ISO 8871-4:2006
Current
Current
The latest, up-to-date edition.
Elastomeric parts for parenterals and for devices for pharmaceutical use Part 4: Biological requirements and test methods
Available format(s)
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
Language(s)
English, Russian
Published date
14-06-2006
Important note : All end users must be registered with an Account prior to user licenses being assigned.
ISO 8871-4:2006 specifies biological requirements for elastomeric parts for parenterals and for devices for pharmaceutical use. It also specifies the test methods, i.e. it offers the extraction procedures for elastomeric parts, and it makes reference to relevant biological test instructions in Pharmacopoeias and standards.
| DevelopmentNote |
Supersedes ISO/DIS 8871-4 Together with ISO 8871-1, ISO 8871-2, ISO 8871-3 and ISO 8871-5, supersedes ISO 8871. (06/2006)
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| DocumentType |
Standard
|
| Pages |
9
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| PublisherName |
International Organization for Standardization
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| Status |
Current
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| Supersedes |
| Standards | Relationship |
| GOST R ISO 8871-4 : 2010 | Identical |
| NF EN ISO 8871-4 : 2006 | Identical |
| NBN EN ISO 8871-4 : 2008 | Identical |
| NEN EN ISO 8871-4 : 2006 | Identical |
| NS EN ISO 8871-4 : 1ED 2006 | Identical |
| I.S. EN ISO 8871-4:2006 | Identical |
| PN EN ISO 8871-4 : 2006 | Identical |
| SN EN ISO 8871-4 : 2006 | Identical |
| UNI EN ISO 8871-4 : 2006 | Identical |
| SS-EN ISO 8871-4:2006 | Identical |
| UNE-EN ISO 8871-4:2007 | Identical |
| BS EN ISO 8871-4:2006 | Identical |
| EN ISO 8871-4:2006 | Identical |
| DIN EN ISO 8871-4:2006-09 | Identical |
| 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 11040-5:2012 | Prefilled syringes Plunger stoppers for injectables |
| BS ISO 11040-3:2012 | Prefilled syringes Seals for dental local anaesthetic cartridges |
| DIN ISO 11040-5:2013-12 | PREFILLED SYRINGES - PART 5: PLUNGER STOPPERS FOR INJECTABLES (ISO 11040-5:2012) |
| 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 |
| 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 |
| BS ISO 11040-2:2011 | Prefilled syringes Plunger stoppers for dental local anaesthetic cartridges |
| 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 |
| 10/30216808 DC : 0 | BS ISO 11040-3 - PREFILLED SYRINGES - PART 3: SEALS FOR DENTAL LOCAL ANAESTHETIC CARTRIDGES |
| DIN EN ISO 8362-2:2016-02 | Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-2:2015) |
| DIN ISO 8362-5:2011-06 | INJECTION CONTAINERS AND ACCESSORIES - PART 5: FREEZE DRYING CLOSURES FOR INJECTION VIALS |
| 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 EN ISO 8362-5:2016 | Injection containers and accessories Freeze drying closures for injection vials |
| ISO 8536-6:2016 | Infusion equipment for medical use — Part 6: Freeze drying closures for infusion bottles |
| 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 11040-2:2012-10 | Prefilled syringes - Part 2: Plunger stoppers for dental local anaesthetic cartridges (ISO 11040-2:2011) |
| 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) |
| 08/30172620 DC : DRAFT OCT 2008 | BS EN ISO 8536-6 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 6: FREEZE DRYING CLOSURES FOR INFUSION BOTTLES |
| I.S. EN ISO 8362-5:2016 | INJECTION CONTAINERS AND ACCESSORIES - PART 5: FREEZE DRYING CLOSURES FOR INJECTION VIALS (ISO 8362-5:2016) |
| ISO 11040-2:2011 | Prefilled syringes Part 2: Plunger stoppers for dental local anaesthetic cartridges |
| 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) |
| DIN EN ISO 8536-2:2010-08 | Infusion equipment for medical use - Part 2: Closures for infusion bottles (ISO 8536-2:2010) |
| 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 |
| 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) |
| BS ISO 8536-6:2016 | Infusion equipment for medical use Freeze drying closures for infusion bottles |
| ISO 11040-5:2012 | Prefilled syringes — Part 5: Plunger stoppers for injectables |
| 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 |
| ISO 13926-3:2012 | Pen systems Part 3: Seals for pen-injectors for medical use |
| DIN ISO 13926-2:2012-09 | PEN SYSTEMS - PART 2: PLUNGER STOPPERS FOR PEN-INJECTORS FOR MEDICAL USE (ISO 13926-2:2011) |
| ISO 11737-1:2006 | Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products |
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