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:
ISO 5467-1 (Standard)
Dentistry
Mobile dental units and patient couches - Part 1: General requirements
Date: 2022-09
ISO 5467-2 (Standard)
Dentistry
Mobile treatment centres and patient beds - Part 2: Air, water, suction and waste water
Date: 2022-09
DIN EN ISO 10993-7 (Standard)
Biological evaluation of medical devices
Part 7: Ethylene oxide sterilisation residue
Date: 2022-09
DIN EN ISO 21917 (Draft)
Anaesthetic and Respiratory Equipment
Voice prostheses (ISO 21917:2021); German and English version prEN ISO 21917:2022
Date: 2022-09
DIN EN IEC 60601-2-33; VDE 0750-2-33:2022-09 (Draft)
Medical Electrical Equipment
Part 2-33: Particular requirements for the safety, including essential performance, of magnetic resonance equipment for medical diagnosis
Date: 2022-09
DIN EN ISO 8536-15/A1 (Draft)
Infusion equipment for medical use
Part 15: Light-resistant single-use infusion devices - Amendment 1
Date: 2022-09
DIN EN ISO 9360-1 rev (Project)
Anaesthetic and Respiratory Equipment
Heat and moisture exchangers for humidification of respiratory gases in humans - Part 1: Heat and moisture exchangers for use with minimum stroke volumes of 250 ml
Date: 2022-09-30
ISO/AWI 16955 (Project)
Prosthetics
Quantification of physical parameters of ankle foot devices and foot units
Date: 2022-09-27
DIN EN ISO 13402 rev (Project)
Surgical and dental hand instruments
Determination of resistance against autoclaving, corrosion and thermal exposure
Date: 2022-09-26
ISO/AWI 7206-1 (Project)
Implants for surgery
Partial and total hip joint prostheses – Part 1: Classification and designation of dimensions
Date: 2022-09-21
ISO/AWI 7207-2 (Project)
Implants for surgery
Components for partial and total knee joint prostheses – Part 2: Articulating surfaces made of metal, ceramic and plastics materials
Date: 2022-09-21
ISO/AWI 7206-12 (Project)
Implants for surgery
Partial and total hip joint prostheses – Part 12: Deformation test method for acetabular shells
Date: 2022-09-21
ISO/AWI 18993 (Project)
Implants for surgery
Method of wear measurement of joint prostheses components
Date: 2022-09-21
ISO/AWI 18190 (Project)
Anaesthetic and respiratory equipment
General requirements for airways and related equipment
Date: 2022-09-16
DIN EN IEC 60601-2-37 (Project)
Medical Electrical Equipment
Part 2-37: Particular requirements for basic safety and essential performance of ultrasonic equipment for medical diagnosis and monitoring
Date: 2022-09-06
ISO/AWI 17966 (Project)
Aids for personal hygiene
To support users - requirements and test procedures
Date: 2022-09-05
Read more about:
- New standards and standards projects from August 2022
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