FprEN ISO 7886-1, Sterile hypodermic syringes for single use - Part 1: Syringes for manual use (ISO/FDIS 7886-1:2026) (50.20)
FprEN ISO 8536-5, Infusion equipment for medical use - Part 5: Burette infusion sets for single use, gravity feed (ISO/FDIS 8536-5:2026) (50.20)
FprEN ISO 8537, Sterile single-use syringes, with or without needle, for insulin (ISO/FDIS 8537:2026) (50.20)
FprEN ISO 8637-2, Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO/FDIS 8637‑2:2026) (50.20)
ISO/FDIS 10555-3, Intravascular catheters — Sterile and single-use catheters — Part 3: Central venous catheters (50.00)
ISO/FDIS 10555-5, Intravascular catheters — Sterile and single-use catheters — Part 5: Over-needle peripheral intravenous catheters (50.00)
ISO/FDIS 11040-5, Prefilled syringes — Part 5: Plunger stoppers for injectables (50.00)
EN 455-3:2023/FprA1, Medical gloves for single use - Part 3: Requirements and testing for biological evaluation (45.99)
prEN ISO 10555-3, Intravascular catheters - Sterile and single-use catheters - Part 3: Central venous catheters (ISO/DIS 10555-3:2026) (45.99)
prEN ISO 10555-5, Intravascular catheters - Sterile and single-use catheters - Part 5: Over-needle peripheral intravenous catheters (ISO/DIS 10555-5:2026) (45.99)
ISO/DIS 13926-2, Cartridge systems — Part 2: Plunger stoppers for cartridge-type needle-based injection systems (NIS) for medical use (40.99)
ISO/DIS 9626, Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods (40.60)
ISO/DIS 18972, Transfusion and infusion sets and accessories — Infusate compatibility — Requirements and assessment methods (40.60)
ISO/DIS 24645, General requirements for Luer activated needle-free connectors (LANCs) for intravascular applications (40.60)
ISO/DIS 3826-2, Plastics collapsible containers for human blood and blood components — Part 2: Graphical symbols for use on labels and instruction leaflets (40.60)
ISO/DIS 3826-3, Plastics collapsible containers for human blood and blood components — Part 3: Blood bag systems and its integrated features (40.60)
ISO/DIS 3826-4, Plastics collapsible containers for human blood and blood components — Part 4: Aphaeresis blood bag systems with integrated features (40.60)
ISO/DIS 7864, Sterile hypodermic needles for single use — Requirements and test methods (40.60)
prEN ISO 9626, Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO/DIS 9626:2025) (40.60)
prEN ISO 3826-2, Plastics collapsible containers for human blood and blood components - Part 2: Graphical symbols for use on labels and instruction leaflets (ISO/DIS 3826‑2:2026) (40.60)
prEN ISO 3826-3, Plastics collapsible containers for human blood and blood components - Part 3: Blood bag systems with integrated features (ISO/DIS 3826‑3:2026) (40.60)
prEN ISO 3826-4, Plastics collapsible containers for human blood and blood components - Part 4: Aphaeresis blood bag systems with integrated features (ISO/DIS 3826-4:2026) (40.60)
prEN ISO 7864, Sterile hypodermic needles for single use - Requirements and test methods (ISO/DIS 7864:2025) (40.60)
prEN ISO 80601-2-56, Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO/DIS 80601-2-56:2025) (40.60)
prEN ISO 81060-2, Non-invasive sphygmomanometers - Part 2: Clinical performance verification of intermittent automated measurement type (ISO/DIS 81060-2:2026) (40.60)
ISO/DIS 11194, Single-use syringes and needles — Requirements for ophthalmic use (40.20)
ISO/DIS 8871-2, Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 2: Identification and characterization (40.00)
ISO/CD 21881, Sterile packaged ready for filling glass cartridges (30.60)
ISO/CD 21882, Sterile packaged ready for filling glass vials (30.60)
ISO/CD 8871-1, Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 1: Extractables in aqueous autoclavates (30.60)
ISO/CD 8871-3, Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 3: Determination of released-particle count (30.60)
ISO/CD 8871-4, Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 4: Biological requirements and test methods (30.60)
ISO 10555-8:2024/CD Amd 1, Intravascular catheters — Sterile and single-use catheters — Part 8: Catheters for extracorporeal blood treatment — Amendment 1 (30.20)
FprCEN/TS XXX, Respiratory infection prevention devices for self- and third-party protection - Part 3: Sustainability, human factors and rationales (20.60)
FprCEN/TS XXX, Respiratory infection prevention devices for self- and third-party protection - Part 4: Selection and use (20.60)
ISO/WD 26314, Sterile polymer vials ready for filling (20.60)
ISO/AWI 20696, Sterile urethral catheters for single use (20.00)
ISO/AWI 23907-3, Sharps injury protection — Requirements and test methods — Part 3: Containers for secure sharps medical waste (20.00)
