ISO 8871-1:2003
Current
Current
The latest, up-to-date edition.
Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 1: Extractables in aqueous autoclavates
Available format(s)
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
Language(s)
English, French, Russian
Published date
19-09-2003
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ISO 8871-1:2003 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 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 ISO 8871 are regarded as minimum requirements.
Elastomeric parts for empty syringes for single use are excluded from the scope of this part of ISO 8871 as they are not in contact with the injected preparation for a significant length of time.
Compatibility studies with the intended preparation have to be performed before the approval for final use can be given; however, this part of ISO 8871 does not specify procedures for carrying out compatibility studies.
| Committee |
ISO/TC 76
|
| DevelopmentNote |
Supersedes ISO/DIS 8871-1 (09/2003) Together with ISO 8871-2, ISO 8871-3, ISO 8871-4 and ISO 8871-5, supersedes ISO 8871. (08/2005)
|
| DocumentType |
Standard
|
| Pages |
19
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| GOST R ISO 8871-1 : 2010 | Identical |
| NF EN ISO 8871-1 : 2005 | Identical |
| NBN EN ISO 8871-1 : 2004 | Identical |
| NEN EN ISO 8871-1 : 2004 | Identical |
| NEN ISO 8871-1 : 2003 | Identical |
| NS EN ISO 8871-1 : 1ED 2004 | Identical |
| I.S. EN ISO 8871-1:2004 | Identical |
| PN EN ISO 8871-1 : 2005 | 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 EN ISO 8871-1:2004-11 | Identical |
| ISO 11040-5:2012 | Prefilled syringes — Part 5: Plunger stoppers for injectables |
| 00/560909 DC : DRAFT MAR 2000 | BS ISO 8871-2 - ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 2: IDENTIFICATION AND CHARACTERIZATION |
| BS ISO 11040-5:2012 | Prefilled syringes Plunger stoppers for injectables |
| 08/30172620 DC : DRAFT OCT 2008 | BS EN ISO 8536-6 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 6: FREEZE DRYING CLOSURES FOR INFUSION BOTTLES |
| BS ISO 11040-3:2012 | Prefilled syringes Seals for dental local anaesthetic cartridges |
| UNE-EN ISO 8362-5:2016 | Injection containers and accessories - Part 5: Freeze drying closures for injection vials (ISO 8362-5:2016) |
| BS ISO 13926-3:2012 | Pen systems Seals for pen-injectors for medical use |
| UNI EN ISO 8871-2 : 2014 | ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 2: IDENTIFICATION AND CHARACTERIZATION |
| DIN ISO 8536-6:2017-09 | INFUSION EQUIPMENT FOR MEDICAL USE - PART 6: FREEZE DRYING CLOSURES FOR INFUSION BOTTLES (ISO 8536-6:2016) |
| ONORM EN ISO 8536-2 : 2010 | INFUSION EQUIPMENT FOR MEDICAL USE - PART 2: CLOSURES FOR INFUSION BOTTLES |
| NF EN ISO 8536-2 : 2010 | INFUSION EQUIPMENT FOR MEDICAL USE - PART 2: CLOSURES FOR INFUSION BOTTLES |
| DIN ISO 8536-6:2012-09 | INFUSION EQUIPMENT FOR MEDICAL USE - PART 6: FREEZE DRYING CLOSURES FOR INFUSION BOTTLES (ISO 8536-6:2016) |
| 10/30218554 DC : 0 | BS ISO 13926-3 - PEN SYSTEMS - PART 3: SEALS FOR PEN-INJECTORS FOR MEDICAL USE |
| BS ISO 11040-2:2011 | Prefilled syringes Plunger stoppers for dental local anaesthetic cartridges |
| 10/30216808 DC : 0 | BS ISO 11040-3 - PREFILLED SYRINGES - PART 3: SEALS FOR DENTAL LOCAL ANAESTHETIC CARTRIDGES |
| 17/30357741 DC : 0 | BS ISO 11040-6 - PREFILLED SYRINGES - PART 6: PLASTIC BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING |
| BS ISO 11040-4:2015 | Prefilled syringes Glass barrels for injectables and sterilized subassembled syringes ready for filling |
| ISO 11040-3:2012 | Prefilled syringes — Part 3: Seals for dental local anaesthetic cartridges |
| I.S. EN ISO 8536-2:2010 | INFUSION EQUIPMENT FOR MEDICAL USE - PART 2: CLOSURES FOR INFUSION BOTTLES |
| 13/30273499 DC : 0 | BS ISO 11040-4 - PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING |
| DIN EN ISO 8362-2:2016-02 | Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-2:2015) |
| BS ISO 8536-12 : 2007 | INFUSION EQUIPMENT FOR MEDICAL USE - PART 12: CHECK VALVES |
| DIN ISO 8362-5:2011-06 | INJECTION CONTAINERS AND ACCESSORIES - PART 5: FREEZE DRYING CLOSURES FOR INJECTION VIALS |
| DIN ISO 11040-5:2013-12 | PREFILLED SYRINGES - PART 5: PLUNGER STOPPERS FOR INJECTABLES (ISO 11040-5:2012) |
