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AAMI ISO 27185 : 2012

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

CARDIAC RHYTHM MANAGEMENT DEVICES - SYMBOLS TO BE USED WITH CARDIAC RHYTHM MANAGEMENT DEVICE LABELS, AND INFORMATION TO BE SUPPLIED - GENERAL REQUIREMENTS
Available format(s)

Hardcopy , PDF

Superseded date

05-08-2020

Language(s)

English

Published date

01-01-2012

Publisher

Association for the Advancement of Medical Instrumentation

Glossary of equivalent standards
Committee representation
Background of AAMI adoption of ISO 27185:2012
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Abbreviated terms
5 General requirements
6 Symbols
Annex A (informative) - Examples of use of symbols
Annex B (informative) - Graphical symbol system for
        implantable cardiac devices
Annex C (informative) - Validation report for symbols
        included in this International Standard
Annex D (informative) - ISO 27185 response to comment
        in DIS
Bibliography

Describes requirements for the use of symbols conveying information on the safe and effective use of cardiac rhythm management medical devices.

DocumentType
Standard
Pages
43
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Superseded
SupersededBy

Standards Relationship
ISO 27185:2012 Identical

ISO 15223-2:2010 Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation
IEC 60417-1:2002 Graphical symbols for use on equipment - Part 1: Overview and application
EN 45502-2-2 : 2008 COR 2009 ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-2: PARTICULAR REQUIREMENTS FOR ACTIVE IMPLANTABLE MEDICAL DEVICES INTENDED TO TREAT TACHYARRHYTHMIA (INCLUDES IMPLANTABLE DEFIBRILLATORS)
ISO 14708-2:2012 Implants for surgery Active implantable medical devices Part 2: Cardiac pacemakers
IEC TR 60878:2015 Graphical symbols for electrical equipment in medical practice
ISO 780:2015 Packaging Distribution packaging Graphical symbols for handling and storage of packages
ISO 14708-1:2014 Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
EN 45502-1:2015 IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER
IEC 80416-1:2008 Basic principles for graphical symbols for use on equipment - Part 1: Creation of graphical symbols for registration
ISO 80416-2:2001 Basic principles for graphical symbols for use on equipment — Part 2: Form and use of arrows
ISO 15225:2016 Medical devices Quality management Medical device nomenclature data structure
EN 45502-1 : 2015 IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
EN 45502-2-1:2003 Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
EN 980:2008 Symbols for use in the labelling of medical devices
EN 45502-2-2 : 2008 COR 2009 ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-2: PARTICULAR REQUIREMENTS FOR ACTIVE IMPLANTABLE MEDICAL DEVICES INTENDED TO TREAT TACHYARRHYTHMIA (INCLUDES IMPLANTABLE DEFIBRILLATORS)
ISO 14708-6:2010 Implants for surgery Active implantable medical devices Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)

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Hardcopy - English
PDF - English - DRM
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