BS ISO 27185:2012
Current
The latest, up-to-date edition.
Cardiac rhythm management devices. Symbols to be used with cardiac rhythm management device labels, and information to be supplied. General requirements
Hardcopy , PDF
English
31-03-2012
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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.
| Committee |
CH/150/2
|
| DevelopmentNote |
Supersedes 10/30195946 DC. (03/2012)
|
| DocumentType |
Standard
|
| Pages |
42
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
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.
| 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 |
| 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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