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UNE-EN ISO 23500-2:2025  UNE

Status: Vigente/ 2025-03-05

Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies (ISO 23500-2:2024)

UNE-EN IEC 60601-2-40:2025  UNE

Status: Vigente/ 2025-03-01

Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment (Endorsed by Asociación Española de Normalización in March of 2025.)

UNE-EN ISO 23500-3:2024  UNE

Status: Vigente/ 2024-11-27

Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies (ISO 23500-3:2024)

UNE-EN ISO 23500-4:2024  UNE

Status: Vigente/ 2024-11-27

Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies (ISO 23500-4:2024)

UNE-EN ISO 8536-13:2024  UNE

Status: Current/ 2024-11-01

Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact (ISO 8536-13:2024) (Endorsed by Asociación Española de Normalización in November of 2024.)

UNE-EN ISO 8637-2:2024  UNE

Status: Vigente/ 2024-06-01

Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-2:2024) (Endorsed by Asociación Española de Normalización in June of 2024.)

UNE-EN ISO 24072:2024  UNE

Status: Vigente/ 2024-01-24

Aerosol bacterial retention test method for air-inlet on administration devices (ISO 24072:2023)

UNE-EN ISO 3826-1:2020/A1:2023  UNE

Status: Vigente/ 2023-10-25

Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers - Amendment 1 (ISO 3826-1:2019/Amd1:2023)

UNE-EN ISO 21649:2023  UNE

Status: Vigente/ 2023-10-04

Needle-free injection systems for medical use - Requirements and test methods (ISO 21649:2023)

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 ISO 8536-15:2022/A1:2023  UNE

Status: Vigente/ 2023-06-21

Infusion equipment for medical use - Part 15: Light-protective infusion sets for single use - Amendment 1 (ISO 8536-15:2022/Amd 1:2023)

UNE-EN 12439:1999  UNE

Status: Vigente/ 2023-06-05

STERILE RECTAL CATHETERS FOR SINGLE USE

UNE-EN ISO 8536-15:2022  UNE

Status: Vigente/ 2022-11-02

Infusion equipment for medical use - Part 15: Light-protective infusion sets for single use (ISO 8536-15:2022)

UNE-EN IEC 60601-2-41:2021  UNE

Status: Vigente/ 2022-02-01

Medical electrical equipment - Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis (Endorsed by Asociación Española de Normalización in February of 2022.)

UNE-EN ISO 8536-12:2021  UNE

Status: Vigente/ 2021-10-06

Infusion equipment for medical use - Part 12: Check valves for single use (ISO 8536-12:2021)

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 8637-1:2020  UNE

Status: Vigente/ 2020-10-21

Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017)

UNE-EN ISO 8536-4:2020  UNE

Status: Vigente/ 2020-09-30

Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2019)

UNE-EN ISO 3826-1:2020  UNE

Status: Vigente/ 2020-07-15

Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2019)

UNE-EN ISO 8362-1:2020  UNE

Status: Vigente/ 2020-07-15

Injection containers and accessories - Part 1: Injection vials made of glass tubing (ISO 8362-1:2018)

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 8871-3:2004/A1:2019  UNE

Status: Vigente/ 2019-12-04

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 3: Determination of released-particle count - Amendment 1 (ISO 8871-3:2003/Amd 1:2018)

UNE-EN ISO 80369-1:2019  UNE

Status: Vigente/ 2019-07-29

Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2018)

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 60601-2-40:2019  UNE

Status: Vigente/ 2019-02-01

Medical Electrical Equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment (Endorsed by Asociación Española de Normalización in February of 2019.)

