-50% discount* If you buy the same UNE standard in different languages. * Discount on the lower pvp.

DIN EN ISO 7198:2017-07

Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016); German version EN ISO 7198:2017 / Note: DIN EN 12006-2 (2009-08) remains valid alongside this standard until 2020-03-31.

Edition date: 2017-07-01
In Force
Available languages: English, German
Summary: 1.1 This International Standard specifies requirements for the evaluation of vascular prostheses and requirements with respect to nomenclature, design attributes and information supplied by the manufacturer, based upon current medical knowledge. Guidance for the development of in vitro test methods is included in an informative annex to this standard. This standard should be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants.With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer. This standard is supplemental to ISO 14630, which specifies general requirements for the performance of non-active surgical implants.NOTE - Due to the variations in the design of implants covered by this International Standard and in some cases due to the relatively recent development of some of these implants (e. g. bioabsorbable vascular prostheses, cell based tissue engineered vascular prostheses), acceptable standardized in vitro tests and clinical results are not always available. As further scientific and clinical data become available, appropriate revision of this document will be necessary.1.2 This International Standard includes is applicable to sterile tubular vascular prostheses implanted by direct visualization surgical techniques as opposed to fluoroscopic or other non-direct imaging (e. g., computerized tomography or magnetic resonance imaging), intended to replace, bypass, or form shunts between segments of the vascular system in humans and vascular patches intended for repair and reconstruction of the vascular system. 1.3 Vascular prostheses that are made of synthetic textile materials, and synthetic nontextile materials are included in thewithin the scope of this standard. 1.4 While vascular prostheses that are made wholly or partly of materials of non-viable biological origin, including tissue engineered vascular prostheses are within the scope, thise standard does not specifically address sourcing, harvesting, and manufacturing and all testinfg requirements for biological materials. It is further noted that different regulatory requirements may exist for tissues from human and animal sources.
Keywords: By-pass|Cardiac valves|Cardiology|Classification|Construction details|Definitions|Evaluations|Grafts|Heart|Implants (surgical)|In vitro|Information supplied by the manufacturer|Inspection|Marking|Measurement|Mechanical properties|Medical products|Medical technology|Nomenclature|Quality assurance|Specification (approval)|Surgical implants|Testing|Vascular|Vascular prostheses|Verification
ICS: 11.040.40-Implants for surgery, prosthetics and orthotics
CTN:

International Equivalence

Identic EN ISO 7198:2017

Identic ISO 7198:2016

Reemplazo Normas

Reemplaza a DIN EN 12006-2:2009-08

Reemplaza a DIN EN ISO 7198:2014-10

The book in the author's words

Ultricies magna feugiat malesuada sociosqu varius vivamus cubilia parturient, himenaeos vitae vehicula nam placerat netus urna platea, nostra rutrum felis mattis penatibus velit quisque.

Button
Frequently Asked Questions Do you have any questions about our products?
  • Standards UNE, EN, ISO, IEC, BSI, DIN, ASTM, AFNOR, IEEE, SAE
  • In addition, you can request the rules of the rest of the organizations through the e-mail normas@aenor.com
  • Technical books on paper and in electronic format (PDF, epub).

The standards can be purchased in PDF, reading or paper. The reading standards are not download files, they can only be viewed in the client area. The standards ordered on paper and some of the books in the catalogue are printed on demand. 

Check deadlines in normas@aenor.com.

The license of use is for one user and one device, if you want to reproduce the content of the standard, you must request a license that will have an additional cost. Send us your inquiry here 

The AENOR standards and books that appear in the online store can only be purchased exclusively through the website. AENOR does not have a physical store.

Purchase procedure: by clicking on "Buy" the desired products will go to the shopping cart. If there are display problems, the recommended browser is Chrome.

To formalize the purchase you must access the customer area. If you are not registered as a customer, you must fill in a form with the data along with a password and username. This will create the account.

Once the "Customer data" form has been completed, "Order in progress" will be displayed with all the items loaded in the shopping cart, their prices, taxes established in current legislation and shipping costs if applicable.

