Medical Devices | Monthly bulletin | January 2020
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(*) Date of withdrawal: latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn.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 |
|
Medical supply units (ISO 11197:2019) |
2020-05-31 |
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Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tables |
2022-11-15 |
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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 |
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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 |
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|
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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 |
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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 |
Standards updates
See below a table summarising some recent ASTM standards updates:
|
Reference |
Title |
|
Standard Specification for Rubber Surgical Gloves |
|
|
Standard Specification for Rubber Examination Gloves |
