ISO 8871-5:2016
Current
Current
The latest, up-to-date edition.
Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 5: Functional requirements and testing
Available format(s)
Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users
Language(s)
English, French
Published date
13-10-2016
ISO 8871-5:2016 specifies requirements and test methods for functional parameters of elastomeric closures used in combination with vials and when pierced by an injection needle.
NOTE Functional testing with spikes is specified in ISO 8536‑2 and in ISO 8536‑6.
| DevelopmentNote |
Together with ISO 8871-1, ISO 8871-2 and ISO 8871-3 ISO 8871-4, supersedes ISO 8871. (08/2005) Supersedes ISO/DIS 8871-5. (10/2016)
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| DocumentType |
Standard
|
| Pages |
10
|
| PublisherName |
International Organization for Standardization
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| Status |
Current
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| Supersedes |
| Standards | Relationship |
| NF EN ISO 8871-5 : 2017 | Identical |
| NEN EN ISO 8871-5 : 2016 | Identical |
| NS EN ISO 8871-5 : 2016 | Identical |
| I.S. EN ISO 8871-5:2016 | Identical |
| SN EN ISO 8871-5 : 2017 | Identical |
| UNI EN ISO 8871-5 : 2017 | Identical |
| SS-EN ISO 8871-5:2016 | Identical |
| UNE-EN ISO 8871-5:2017 | Identical |
| BS EN ISO 8871-5:2016 | Identical |
| EN ISO 8871-5:2016 | Identical |
| DIN EN ISO 8871-5:2015-08 (Draft) | Identical |
| DIN EN ISO 8871-5 E : 2017 | Identical |
| DIN EN ISO 8871-5:2017-03 | Identical |
| DIN ISO 8871-5:2006-01 | Identical |
| NBN EN ISO 8871-5 : 2014 | Identical |
| PN EN ISO 8871-5 : 2017 | Identical |
| GOST R ISO 8871-5 : 2010 | Identical |
| 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 |
| 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) |
| 10/30218554 DC : 0 | BS ISO 13926-3 - PEN SYSTEMS - PART 3: SEALS FOR PEN-INJECTORS FOR MEDICAL USE |
| DIN EN ISO 8362-5 E : 2016 | INJECTION CONTAINERS AND ACCESSORIES - PART 5: FREEZE DRYING CLOSURES FOR INJECTION VIALS (ISO 8362-5:2016) |
| 10/30216808 DC : 0 | BS ISO 11040-3 - 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 |
| DIN EN ISO 8362-2:2016-02 | Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-2:2015) |
| BS EN ISO 8362-5:2016 | Injection containers and accessories Freeze drying closures for injection vials |
| I.S. EN ISO 8362-5:2016 | INJECTION CONTAINERS AND ACCESSORIES - PART 5: FREEZE DRYING CLOSURES FOR INJECTION VIALS (ISO 8362-5:2016) |
| 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 |
| DIN ISO 8362-5:2011-06 | INJECTION CONTAINERS AND ACCESSORIES - PART 5: FREEZE DRYING CLOSURES FOR INJECTION VIALS |
| 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 |
| DIN EN ISO 8362-5:2016-07 | INJECTION CONTAINERS AND ACCESSORIES - PART 5: FREEZE DRYING CLOSURES FOR INJECTION VIALS (ISO 8362-5:2016) |
| NF ISO 8362-5 : 2008 | INJECTION CONTAINERS AND ACCESSORIES - PART 5: FREEZE DRYING CLOSURES FOR INJECTION VIALS |
| ISO 11040-3:2012 | Prefilled syringes — Part 3: Seals for dental local anaesthetic cartridges |
| ISO 13926-3:2012 | Pen systems Part 3: Seals 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 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 |
| 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 |
| 06/30149088 DC : DRAFT SEP 2006 | ISO 8362-5 - INJECTION CONTAINERS AND ACCESSORIES - PART 5: FREEZE DRYING CLOSURES FOR INJECTION VIALS |
| 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 |
| DIN EN ISO 8536-2:2010-08 | Infusion equipment for medical use - Part 2: Closures for infusion bottles (ISO 8536-2:2010) |
| ISO 8362-4:2011 | Injection containers and accessories Part 4: Injection vials made of moulded glass |
| ISO 8536-6:2016 | Infusion equipment for medical use — Part 6: Freeze drying closures for infusion bottles |
| ISO 8362-3:2001 | Injection containers and accessories Part 3: Aluminium caps for injection vials |
| ISO 8362-6:2010 | Injection containers and accessories Part 6: Caps made of aluminium-plastics combinations for injection vials |
| ISO 7864:2016 | Sterile hypodermic needles for single use — Requirements and test methods |
| ISO 8362-1:2009 | Injection containers and accessories Part 1: Injection vials made of glass tubing |
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Hardcopy - English
PDF 1 User - English
PDF 3 Users - English
PDF 5 Users - English
PDF 9 Users - English
Hardcopy - French
PDF 1 User - French
PDF 3 Users - French
PDF 5 Users - French
PDF 9 Users - French
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