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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 , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English, French

Published date

13-10-2016

£58.00
Excluding VAT

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)
DocumentType
Standard
Pages
10
PublisherName
International Organization for Standardization
Status
Current
Supersedes

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
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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