ISO 8871-5:2016
Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 5: Functional requirements and testing
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.
| Get this standard | Prices exclude GST | |
|---|---|---|
| PDF ( Single user document) |
$118.26 NZD
|
|
| Networkable PDF |
Price varies
|
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
4.1 Penetrability
4.2 Fragmentation
4.3 Self-sealing and aqueous solution tightness
4.4 Aqueous solution tightness
5 Preparation of elastomeric closures for testing
5.1 Sampling
5.2 Cleaning
5.3 Sterilization
Annex A (normative) Test for penetrability
Annex B (normative) Test for fragmentation
Annex C (normative) Test for self-sealing and dye solution tightness
Annex D (normative) Test for dye solution tightness
Bibliography
Previous versions
Keep me up-to-date
Register to receive notifications when updates are made to this standard.
Related Information
Similar Standards
-
AS/NZS 2696:1996
Medical devices - Polymer urethral catheters for general medical use
-
AS/NZS 2696:1996 A1
Medical devices - Polymer urethral catheters for general medical use: Amendment 1
-
AS/NZS 3200.2.24:1999
Approval and test specification - Medical electrical equipment - Particular requirements for safety - Infusion pumps and controllers
-
AS/NZS IEC 60601.2.16:2015
Medical electrical equipment - Part 2.16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
4.1 Penetrability
4.2 Fragmentation
4.3 Self-sealing and aqueous solution tightness
4.4 Aqueous solution tightness
5 Preparation of elastomeric closures for testing
5.1 Sampling
5.2 Cleaning
5.3 Sterilization
Annex A (normative) Test for penetrability
Annex B (normative) Test for fragmentation
Annex C (normative) Test for self-sealing and dye solution tightness
Annex D (normative) Test for dye solution tightness
Bibliography