Medical Devices | Monthly bulletin | December 2019
Recent SCHEER publications on Medical Device
See below recent publications by the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER):
- SCHEER - Read the new factsheet: "Why are potential dangerous phthalates allowed in medical devices, and who decides if their use is warranted?"
- SCHEER - Minutes of the Working Group meeting on safety of breast implants in relation to anaplastic large cell lymphoma (BIA-ALCL) of 4 November 2019
- SCHEER - Call for external experts for the Working Group on safety of breast implants in relation to anaplastic large cell lymphoma (BIA-ALCL)
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(*) Date of withdrawal: latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn.
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Reference |
Title |
Date of Withdrawal (*) |
Supersedes |
|
Implants for surgery - Metallic materials - Part 1: Wrought stainless steel (ISO 5832-1:2016) |
2020-04-30 |
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Implants for surgery - Metallic materials - Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy (ISO 5832-6:1997) |
2020-04-30 |
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Implants for surgery - Metallic materials - Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy (ISO 5832-7:2016) |
2020-04-30 |
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Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators |
2022-10-11 |
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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 |
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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 |
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Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment |
2022-08-07 |
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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 |
Standards updates
See below a table summarising some recent ASTM standards updates:
|
Reference |
Title |
|
Standard Test Method for Detection of Holes in Medical Gloves |
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Standard Guide for Assessment of Medical Gloves |
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Standard Specification for Neurosurgical Head Holder Devices |
