Protocol to the European Agreement on the Exchange of Blood-grouping Reagents (21987A0207(05))
Protocol to the European Agreement on the Exchange of Blood-grouping Reagents
- PROTOCOL TO THE EUROPEAN AGREEMENT
- on the Exchange of Blood-grouping Reagents
- GENERAL PROVISIONS
- 1.
- Specificity
- 2.
- Potency
- 3.
- International Standards and International Units
- 4.
- Stability and expiry date
- 5.
- Preservation
- 6.
- Coloration
- 7.
- Dispensing and volume
- 8.
- Records and samples
- 9.
- Classification of reagents
- 10.
- Labels, leaflets and certificates
- SPECIFIC PROVISIONS
- A. BLOOD-GROUPING SERA OF HUMAN ORIGIN
- (a) SERA OF HUMAN ORIGIN FOR AB0 GROUPING
- (i)
- Anti-A blood-grouping serum (human)
- Potency
- Titration
- Determination of avidity
- (ii)
- Anti-B blood-grouping serum (human)
- Potency
- Titration
- Determination of avidity
- (iii)
- Anti-A + Anti-B (group 0) blood-grouping serum (human)
- Potency
- Titration
- Determination of avidity
- (b) SERA OF HUMAN ORIGIN FOR Rh GROUPING
- (i)
- Anti-D (anti-Rh
- o
- ) blood-grouping serum (human)
- Potency
- Titration
- Determination of avidity
- (ii)
- Anti-C (anti Rh′) blood-grouping serum (human)
- Potency
- Titration
- Determination of avidity
- (iii)
- Anti-E (anti-rh″) blood-grouping serum (human)
- Potency
- Titration
- Determination of avidity
- B. REAGENTS OF NON-HUMAN ORIGIN
- (a) SERA OF ANIMAL ORIGIN
- (i)
- Anti-A blood-grouping serum (animal)
- Potency
- Titration
- Determination of avidity
- (ii)
- Anti-B blood-grouping serum (animal)
- Potency
- Titration
- Determination of avidity
- (iii)
- Anti-human-globulin serum (animal)
- (4)
- Specificity
- Potency
- Titration
- (b) BLOOD-GROUPING REAGENTS OF VEGETABLE ORIGIN
- (i)
- Anti-A blood-grouping reagent (vegetable)
- Potency
- Titration
- Determination of avidity
- (ii)
- Anti-B blood-grouping reagent (vegetable)
- Potency
- Titration
- Determination of avidity
- EXEMPLES D'ÉTIQUETTE
- EXAMPLES OF LABEL
- CONSEIL DE L'EUROPE
- COUNCIL OF EUROPE
- ACCORD EUROPÉEN RELATIF A L'ÉCHANGE DES RÉACTIFS POUR LA DETERMINATION DES GROUPES SANGUINS
- EUROPEAN AGREEMENT ON THE EXCHANGE OF BLOOD-GROUPING REAGENTS
- EXEMPLE DE NOTICE
- CONSEIL DE L'EUROPE
- ACCORD EUROPÉEN RELATIF À L'ÉCHANGE DES RÉACTIFS POUR LA DÉTERMINATION DES GROUPES SANGUINS
- EXAMPLE OF LEAFLET
- COUNCIL OF EUROPE
- EUROPEAN AGREEMENT ON THE EXCHANGE OF BLOOD-GROUPING REAGENTS
- ANNEXE AU PROTOCOLE
- ANNEX TO THE PROTOCOL
- CONSEIL DE L'EUROPE
- COUNCIL OF EUROPE
- ACCORD EUROPÉEN RELATIF À L'ÉCHANGE DES RÉACTIFS POUR LA DÉTERMINATION DE GROUPES SANGUINS
- EUROPEAN AGREEMENT ON THE EXCHANGE OF BLOOD-GROUPING REAGENTS
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