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 EN ISO 80601-2-70 (standard)
Medical Electrical Equipment
Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment
Date: 2021-06
DIN 58950-2 (standard)
Sterilization
Steam sterilisers for pharmaceutical sterilisation goods
Part 2: Device requirements; Text German and English
Date: 2021-06
DIN 58950-3 (standard)
Sterilization
Steam sterilisers for pharmaceutical sterilisation goods
Teil 3: Prüfungen
Date: 2021-06
DIN EN ISO 80601-2-67 (Standard)
Medical Electrical Equipment
Part 2-67: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment
Date: 2021-06
DIN EN ISO 80601-2-69 (Standard)
Medical Electrical Equipment
Part 2-69: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment
Date: 2021-06
DIN CEN ISO/TS 5499 (Project)
Health informatics
Clinical specificities - Basic principles for the harmonisation of indication terms and identifiers
Date: 2021-06-24
DIN EN 00205320 (Project)
Antimicrobial wound dressings
Requirements and test methods
Date: 2021-06-22
ISO/AWI 8549-2 (Project)
Prosthetics and Orthotics
Vocabulary
Part 2: Terms related to prosthetic limbs and the users of these prostheses
Date: 2021-06-15
DIN EN ISO 10993-18/A1 (Project)
Biological evaluation of medical devices
Part 18: Chemical characterization of materials for medical devices as part of a risk management system
Amendment 1: Determination of the uncertainty factor
Date: 2021-06-14
DIN EN 15194/A1 (Project)
Bicycles
Electric power assisted cycles - EPAC
Date: 2021-06-14
DIN EN ISO 81060-3 (draft)
Non-invasive blood pressure monitors
Part 3: Clinical testing of the continuous automated type
Date: 2021-06
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