ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 1: EXTRACTABLE IN AQUEOUS AUTOCLAVATES

Available format(s)

Hardcopy , PDF

Language(s)

German

Published date

01-01-2004

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

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

This standard is included in DIN Handbook 231. 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.

DevelopmentNote	Supersedes DIN 58367-2 and DIN ISO 8871 (11/2004)
DocumentType	Standard
Pages	32
PublisherName	German Institute for Standardisation (Deutsches Institut für Normung)
Status	Current
Supersedes	DIN 58367-2:1996-06 DIN ISO 8871 : 1990 AMD 1 1996

Standards	Relationship
ISO 8871-1:2003	Identical
NF EN ISO 8871-1 : 2005	Identical
NBN EN ISO 8871-1 : 2004	Identical
NEN EN ISO 8871-1 : 2004	Identical
NS EN ISO 8871-1 : 1ED 2004	Identical
I.S. EN ISO 8871-1:2004	Identical
SN EN ISO 8871-1 : 2005	Identical
UNI EN ISO 8871-1 : 2006	Identical
UNE-EN ISO 8871-1:2005	Identical
BS EN ISO 8871-1:2004	Identical
EN ISO 8871-1 : 2004	Identical

DIN ISO 8536-6:2017-09	INFUSION EQUIPMENT FOR MEDICAL USE - PART 6: FREEZE DRYING CLOSURES FOR INFUSION BOTTLES (ISO 8536-6:2016)
DIN ISO 8536-6:2012-09	INFUSION EQUIPMENT FOR MEDICAL USE - PART 6: FREEZE DRYING CLOSURES FOR INFUSION BOTTLES (ISO 8536-6:2016)
DIN EN ISO 8362-5 E : 2016	INJECTION CONTAINERS AND ACCESSORIES - PART 5: FREEZE DRYING CLOSURES FOR INJECTION VIALS (ISO 8362-5:2016)
DIN ISO 11040-4 E : 2017	PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING (ISO 11040-4:2015)
DIN ISO 11040-2 E : 2012	PREFILLED SYRINGES - PART 2: PLUNGER STOPPERS FOR DENTAL LOCAL ANAESTHETIC CARTRIDGES (ISO 11040-2:2011)
DIN EN ISO 8362-2:2016-02	Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-2:2015)
DIN EN ISO 8871-2:2014-08	ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 2: IDENTIFICATION AND CHARACTERIZATION (ISO 8871-2:2003 + AMD.1:2005)
DIN ISO 8362-5:2011-06	INJECTION CONTAINERS AND ACCESSORIES - PART 5: FREEZE DRYING CLOSURES FOR INJECTION VIALS
DIN ISO 15759:2006-05	Medical infusion equipment - Plastics caps with inserted elastomeric liner for containers manufactured by the blow-fill-seal (BFS) process (ISO 15759:2005)
DIN ISO 11040-5:2013-12	PREFILLED SYRINGES - PART 5: PLUNGER STOPPERS FOR INJECTABLES (ISO 11040-5:2012)
DIN EN ISO 8362-5:2016-07	INJECTION CONTAINERS AND ACCESSORIES - PART 5: FREEZE DRYING CLOSURES FOR INJECTION VIALS (ISO 8362-5:2016)
DIN HDBK 231 : 4ED 2012
DIN ISO 11040-5 E : 2013	PREFILLED SYRINGES - PART 5: PLUNGER STOPPERS FOR INJECTABLES (ISO 11040-5:2012)
DIN ISO 11040-2:2012-10	Prefilled syringes - Part 2: Plunger stoppers for dental local anaesthetic cartridges (ISO 11040-2:2011)
DIN ISO 8536-12:2013-04	Infusion equipment for medical use - Part 12: Check valves (ISO 8536-12:2007 + Amd. 1:2012)
DIN ISO 11040-4:2007-10	PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING (ISO 11040-4:2015)
DIN EN ISO 8536-2:2010-08	Infusion equipment for medical use - Part 2: Closures for infusion bottles (ISO 8536-2:2010)
DIN ISO 11040-4:2017-07	PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING (ISO 11040-4:2015)
DIN ISO 13926-2:2012-09	PEN SYSTEMS - PART 2: PLUNGER STOPPERS FOR PEN-INJECTORS FOR MEDICAL USE (ISO 13926-2:2011)

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DIN EN ISO 8871-1:2004-11

ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 1: EXTRACTABLE IN AQUEOUS AUTOCLAVATES

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Abstract

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International Equivalents

Standards Referenced By This Book

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