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Media Centre >> News >> Medical Devices | Monthly bulletin | January 2020

Medical Devices | Monthly bulletin | January 2020

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Wednesday, January 8, 2020

Eurofins newsflash Medical Device

 

Europe/International

 

Standards updates

 

Please see below a table summarising 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(*) Date of withdrawal: latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn.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 11197:2019

Medical supply units (ISO 11197:2019)

2020-05-31

EN ISO 11197:2016

EN IEC 60601-2-46:2019

Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tables

2022-11-15

EN 60601-2-46:2011

EN IEC 61223-3-5:2019

Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests and and constancy tests - Imaging performance of computed tomography X-ray equipment

2022-10-21

EN 61223-3-5:2004

EN ISO 80601-2-13:2012 /A1:2019

Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation - Amendment 1 (ISO 80601-2-13:2011/Amd 1:2015)

2020-05-31

 

EN ISO 80601-2-79:2019

Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment (ISO 80601-2-79:2018)

2020-03-31

EN ISO 10651-6:2009

EN ISO 80601-2-80:2019

Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency (ISO 80601-2-80:2018)

2020-03-31

EN ISO 10651-6:2009

 

US

 

Standards updates

 

See below a table summarising some recent ASTM standards updates:

 

Reference

Title

ASTM D3577 - 19

Standard Specification for Rubber Surgical Gloves

ASTM D3578 - 19

Standard Specification for Rubber Examination Gloves