ONORM EN 1041 : 2013
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
INFORMATION SUPPLIED BY THE MANUFACTURER WITH MEDICAL DEVICES
18-11-2021
12-01-2013
Die vorliegende Norm legt Anforderungen an Informationen fest, die von einem Hersteller für Medizinprodukte nach der EU-Richtlinie 90/385/EWG zu aktiven implantierbaren medizinischen Geräten und EU-Richtlinie 93/42/EWG zu Medizinprodukten zur Verfügung zu stellen sind. Es werden weder die verwendete Sprache für diese Informationen noch die Mittel festgelegt, mit denen die Informationen zu geben sind. Es ist ferner beabsichtigt, die besonderen Anforderungen der genannten EU-Richtlinien zu Medizinprodukten durch die Bereitstellung einer Anleitung zu ergänzen, wie bestimmte Anforderungen erfüllt werden können. Wenn diese Hinweise von einem Hersteller befolgt werden, so liefern sie eine Annahme der Übereinstimmung mit den relevanten grundlegenden Anforderungen hinsichtlich der bereitzustellenden Information.
| DocumentType |
Standard
|
| PublisherName |
Osterreichisches Normungsinstitut/Austrian Standards
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| DIN EN 1041:2013-12 | Identical |
| I.S. EN 1041:2008+A1:2013 | Identical |
| NBN EN 1041 : 2008 + A1 2013 | Identical |
| BS EN 1041 : 2008 | Identical |
| EN 1041:2008+A1:2013 | Identical |
| NS EN 1041 : 2008 + A1 2013 | Identical |
| NEN EN 1041 : 2008 + A1 2013 | Identical |
| UNI EN 1041 : 2000 | Identical |
| UNE-EN 1041:2009 | Identical |
| ONORM EN 13060 : 2015 | SMALL STEAM STERILIZERS |
| ONORM EN 1789 : 2014 | MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES |
| ONORM EN ISO 5367 : 2015 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS (ISO 5367:2014) |
| ONORM EN ISO 15798 : 2013 AMD 1 2018 | OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES (ISO 15798:2013) |
| ONORM EN ISO 18778 : 2009 | RESPIRATORY EQUIPMENT - INFANT MONITORS - PARTICULAR REQUIREMENTS |
| ONORM EN 13544-3 : 2010 | RESPIRATORY THERAPY EQUIPMENT - PART 3: AIR ENTRAINMENT DEVICES |
| ONORM EN ISO 10079-2 : 2014 | MEDICAL SUCTION EQUIPMENT - PART 2: MANUALLY POWERED SUCTION EQUIPMENT (ISO 10079-2:2014) |
| ONORM EN ISO 10079-3 : 2014 | MEDICAL SUCTION EQUIPMENT - PART 3: SUCTION EQUIPMENT POWERED FROM A VACUUM OR POSITIVE PRESSURE GAS SOURCE (ISO 10079-3:2014) |
| ONORM EN ISO 16672 : 2015 | OPHTHALMIC IMPLANTS - OCULAR ENDOTAMPONADES (ISO 16672:2015) |
| ONORM EN ISO 7376 : 2010 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - LARYNGOSCOPES FOR TRACHEAL INTUBATION |
| ONORM EN ISO 8836 : 2015 | SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT (ISO 8836:2014) |
| ONORM EN 13718-1 : 2014 | MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES |
| ONORM EN 455-3 : 2015 | MEDICAL GLOVES FOR SINGLE USE - PART 3: REQUIREMENTS AND TESTING FOR BIOLOGICAL EVALUATION |
| ONORM EN 1865-2 : 2015 | PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 2: POWER ASSISTED STRETCHER |
| ONORM EN 455-2 : 2015 | MEDICAL GLOVES FOR SINGLE USE - PART 2: REQUIREMENTS AND TESTING FOR PHYSICAL PROPERTIES |
| ISO 639-1:2002 | Codes for the representation of names of languages — Part 1: Alpha-2 code |
| CEN/TR 15133:2005 | Nomenclature - Collective terms and codes for groups of medical devices |
| ISO 8601:2004 | Data elements and interchange formats Information interchange Representation of dates and times |
| ISO 3166-1:2013 | Codes for the representation of names of countries and their subdivisions Part 1: Country codes |
| ONORM EN ISO 3166-1 : 2015 | CODES FOR THE REPRESENTATION OF NAMES OF COUNTRIES AND THEIR SUBDIVISIONS - PART 1: COUNTRY CODES (ISO 3166-1:2013) |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.