DIN EN ISO 15223-1:2015-08 (Draft)
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS (ISO 15223-1:2016, CORRECTED VERSION 2017-03)
Available format(s)
Hardcopy , PDF
Superseded date
30-01-2021
Superseded by
Language(s)
German
Published date
01-01-2015
Important note : Users cannot be edited or removed once added to your Multi user PDF.
National foreword
National Annex NA (informative) - Bibliography
European foreword
Annex ZA (informative) - Relationship between this
European Standard and the Essential Requirements
of EU Directive 93/42/EEC [OJ L 169] on Medical
Devices
Annex ZB (informative) - Relationship between this
European standard and the essential requirements
of Directive 90/385/EEC [OJ L 189] aimed to be
covered
Annex ZC (informative) - Relationship between this
European standard and the essential requirements
of Directive 98/79/EC [OJ L 331] aimed to be
covered
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Symbols
Annex A (informative) - Examples
Annex B (informative) - Use of general prohibition
symbol and negation symbol
Bibliography
Describes requirements for symbols used in medical device labelling that convey information on the safe and effective use of medical devices.
| DevelopmentNote |
Available with CD-ROM. Supersedes DIN EN 980. (10/2012)
|
| DocumentType |
Draft
|
| Pages |
78
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 15223-1:2016 | Identical |
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| DIN EN ISO 1135-3:2014-12 (Draft) | TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 3: BLOOD-TAKING SETS FOR SINGLE USE (ISO 1135-3:2016) |
| DIN EN ISO 5367:2015-02 | Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014) |
| DIN EN ISO 10650:2016-02 | DENTISTRY - POWERED POLYMERIZATION ACTIVATORS (ISO 10650:2015) |
| DIN EN ISO 8536-11:2015-11 | INFUSION EQUIPMENT FOR MEDICAL USE - PART 11: INFUSION FILTERS FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT (ISO 8536-11:2015) |
| DIN EN ISO 10079-1:2016-05 | MEDICAL SUCTION EQUIPMENT - PART 1: ELECTRICALLY POWERED SUCTION EQUIPMENT (ISO 10079-1:2015) |
| DIN EN ISO 8536-4:2013-07 | INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: INFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 8536-4:2010 + AMD 1:2013) |
| DIN EN ISO 14534:2015-08 | Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011) |
| DIN EN ISO 10079-2:2014-09 | Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:2014); German version EN ISO 10079-2:2014 |
| DIN EN ISO 11979-4:2013-01 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 4: LABELLING AND INFORMATION (ISO 11979-4:2008 + AMD.1:2012) |
| DIN EN ISO 3665:2013-07 | PHOTOGRAPHY - INTRA-ORAL DENTAL RADIOGRAPHIC FILM AND FILM PACKETS - MANUFACTURER SPECIFICATIONS (ISO 3665:2011) |
| DIN 19403:2016-08 | DENTISTRY - MULTIFUNCTION HANDPIECES |
| DIN EN ISO 9687:2015-05 | DENTISTRY - GRAPHICAL SYMBOLS FOR DENTAL EQUIPMENT (ISO 9687:2015) |
| DIN ISO 8536-12:2013-04 | Infusion equipment for medical use - Part 12: Check valves (ISO 8536-12:2007 + Amd. 1:2012) |
| DIN HDBK 268 : 3ED 2015 | NICHT AKTIVE MEDIZINPRODUKTE - HORIZONTALE, HARMONISIERTE EUROPAEISCHE NORMEN GEMAESS EU-RICHTLINIEN AUF DEM GEBIET DER MEDIZIN |
| DIN EN ISO 80601-2-69:2014-12 | Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2014) |
| DIN EN ISO 25539-1:2015-07 (Draft) | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017) |
| DIN EN ISO 23908:2013-10 | SHARPS INJURY PROTECTION - REQUIREMENTS AND TEST METHODS - SHARPS PROTECTION FEATURES FOR SINGLE-USE HYPODERMIC NEEDLES, INTRODUCERS FOR CATHETERS AND NEEDLES USED FOR BLOOD SAMPLING (ISO 23908:2011) |
| DIN EN ISO 11138-1:2015-10 (Draft) | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS (ISO 11138-1:2017) |
| DIN EN ISO 8536-8:2015-11 | INFUSION EQUIPMENT FOR MEDICAL USE - PART 8: INFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS (ISO 8536-8:2015) |
| DIN ISO 7000:2008-12 | Graphical symbols for use on equipment - Index and synopsis (ISO 7000:2004 + ISO 7000 Database:2008 up to ISO 7000-2750) |
| DIN ISO 8601:2006-09 | DATA ELEMENTS AND INTERCHANGE FORMATS - INFORMATION INTERCHANGE - REPRESENTATION OF DATES AND TIMES |
| ISO 7010:2011 | Graphical symbols Safety colours and safety signs Registered safety signs |
| 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 |
| DIN ISO 3864-1:2012-06 | Graphical symbols - Safety colours and safety signs - Part 1: Design principles for safety signs and safety markings (ISO 3864-1:2011) |
| ISO 18113-1:2009 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements |
| ISO 18113-4:2009 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing |
| DIN EN ISO 18113-2:2013-01 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009) |
| DIN EN ISO 14971:2013-04 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007) |
| DIN EN ISO 18113-4:2013-01 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009) |
| EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| DIN EN ISO 18113-3:2013-01 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009) |
| ISO 8601:2004 | Data elements and interchange formats Information interchange Representation of dates and times |
| DIN EN 80416-3:2003-08 | BASIC PRINCIPLES FOR GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT - PART 3: GUIDELINES FOR THE APPLICATION OF GRAPHICAL SYMBOLS |
| DIN EN ISO 18113-5:2013-01 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009) |
| IEC 80416-3:2002+AMD1:2011 CSV | Basic principles for graphical symbols for use on equipment - Part 3: Guidelines for the application of graphical symbols |
| IEC 80416-1:2008 | Basic principles for graphical symbols for use on equipment - Part 1: Creation of graphical symbols for registration |
| 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 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 7000:2014 | Graphical symbols for use on equipment Registered symbols |
| 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 |
| DIN EN ISO 7010:2012-10 | GRAPHISCHE SYMBOLE - SICHERHEITSFARBEN UND SICHERHEITSZEICHEN - REGISTRIERTE SICHERHEITSZEICHEN (ISO 7010:2011/AMD 5:2014) |
| DIN EN ISO 18113-1:2013-01 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009) |
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