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UNE-EN ISO 11608-4:2022  UNE

Status: Vigente/ 2025-01-08

Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics (ISO 11608-4:2022, Corrected version 2024-12)

UNE-EN ISO 10555-1:2024  UNE

Status: Vigente/ 2024-09-11

Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements (ISO 10555-1:2023)

UNE-EN ISO 10555-4:2024  UNE

Status: Vigente/ 2024-07-17

Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters (ISO 10555-4:2023)

UNE-EN ISO 11608-5:2023  UNE

Status: Vigente/ 2023-10-04

Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2022)

UNE-EN ISO 80369-3:2017/A1:2023  UNE

Status: Vigente/ 2023-07-19

Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications - Amendment 1 (ISO 80369-3:2016/Amd 1:2019)

UNE-EN 13868:2003  UNE

Status: Vigente/ 2023-06-05

Catheters - Test methods for kinking of single lumen catheters and medical tubing

UNE-EN ISO 26825:2023  UNE

Status: Vigente/ 2023-02-01

Anaesthetic and respiratory equipment - User-applied labels for syringes containing drugs used during anaesthesia - Colours, design and performance (ISO 26825:2020)

UNE-EN ISO 11608-3:2022  UNE

Status: Vigente/ 2023-01-25

Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths (ISO 11608-3:2022, Corrected version 2023-01)

UNE-EN ISO 11608-2:2022  UNE

Status: Vigente/ 2022-07-01

Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ended pen needles (ISO 11608-2:2022) (Endorsed by Asociación Española de Normalización in July of 2022.)

UNE-EN ISO 11608-1:2022  UNE

Status: Vigente/ 2022-07-01

Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2022) (Endorsed by Asociación Española de Normalización in July of 2022.)

UNE-EN 80369-5:2017/AC:2021-06  UNE

Status: Vigente/ 2021-09-01

Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications

UNE-EN ISO 7886-1:2018  UNE

Status: Vigente/ 2021-07-28

Sterile hypodermic syringes for single use - Part 1: Syringes for manual use (ISO 7886-1:2017, Corrected version 2019-08)

UNE-EN ISO 7886-2:2020  UNE

Status: Vigente/ 2020-12-23

Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven syringe pumps (ISO 7886-2:2020)

UNE-EN ISO 7886-3:2020  UNE

Status: Vigente/ 2020-12-23

Sterile hypodermic syringes for single use - Part 3: Auto-disabled syringes for fixed-dose immunization (ISO 7886-3:2020)

UNE-EN ISO 10555-6:2018/A1:2020  UNE

Status: Vigente/ 2020-07-15

Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports - Amendment 1 (ISO 10555-6:2015/Amd 1:2019)

UNE-EN ISO 20696:2019  UNE

Status: Vigente/ 2020-01-22

Sterile urethral catheters for single use (ISO 20696:2018, Corrected version 2019-12)

UNE-EN ISO 7886-4:2019  UNE

Status: Vigente/ 2019-10-02

Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature (ISO 7886-4:2018)

UNE-EN ISO 20697:2019  UNE

Status: Vigente/ 2019-07-03

Sterile drainage catheters and accessory devices for single use (ISO 20697:2018, Corrected version 2018-09)

UNE-EN ISO 11070:2015/A1:2018  UNE

Status: Vigente/ 2018-12-26

Sterile single-use intravascular introducers, dilators and guidewires - Amendment 1 (ISO 11070:2014/Amd 1:2018)

UNE-EN ISO 10555-6:2018  UNE

Status: Vigente/ 2018-05-16

Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports (ISO 10555-6:2015)

UNE-EN ISO 11608-7:2018  UNE

Status: Vigente/ 2018-01-24

Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment (ISO 11608-7:2016)

UNE-EN 80369-5:2017  UNE

Status: Vigente/ 2017-04-26

Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications

UNE-EN ISO 7864:2017  UNE

Status: Vigente/ 2017-04-12

Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016)

UNE-EN ISO 80369-3:2017  UNE

Status: Vigente/ 2017-04-12

Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications (ISO 80369-3:2016)

UNE-EN ISO 9626:2017  UNE

Status: Vigente/ 2017-04-12

Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO 9626:2016)

