1Key Takeaways
ISO 18113-3 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for professional use. It also applies to apparatus and equipment intended to be used with IVD instruments for professional use. ISO 18113-3 can also be applied to accessories.ISO 18113-3 is …
2Scope / Description
ISO 18113-3 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for professional use. It also applies to apparatus and equipment intended to be used with IVD instruments for professional use. ISO 18113-3 can also be applied to accessories.ISO 18113-3 is concerned solely with information supplied with IVD instruments and equipment intended for professional use. It is intended to be used in conjunction with ISO 18113-1, which contains the general requirements for information supplied by the manufacturer and definitions of general labelling concepts.ISO 18113-3:2022 text has been approved in Europe as EN ISO 18113-3:2024 without any changes.
6Frequently Asked Questions
What is EVS-EN ISO 18113-3:2024?
EVS-EN ISO 18113-3:2024 — In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2022) is an international standard developed by Estonian Centre for Standardisation. ISO 18113-3 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for professional use. It also applies to apparatus and equipment intended to be used with IVD instruments for...
What does EVS-EN ISO 18113-3:2024 cover?
This standard covers: ISO 18113-3 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for professional use. It also applies to apparatus and equipment intended to be used with IVD instruments for professional use. ISO 18113-3 can also be applied to...
Who should use this standard?
This standard is intended for organizations, professionals, and stakeholders involved in various industries and sectors. It is applicable to manufacturers, service providers, regulatory bodies, and certification organizations.
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