
BS EN ISO 8871-1:2004
Current
The latest, up-to-date edition.

Elastomeric parts for parenterals and for devices for pharmaceutical use Extractables in aqueous autoclavates
Hardcopy , PDF
English
08-09-2004
FOREWORD
1 Scope
2 Normative reference
3 Terms and definitions
4 Symbols
5 Currents during two separate simultaneous line-to-earth
short circuits
5.1 Calculation method
5.1.1 Initial symmetrical short-circuit current
5.1.2 Peak short-circuit current, symmetrical
short-circuit breaking current and steady-state
short-circuit current
5.1.3 Distribution of line-to-earth short-circuit
currents during two separate simultaneous
line-to-earth short circuits
6 Partial short-circuit currents flowing through earth in
the case of an unbalanced short circuit
6.1 Calculation method
6.1.1 General
6.1.2 Line-to-earth short circuit in a station
6.1.3 Line-to-earth short circuit far outside a station
6.1.4 Line-to-earth short circuit in the vicinity of a
station
6.1.5 Reduction factor for overhead lines and cables
Annex A (informative) Example for the calculation of two
separate simultaneous line-to-earth
short-circuit currents
Annex B (informative) Examples for the calculation of partial
short-circuit currents through earth
Annex ZA (normative) Normative references to international
publications with their corresponding
European publications
Describes procedures for classifying elastomeric parts for primary packs and medical devices used in direct contact with preparations for parenteral use, including both aqueous preparations and dry preparations which have to be dissolved before use.
Committee |
CH/212
|
DevelopmentNote |
Together with BS EN ISO 8871-2 and BS EN ISO 8871-3 it supersedes BS EN ISO 8871. Supersedes 00/560949 DC. (09/2004)
|
DocumentType |
Standard
|
Pages |
32
|
PublisherName |
British Standards Institution
|
Status |
Current
|
Supersedes |
1.1 This part of ISO8871 defines procedures for classifying elastomeric parts for primary packs and medical devices used in direct contact with preparations for parenteral use, including both aqueous preparations and dry preparations which have to be dissolved before use.
It specifies a series of comparative test methods for chemical evaluation by the determination of extractables in aqueous autoclavates (see Clause4) and describes the various fields of application for elastomeric parts. Dimensions and functional characteristics are specified in the relevant International Standards. Required properties as specified in this part of ISO8871 are regarded as minimum requirements.
1.2 This part of ISO8871 is applicable for the categories of elastomeric parts given in Clause3; specific requirements, however, are laid down in the relevant International Standards dealing with the items or devices listed in Clause3.
Elastomeric parts for empty syringes for single use are excluded from the scope of this part of ISO8871 as they are not in contact with the injected preparation for a significant length of time.
1.3 Compatibility studies with the intended preparation have to be performed before the approval for final use can be given; however, this part of ISO8871 does not specify procedures for carrying out compatibility studies.
Standards | Relationship |
DIN EN ISO 8871-1:2004-11 | Identical |
EN ISO 8871-1:2004 | Identical |
NEN EN ISO 8871-1 : 2004 | Identical |
UNI EN ISO 8871-1 : 2006 | Identical |
ISO 8871-1:2003 | Identical |
NF EN ISO 8871-1 : 2005 | Identical |
UNE-EN ISO 8871-1:2005 | Identical |
NBN EN ISO 8871-1 : 2004 | Identical |
SN EN ISO 8871-1 : 2005 | Identical |
NS EN ISO 8871-1 : 1ED 2004 | Identical |
I.S. EN ISO 8871-1:2004 | Identical |
ISO 11040-2:2011 | Prefilled syringes Part 2: Plunger stoppers for dental local anaesthetic cartridges |
ISO 8362-2:2015 | Injection containers and accessories — Part 2: Closures for injection vials |
ISO 8536-2:2010 | Infusion equipment for medical use — Part 2: Closures for infusion bottles |
ISO 11040-5:2012 | Prefilled syringes — Part 5: Plunger stoppers for injectables |
ISO 8871-3:2003 | Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 3: Determination of released-particle count |
EN 28362-2 : 1993 | INJECTION CONTAINERS FOR INJECTABLES AND ACCESSORIES - CLOSURES FOR INJECTION VIALS |
ISO 8871-2:2003 | Elastomeric parts for parenterals and for devices for pharmaceutical use Part 2: Identification and characterization |
ISO 8536-6:2016 | Infusion equipment for medical use — Part 6: Freeze drying closures for infusion bottles |
ISO 7886-1:2017 | Sterile hypodermic syringes for single use — Part 1: Syringes for manual use |
ISO 8362-5:2016 | Injection containers and accessories Part 5: Freeze drying closures for injection vials |
ISO 3696:1987 | Water for analytical laboratory use — Specification and test methods |
ISO 247:2006 | Rubber Determination of ash |
ISO 48:2010 | Rubber, vulcanized or thermoplastic Determination of hardness (hardness between 10 IRHD and 100 IRHD) |
ISO 2781:2008 | Rubber, vulcanized or thermoplastic Determination of density |
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