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New Standards and Standard Projects in June 2021

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 CEN ISO/TS 5499 (Project)

Medical informatics

Clinical features
Basic principles for harmonization of indication terms and identifiers

Date: 2021-06-24

DIN EN 00205320 (Project)

Antimicrobial dressing

Requirements and test methods

Date: 2021-06-22

ISO/AWI 8549-2 (Project)

Prosthetics and orthotics

Vocabulary
Part 2: Terms relating to external limb prostheses and wearers of these prostheses

Date: 2021-06-15

DIN EN ISO 10993-18/A1 (Project)

Biologische Beurteilung von Medizinprodukten

Teil 18: Chemische Charakterisierung von Werkstoffen für Medizinprodukte im Rahmen eines Risikomanagementsystems
Änderung 1: Bestimmung des Unsicherheitsfaktors

Date: 2021-06-14

DIN EN 15194/A1 (Project)

Bicycles

Electric motor assisted bikes – EPAC

Date: 2021-06-14

DIN EN ISO 81060-3 (Draft)

Non-invasive sphygmomanometers

Part 3: Clinical investigation of continuous automated measurement type

Date: 2021-06

DIN EN ISO 80601-2-70

Medical electrical equipment

Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment

Date: 2021-06

DIN 58950-2

Sterilization

Steam sterilizers for pharmaceutical products
Part 2: Technical requirements; Text in German and English

Date: 2021-06

DIN 58950-3

Sterilization

Steam sterilizers for pharmaceutical products
Part 3: Tests

Date: 2021-06

DIN EN ISO 80601-2-67

Medical electrical equipment

Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment

Date: 2021-06

DIN EN ISO 80601-2-69

Medical electrical equipment

Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment

Datum: 2021-06

 

Continue reading Standards and Standard Projects from May 2021.

 

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