Commission Directive 2004/33/EC of 22 March 2004 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards certain technical requirements for blood and blood components (Text with EEA relevance)
Date: 2004-03-22
Institutions: European Commission
Subjects: blood transfusion, health control, quality standard, safety standard

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COMMISSION DIRECTIVE 2004/33/EC

of 22 March 2004

implementing Directive 2002/98/EC of the European Parliament and of the Council as regards
certain technical requirements for blood and blood components

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community,

Having regard to Directive 2002/98/EC of the European Parlia-
ment and of the Council of 27 January 2003 setting standards
of quality and safety for the collection, testing, processing,
storage and distribution of human blood and blood compo-
nents and amending Directive 2001/83/EC (1), and in particular
points (b) to (g) of the second paragraph of Article 29 thereof,

Whereas:

(1)

(2)

(3)

blood

Directive 2002/98/EC lays down standards of quality
and safety for the collection and testing of human blood
and
intended
purpose, and for their processing, storage and distribu-
tion when intended for transfusion so as to ensure a
high level of human health protection.

components, whatever

their

In order to prevent the transmission of diseases by blood
and blood components and to ensure an equivalent level
of quality and safety, Directive 2002/98/EC calls for the
establishment of specific technical requirements.

This Directive lays down those technical requirements,
which take account of Council Recommendation 98/
463/EC of 29 June 1998 on the suitability of blood and
plasma donors and the screening of donated blood in
the European Community (2), certain recommendations
of the Council of Europe, the opinion of the Scientific
Committee for Medicinal Products and Medical Devices,
the monographs of the European Pharmacopoeia, parti-
cularly in respect of blood or blood components as a
starting material
for the manufacture of proprietary
medicinal products and recommendations of the World
Health Organisation (WHO), as well as international
experience in this field.

(6)

(7)

is necessary to determine common definitions for
It
technical terminology in order to ensure the consistent
implementation of Directive 2002/98/EC.

The measures provided for in this Directive are in
accordance with the opinion of the Committee set up by
Directive 2002/98/EC,

HAS ADOPTED THIS DIRECTIVE:

Article 1

Definitions

For the purposes of this Directive, the definitions set out in
Annex I shall apply.

Article 2

Provision of information to prospective donors

Member States shall ensure that blood establishments provide
prospective donors of blood or blood components with the
information set out in Part A of Annex II.

Article 3

Information required from donors

Member States shall ensure that upon agreement of willingness
to commence the donation of blood or blood components,
donors provide the information set out in Part B of Annex II to
the blood establishment.

(4)

Blood and blood components imported from third coun-
tries, including those used as starting material/raw mate-
rial for the manufacture of medicinal products derived
from human blood and human plasma, should meet the
quality and safety requirements set out in this Directive.

(5) With regard to blood and blood components collected
for the sole purpose of, and exclusive use in, autologous
transfusion (autologous donation),
technical
requirements should be laid down, as required by Article
2(2) of Directive 2002/98/EC. Such donations should be
clearly identified and kept separate from other donations
to ensure that they are not used for transfusion to other
patients.

specific

(1) OJ L 33, 8.2.2003, p. 30.
(2) OJ L 203, 21.7.1998, p. 14.

Article 4

Eligibility of donors

Blood establishments shall ensure that donors of whole blood
and blood components comply with the eligibility criteria set
out in Annex III.

Article 5

Storage, transport and distribution conditions for blood
and blood components

Blood establishments shall ensure that the storage, transport
and distribution conditions for blood and blood components
comply with the requirements set out in Annex IV.

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Article 6

Quality and safety requirements for blood and blood
components

Blood establishments shall ensure that the quality and safety
requirements for blood and blood components comply with
the requirements set out in Annex V.

Article 7

Autologous donations

1.
Blood establishments shall ensure that autologous dona-
tions comply with the requirements set out in Directive 2002/
98/EC and the specific requirements set out in this Directive.

Autologous donations shall be clearly identified as such

2.
and shall be kept separate from allogeneic donations.

Article 8

Validation

Member States shall ensure that all
referred to in Annexes II to V are validated.

testing and processes

communicate to the Commission the text of those provisions
and a correlation table between those provisions and this Direc-
tive.

When Member States adopt those provisions, they shall contain
a reference to this Directive or be accompanied by such a refer-
ence on the occasion of their official publication. Member
States shall determine how such reference is to be made.

