Healthcare

ISO/DIS 15002 - Flow control devices for connection to a medical gas supply system
Categories: Anaesthetic, respiratory and reanimation equipment
Committee: ISO/TC 121/SC 6 (Medical gas supply systems)
Origin: ISO
Close date: 16 Aug 2022
Draft Details
View moreView less
 
IEC 60601-2-57 ED2 - Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
Categories: Medical equipment.Therapy
Committee: IEC/TC 76 (Optical radiation safety and laser equipment)
Origin: IEC
Close date: 19 Aug 2022
Draft Details
View moreView less
 
prEN 17854 - Antimicrobial wound dressings - Requirements and test method
Categories: Wound dressings and compresses
Committee: CEN/TC 205 (Non-active medical devices)
Origin: CEN
Close date: 25 Aug 2022
Draft Details
View moreView less
 
ISO/DIS 7176-31 - Wheelchairs — Part 31: Lithium-ion battery systems and chargers for powered wheelchairs – Requirements and test methods
Categories: Aids. Adaptation for moving
Committee: ISO/TC 173/SC 1 (Wheelchairs)
Origin: ISO
Close date: 29 Aug 2022
Draft Details
View moreView less
 
ISO/DIS 23217 - Injection systems for self-administration by paediatric patients — Guidance for design
Categories: Syringes, needles and catheters
Committee: ISO/TC 84 (Devices for administration of medicinal products and catheters)
Origin: ISO
Close date: 30 Aug 2022
Draft Details
View moreView less
 
ISO/DIS 4865 - Dentistry — General requirements of non-hinged hand instruments
Categories: Dental equipment
Committee: ISO/TC 106/SC 4 (Dental instruments)
Origin: ISO
Close date: 05 Sep 2022
Draft Details
View moreView less
 
prEN ISO 4865 - Dentistry - General requirements of non-hinged hand instruments (ISO/DIS 4865:2022)
Categories: Dental equipment
Committee: CEN/TC 55 (Dentistry)
Origin: CEN
Close date: 05 Sep 2022
Draft Details
View moreView less
 
ISO/DIS 6028 - Pandemic Response — Functional requirements for self-symptom checker app
Categories: Medical equipment. Diagnostic
Committee: ISO/TC 304 (Healthcare organization management)
Origin: ISO
Close date: 06 Sep 2022
Draft Details
View moreView less
 
ISO/DIS 5228 - Traditional Chinese Medicine --Rheum palmatum, Rheum tanguticum, and Rheum officinale root and rhizome
Categories: Medicaments
Committee: ISO/TC 249 (Traditional Chinese medicine)
Origin: ISO
Close date: 08 Sep 2022
Draft Details
View moreView less
 
prEN IEC 61223-3-8:2022 - Evaluation and routine testing in medical imaging departments - Part 3-8: Acceptance and constancy tests - Imaging performance of X-ray equipment for radiography and radioscopy
Categories: Medical equipment. Radiographic
Committee: CLC/TC 62 (Electrical equipment in medical practice)
Origin: CENELEC
Close date: 09 Sep 2022
Draft Details
View moreView less
 
IEC 61223-3-8 ED1 - Evaluation and routine testing in medical imaging departments - Part 3-8: Acceptance and constancy tests - Imaging performance of X-ray equipment for radiography and radioscopy
Categories: Medical equipment. Radiographic
Committee: IEC/TC 62 (Electrical equipment in medical practice)
Origin: IEC
Close date: 09 Sep 2022
Draft Details
View moreView less
 
ISO/DIS 7177 - Traditional Chinese Medicine — Coptis chinensis and Coptis japonica rhizome
Categories: Medicaments
Committee: ISO/TC 249 (Traditional Chinese medicine)
Origin: ISO
Close date: 14 Sep 2022
Draft Details
View moreView less
 
ISO/DIS 20658 - Medical laboratories — Requirements for collection and transport of samples
Categories: Laboratory medicine. General
Committee: ISO/TC 212 (Clinical laboratory testing and in vitro diagnostic test systems)
Origin: ISO
Close date: 19 Sep 2022
Draft Details
View moreView less
 
EN ISO 80369-3:2016/prA1 - 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)
Categories: Syringes, needles and catheters
Committee: CEN/CLC/JTC 3 (Quality management and corresponding general aspects for medical devices)
Origin: CENELEC
Close date: 22 Sep 2022
Draft Details
View moreView less
 
prEN 1865-2 - Patient handling equipment used in ambulances - Part 2: Power assisted stretcher
Categories: First aid
Committee: CEN/TC 239 (Rescue systems)
Origin: CEN
Close date: 22 Sep 2022
Draft Details
View moreView less
 
EN ISO 80369-3:2016/prA1 - 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)
Categories: Syringes, needles and catheters
Committee: CEN/CLC/JTC 3 (Quality management and corresponding general aspects for medical devices)
Origin: CEN
Close date: 22 Sep 2022
Draft Details
View moreView less
 
prEN 1865-6 - Patient handling equipment used in ambulances - Part 6: Powered chairs
Categories: First aid
Committee: CEN/TC 239 (Rescue systems)
Origin: CEN
Close date: 22 Sep 2022
Draft Details
View moreView less
 
ISO 11607-1:2019/DAmd 1 - Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems — Amendment 1
Categories: Sterilized packaging
Committee: ISO/TC 198 (Sterilization of health care products)
Origin: ISO
Close date: 27 Sep 2022
Draft Details
View moreView less
 
ISO 11607-2:2019/DAmd 1 - Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes — Amendment 1
Categories: Sterilized packaging
Committee: ISO/TC 198 (Sterilization of health care products)
Origin: ISO
Close date: 27 Sep 2022
Draft Details
View moreView less
 
EN ISO 11607-1:2020/prA1 - Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems - Amendment 1 (ISO 11607-1:2019/DAM 1:2022)
Categories: Sterilized packaging
Committee: CEN/TC 102 (Sterilizers and associated equipment for processing of medical devices)
Origin: CEN
Close date: 27 Sep 2022
Draft Details
View moreView less