BS EN ISO 8871-1:2004

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.

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.