2. Member States shall communicate to the Commission the
text of the main provisions of national law which they adopt in
the field covered by this Directive.

Article 10

Entry into force

This Directive shall enter into force on the 20th day following
that of its publication in the Official Journal of the European
Union.

Article 11

Addressees

This Directive is addressed to the Member States.

Article 9

Transposition

Done at Brussels, 22 March 2004.

1. Without prejudice to Article 7 of Directive 2002/98/EC,
Member States shall bring into force the laws, regulations and
administrative provisions necessary to comply with this Direc-
tive by 8 February 2005 at the latest. They shall forthwith

For the Commission

David BYRNE

Member of the Commission

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ANNEX I

DEFINITIONS

(as referred to in Article 1)

1.

2.

‘Autologous donation’ means blood and blood components collected from an individual and intended solely for
subsequent autologous transfusion or other human application to that same individual.

‘Allogeneic donation’ means blood and blood components collected from an individual and intended for transfusion
to another individual, for use in medical devices or as starting material/raw material for manufacturing into medic-
inal products.

3.

‘Validation’ means the establishment of documented and objective evidence that the particular requirements for a
specific intended use can be consistently fulfilled.

4.

‘Whole blood’ means a single blood donation.

5.

‘Cryopreservation’ means prolongation of the storage life of blood components by freezing.

6.

7.

8.

‘Plasma’ means the liquid portion of the blood in which the cells are suspended. Plasma may be separated from the
cellular portion of a whole blood collection for therapeutic use as fresh-frozen plasma or further processed to cryo-
precipitate and cryoprecipitate-depleted plasma for transfusion. It may be used for the manufacture of medicinal
products derived from human blood and human plasma or used in the preparation of pooled platelets, or pooled,
leucocyte-depleted platelets. It may also be used for re-suspension of red cell preparations for exchange transfusion
or perinatal transfusion.

‘Cryoprecipitate’ means a plasma component prepared from plasma, fresh-frozen, by freeze-thaw precipitation of
proteins and subsequent concentration and re-suspension of the precipitated proteins in a small volume of the
plasma.

‘Washed’ means a process of removing plasma or storage medium from cellular products by centrifugation,
decanting of the supernatant liquid from the cells and addition of an isotonic suspension fluid, which in turn is
generally removed and replaced following further centrifugation of the suspension. The centrifugation, decanting,
replacing process may be repeated several times.

9.

‘Red cells’ means the red cells from a single whole blood donation, with a large proportion of the plasma from the
donation removed.

10.

‘Red cells, buffy coat removed’ means the red cells from a single whole blood donation, with a large proportion of
the plasma from the donation removed. The buffy coat, containing a large proportion of the platelets and leucocytes
in the donated unit, is removed.

11.

‘Red cells, leucocyte-depleted’ means the red cells from a single whole blood donation, with a large proportion of
the plasma from the donation removed, and from which leucocytes are removed.

12.

‘Red cells in additive solution’ means the red cells from a single whole blood donation, with a large proportion of
the plasma from the donation removed. A nutrient/preservative solution is added.

13.

‘Additive solution’ means a solution specifically formulated to maintain beneficial properties of cellular components
during storage.

14.

‘Red cells, buffy coat removed, in additive solution’ means the red cells from a single whole blood donation, with a
large proportion of the plasma from the donation removed. The buffy coat, containing a large proportion of the
platelets and leucocytes in the donated unit, is removed. A nutrient/preservative solution is added.

15.

‘Buffy coat’ means a blood component prepared by centrifugation of a unit of whole blood, and which contains a
considerable proportion of the leucocytes and platelets.

16.

‘Red cells, leucocyte-depleted, in additive solution’ means the red cells from a single whole blood donation, with a
large proportion of the plasma from the donation removed, and from which leucocytes are removed. A nutrient/
preservative solution is added.

17.

‘Red cells, apheresis’ means the red cells from an apheresis red cell donation.

18.

‘Apheresis’ means a method of obtaining one or more blood components by machine processing of whole blood in
which the residual components of the blood are returned to the donor during or at the end of the process.

19.

‘Platelets, apheresis’ means a concentrated suspension of blood platelets obtained by apheresis.

20.

‘Platelets, apheresis, leucocyte-depleted’ means a concentrated suspension of blood platelets, obtained by apheresis,
and from which leucocytes are removed.

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21.

