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

ISO 10993-6:2016

Biological evaluation of medical devices — Part 6: Tests for local effects after implantation

Edition date: 2026-04-15
Cancelled
Available languages: French, English
Summary:

ISO 10993-6:2016 spécifie les méthodes d'essai pour l'évaluation des effets locaux après une implantation de biomatériaux destinés à être utilisés dans des dispositifs médicaux.

ISO 10993-6:2016 s'applique aux matériaux qui sont

- solides et non absorbables,

- non solides, comme les matériaux poreux, liquides, en gel, pâteux et particulaires, et

- dégradables et/ou absorbables, qui peuvent être solides ou non solides.

L'échantillon d'essai est implanté dans un site et dans une espèce animale appropriés à l'évaluation de la sécurité biologique du matériau. Ces essais d'implantation ne sont pas destinés à évaluer ou à déterminer les performances de l'échantillon d'essai en matière de charge mécanique ou fonctionnelle. La présente partie de l'ISO 10993 peut également être appliquée à des dispositifs médicaux destinés à une utilisation topique dans des indications cliniques où la surface ou le revêtement pourrait perdre son intégrité, afin d'évaluer les réponses tissulaires locales.

Les effets locaux sont évalués par comparaison de la réponse tissulaire induite par un échantillon d'essai avec celle induite par des matériaux de contrôle utilisés dans des dispositifs médicaux dont les caractéristiques d'acceptabilité clinique et de biocompatibilité ont été établies. L'objectif des méthodes d'essai est de caractériser l'historique et l'évolution de la réponse tissulaire après l'implantation d'un dispositif médical ou biomatériau, y compris l'intégration finale ou l'absorption/dégradation du matériau. Particulièrement pour les matériaux dégradables/absorbables, il convient de déterminer les caractéristiques de dégradation du matériau et la réponse tissulaire résultante.

ISO 10993-6:2016 ne traite pas de la toxicité systémique, de la cancérogénicité, de la tératogénicité ou de la mutagénicité. Les études d'implantation à long terme destinées à l'évaluation des effets biologiques locaux pourraient, cependant, apporter des informations sur certaines de ces propriétés. Des études de toxicité systémique effectuées par implantation pourraient répondre aux exigences de la présente partie de l'ISO 10993. Lors de la réalisation d'études combinées pour l'évaluation des effets locaux et systémiques, les exigences des deux normes appliquées doivent être satisfaites.



ISO 10993-6:2016 specifies test methods for the assessment of the local effects after implantation of biomaterials intended for use in medical devices.

ISO 10993-6:2016 applies to materials that are

- solid and non-absorbable,

- non-solid, such as porous materials, liquids, gels, pastes, and particulates, and

- degradable and/or absorbable, which may be solid or non-solid.

The test sample is implanted into a site and animal species appropriate for the evaluation of the biological safety of the material. These implantation tests are not intended to evaluate or determine the performance of the test sample in terms of mechanical or functional loading. This part of ISO 10993 can also be applied to medical devices that are intended to be used topically in clinical indications where the surface or lining might have been breached, in order to evaluate local tissue responses.

The local effects are evaluated by a comparison of the tissue response caused by a test sample to that caused by control materials used in medical devices whose clinical acceptability and biocompatibility characteristics have been established. The objective of the test methods is to characterize the history and evolution of the tissue response after implantation of a medical device/biomaterial including final integration or absorption/degradation of the material. In particular for degradable/absorbable materials, the degradation characteristics of the material and the resulting tissue response should be determined.

ISO 10993-6:2016 does not deal with systemic toxicity, carcinogenicity, teratogenicity or mutagenicity. However, the long-term implantation studies intended for evaluation of local biological effects might provide insight into some of these properties. Systemic toxicity studies conducted by implantation might satisfy the requirements of this part of ISO 10993. When conducting combined studies for evaluating local effects and systemic effects, the requirements of both standards is to be fulfilled.
ICS: 11.100.20-Biological evaluation of medical devices
CTN: ISO/TC 194 - 54508

Standards Cancellations

Anula a ISO 10993-6:2007

Es anulada por ISO/DIS 10993-6

International Equivalence

Identic UNE-EN ISO 10993-6:2017

Normas Conjuntas

Trabajo conjunto ISO/IEC 17342:2004

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.