Search Legislation

Commission Directive 2006/17/ECShow full title

Commission Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells (Text with EEA relevance)

 Help about what version

What Version

 Help about advanced features

Advanced Features

More Resources

Close

This is a legislation item that originated from the EU

After exit day there will be three versions of this legislation to consult for different purposes. The legislation.gov.uk version is the version that applies in the UK. The EU Version currently on EUR-lex is the version that currently applies in the EU i.e you may need this if you operate a business in the EU.

The web archive version is the official version of this legislation item as it stood on exit day before being published to legislation.gov.uk and any subsequent UK changes and effects applied. The web archive also captured associated case law and other language formats from EUR-Lex.

Changes over time for: Division 2.

 Help about opening options

Status:

EU Directives are being published on this site to aid cross referencing from UK legislation. After exit day no further amendments will be applied to this version.

2.General requirements to be met for determining biological markersU.K.+E.U.

2.1.The tests must be carried out by a qualified laboratory, authorised as a testing centre by the competent authority in the Member State, using EC-marked testing kits where appropriate. The type of test used must be validated for the purpose in accordance with current scientific knowledge.U.K.+E.U.

2.2.The biological tests will be carried out on the donor’s serum or plasma; they must not be performed on other fluids or secretions such as the aqueous or vitreous humour unless specifically justified clinically using a validated test for such a fluid.U.K.+E.U.

2.3.When potential donors have lost blood and have recently received donated blood, blood components, colloids or crystalloids, blood testing may not be valid due to haemodilution of the sample. An algorithm must be applied to assess the degree of haemodilution in the following circumstances:U.K.+E.U.

(a) ante-mortem blood sampling

:

if blood, blood components and/or colloids were infused in the 48 hours preceding blood sampling or if crystalloids were infused in the hour preceding blood sampling;

(b) post-mortem blood sampling

:

if blood, blood components and/or colloids were infused in the 48 hours preceding death or if crystalloids were infused in the hour preceding death.

Tissue establishments may accept tissues and cells from donors with plasma dilution of more than 50 % only if the testing procedures used are validated for such plasma or if a pre-transfusion sample is available.

2.4.In the case of a deceased donor, blood samples must have been obtained just prior to death or, if not possible, the time of sampling must be as soon as possible after death and in any case within 24 hours after death.U.K.+E.U.

2.5.

2.6.If in a living donor (except bone marrow stem-cell and peripheral blood stem-cell donors) the ‘donation sample’, as defined in point 2(5)(a) above, is additionally tested by the nucleic acid amplification technique (NAT) for HIV, HBV and HCV, testing of a repeat blood sample is not required. Retesting is also not required if the processing includes an inactivation step that has been validated for the viruses concerned.U.K.+E.U.

2.7.In the case of bone marrow and peripheral blood stem-cell collection, blood samples must be taken for testing within 30 days prior to donation.U.K.+E.U.

2.8.In the case of neonatal donors, the biological tests may be carried out on the donor’s mother to avoid medically unnecessary procedures upon the infant.U.K.+E.U.

Back to top

Options/Help

Print Options

Close

Legislation is available in different versions:

Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.

Original (As adopted by EU): The original version of the legislation as it stood when it was first adopted in the EU. No changes have been applied to the text.

Close

See additional information alongside the content

Geographical Extent: Indicates the geographical area that this provision applies to. For further information see ‘Frequently Asked Questions’.

Show Timeline of Changes: See how this legislation has or could change over time. Turning this feature on will show extra navigation options to go to these specific points in time. Return to the latest available version by using the controls above in the What Version box.

Close

Opening Options

Different options to open legislation in order to view more content on screen at once

Close

More Resources

Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:

  • the original print PDF of the as adopted version that was used for the EU Official Journal
  • lists of changes made by and/or affecting this legislation item
  • all formats of all associated documents
  • correction slips
  • links to related legislation and further information resources
Close

Timeline of Changes

This timeline shows the different versions taken from EUR-Lex as well as any subsequent versions created after exit day as a result of changes made by UK legislation.

The dates for the EU versions are taken from the document dates on EUR-LEx and may not always coincide with when the changes came into force for the document.

For any versions created after exit day as a result of changes made by UK legislation the date will coincide with the earliest date on which the change (e.g an insertion, a repeal or a substitution) that was applied came into force. For further information see our guide to revised legislation on Understanding Legislation.

Close

More Resources

Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:

  • the original print PDF of the as adopted version that was used for the print copy
  • correction slips

Click 'View More' or select 'More Resources' tab for additional information including:

  • lists of changes made by and/or affecting this legislation item
  • confers power and blanket amendment details
  • all formats of all associated documents
  • links to related legislation and further information resources