‘Platelets, recovered, pooled’ means a concentrated suspension of blood platelets, obtained by processing of whole
blood units and pooling the platelets from the units during or after separation.

22.

‘Platelets, recovered, pooled, leucocyte-depleted’ means a concentrated suspension of blood platelets, obtained by
processing of whole blood units and pooling the platelets from the units during or after separation, and from which
leucocytes are removed.

23.

‘Platelets, recovered, single unit’ means a concentrated suspension of blood platelets, obtained by processing of a
single unit of whole blood.

24.

‘Platelets, recovered, single unit, leucocyte-depleted’ means a concentrated suspension of blood platelets, obtained by
processing of a single whole blood unit from which leucocytes are removed.

25.

‘Plasma, fresh-frozen’ means the supernatant plasma separated from a whole blood donation or plasma collected by
apheresis, frozen and stored.

26.

‘Plasma, cryoprecipitate-depleted for transfusion’ means a plasma component prepared from a unit of plasma, fresh-
frozen. It comprises the residual portion after the cryoprecipitate has been removed.

27.

‘Granulocytes, apheresis’ means a concentrated suspension of granulocytes obtained by apheresis.

28.

‘Statistical process control’ means a method of quality control of a product or a process that relies on a system of
analysis of an adequate sample size without the need to measure every product of the process.

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ANNEX II

INFORMATION REQUIREMENTS

(as referred to in Articles 2 and 3)

PART A

Information to be provided to prospective donors of blood or blood components

1. Accurate educational materials, which are understandable for members of the general public, about the essential
nature of blood, the blood donation procedure, the components derived from whole blood and apheresis donations,
and the important benefits to patients.

2. For both allogeneic and autologous donations, the reasons for requiring an examination, health and medical history,

and the testing of donations and the significance of ‘informed consent’.

For allogeneic donations, self-deferral, and temporary and permanent deferral, and the reasons why individuals are
not to donate blood or blood components if there could be a risk for the recipient.

For autologous donations, the possibility of deferral and the reasons why the donation procedure would not take
place in the presence of a health risk to the individual whether as donor or recipient of the autologous blood or
blood components.

3. Information on the protection of personal data: no unauthorised disclosure of the identity of the donor, of informa-

tion concerning the donor's health, and of the results of the tests performed.

4. The reasons why individuals are not to make donations which may be detrimental to their health.

5. Specific information on the nature of the procedures involved either in the allogeneic or autologous donation
process and their respective associated risks. For autologous donations, the possibility that the autologous blood and
blood components may not suffice for the intended transfusion requirements.

6. Information on the option for donors to change their mind about donating prior to proceeding further, or the
possibility of withdrawing or self-deferring at any time during the donation process, without any undue embarrass-
ment or discomfort.

7. The reasons why it is important that donors inform the blood establishment of any subsequent event that may

render any prior donation unsuitable for transfusion.

8. Information on the responsibility of the blood establishment to inform the donor, through an appropriate

mechanism, if test results show any abnormality of significance to the donor's health.

9. Information why unused autologous blood and blood components will be discarded and not transfused to other

patients.

10. Information that test results detecting markers for viruses, such as HIV, HBV, HCV or other relevant blood transmis-

sible microbiologic agents, will result in donor deferral and destruction of the collected unit.

11. Information on the opportunity for donors to ask questions at any time.

Information to be obtained from donors by blood establishments at every donation

PART B

1. Identification of the donor

Personal data uniquely, and without any risk of mistaken identity, distinguishing the donor, as well as contact details.

2. Health and medical history of the donor

Health and medical history, provided on a questionnaire and through a personal interview performed by a qualified
healthcare professional, that includes relevant factors that may assist in identifying and screening out persons whose
donation could present a health risk to others, such as the possibility of transmitting diseases, or health risks to them-
selves.

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3. Signature of the donor

Signature of the donor, on the donor questionnaire, countersigned by the health care staff member responsible for
obtaining the health history confirming that the donor has:

(a) read and understood the educational materials provided;

(b) had an opportunity to ask questions;

(c) been provided with satisfactory responses to any questions asked;

(d) given informed consent to proceed with the donation process;

(e) been informed, in the case of autologous donations, that the donated blood and blood components may not be

sufficient for the intended transfusion requirements; and

(f) acknowledged that all the information provided by the donor is true to the best of his/her knowledge.