| BS EN ISO 8362-5:2016 | Injection containers and accessories Freeze drying closures for injection vials |
| 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) |
| ISO 8536-6:2016 | Infusion equipment for medical use — Part 6: Freeze drying closures for infusion bottles |
| I.S. EN ISO 8871-2:2004 | ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 2: IDENTIFICATION AND CHARACTERIZATION (ISO 8871-2:2003) |
| EN ISO 8362-2:2015 | Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-2:2015) |
| UNI EN ISO 8536-2 : 2010 | INFUSION EQUIPMENT FOR MEDICAL USE - PART 2: CLOSURES FOR INFUSION BOTTLES |
| 17/30353012 DC : 0 | BS ISO 13926-2 - PEN SYSTEMS - PART 2: PLUNGER STOPPERS FOR PEN-INJECTORS FOR MEDICAL USE |
| 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) |
| 14/30304354 DC : 0 | BS EN ISO 8362-5 - INJECTION CONTAINERS AND ACCESSORIES - PART 5: FREEZE DRYING CLOSURES FOR INJECTION VIALS |
| BS EN ISO 8362-2:2015 | Injection containers and accessories Closures for injection vials |
| BS ISO 13926-2:2017 | Pen systems Plunger stoppers for pen-injectors for medical use |
| DIN EN ISO 8362-5:2016-07 | INJECTION CONTAINERS AND ACCESSORIES - PART 5: FREEZE DRYING CLOSURES FOR INJECTION VIALS (ISO 8362-5:2016) |
| I.S. EN ISO 8362-5:2016 | INJECTION CONTAINERS AND ACCESSORIES - PART 5: FREEZE DRYING CLOSURES FOR INJECTION VIALS (ISO 8362-5:2016) |
| ISO 13926-3:2012 | Pen systems Part 3: Seals for pen-injectors for medical use |
| ISO 11040-2:2011 | Prefilled syringes Part 2: Plunger stoppers for dental local anaesthetic cartridges |
| ISO 11040-4:2015 | Prefilled syringes — Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling |
| ISO 13926-2:2017 | Pen systems — Part 2: Plunger stoppers for pen-injectors for medical use |
| I.S. EN ISO 8362-2:2015 | INJECTION CONTAINERS AND ACCESSORIES - PART 2: CLOSURES FOR INJECTION VIALS (ISO 8362-2:2015) |
| ISO 8536-2:2010 | Infusion equipment for medical use — Part 2: Closures for infusion bottles |
| ISO 8362-5:2016 | Injection containers and accessories Part 5: Freeze drying closures for injection vials |
| ISO 8362-2:2015 | Injection containers and accessories — Part 2: Closures for injection vials |
| ISO 8871-2:2003 | Elastomeric parts for parenterals and for devices for pharmaceutical use Part 2: Identification and characterization |
| BS EN ISO 8536-2:2010 | Infusion equipment for medical use Closures for infusion bottles |
| EN ISO 8536-2:2010 | Infusion equipment for medical use - Part 2: Closures for infusion bottles (ISO 8536-2:2010) |
| EN ISO 8362-5:2016 | Injection containers and accessories - Part 5: Freeze drying closures for injection vials (ISO 8362-5:2016) |
| DIN ISO 11040-2:2012-10 | Prefilled syringes - Part 2: Plunger stoppers for dental local anaesthetic cartridges (ISO 11040-2:2011) |
| ISO 8536-12:2007 | Infusion equipment for medical use Part 12: Check valves |
| BS ISO 8536-6:2016 | Infusion equipment for medical use Freeze drying closures for infusion bottles |
| DIN ISO 8536-12:2013-04 | Infusion equipment for medical use - Part 12: Check valves (ISO 8536-12:2007 + Amd. 1:2012) |
| 06/30149088 DC : DRAFT SEP 2006 | ISO 8362-5 - INJECTION CONTAINERS AND ACCESSORIES - PART 5: FREEZE DRYING CLOSURES FOR INJECTION VIALS |
| 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) |
| 08/30172616 DC : 0 | BS EN ISO 8536-2 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 2: CLOSURES FOR INFUSION BOTTLES |
| 14/30301958 DC : 0 | BS EN ISO 8362-2 - INJECTION CONTAINERS AND ACCESSORIES - PART 2: CLOSURES FOR INJECTION |
| 06/30149441 DC : DRAFT SEP 2006 | ISO 8362-5 - INJECTION CONTAINERS AND ACCESSORIES - PART 5: FREEZE DRYING CLOSURES FOR INJECTION VIALS |
| ISO 15759:2005 | Medical infusion equipment — Plastics caps with inserted elastomeric liner for containers manufactured by the blow-fill-seal (BFS) process |
| DIN EN ISO 8536-2:2010-08 | Infusion equipment for medical use - Part 2: Closures for infusion bottles (ISO 8536-2:2010) |
| BS EN ISO 8871-2 : 2004 | ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 2: IDENTIFICATION AND CHARACTERIZATION |
| 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) |
| 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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