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Technical rule [CURRENT]

ISO/PAS 7020

Sizing parameters of surgical valve prostheses: Requirements regarding the application of ISO 5840-2
Edition 2023-05

Standards [CURRENT]

ISO 80601-2-85

Medical electrical equipment - Part 2-85: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment
Edition 2021-03

Standards [CURRENT]

ISO 80601-2-74

Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
Edition 2021-07

Standards [CURRENT]

ISO 21856

Assistive products - General requirements and test methods
Edition 2022-07

Standards [CURRENT]

ISO 10651-4

Lung ventilators - Part 4: Particular requirements for user-powered resuscitators
Edition 2023-03

Draft standard

ISO/DIS 11197

Medical supply units
Edition 2024-03

Draft standard [New]

ISO/FDIS 80601-2-80

Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency
Edition 2024-05

Draft standard [New]

ISO/FDIS 80601-2-79

Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment
Edition 2024-05

Technical rule [CURRENT]

IEC/TR 80001-2-5

Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance for distributed alarm systems
Edition 2014-12

Standards [CURRENT]

ISO 80601-2-69

Medical electrical equipment - Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment
Edition 2020-11

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