UNE-EN ISO 8536-14:2018  UNE

Status: Vigente/ 2018-11-21

Infusion equipment for medical use - Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact (ISO 8536-14:2016)

UNE-EN ISO 6710:2018  UNE

Status: Vigente/ 2018-06-06

Single-use containers for human venous blood specimen collection (ISO 6710:2017)

UNE-EN ISO 1135-3:2017  UNE

Status: Vigente/ 2017-11-02

Transfusion equipment for medical use - Part 3: Blood-taking sets for single use (ISO 1135-3:2016)

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 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 6009:2017  UNE

Status: Vigente/ 2017-03-29

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

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 8362-5:2016  UNE

Status: Vigente/ 2016-10-26

Injection containers and accessories - Part 5: Freeze drying closures for injection vials (ISO 8362-5:2016)

UNE-EN ISO 1135-5:2016  UNE

Status: Vigente/ 2016-07-27

Transfusion equipment for medical use - Part 5: Transfusion sets for single use with pressure infusion apparatus (ISO 1135-5:2015)

UNE-EN ISO 1135-4:2016  UNE

Status: Vigente/ 2016-07-06

Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed (ISO 1135-4:2015)

UNE-EN ISO 3826-4:2015  UNE

Status: Vigente/ 2015-12-16

Plastics collapsible containers for human blood and blood components - Part 4: Aphaeresis blood bag systems with integrated features (ISO 3826-4:2015)

UNE-EN ISO 8536-8:2015  UNE

Status: Vigente/ 2015-11-11

Infusion equipment for medical use - Part 8: Infusion sets for single use with pressure infusion apparatus (ISO 8536-8:2015)

UNE-EN ISO 8536-10:2015  UNE

Status: Vigente/ 2015-11-11

Infusion equipment for medical use - Part 10: Accessories for fluid lines for single use with pressure infusion equipment (ISO 8536-10:2015)

UNE-EN ISO 8536-9:2015  UNE

Status: Vigente/ 2015-11-11

Infusion equipment for medical use - Part 9: Fluid lines for single use with pressure infusion equipment (ISO 8536-9:2015)

UNE-EN ISO 8536-11:2015  UNE

Status: Vigente/ 2015-11-11

Infusion equipment for medical use - Part 11: Infusion filters for single use with pressure infusion equipment (ISO 8536-11:2015)

UNE-EN 60601-2-24:2015  UNE

Status: Vigente/ 2015-07-01

Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers (Endorsed by AENOR in July of 2015.)

UNE-EN ISO 8536-5:2013  UNE

Status: Vigente/ 2013-04-03

Infusion equipment for medical use - Part 5: Burette infusion sets for single use, gravity feed (ISO 8536-5:2004)

UNE-EN ISO 8362-4:2012  UNE

Status: Vigente/ 2012-02-29

Injection containers and accessories - Part 4: Injection vials made of moulded glass (ISO 8362-4:2011)

UNE-EN ISO 8536-1:2012  UNE

Status: Vigente/ 2012-02-22

Infusion equipment for medical use - Part 1: Infusion glass bottles (ISO 8536-1:2011)

UNE-EN ISO 8362-6:2011  UNE

Status: Vigente/ 2011-10-26

Injection containers and accessories - Part 6: Caps made of aluminium-plastics combinations for injection vials (ISO 8362-6:2010)

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 9187-1:2011  UNE

Status: Vigente/ 2011-03-09

Injection equipment for medical use - Part 1: Ampoules for injectables (ISO 9187-1:2010)

UNE-EN ISO 3826-2:2008  UNE

Status: Vigente/ 2008-12-17

Plastics collapsible containers for human blood and blood components - Part 2: Graphical symbols for use on labels and instruction leaflets (ISO 3826-2:2008)

UNE-EN ISO 3826-3:2008  UNE

Status: Vigente/ 2008-06-04

Plastics collapsible containers for human blood and blood components - Part 3: Blood bag systems with integrated features (ISO 3826-3:2006)

UNE-EN ISO 8871-3:2004  UNE

Status: Vigente/ 2004-12-10

Elastomeric parts for parenterals and for devices for pharmaceuticals use - Part 3: Determination of released-particle count (ISO 8871-3:2003)