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ANNEX III

ELIGIBILITY CRITERIA FOR DONORS OF WHOLE BLOOD AND BLOOD COMPONENTS

(as referred to in Article 4)

1.

ACCEPTANCE CRITERIA FOR DONORS OF WHOLE BLOOD AND BLOOD COMPONENTS

Under exceptional circumstances, individual donations from donors who do not comply with the following
criteria may be authorised by a qualified healthcare professional in the blood establishment. All such cases
must be clearly documented and subject to the quality management provisions in Articles 11, 12, and 13 of
Directive 2002/98/EC.

The following criteria do not apply to autologous donations.

1.1. Age and body weight of donors

Age

18 to 65 years

17 to 18 years

— unless classified as a minor by law, or
with written consent of parent or legal
guardian in accordance with law

First time donors over 60 years

— at the discretion of the physician in the

blood establishment

Over 65 years

— with permission of the physician in the
blood establishment, given annually

Body weight

≥ 50 kg for donors either of whole blood or apheresis blood components

1.2. Haemoglobin levels in donor's blood

Haemoglobin

for females
≥ 125 g/l

for males
≥ 135 g/l

1.3.

Protein levels in donor's blood

Applicable
donors
whole blood and cellular components

allogeneic

to

of

Protein

≥ 60 g/l

The protein analysis for apheresis plasma donations must be performed at
least annually

1.4.

Platelet levels in donor's blood

Platelets

Platelet number greater than or equal to
150 × 109/l

Level required for apheresis platelet donors

2.

DEFERRAL CRITERIA FOR DONORS OF WHOLE BLOOD AND BLOOD COMPONENTS

The tests and deferral periods indicated by an asterisk (*) are not required when the donation is used exclu-
sively for plasma for fractionation.

2.1.

Permanent deferral criteria for donors of allogeneic donations

Cardiovascular disease

Prospective donors with active or past serious cardiovascular
disease, except congenital abnormalities with complete cure

Central nervous system disease

A history of serious CNS disease

Abnormal bleeding tendency

Prospective donors who give a history of a coagulopathy

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Repeated episodes of syncope, or a history
of convulsions

Other than childhood convulsions or where at least three years
have elapsed since the date the donor last took anticonvulsant
medication without any recurrence of convulsions

Gastrointestinal, genitourinary, haemato-
logical,
immunological, metabolic, renal,
or respiratory system diseases

Prospective donors with serious active, chronic, or
disease

relapsing

Diabetes

If being treated with insulin

Infectious diseases

Hepatitis B, except for HBsAg-negative persons who are demon-
strated to be immune

Hepatitis C

HIV-1/2

HTLV I/II

Babesiosis (*)

Kala Azar (visceral leishmaniasis) (*)

Trypanosomiasis cruzi (Chagas' disease) (*)

Malignant diseases

Except in situ cancer with complete recovery

Transmissible
thies
(TSEs),
Disease,
Disease)

spongiform encephalopa-
Jakob
(e.g. Creutzfeldt
Jakob
Creutzfeldt

variant

Persons who have a family history which places them at risk of
developing a TSE, or persons who have received a corneal or dura
mater graft, or who have been treated in the past with medicines
made from human pituitary glands. For variant Creutzfeldt Jacob
disease, further precautionary measures may be recommended.

Intravenous (IV) or intramuscular (IM)
drug use

Any history of non-prescribed IV or IM drug use, including body-
building steroids or hormones

Xenotransplant recipients

Sexual behaviour

Persons whose sexual behaviour puts
them at high risk of
acquiring severe infectious diseases that can be transmitted by
blood

2.2.

Temporary deferral criteria for donors of allogeneic donations

2.2.1. Infections

Du r a ti on of de fe r r a l p e r i o d

After an infectious illness, prospective donors shall be deferred for at least two weeks following the date of full
clinical recovery.