ISO/AWI 25992, Single-use receptacles for human arterial blood specimen collection (20.00)
ISO/AWI 8536-13, Infusion equipment for medical use — Part 13: Graduated flow regulators for single use with fluid contact (20.00)
ISO/AWI 8536-4, Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed (20.00)
ISO/AWI 8536-8, Infusion equipment for medical use — Part 8: Infusion sets for single use with pressure infusion apparatus (20.00)
ISO/AWI 8536-9, Infusion equipment for medical use — Part 9: Fluid lines for single use with pressure infusion equipment (20.00)
prEN 455-1 rev, Medical gloves for single use - Part 1: Requirements and testing for freedom of holes (10.99)
prEN 455-4 rev, Medical gloves for single use - Part 4: Requirements and testing for shelf life determination (10.99)
IEC/AWI 80369-5, Small-bore connectors for liquids and gases in healthcare applications — Part 5: Connectors for limb cuff inflation applications (10.99)
prCEN ISO/TS 24971-1, Medical devices — Guidance on the application of ISO 14971 — Part 1: Part 1: General (10.99)
prEN ISO 20696 rev, Sterile urethral catheters for single use (10.99)
prEN ISO 23500-1 rev, Preparation and quality management of fluids for haemodialysis and related therapies — Part 1: General requirements (10.99)
prEN ISO 23500-2 rev, Preparation and quality management of fluids for haemodialysis and related therapies — Part 2: Water treatment equipment for haemodialysis applications and related therapies (10.99)
prEN ISO 23500-3 rev, Preparation and quality management of fluids for haemodialysis and related therapies — Part 3: Water for haemodialysis and related therapies (10.99)
prEN ISO 23500-4 rev, Preparation and quality management of fluids for haemodialysis and related therapies — Part 4: Concentrates for haemodialysis and related therapies (10.99)
prEN ISO 23500-5 rev, Preparation and quality management of fluids for haemodialysis and related therapies — Part 5: Quality of dialysis fluid for haemodialysis and related therapies (10.99)
prEN ISO 23907-3, Sharps injury protection - Requirements and test methods - Part 3: Containers for secure sharps medical waste (10.99)
prEN ISO 81060-3 rev, Non-invasive sphygmomanometers — Part 3: Clinical investigation of continuous automated measurement type (10.99)
prEN ISO 8536-13 rev, Infusion equipment for medical use — Part 13: Graduated flow regulators for single use with fluid contact (10.99)
prEN ISO 8536-4 rev, Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed (10.99)
prEN ISO 8536-8 rev, Infusion equipment for medical use — Part 8: Infusion sets for single use with pressure infusion apparatus (10.99)
prEN ISO 8536-9 rev, Infusion equipment for medical use — Part 9: Fluid lines for single use with pressure infusion equipment (10.99)
prEN ISO 8871-1 rev, Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 1: Extractables in aqueous autoclavates (10.99)
prEN ISO 8871-2 rev, Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 2: Identification and characterization (10.99)
prEN ISO 8871-3 rev, Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 3: Determination of released-particle count (10.99)
prEN ISO 8871-4 rev, Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 4: Biological requirements and test methods (10.99)
EN IEC 63044-4:2021/prAC, Home and building electronic systems (HBES) and building automation and control systems (BACS) - Part 4: General functional safety requirements for products intended to be integrated in HBES and BACS (10.99)
EN ISO 23908:2025/prA1, Sharps injury protection — Sharps protection mechanisms for single-use needles, introducers for catheters and needles used for blood testing, monitoring, sampling and medical substance administration — Requirements and test methods — Amendment 1 (10.99)
ISO 23908:2024/AWI Amd 1, Sharps injury protection — Sharps protection mechanisms for single-use needles, introducers for catheters and needles used for blood testing, monitoring, sampling and medical substance administration — Requirements and test methods — Amendment 1 (10.99)
ISO/AWI TR 19244, Guidance on transition periods for standards developed by ISO/TC 84 — Devices for administration of medicinal products and catheters (10.99)
prEN 13726 rev, Test methods for wound dressings - Aspects of absorption, moisture vapour transmission, waterproofness and extensibility, adhesiveness and odour control (00.60)
ISO/PWI 11608-1, Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems (00.00)
ISO/PWI 20697, Sterile drainage catheters and accessory devices for single use (00.00)
ISO/PWI TR 22740, Devices incorporating small-bore connectors — Recommended colour allocation for each application (00.00)
ISO/PWI TR 27175, Nomenclature for catheters used as VAD (00.00)