The prices of the standards and books that appear in the various sections do not include taxes or shipping costs.

AENOR promotional codes consist of alphanumeric characters and can only be applied to online purchases, received through a specific offer and for a limited time. To apply your promotional code, you just have to enter it in step 2 of 4 of the purchase process on the website and click on "apply", after you have identified yourself and chosen the payment methods. Promo codes are not cumulative.

 

  • Credit or debit card (Visa, Mastercard) and PayPal.
  • Bank transfer. If you opt for this form of payment, you must first send AENOR a copy of the transfer by email to normas@aenor.com
  • The purchase invoice can be downloaded from the customer area, in my previous orders

In the case of clients of companies based abroad, the taxpayer identification number of the corresponding country (for example, in Argentina the CUIT), must be filled in the CIF/NIF - VAT field .

  • Direct download via the website in the Customer Area. In the customer area, which can only be accessed with a password and username, the products purchased will be available for a period of fifteen days from the date of purchase, as long as the payment has been accepted. Files in digital format are protected and in no case editable. Before purchasing them, it is important that the license of use is read and accepted as a prior step to purchase.
  • Shipping by courier. Products purchased on physical media are shipped by courier. The maximum delivery time in Spanish territory, from the acceptance of the order by AENOR, is:
  •  Approximately seven working days for all standards purchased through the store in paper format.
  • Approximately three days for books purchased through the store. Stocks of paper books are limited and their offer on the website does not imply availability within the indicated period. In the event that the requested book is not available, the customer is notified of the delay in receiving the order, which will be approximately seven working days. 

For the rest of the products that are not on the website, check availability and delivery time at normas@aenor.com.

1. For digital products (PDF, Epub), once delivery has been made by direct download via the website in the Customer Area, you will not have the right to exercise your right of withdrawal.

2. For personalised products on paper, once the purchase has been made, you will not have the right to exercise your right of withdrawal.

3.  For all other paper products, you have the right to withdraw from the sale within 14 calendar days from the date of purchase. Remember that for the return it is essential that the product is in perfect condition, sealed by the packaging and preserving its original packaging. The customer will be responsible for pickup and shipping costs.

The order invoice includes shipping costs, so there is no amount to pay to the courier. Shipping costs are calculated based on both the final destination of the order and the number of products ordered. They include transport and packaging costs. Shipping costs are subject to periodic revisions. Outlet books will have free shipping costs only if the shipment is made in the Peninsula.

Destination Up to three standards and/or publications From three standards and/or publications
Peninsula 7,31€ 8,60€
Balearic Islands 18,04€ 23,34€
Canary Islands, Ceuta and Melilla  18,04€ 23,34€
Europe 59,17€ 80,07€
United States and Canada 70,07€ 96,94€
Rest of the world 91,94€ 115,91€
  • Purchases made by residents of the Member States of the European Union will be subject to the payment of VAT (value added tax).
  • ​​
  • In the case of legal persons and natural persons who, acting as entrepreneurs, are domiciled in a Member State of the European Union (except residents in Spain) and have an intra-community NIF/VAT registered in the VIES census, they will be exempt from paying VAT, being an essential condition the sending of this document by email to normas@aenor.com.
  • Purchases made in a private capacity (natural person), regardless of where they have their residence, will be subject to the payment of VAT.
  • Purchases made by entities in non-EU countries will be exempt from paying VAT, as long as they send the corresponding tax residence document by email to normas@aenor.com.
  • The sale operations will be understood to have been carried out at AENOR's registered office: Génova 6, 28004, Madrid – Spain. 

The contract for the purchase of products through this Website shall be governed by Spanish law. Any dispute arising out of or in connection with the use of the Website or such contract shall be subject to the exclusive jurisdiction of the Courts and Tribunals of Madrid.

Notwithstanding the foregoing, if you are entering into this contract as a consumer under the terms of Royal Decree 1/2007, nothing in this clause shall affect the rights that may be granted to you as such under applicable law.