However, the following deferral periods shall apply for the infections listed in the table:

Brucellosis (*)

Osteomyelitis

Q fever (*)

Syphilis (*)

2 years following the date of full recovery

2 years after confirmed cured

2 years following the date of confirmed cured

1 year following the date of confirmed cured

Toxoplasmosis (*)

6 months following the date of clinical recovery

Tuberculosis

2 years following the date of confirmed cured

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Rheumatic fever

2 years following the date of cessation of symptoms, unless
evidence of chronic heart disease

Fever > °C

2 weeks following the date of cessation of symptoms

Flu-like illness

2 weeks after cessation of symptoms

Malaria (*)

— individuals who have lived in a malarial
area within the first five years of life

3 years following return from last visit
provided person remains symptom free;
may be reduced to 4 months if an immunologic or molecular
genomic test is negative at each donation

to any endemic area,

— individuals with a history of malaria

3 years following cessation of treatment and absence of symptoms.
Accept thereafter only if an immunologic or molecular genomic
test is negative

— asymptomatic visitors to endemic areas

6 months after leaving the endemic area unless an immunologic or
molecular genomic test is negative

— individuals with a history of undiag-
nosed febrile illness during or within six
months of a visit to an endemic area

3 years following resolution of symptoms;
may be reduced to 4 months if an immunologic or molecular test
is negative

West Nile Virus (WNV) (*)

28 days after leaving an area with ongoing transmission of WNV
to humans

2.2.2. Exposure to risk of acquiring a transfusion-transmissible infection

Defer for 6 months, or for 4 months provided a NAT
test for hepatitis C is negative

— Endoscopic examination using flexible instruments,
— mucosal splash with blood or needlestick injury,
— transfusion of blood components,
— tissue or cell transplant of human origin,
— major surgery,
— tattoo or body piercing,
— acupuncture unless performed by a qualified practi-

tioner and with sterile single-use needles,

— persons at risk due to close household contact with

persons with hepatitis B.

Persons whose behaviour or activity places them at risk
of acquiring infectious diseases that may be transmitted
by blood.

Defer after cessation of risk behaviour for a period
determined by the disease in question, and by the avail-
ability of appropriate tests

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2.2.3. Vaccination

Attenuated viruses or bacteria

4 weeks

Inactivated/killed viruses, bacteria or rickettsiae

No deferral if well

Toxoids

No deferral if well

Hepatitis A or hepatitis B vaccines

No deferral if well and if no exposure

Rabies

No deferral if well and if no exposure
If vaccination is given following exposure defer for one
year

Tick-borne encephalitis vaccines

No deferral if well and if no exposure

2.2.4. Other temporary deferrals

Pregnancy

Minor surgery

Dental treatment

Medication

6 months after delivery or termination, except in exceptional circum-
stances and at the discretion of a physician

1 week

Minor treatment by dentist or dental hygienist — defer until next day
(NB: Tooth extraction, root-filling and similar treatment is considered as
minor surgery)

Based on the nature of the prescribed medicine, its mode of action and the
disease being treated

2.3. Deferral for particular epidemiological situations

Particular
outbreaks)

epidemiological

situations

(e.g.

disease

Deferral consistent with the epidemiological situation
(These deferrals should be notified by the competent
authority to the European Commission with a view to
Community action)

2.4. Deferral criteria for donors of autologous donations

Serious cardiac disease

Depending on the clinical setting of the blood collec-
tion

Persons with or with a history of
— hepatitis B, except for HBsAg-negative persons who

Member States may, however, establish specific provi-
sions for autologous donations by such persons

are demonstrated to be immune

— hepatitis C
— HIV-1/2
— HTLV I/II

Active bacterial infection

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ANNEX IV

STORAGE, TRANSPORT AND DISTRIBUTION CONDITIONS FOR BLOOD AND BLOOD COMPONENTS

(as referred to in Article 5)

1.

STORAGE

1.1. Liquid storage

Component

Temperature of storage

Maximum storage time

Red cell preparations and whole
blood (if used for transfusion as
whole blood)

+ 2 to + 6 °C

Platelet preparations

+ 20 to + 24 °C

28 to 49 days according to the processes
used for collection, processing and storage

5 days; may be stored for 7 days
in
conjunction with detection or reduction of
bacterial contamination

Granulocytes

+ 20 to + 24 °C

24 hours

1.2. Cryopreservation

Component

Storage conditions and duration

Red blood cells

Up to 30 years according to processes used for collection, processing and storage

Platelets

Up to 24 months according to processes used for collection, processing and storage

Plasma and cryoprecipitate

Up to 36 months according to processes used for collection, processing and storage

Cryopreserved red blood cells and platelets must be formulated in a suitable medium after thawing. The allow-
able storage period after thawing to depend on the method used.

2.

TRANSPORT AND DISTRIBUTION

Transport and distribution of blood and blood components at all stages of the transfusion chain must be under
conditions that maintain the integrity of the product.

