Codes & Standards
CSA C22.2 NO. 60601-2-16:19
Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment (Adopted IEC 60601-1-16:2018, fifth edition, 2018-04, with Canadian deviations) | Appareils électromédicaux - Partie 2-16 : Exigences particulières pour la sécurité de base et les performances essentielles des appareils d'hémodialyse, d'hémodiafiltration et d'hémofiltration (norme IEC 60601-2-16:2018 adoptée, cinquième édition, 2018-04, avec exigences propres au Canada)
- Bilingual
- Published in 2019
- Published by CSA Group
- Subscription Available
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CSA ISO 26825:10 (R2020)
Anaesthetic and respiratory equipment - User-applied labels for
syringes containing drugs used during anaesthesia - Colours, design and performance (Adopted ISO 26825:2008, first edition,
2008-08-15)
- English, French
- Published in 2010
- Reaffirmed in 2020
- Published by CSA Group
Codes & Standards
CSA ISO 8836:20
Suction catheters for use in the respiratory tract (Adopted ISO 8836:2019, fifth edition, 2019-12)
- English, French
- Published in 2020
- Published by CSA Group
- Subscription Available
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IEC 60601-2-16:2018
Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
- Bilingual
- Published in 2018
- Published by IEC
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IEC 60601-2-16:2018 RLV
Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
- English
- Published in 2018
- Published by IEC
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IEC TR 62653:2020
Guideline for safe operation of medical equipment used for haemodialysis treatments
- English
- Published in 2020
- Published by IEC
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IEC TR 62653:2020 RLV
Guideline for safe operation of medical equipment used for haemodialysis treatments
- English
- Published in 2020
- Published by IEC
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ISO 10555-3:2013
Intravascular catheters -- Sterile and single-use catheters -- Part 3: Central venous catheters
- English, French
- Published in 2013
- Published by ISO
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ISO 10555-5:2013
Intravascular catheters -- Sterile and single-use catheters -- Part 5: Over-needle peripheral catheters
- English, French
- Published in 2013
- Published by ISO
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ISO 10555-6:2015
Intravascular catheters -- Sterile and single-use catheters -- Part 6: Subcutaneous implanted ports
- English, French
- Published in 2015
- Published by ISO
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ISO 10555-6:2015/Amd 1:2019
Intravascular catheters β Sterile and single-use catheters β Part 6: Subcutaneous implanted ports β Amendment 1
- English, French
- Published in 2019
- Published by ISO
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ISO 11040-1:2015
Prefilled syringes -- Part 1: Glass cylinders for dental local anaesthetic cartridges
- English
- Published in 2015
- Published by ISO
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ISO 11040-2:2011
Prefilled syringes -- Part 2: Plunger stoppers for dental local anaesthetic cartridges
- English
- Published in 2011
- Published by ISO
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ISO 11040-3:2012
Prefilled syringes -- Part 3: Seals for dental local anaesthetic cartridges
- English, French
- Published in 2012
- Published by ISO
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ISO 11040-4:2015
Prefilled syringes -- Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling
- English, French
- Published in 2015
- Published by ISO
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ISO 11040-4:2015/Amd 1:2020
Prefilled syringes β Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling β Amendment 1
- English, French
- Published in 2020
- Published by ISO
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ISO 11040-5:2012
Prefilled syringes -- Part 5: Plunger stoppers for injectables
- English, French
- Published in 2012
- Published by ISO
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ISO 11040-6:2019
Prefilled syringes -- Part 6: Plastic barrels for injectables and sterilized subassembled syringes ready for filling
- English, French
- Published in 2019
- Published by ISO
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ISO 11040-7:2015
Prefilled syringes -- Part 7: Packaging systems for sterilized subassembled syringes ready for filling
- English, French
- Published in 2015
- Published by ISO
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ISO 11040-8:2016
Prefilled syringes -- Part 8: Requirements and test methods for finished prefilled syringes
- English, French
- Published in 2016
- Published by ISO
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ISO 11070:2014
Sterile single-use intravascular introducers, dilators and guidewires
- English, French
- Published in 2014
- Published by ISO
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ISO 11070:2014/Amd 1:2018
Sterile single-use intravascular introducers, dilators and guidewires β Amendment 1
- English, French
- Published in 2018
- Published by ISO
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ISO 11608-1:2022
Needle-based injection systems for medical use β Requirements and test methods β Part 1: Needle-based injection systems
