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Electromagnetic compatibility and Radio spectrum Matters (ERM); Radio equipment in the frequency range 30 MHz to 37,5 MHz for Ultra Low Power Active Medical Membrane Implants and Accessories; Part 2: Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive

60.60   Standard published

NETSI more

Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)

60.60   Standard published

N062 more

Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)

60.60   Standard published

Z076 more

Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems

60.60   Standard published

Z076 more

List of interpretations on published standards on "Alarm Systems"

60.60   Standard published

N079 more

Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 1: General

90.93   Standard confirmed

N210 more

Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 2-1: Specific assessment for workers with cardiac pacemakers

60.60   Standard published

N210 more

Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 2-2: Specific assessment for workers with cardioverter defibrillators (ICDs)

90.93   Standard confirmed

N210 more

Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 2-3: Specific assessment for workers with implantable neurostimulators

60.60   Standard published

N210 more

Implants for surgery - Metallic materials - Part 1: Wrought stainless steel (ISO 5832-1:2024, Corrected version 2025-06)

60.60   Standard published

Z076 more

Implants for surgery - Metallic materials - Part 2: Unalloyed titanium (ISO 5832-2:2025)

60.60   Standard published

Z106 more

Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy (ISO 5832-3:2021)

60.60   Standard published

Z106 more

Implants for surgery - Metallic materials - Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy (ISO 5832-6:2022)

60.60   Standard published

Z076 more

Implants for surgery - Metallic materials - Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy (ISO 5832-7:2024)

60.60   Standard published

Z076 more

Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2021)

60.60   Standard published

Z076 more

Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements - Amendment 1 (ISO 5840-1:2021/Amd 1:2025)

60.60   Standard published

Z076 more

Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2021)

60.60   Standard published

Z076 more

Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes - Amendment 1 (ISO 5840-2:2021/Amd 1:2025)

60.60   Standard published

Z076 more