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

Language(s)

English

Published date

31-03-2012

Publisher

British Standards Institution

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.

This International Standard specifies requirements for the use of symbols conveying information on the safe and effective use of cardiac rhythm management medical devices. Table1 gives a list of existing symbols that comply with the requirements of this International Standard.

This International Standard is applicable to, and limited to, symbols for cardiac rhythm management medical devices that can be marketed globally. These symbols can be used on the devices themselves or their labelling.

NOTE Other standards specify additional symbols that are applicable to particular kinds or groups of devices or to particular situations. Examples of such sources are identified in the Bibliography. This listing is not exhaustive.

Committee	CH/150/2
DevelopmentNote	Supersedes 10/30195946 DC. (03/2012)
DocumentType	Standard
Pages	42
PublisherName	British Standards Institution
Status	Current
Supersedes	10/30195946 DC : DRAFT DEC 2010

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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BS ISO 27185:2012

Cardiac rhythm management devices. Symbols to be used with cardiac rhythm management device labels, and information to be supplied. General requirements

Table of Contents

Abstract

Scope

General Product Information

International Equivalents

Standards Referencing This Book

Category

Subcategory