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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 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English, Russian

Published date

14-06-2006

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)
DocumentType
Standard
Pages
9
PublisherName
International Organization for Standardization
Status
Current
Supersedes

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10/30218554 DC : 0 BS ISO 13926-3 - PEN SYSTEMS - PART 3: SEALS FOR PEN-INJECTORS FOR MEDICAL USE
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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
DIN EN ISO 8362-5 E : 2016 INJECTION CONTAINERS AND ACCESSORIES - PART 5: FREEZE DRYING CLOSURES FOR INJECTION VIALS (ISO 8362-5:2016)
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
DIN ISO 11040-2 E : 2012 PREFILLED SYRINGES - PART 2: PLUNGER STOPPERS FOR DENTAL LOCAL ANAESTHETIC CARTRIDGES (ISO 11040-2:2011)
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
DIN ISO 11040-5 E : 2013 PREFILLED SYRINGES - PART 5: PLUNGER STOPPERS FOR INJECTABLES (ISO 11040-5:2012)
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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