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:

• NARK
• DKE
• NADENT
• NAErg
• NAFuO
• NAMed
• NASport
• ISO
• IEC

ISO/TS 82304-2:2021 (standard)

Health software

Part 2: Health and wellness apps — Quality and reliability

Date: 2021-07

ISO 80601-2-74:2021 (Standard)

Medical Electrical Equipment

Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment

Date: 2021-07

ISO 15883-5:2021 (Standard)

Washer-disinfectors

Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy

Date: 2021-07

ISO 17664-1:2021 (Standard)

Processing of health care products

Information to be provided by the medical device manufacturer for the processing of medical devices

Part 1: Critical and semi-critical medical devices

Date: 2021-07

ISO 15223-1:2021 (standard)

Medical devices

Symbols to be used with information to be supplied by the manufacturer

Part 1: General requirements

Date: 2021-07

DIN EN ISO 80601-2-79 (Project)

Medical Electrical Equipment

Part 2-79: Particular requirements for the basic safety and essential performance of home ventilators for respiratory support of patients with respiratory impairment

Date: 2021-07-27

DIN EN ISO 80601-2-55/A1 (Project)

Medical Electrical Equipment

Part 2-55: Particular requirements for the safety, including essential performance, of respiratory gas monitors - Amendment A1

Date: 2021-07-27

DIN EN ISO 21549-5 (Project)

Health informatics

Patient data on cards in healthcare

Part 5: Identification data

Date: 2021-07-27

ISO/IEEE DIS 11073-40101 (Project)

Health informatics

Device interoperability - Part 40101: Basic cybersecurity - Vulnerability assessment process

Date: 2021-07-26

IEC 80601-2-59 DAM 1 (Project)

Medical Electrical Equipment

Part 2-59: Particular requirements for the basic safety and essential performance of thermal imaging cameras for screening of humans for fever - Amendment 1

Date: 2021-07-16

Read more about:

• Standards and standards projects from the month of June 2021..

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