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New standards and standards projects from September 2022

ISO 5467-1 (Norm), ISO 5467-2 (Norm), DIN EN ISO 10993-7 (Norm)

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

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  • New standards and standards projects from August 2022
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