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New Standards and Standards Projects in May 2022

ISO 7176-32, ISO 23372, ISO 16840-11,

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 7176-32 (Standard)

Wheelchairs

Part 32: Standard method for testing the durability of wheelchair wheels

Date: 2022-05

ISO 23372 (Standard)

Respiratory therapy devices - Air admixing devices

Date: 2022-05

ISO 16840-11 (Standard)

Wheelchair seating

Part 11: Determination of the transfer behavior of sensible sweat into the seat cushion

Date: 2022-05

ISO 23371 (Standard)

Anaesthetic and Respiratory Equipment

Cuff pressure indicators

Date: 2022-05

ISO 18675 (Standard)

Dentistry - Millable ceramic blanks

Date: 2022-05

ISO 22683 (Standard)

Dentistry

Checking the fit between implant body and implant abutment for dental implant systems

Date: 2022-05

ISO 12312-3 (Standard)

Eye and face protection - sunglasses and similar eye protection

Part 3: Sunglasses for running, cycling and similar active lifestyle activities

Date: 2022-05

ISO 10993-18 AMD 1 (Standard)

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: 2022-05

DIN EN ISO 16672 (Standard)

Ophthalmic implants - Ocular endotamponades

Date: 2022-05

DIN EN ISO 15253 (Standard)

Ophthalmic optics and ophthalmic instruments

Optical and electro-optical magnifying visual aids for the visually impaired

Date: 2022-05

DIN EN ISO 15253 (Standard)

Ophthalmic optics and instruments

Optical and electro-optical devices for enhancing low vision

Date: 2022-05

ISO 9999 (Standard)

Tools - Classification and terminology

Date: 2022-05

DIN EN ISO 7439 (Draft)

Copper-containing intrauterine devices for contraception

Requirements and tests

Date: 2022-05

DIN EN ISO 22523 (Draft)

External limb prostheses and external orthoses

Requirements and test methods

Date: 2022-05

DIN EN IEC 80601-2-59/A1; VDE 0750-2-59/A1:2022-05 (Draft)

Medical Electrical Equipment

Part 2-59: Particular requirements for the safety, including essential performance, of thermal imaging cameras for screening humans for fever

Date: 2022-05

DIN EN 60601-2-45/A2; VDE 0750-2-45/A2:2022-05 (Draft)

Medical Electrical Equipment

Part 2-45: Particular requirements for the safety, including essential performance, of X-ray mammography equipment and mammographic stereotactic devices

Date: 2022-05

DIN EN IEC 60601-2-50/A1; VDE 0750-2-50/A1:2022-05 (Draft)

Medical Electrical Equipment

Part 2-50: Particular requirements for the safety, including essential performance, of infant phototherapy equipment

Date: 2022-05

DIN EN IEC 60601-2-19/A1; VDE 0750-2-19/A1:2022-05  (Draft)

Medical Electrical Equipment

Part 2-19: Particular requirements for the safety, including essential performance, of infant incubators

Date: 2022-05

DIN EN IEC 60601-2-21/A1; VDE 0750-2-21/A1:2022-05 (Draft)

Medical Electrical Equipment

Part 2-21: Particular requirements for the safety, including essential performance, of radiant warmers for infants

Date: 2022-05

DIN EN IEC 60601-2-34; VDE 0750-2-34:2022-05 (Draft)

Medical Electrical Equipment

Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring devices

Date: 2022-05

DIN EN ISO 3990 (Draft)

Dentistry

Evaluation of the antibacterial effect of dental restorative materials, luting cements, fissure sealants and orthodontic bonding or luting materials

Date: 2022-05

DIN EN ISO 15854 (Draft)

Dentistry - Casting and base plate waxes

Date: 2022-05

DIN EN ISO 13078-3 (Draft)

Dentistry - Sintering oven

Part 3: Test method for the evaluation of high temperature sintering furnace measurement with separate thermocouple

Date: 2022-05

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