3. ADDITIONAL REQUIREMENTS FOR AUTOLOGOUS DONATIONS

3.1. Autologous blood and blood components must be clearly identified as such and stored, transported and distributed

separately from allogeneic blood and blood components.

3.2. Autologous blood and blood components must be labelled as required by Directive 2002/98/EC and in addition
the label must include the identification of the donor and the warning ‘FOR AUTOLOGOUS TRANSFUSION
ONLY’.

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ANNEX V

QUALITY AND SAFETY REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS

(as referred to in Article 6)

1.

THE BLOOD COMPONENTS

1. Red cell preparations

The components listed in points 1.1 to 1.8 may be further processed within blood
establishments and must be labelled accordingly

1.1

1.2

1.3

1.4

1.5

1.6

1.7

1.8

Red cells

Red cells, buffy coat removed

Red cells, leucocyte-depleted

Red cells, in additive solution

Red cells, buffy coat removed, in additive solution

Red cells, leucocyte-depleted, in additive solution

Red cells, apheresis

Whole blood

2. Platelet preparations

The components listed in points 2.1 to 2.6 may be further processed within blood
establishments and must be labelled accordingly

2.1

2.2

2.3

2.4

2.5

2.6

Platelets, apheresis

Platelets, apheresis, leucocyte-depleted

Platelets, recovered, pooled

Platelets, recovered, pooled, leucocyte-depleted

Platelets, recovered, single unit

Platelets, recovered, single unit, leucocyte-depleted

3. Plasma preparations

The components listed in 3.1 to 3.3 may be further processed within blood estab-
lishments and must be labelled accordingly.

3.1

3.2

3.3

4.

Fresh-frozen plasma

Fresh-frozen plasma, cryoprecipitate-depleted

Cryoprecipitate

Granulocytes, apheresis

5. New components

Quality and safety requirements for new blood components must be regulated by
the competent national authority. Such new components must be notified to the
European Commission with a view to Community action

2. QUALITY CONTROL REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS

2.1. Blood and blood components must comply with the following technical quality measurements and meet the accep-

table results.

2.2. Appropriate bacteriological control of the collection and manufacturing process must be performed.

2.3. Member States must take all necessary measures to ensure that all imports of blood and blood components from
third countries, including those used as starting material/raw material for the manufacture of medicinal products
derived from human blood or human plasma, shall meet equivalent standards of quality and safety to the ones laid
down in this Directive.

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2.4. For autologous donations, the measures marked with an asterisk (*) are recommendations only.

Component

Quality measurements
required
The required frequency of
sampling for all measurements
shall be determined using statis-
tical process control

Acceptable results for quality measurements

Red cells

Volume

Valid for storage characteristics to maintain product
within specifications for haemoglobin and haemolysis

Haemoglobin (*)

Not less than 45 g per unit

Haemolysis

Less than 0,8 % of red cell mass at the end of the shelf
life

Red cells, buffy
removed

coat

Volume

Valid for storage characteristics to maintain product
within specifications for haemoglobin and haemolysis

Haemoglobin (*)

Not less than 43 g per unit

Haemolysis

Less than 0,8 % of red cell mass at the end of the shelf
life

cells,

Red
depleted

leucocyte-

Volume

Valid for storage characteristics to maintain product
within specifications for haemoglobin and haemolysis

Haemoglobin (*)

Not less than 40 g per unit

Leucocyte content

Less than 1 × 106 per unit

Haemolysis

Less than 0,8 % of red cell mass at the end of the shelf
life

Red cells,
solution

in additive

Volume

Valid for storage characteristics to maintain product
within specifications for haemoglobin and haemolysis

Red cells, buffy
removed,
solution

in

coat
additive

Haemoglobin (*)

Not less than 45 g per unit

Haemolysis

Volume

Less than 0,8 % of red cell mass at the end of the shelf
life

Valid for storage characteristics to maintain product
within specifications for haemoglobin and haemolysis

Haemoglobin (*)

Not less than 43 g per unit

Haemolysis

Less than 0,8 % of red cell mass at the end of the shelf
life

cells,

Red
depleted,
solution

leucocyte-
additive

in

Volume

Valid for storage characteristics to maintain product
within specifications for haemoglobin and haemolysis

Haemoglobin (*)

