JavaScript is disabled. Please enable to continue!
Mobile search icon
Media Centre >> News >> Medical Devices | Monthly bulletin | December 2019

Medical Devices | Monthly bulletin | December 2019

Sidebar Image

Monday, December 16, 2019

Eurofins newsflash Medical Device

 

Europe

 

Recent SCHEER publications on Medical Device

 

See below recent publications by the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER):

 

 

Europe/International

 

Standards updates

 

See below a summary table outlining some recent standards updates and upcoming dates of withdrawal (non-exhaustive):

 

(*) Date of withdrawal: latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn.

 

Reference

Title

Date of Withdrawal (*)

Supersedes

EN ISO 5832-1:2019

Implants for surgery - Metallic materials - Part 1: Wrought stainless steel (ISO 5832-1:2016)

2020-04-30

 

EN ISO 5832-6:2019

Implants for surgery - Metallic materials - Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy (ISO 5832-6:1997)

2020-04-30

 

EN ISO 5832-7:2019

Implants for surgery - Metallic materials - Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy (ISO 5832-7:2016)

2020-04-30

 

EN 60601-2-4:2011/A1:2019

Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators

2022-10-11

 

EN 60601-2-63:2015/A1:2019

Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment

2022-10-11

 

EN IEC 60601-2-75:2019

Medical Electrical Equipment - Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment

2022-08-07

 

EN IEC 80601-2-49:2019

Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment

2022-08-07

EN 60601-2-49:2015

EN IEC 80601-2-59:2019

Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening

2022-10-11

EN 80601-2-59:2009

 

US

 

Standards updates

 

See below a table summarising some recent ASTM standards updates:

 

Reference

Title

ASTM D5151 - 19

Standard Test Method for Detection of Holes in Medical Gloves

ASTM D7103 - 19

Standard Guide for Assessment of Medical Gloves

ASTM F3395 / F3395M - 19

Standard Specification for Neurosurgical Head Holder Devices