The list of new standards, current draft standards and projects is a selection that might be relevant for our clients. It therefore does not claim to be complete. The compilation has been made very carefully and serves as an overview for you. However, errors cannot be excluded, and we cannot assume any liability. The selection draws information from the following standards committees:
DIN 75078-1(standard)
Motor vehicles for the transport of persons with mobility impairments (KMP) - Terms, requirements, testing
Part 1: Vehicle characteristics and equipment
DIN 75078-2 (standard)
Motor vehicles for the transport of persons with mobility impairments (KMP) - Terms, requirements, testing
Part 2: Restraint systems
Date: 2023-01
ISO 5361(standard)
Anaesthetic and Respiratory Equipment
Tracheal tubes and connecting pieces
Date: 2023-01
IEC 60601-1:2023 SER (standard)
Medical Electrical Equipment
ALL PARTS
Date: 2023-01
IEC 60601-2-10:2012+AMD1:2016+AMD2:2023 CSV (standard)
Medical Electrical Equipment
Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
Date: 2023-01
IEC 60601-2-75:2017+AMD1:2023 CSV (standard)
Medical Electrical Equipment
Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment
Date: 2023-01
IEC TS 62736:2023 RLV (standard)
Ultrasonics – Pulse-echo scanners
Simple methods for periodic testing to verify stability of an imaging system’s elementary performance
Date: 2023-01
IEC 80601-2-59:2017+AMD1:2023 CSV (standard)
Medical Electrical Equipment
Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening
Date: 2023-01
DIN EN 455-1/A2 (Draft)
Medical gloves for single use
Part 1: Requirements and leakage test; German and English version EN 455-1:2020+A1:2022/prA2:2023
Date: 2023-01
DIN EN 455-2 (Draft)
Medical gloves for single use
Part 2: Requirements and testing of physical properties; German and English version prEN 455-2:2022
Date: 2023-01
DIN EN ISO 8637-2 (Draft)
Extracorporeal blood purification systems
Part 2: Extracorporeal blood and fluid circulation in haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO/DIS 8637-2:2022); German and English version prEN ISO 8637-2:2022
Date: 2023-01
ISO 16840-10 AMD 1 (Project)
Wheelchairs
Part 10: Resistance to ignition of postural supports - Requirements and test methods - Amendment 1
Date: 2023-01-23
ISO/AWI TS 17021-15 (Project)
Conformity assessment - Requirements for bodies that audit and certify management systems
Part 15: Competence requirements for the auditing and certification of quality management systems in the healthcare sector
Date: 2023-01-03
DIN EN ISO 10322 rev (Project)
Ophthalmic optics
One-sided finished lens blanks
Date: 2023-01-31
DIN EN ISO 10993-6 rev (Project)
Biological evaluation of medical devices
Part 6: Tests for local effects after implantation
Date: 2023-01-27
DIN EN ISO 14155 rev (Project)
Clinical testing of medical devices on humans
Good clinical practice
Date: 2023-01-03
ISO/AWI 10555-8 (Project)
Intravascular catheters - Sterile catheters for single use
Part 8: Catheters for extracorporeal blood treatment
Date: 2023-01-10
DIN EN ISO 15223-1/A1 (Project)
Medical devices - Symbols for use in the context of the information to be provided by the manufacturer
Part 1: General requirements - Modification 1
Date: 2023-01-04
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