Not less than 40 g per unit

Leucocyte content

Less than 1 × 106 per unit

Haemolysis

Less than 0,8 % of red cell mass at the end of the shelf
life

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Component

Quality measurements
required
The required frequency of
sampling for all measurements
shall be determined using statis-
tical process control

Acceptable results for quality measurements

Red cells, apheresis

Volume

Valid for storage characteristics to maintain product
within specifications for haemoglobin and haemolysis

Haemoglobin (*)

Not less than 40 g per unit

Haemolysis

Less than 0,8 % of red cell mass at the end of the shelf
life

Whole blood

Volume

Valid for storage characteristics to maintain product
within specifications for haemoglobin and haemolysis
450 ml +/- 50ml
For paediatric autologous whole blood collections — not
to exceed 10,5 ml per kg body weight

Haemoglobin (*)

Not less than 45 g per unit

Haemolysis

Less than 0,8 % of red cell mass at the end of the shelf
life

Platelets, apheresis

Volume

Valid for storage characteristics to maintain product
within specifications for pH

Platelet content

Variations in platelet content per single donation are
that comply with validated
permitted within limits
preparation and preservation conditions

pH

6,4 – 7,4 corrected for 22 °C, at the end of the shelf life

Platelets,
leucocyte-depleted

apheresis,

Volume

Valid for storage characteristics to maintain product
within specifications for pH

Platelet content

Variations in platelet content per single donation are
permitted within limits
that comply with validated
preparation and preservation conditions

Leucocyte content

Less than 1 × 106 per unit

pH

6,4 – 7,4 corrected for 22 °C, at the end of the shelf life

Platelets,
pooled

recovered,

Volume

Valid for storage characteristics to maintain product
within specifications for pH

Platelet content

Variations in platelet content per pool are permitted
within limits that comply with validated preparation and
preservation conditions

Leucocyte content

Less than 0,2 × 109 per single unit (platelet-rich plasma
method)
Less than 0,05 × 109 per single unit (buffy coat method)

pH

6,4 – 7,4 corrected for 22 °C, at the end of the shelf life

30.3.2004

EN

Official Journal of the European Union

L 91/39

Component

Quality measurements
required
The required frequency of
sampling for all measurements
shall be determined using statis-
tical process control

Platelets,
pooled,
depleted

recovered,
leucocyte-

Volume

Platelet content

Acceptable results for quality measurements

Valid for storage characteristics to maintain product
within specifications for pH

Variations in platelet content per pool are permitted
within limits that comply with validated preparation and
preservation conditions

Leucocyte content

Less than 1 × 106 per pool

pH

6,4 – 7,4 corrected for 22 °C, at the end of the shelf life

Platelets,
single unit

recovered,

Volume

Valid for storage characteristics to maintain product
within specifications for pH

Platelets,
single unit,
depleted

recovered,
leucocyte-

Platelet content

Leucocyte content

pH

Volume

Platelet content

Variations in platelet content per single unit are permitted
within limits that comply with validated preparation and
preservation conditions

Less than 0,2 × 109 per single unit (platelet-rich plasma
method)
Less than 0,05 × 109 per single unit (buffy coat method)

6,4 – 7,4 corrected for 22 °C, at the end of the shelf life

Valid for storage characteristics to maintain product
within specifications for pH

Variations in platelet content per single unit are permitted
within limits that comply with validated preparation and
preservation conditions

Leukocyte content

Less than 1 × 106 per unit

pH

6, 4 — 7,4 corrected for 22 °C, at the end of the shelf life

Plasma, fresh-frozen

Volume

Stated volume +/- 10 %

Factor VIIIc (*)

Average (after freezing and thawing): 70 % or more of
the value of the freshly collected plasma unit

Total protein (*)

Not less than 50 g/l

Residual cellular content (*) Red cells: less than 6,0 × 109/l

Plasma,
cryoprecipitate-depleted

fresh-frozen,

Volume

Leucocytes: less than 0, 1 × 109/l
Platelets: less than 50 × 109/l

Stated volume: +/- 10 %

Residual cellular content (*) Red cells: less than 6,0 × 109/l

Leucocytes: less than 0,1 × 109/l
Platelets: less than 50 × 109/l

Cryoprecipitate

Fibrinogen content (*)

Greater than or equal to 140 mg per unit

Factor VIIIc content (*)

Greater than or equal to 70 international units per unit

Granulocytes, apheresis

Volume

Less than 500 ml

Granulocyte content

Greater than 1 × 1010 granulocytes per unit