UNE-EN ISO 6009:2017  UNE

Status: Vigente/ 2017-03-29

Hypodermic needles for single use - Colour coding for identification (ISO 6009:2016)

UNE-EN ISO 80369-6:2016  UNE

Status: Vigente/ 2016-11-30

Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications (ISO 80369-6:2016, Corrected version 2016-11-15)

UNE-EN ISO 8537:2016  UNE

Status: Vigente/ 2016-11-16

Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016)

UNE-EN ISO 11070:2015  UNE

Status: Vigente/ 2015-05-20

Sterile single-use intravascular introducers, dilators and guidewires (ISO 11070:2014)

UNE-EN ISO 10555-5:2014  UNE

Status: Vigente/ 2014-02-19

Intravascular catheters - Sterile and single-use catheters - Part 5: Over-needle peripheral catheters (ISO 10555-5:2013)

UNE-EN ISO 10555-3:2013  UNE

Status: Vigente/ 2013-12-23

Intravascular catheters - Sterile and single-use catheters - Part 3: Central venous catheters (ISO 10555-3:2013)

UNE-EN ISO 23908:2013  UNE

Status: Vigente/ 2013-04-03

Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling (ISO 23908:2011)

UNE-EN ISO 8362-7:2011  UNE

Status: Vigente/ 2011-06-01

Injection containers and accessories - Part 7: Injection caps made of aluminium-plastics combinations without overlapping plastics part (ISO 8362-7:2006)

UNE-EN ISO 80369-2:2025  UNE

Status: Vigente/ 2025-07-16

Small-bore connectors for liquids and gases in healthcare applications - Part 2: Connectors for respiratory applications (ISO 80369-2:2024, Corrected version 2025-06)

UNE-EN IEC 60601-2-16:2025  UNE

Status: Vigente/ 2025-04-01

Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment (Endorsed by Asociación Española de Normalización in April of 2025.)

UNE-EN ISO 80369-20:2024  UNE

Status: Current/ 2025-01-01

Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods (ISO 80369-20:2024)

UNE-EN ISO 80369-7:2022  UNE

Status: Vigente/ 2023-06-21

Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO 80369-7:2021)

UNE-EN ISO 8836:2021  UNE

Status: Vigente/ 2021-04-28

Suction catheters for use in the respiratory tract (ISO 8836:2019)

UNE-EN ISO 20695:2020  UNE

Status: Vigente/ 2020-10-21

Enteral feeding systems - Design and testing (ISO 20695:2020)

UNE-EN ISO 9997:2020  UNE

Status: Vigente/ 2020-09-23

Dentistry - Cartridge syringes (ISO 9997:2020)

UNE-EN IEC 60601-2-16:2019  UNE

Status: Vigente/ 2019-07-01

Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment (Endorsed by Asociación Española de Normalización in July of 2019.)

UNE-EN ISO 7885:2010  UNE

Status: Vigente/ 2010-07-21

Dentistry - Sterile injection needles for single use (ISO 7885:2010)

ISO 23217:2024  ISO

Status: Published/ 2024-02-15

Injection systems for self-administration by paediatric patients — Requirements and guidelines for design

ISO 10555-7:2023  ISO

Status: Published/ 2023-12-18

Intravascular catheters — Sterile and single-use catheters — Part 7: Peripherally inserted central catheters

ISO 10555-4:2023  ISO

Status: Published/ 2023-11-14

Intravascular catheters — Sterile and single-use catheters — Part 4: Balloon dilatation catheters

ISO 10555-1:2023  ISO

Status: Published/ 2023-11-14

Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements

ISO 23958-2:2022  ISO

Status: Published/ 2022-05-25

Traditional Chinese medicine — Dermal needles for single use — Part 2: Roller-type

ISO 23958-1:2022  ISO

Status: Published/ 2022-05-17

Traditional Chinese medicine — Dermal needles for single use — Part 1: Tapping-type

ISO 11608-3:2022  ISO

Status: Published/ 2022-04-07

Needle-based injection systems for medical use — Requirements and test methods — Part 3: Containers and integrated fluid paths

ISO 11608-4:2022  ISO

Status: Published/ 2022-04-07

Needle-based injection systems for medical use — Requirements and test methods — Part 4: Needle-based injection systems containing electronics