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CEI UNI EN ISO 15223-1:2022-07

Current

Current

The latest, up-to-date edition.

Medical devices - Symbols to be used with information to be supplied by the manufacturer Part 1: General requirements

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-09-2022

€145.53
Excluding VAT

This document specifies symbols used to express information supplied for a medical device.

Committee
CT 62
DocumentType
Standard
Pages
68
PublisherName
Comitato Elettrotecnico Italiano
Status
Current
Supersedes

Standards Relationship
EN ISO 15223-1:2021 Identical
ISO 15223-1:2021 Identical

IEC TR 60878:2003 Graphical symbols for electrical equipment in medical practice
ISO 14971:2019 Medical devices — Application of risk management to medical devices
ISO 18113-1:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes
ISO 18113-4:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing
ISO 20417:2021 Medical devices — Information to be supplied by the manufacturer
ISO 7010:2003 Graphical symbols — Safety colours and safety signs — Safety signs used in workplaces and public areas
IEC 62570:2014 Standard practice for marking medical devices and other items for safety in the magnetic resonance environment
EN 1041:2008 Information supplied by the manufacturer of medical devices
ISO 7001:2007 Graphical symbols — Public information symbols
ISO 11607-1:2019 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 7000:2019 Graphical symbols for use on equipment — Registered symbols
ISO 18113-2:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use
ISO 3864-1:2011 Graphical symbols — Safety colours and safety signs — Part 1: Design principles for safety signs and safety markings
ISO 11607-2:2019 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
ISO 18113-5:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
ISO 18113-3:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use

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€145.53
Excluding VAT