- English, French
- Published in 2022
- Published by ISO
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ISO 11608-2:2022
Needle-based injection systems for medical use β Requirements and test methods β Part 2: Double-ended pen needles
- English, French
- Published in 2022
- Published by ISO
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ISO 11608-3:2022
Needle-based injection systems for medical use β Requirements and test methods β Part 3: Containers and integrated fluid paths
- English, French
- Published in 2022
- Published by ISO
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ISO 11608-4:2022
Needle-based injection systems for medical use β Requirements and test methods β Part 4: Needle-based injection systems containing electronics
- English, French
- Published in 2022
- Published by ISO
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ISO 11608-5:2022
Needle-based injection systems for medical use β Requirements and test methods β Part 5: Automated functions
- English, French
- Published in 2022
- Published by ISO
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ISO 11608-6:2022
Needle-based injection systems for medical use β Requirements and test methods β Part 6: On-body delivery systems
- English
- Published in 2022
- Published by ISO
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ISO 11608-7:2016
Needle-based injection systems for medical use -- Requirements and test methods -- Part 7: Accessibility for persons with visual impairment
- English, French
- Published in 2016
- Published by ISO
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ISO 13926-1:2018
Pen systems β Part 1: Glass cylinders for pen-injectors for medical use
- English
- Published in 2018
- Published by ISO
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ISO 13926-2:2017
Pen systems -- Part 2: Plunger stoppers for pen-injectors for medical use
- English
- Published in 2017
- Published by ISO
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ISO 13926-3:2019
Pen systems β Part 3: Seals for pen-injectors for medical use
- English
- Published in 2019
- Published by ISO
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ISO 14972:1998
Sterile obturators for single use with over-needle peripheral intravascular catheters
- English, French
- Published in 1998
- Published by ISO
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ISO 17218:2014
Sterile acupuncture needles for single use
- English
- Published in 2014
- Published by ISO
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ISO 18250-1:2018
Medical devices -- Connectors for reservoir delivery systems for healthcare applications -- Part 1: General requirements and common test methods
- English
- Published in 2018
- Published by ISO
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ISO 18250-3:2018
Medical devices -- Connectors for reservoir delivery systems for healthcare applications -- Part 3: Enteral applications
- English
- Published in 2018
- Published by ISO
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ISO 18250-6:2019
Medical devices -- Connectors for reservoir delivery systems for healthcare applications -- Part 6: Neural applications
- English
- Published in 2019
- Published by ISO
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ISO 18250-7:2018
Medical devices -- Connectors for reservoir delivery systems for healthcare applications -- Part 7: Connectors for intravascular infusion
- English
- Published in 2018
- Published by ISO
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ISO 18250-8:2018
Medical devices -- Connectors for reservoir delivery systems for healthcare applications -- Part 8: Citrate-based anticoagulant solution for apheresis applications
- English
- Published in 2018
- Published by ISO
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ISO 18746:2016
Traditional Chinese medicine -- Sterile intradermal acupuncture needles for single use
- English
- Published in 2016
- Published by ISO
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ISO 20487:2019
Traditional Chinese medicine -- Test method of single-use acupuncture needles for electrical stimulation
- English
- Published in 2019
- Published by ISO
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ISO 20695:2020
Enteral feeding systems β Design and testing
- English, French
- Published in 2020
- Published by ISO
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ISO 20696:2018
Sterile urethral catheters for single use
- English, French
- Published in 2018
- Published by ISO
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ISO 20697:2018
Sterile drainage catheters and accessory devices for single use
- English, French
- Published in 2018
- Published by ISO
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ISO 20698:2018
Catheter systems for neuraxial application -- Sterile and single-use catheters and accessories
- English, French
- Published in 2018
- Published by ISO
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ISO 22236:2020
Traditional Chinese medicine βThread-embedding acupuncture needle for single use
- English
- Published in 2020
- Published by ISO
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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
- English, French
- Published in 2011
- Published by ISO