for central venous catheters	Withdrawn
BS ISO 14972:1998	Sterile obturators for single use with over-needle peripheral intravascular catheters	Current
BS EN 12439:1999	Sterile rectal catheters for single use	Current
BS EN ISO 8537:2008	Sterile single-use syringes, with or without needle, for insulin	Current
BS EN 1616:1997	Sterile urethral catheters for single use	Current
BS EN ISO 11070:1999	Sterile, single-use intravascular catheter introducers	Current
BS EN ISO 10555-1:1997	Sterile, single-use intravascular catheters - General requirements	Withdrawn
BS EN ISO 10555-2:1997	Sterile, single-use intravascular catheters - Angiographic catheters	Current
BS EN ISO 10555-4:1997	Sterile, single-use intravascular catheters - Balloon dilatation catheters	Current, Work in Hand
BS EN ISO 10555-3:1997	Sterile, single-use intravascular catheters - Central venous catheters	Current, Work in Hand
BS EN ISO 10555-5:1997	Sterile, single-use intravascular catheters - Over-needle peripheral catheters	Current, Work in Hand
BS EN ISO 10555-1:2009	Sterile, single-use intravascular catheters - General requirements	Current, Work in Hand
BS EN ISO 8537:1995	Sterile, single-use syringes, with or without needle, for insulin	Withdrawn
BS EN ISO 8836:2009	Suction catheters for use in the respiratory tract	Current
BS EN ISO 8836:2008	Suction catheters for use in the respiratory tract	Withdrawn
BS EN 1733:2002	Suction catheters for use in the respiratory tract	Withdrawn
BS EN 1733:1998	Suction catheters for use in the respiratory tract	Withdrawn
BS 1695-1:1990	Urological catheters - Specification for sterile, single-use urethral catheters of the Ne´laton and Foley types	Withdrawn
BS 1695-2:1990	Urological catheters - Specification for sterile, single-use urethral catheters of the Tiemann, whistle tip, 3-way and haematuria types	Withdrawn

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Committees (9)

Sort by: Reference | Name

Committee Reference	Title
CH/121/1	Breathing attachments and anaesthetic machines
CH/150/2	Cardiovascular implants
CH/84	Catheters and syringes
CH/106/4	Dental Instruments and Equipment
CH/62/4	Electromedical equipment
B/540	Energy performance of materials components and buildings
CH/100	Healthcare and medical equipment (European and International)
CH/212	IVDs
CH/121/5	Lung ventilators, tracheal tubes and related equipment

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