🔥🔥 Don’t Miss Out on Our End of Autumn Sale. If you have any questions, feel free to click the bottom right corner to contact our customer service..

Concat us[email protected]
Shopping Cart

No products in the cart.

🔍
BS ISO 11040-4:2024

BS ISO 11040-4:2024

$198.66

Prefilled syringes – Glass barrels for injectables and sterilized subassembled syringes ready for filling

Published By Publication Date Number of Pages
BSI 2024 64
PDF Format Searchable Printable Preview Now
Guaranteed Safe Checkout
Categories: ,

If you have any questions, feel free to reach out to our online customer service team by clicking on the bottom right corner. We’re here to assist you 24/7.
Email:[email protected]

PDF Catalog

PDF Pages PDF Title
2 undefined
7 Foreword
9 Introduction
11 1 Scope
2 Normative references
12 3 Terms and definitions
14 4 General requirements
4.1 Quality systems
4.2 Testing
4.3 Documentation
5 Syringe barrel
5.1 Design including dimensions
5.1.1 Dimensions for 6 % Luer slip and 6 % Luer slip for Luer lock adapter front end syringes
16 5.1.2 Specific dimensions for front end design for 6 % Luer slip and 6 % Luer slip for Luer lock adapter
17 5.1.3 Dimensions for staked needle (SN) syringes
19 5.1.4 Front end design for staked needle syringe
20 5.2 Functional testing of Luer connection
5.3 Material
5.4 Performance requirements
5.4.1 Hydrolytic resistance glass barrel
5.4.2 Annealing quality
5.4.3 Lubrication of the inner surface
5.4.4 Flange breakage resistance
21 5.4.5 Front end breakage resistance
6 Sterilized subassembled syringes ready for filling
6.1 General
6.1.1 Design
6.1.2 Raw materials properties
6.1.3 Documentation
6.2 Sterility
22 6.3 Pyrogenicity/endotoxins
6.4 Particulate matter
6.5 Additional requirements to specific components of sterilized subassembled syringes ready for filling
6.5.1 Syringe barrel
23 6.5.2 Needle
24 6.5.3 Syringe closure system
25 6.6 Syringe closure system tightness
7 Packaging
26 8 Labelling
27 Annex A (informative) Examples of types of sterilized subassembled syringes ready for filling
29 Annex B (informative) Additional components for a subassembled syringe ready for filling
30 Annex C (normative) Test methods for syringe barrels
36 Annex D (informative) Sample preparation for endotoxin and particulate determination
39 Annex E (informative) Glide force test method
42 Annex F (informative) Needle penetration test
45 Annex G (normative) Test methods for front end components
60 Annex H (informative) Tightness test
62 Bibliography

Related products

BS ISO 11040-4:2024
$198.66