Customer Support: +1 416-401-8730

Login to i2i Subscription Intertek.com
  • There are no items in your cart
Please enter a keyword to search
Advanced search

ISO 8536-6:2016

Current
Current

The latest, up-to-date edition.

Infusion equipment for medical use — Part 6: Freeze drying closures for infusion bottles
Available format(s)

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

Language(s)

English

Published date

11-21-2016

Publisher

International Organization for Standardization

ISO 8536-6:2016 specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for infusion bottles, as described in ISO 8536-1, that is used in connection with the freeze-drying (or lyophilization) of drugs and biological materials.

The dimensional requirements are not applicable to barrier-coated closures.

Closures specified in this document are intended for single use only.

DevelopmentNote
Supersedes ISO/DIS 8536-6. (11/2016)
DocumentType
Standard
Pages
16
PublisherName
International Organization for Standardization
Status
Current
Supersedes

Standards Relationship
DIN ISO 8536-6:2017-09 Identical
NEN ISO 8536-6 : 2016 Identical
DIN ISO 8536-6:2012-09 Identical
BS ISO 8536-6:2016 Identical

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
DIN EN ISO 8871-5:2015-08 (Draft) ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 5: FUNCTIONAL REQUIREMENTS AND TESTING (ISO 8871-5:2016)
I.S. EN ISO 8871-5:2016 ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 5: FUNCTIONAL REQUIREMENTS AND TESTING (ISO 8871-5:2016)
ISO 8871-5:2016 Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 5: Functional requirements and testing
UNI EN ISO 8871-2 : 2014 ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 2: IDENTIFICATION AND CHARACTERIZATION
DIN EN ISO 8871-5 E : 2017 ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 5: FUNCTIONAL REQUIREMENTS AND TESTING (ISO 8871-5:2016)
15/30324254 DC : 0 BS EN ISO 8871-5 - ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 5: FUNCTIONAL REQUIREMENTS AND TESTING
BS EN ISO 8871-1:2004 Elastomeric parts for parenterals and for devices for pharmaceutical use Extractables in aqueous autoclavates
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)
EN ISO 8871-2:2004/A1:2014 ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 2: IDENTIFICATION AND CHARACTERIZATION (ISO 8871-2:2003/AMD 1:2005)
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)
BS EN ISO 8871-5:2016 Elastomeric parts for parenterals and for devices for pharmaceutical use Functional requirements and testing
ISO 8871-2:2003 Elastomeric parts for parenterals and for devices for pharmaceutical use Part 2: Identification and characterization
ISO 8871-1:2003 Elastomeric parts for parenterals and for devices for pharmaceutical use Part 1: Extractables in aqueous autoclavates
EN ISO 8871-5:2016 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO 8871-5:2016)
EN ISO 8871-1 : 2004 ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 1: EXTRACTABLES IN AQUEOUS AUTOCLAVATES
UNE-EN ISO 8871-5:2017 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO 8871-5:2016)
BS EN ISO 8871-2 : 2004 ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 2: IDENTIFICATION AND CHARACTERIZATION
DIN EN ISO 8871-5:2017-03 ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 5: FUNCTIONAL REQUIREMENTS AND TESTING (ISO 8871-5:2016)

ISO 8871-1:2003 Elastomeric parts for parenterals and for devices for pharmaceutical use Part 1: Extractables in aqueous autoclavates
ISO 7619-1:2010 Rubber, vulcanized or thermoplastic Determination of indentation hardness Part 1: Durometer method (Shore hardness)
ISO 15510:2014 Stainless steels Chemical composition
ISO 8536-3:2009 Infusion equipment for medical use Part 3: Aluminium caps for infusion bottles
ISO 2230:2002 Rubber products — Guidelines for storage
ISO 15378:2017 Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
ISO 8871-5:2016 Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 5: Functional requirements and testing
ISO 48:2010 Rubber, vulcanized or thermoplastic Determination of hardness (hardness between 10 IRHD and 100 IRHD)
ISO 8871-4:2006 Elastomeric parts for parenterals and for devices for pharmaceutical use Part 4: Biological requirements and test methods
ISO 8536-1:2011 Infusion equipment for medical use Part 1: Infusion glass bottles

View more information
US$111.00
Excluding Tax where applicable
USD
CAD
CHF
CNY
DKK
EUR
GBP
HKD
IDR
INR
JPY
KRW
MXN
NOK
NZD
SEK
SGD
USD
ZAR
Hardcopy - English
PDF - English
PDF 3 Users - English
PDF 5 Users - English
PDF 9 Users - English
01
02
03
04
05
06
07
08
09
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.

Learn more on subscription solutions

or

Get in touch with us