EN ISO 8871:1997/A1:1999
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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ELASTOMERIC PARTS FOR AQUEOUS PARENTERAL PREPARATIONS
01-05-2004
12-01-2013
1 Scope
2 Normative references
3 Classification
4 Identification
5 Requirements
6 Testing
7 Packaging
8 Storage
9 Marking and labelling
Annexes
A Ultraviolet spectrometry of extracts
A.1 Principle
A.2 Procedure
A.3 Expression of results
B Infra-red spectrometry of pyrolysates
B.1 Principle
B.2 Procedure
B.3 Expression of results
C Determination of extracted reducing matter (oxidizables)
C.1 Principle
C.2 Reagents
C.3 Procedure
C.4 Expression of results
D Determination of extracted heavy metals
D.1 Principle
D.2 Reagents
D.3 Procedure
D.4 Expression of results
E Determination of extracted ammonia
E.1 Principle
E.2 Reagents
E.3 Procedure
E.4 Expression of results
F Determination of extracted halides
F.1 Principle
F.2 Reagents
F.3 Procedure
F.4 Expression of results
G Determination of acidity and alkalinity
G.1 Principle
G.2 Reagents
G.3 Procedure
G.4 Expression of results
H Determination of extracted non-volatile solids
H.1 Principle
H.2 Procedure
H.3 Expression of results
J Determination of volatile sulfides
J.1 Principle
J.2 Reagents
J.3 Procedure
J.4 Expression of results
K Determination of extracted zinc
K.1 Principle
K.2 Reagents
K.3 Procedure
K.4 Expression of results
L Determination of conductivity
L.1 Principle
L.2 Procedure
L.3 Expression of results
M Determination of turbidity
M.1 Principle
M.2 Reagents
M.3 Procedure
M.4 Expression or results
Annex ZA (normative) Normative references to international
publications with their relevant European publications
National Annex NA (informative) Amendment 1: 1995 to
ISO 8871:1990
Specifies methods for identification and classification of elastomeric parts for primary packs and medical devices for use in direct contact with aqueous preparations for parenteral use, including dry preparations requiring dissolving prior to use.
Committee |
CEN/TC205
|
DevelopmentNote |
Supersedes EN 28871. (03/2008)
|
DocumentType |
Standard
|
PublisherName |
Comite Europeen de Normalisation
|
Status |
Superseded
|
SupersededBy | |
Supersedes |
Standards | Relationship |
SNV DIN ISO 8871 : 90 AMD 1 1996 | Identical |
BS EN ISO 8871:1997 | Identical |
NEN EN ISO 8871 : 1997 AMD 1 1999 | Identical |
SNV NF EN ISO 8871 : 1997 | Identical |
NF EN ISO 8871 : 97 AMD 1 99 | Identical |
NBN EN ISO 8871 : 97 AMD 1 99 | Identical |
UNE EN ISO 8871 : 98 A1 99 | Identical |
NS EN ISO 8871 : 97 AMD 1 99 | Identical |
UNI EN ISO 8871 : 2000 | Identical |
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