Content demo

Content demo

Content demo

Content demo

Content demo

Content demo

STANDARD

Withdrawn

ÖNORM EN ISO 25539-1

Issue date: 2009 01 01

Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005)

This part of ISO 25539 specifies requirements for endovascular prostheses, based upon current medical knowledge. With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization packaging and information supplied by the manufacturer. It should be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants. This part of ISO 25539 is applicable to endovascular prostheses used to treat arterial aneurysms, arterial stenoses, or other appropriate vascular abnormalities.

read more

General information on ÖNORM EN ISO 25539-1

Format

Digital | 110 Pages

Language

German | English | Download GER/ENG

Publisher

Austrian Standards International

Committee 179 Medical technology

Timeline

An overview of the development of ÖNORM EN ISO 25539-1 from 2004 til today.

• ÖNORM EN ISO 25539-1

  2017 09 15 Standard ÖNORM EN ISO 25539-1, Edition: 2017 09 15

  Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2017)
• ÖNORM EN ISO 25539-1

  2011 03 15 Standard ÖNORM EN ISO 25539-1, Edition: 2011 03 15

  Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 i...
• ÖNORM EN ISO 25539-1

  2009 10 15 Standard ÖNORM EN ISO 25539-1, Edition: 2009 10 15

  Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 i...
• ÖNORM EN ISO 25539-1

  2009 01 01 Standard ÖNORM EN ISO 25539-1, Edition: 2009 01 01

  Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 i...
• ÖNORM EN 14299

  2004 08 01 Standard ÖNORM EN 14299, Edition: 2004 08 01

  Non active surgical implants - Particular requirements for cardiac and vascular implants - Specific ...

Read more

Frequently Asked Questions about ÖNORM EN ISO 25539-1

What is a "Single-User Licence"?

When you purchase a standard from the Austrian Standards webshop (e.g. ÖNORM, ISO), a single-user licence is included as standard. This entitles a single person to use the standard. A multi-user licence is required if several employees need access. It enables company-wide, legally compliant use and sharing of standards.

Find out more about the benefits of multi-user licences

How can I get involved in the further development of this standard?

Standardization thrives on expertise and participation. Anyone interested can play an active role in its further development – for example, by joining the relevant committee or a working group. In this way, you can help shape the content and contribute to advancing the state of the art.

Find out more about getting involved in standardization

How can I manage my standards efficiently?

If you have an extensive portfolio of standards, we recommend using a professional standards management tool. With effects 2.0, you can manage your standards centrally and efficiently. You can optimise your procurement processes and benefit from an integrated information and subscription service. This ensures you are always up to date and never miss any relevant developments.

Find out more about the benefits of effects 2.0

Normative References

Here you will find an extract of the normative references. Please refer to the document itself for the full list.

Dokumentnummer	Titel	Ausgabedatum	Art	Link
Dokumentnummer ISO 11134:1994	Titel Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization	Ausgabedatum 1994 01 27	Art Standard	Zur Produktseite
Dokumentnummer ISO 11135:1994	Titel Medical devices — Validation and routine control of ethylene oxide sterilization	Ausgabedatum 1994 01 27	Art Standard	Zur Produktseite
Dokumentnummer ISO 11137:1995	Titel Sterilization of health care products — Requirements for validation and routine control — Radiation sterilization	Ausgabedatum 1995 03 09	Art Standard	Zur Produktseite
Dokumentnummer ISO 11607:1997	Titel Packaging for terminally sterilized medical devices	Ausgabedatum 1997 01 30	Art Standard	Zur Produktseite
Dokumentnummer ISO 13485:2016	Titel Medical devices — Quality management systems — Requirements for regulatory purposes	Ausgabedatum 2016 02 25	Art Standard	Zur Produktseite
Dokumentnummer ISO 13488:1996	Titel Quality systems — Medical devices — Particular requirements for the application of ISO 9002	Ausgabedatum 1996 12 26	Art Standard	Zur Produktseite
Dokumentnummer ISO 14160:2020	Titel Sterilization of health care products — Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives — Requirements for characterization, development, validation and routine control of a sterilization process for medical devices	Ausgabedatum 2020 09 21	Art Standard	Zur Produktseite
Dokumentnummer ISO 14630:1997	Titel Non-active surgical implants — General requirements	Ausgabedatum 1997 10 30	Art Standard	Zur Produktseite
Dokumentnummer ISO 14937:2009	Titel Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices	Ausgabedatum 2009 10 14	Art Standard	Zur Produktseite
Dokumentnummer ISO 14971:2000	Titel Medical devices — Application of risk management to medical devices	Ausgabedatum 2000 11 30	Art Standard	Zur Produktseite
Dokumentnummer ISO 7198:1998	Titel Cardiovascular implants — Tubular vascular prostheses	Ausgabedatum 1998 07 23	Art Standard	Zur Produktseite

load more

Recently Viewed

ÖNORM EN 17014-1

Electronic public procurement - Pre-award - Part 1: Choreographies

ÖNORM EN 14511-1

Air conditioners, liquid chilling packages and heat pumps for space heating and cooling and process chillers, with electrically driven compressors - Part 1: Terms and definitions

ÖVE/ÖNORM EN 50512

Electrical installations for lighting and beaconing of aerodromes - Advanced Visual Docking Guidance Systems (A-VDGS)