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Eurofins >> Consumer Product Testing >> Media Centre >> News >> Medical Devices | Monthly bulletin | December 2019

Medical Devices | Monthly bulletin | December 2019

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(*) Date of withdrawal: latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn.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