ISO 11040-1:2015
Prefilled syringes — Part 1: Glass cylinders for dental local anaesthetic cartridges
ISO 11040-1:2015 specifies the design, dimensions, materials, performance and test methods for glass cylinders for dental local anaesthetic cartridges with a volume of 1,7 ml, 1,8 ml and 2,2 ml intended for single use only.
NOTE 1 Cartridges of 1,0 ml size are described in ISO 11499.
It applies to primary packs used in direct contact with a drug.
NOTE 2 The potency, purity, stability and safety of a drug during its manufacture and storage can be strongly affected by the nature and performance of the primary pack.
| Get this standard | Prices exclude GST | |
|---|---|---|
| PDF ( Single user document) |
$79.13 NZD
|
|
| Networkable PDF |
Price varies
|
Foreword
1 Scope
2 Normative references
3 Dimensions and designation
3.1 Dimensions
3.2 Designation
4 Requirements
4.1 Material
4.2 Performance
5 Marking
Bibliography
Previous versions
Keep me up-to-date
Sign up to receive updates when there are changes to this standard
Related Information
Similar Standards
-
AS/NZS 3200.2.4:2006
Approval and test specification - Medical electrical equipment - Particular requirements for safety - Cardiac defibrillators
-
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 -
AS/NZS IEC 60601.2.20:2022 (RLV)
Medical electrical equipment, Part 2.20: Particular requirements for the basic safety and essential performance of infant transport incubators
-
AS/NZS IEC 60601.2.21:2015
Medical electrical equipment - Part 2.21: Particular requirements for the basic safety and essential performance of infant radiant warmers
Foreword
1 Scope
2 Normative references
3 Dimensions and designation
3.1 Dimensions
3.2 Designation
4 Requirements
4.1 Material
4.2 Performance
5 Marking
Bibliography