January Standards Update

Published on 10 February 2023 at 14:23
LABORATORY EQUIPMENT
ISO 8655-7:2022 FR Piston-operated volumetric apparatus — Part 7: Alternative measurement procedures for the determination of volume
APPLICATIONS OF STATISTICAL METHODS
ISO/TS 27878:2023   EN Reproducibility of the level of detection (LOD) of binary methods in collaborative and in-house validation studies
ISO 16355-7:2023   EN Applications of statistical and related methods to new  technology and product development process — Part 7: Guidelines for developing digitalized products and services — General principles and perspectives of the QFD method
TRANSFUSION, INFUSION AND INJECTION, AND BLOOD PROCESSING EQUIPMENT FOR MEDICAL AND PHARMACEUTICAL USE
ISO 8536-2:2023 EN Infusion equipment for medical use — Part 2: Closures for infusion bottles
DEVICES FOR ADMINISTRATION OF MEDICINAL PRODUCTS AND CATHETERS
ISO 11608-3:2022   EN FR Needle-based injection systems for medical use — Requirements and test methods — Part 3: Containers and integrated fluid paths
ISO 21649:2023 EN FR Needle-free injection systems for medical use — Requirements and test methods
DENTISTRY
ISO 15854:2023 EN FR Dentistry — Casting and baseplate waxes
ANAESTHETIC AND RESPIRATORY EQUIPMENT
ISO 5361:2023 EN FR Anaesthetic and respiratory equipment — Tracheal tubes and connectors
IEC 80601-2- 59:2017/ Amd 1:2023   EN FR Medical electrical equipment — Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening — Amendment 1
PACKAGING
ISO 23416:2023 EN General specifications and testing methods for temperature-sensitive medicinal packages in good distribution practice principles
STERILIZATION OF HEALTH CARE PRODUCTS
ISO/TS 5111:2022 FR Guidance on quality of water for sterilizers, sterilization and washer-disinfectors for health care products
CLINICAL LABORATORY TESTING AND IN VITRO DIAGNOSTIC TEST SYSTEMS
ISO 15189:2022 ES FR Medical laboratories — Requirements for quality and competence
RISK MANAGEMENT
ISO 31073:2022 FR Risk management — Vocabulary

Complete updates can be found on ISO - ISO Update

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