Standard Swedish standard · SS-EN ISO 11608-2:2022

Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ended pen needles (ISO 11608-2:2022)

Status: Valid

Buy this standard

Standard Swedish standard · SS-EN ISO 11608-2:2022

Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ended pen needles (ISO 11608-2:2022)
Subscribe on standards - Read more Dölj
Price: 1 320 SEK
standard ikon pdf

PDF

Price: 1 320 SEK
standard ikon

Paper

Price: 2 112 SEK
standard ikon pdf + standard ikon

PDF + paper

Show more Show less
Preview this standard
Scope
This document specifies requirements and test methods for single-use, double-ended, sterile needles intended to be used with some needle-based injection systems (NISs) that use a non-integrated double-ended needle according to ISO 11608-1.
This document is not applicable to the following:
—    needles for dental use;
—    pre-attached syringe needles;
—    hypodermic needles;
—    needles intended for different routes of administration (e.g. intravenous, intrathecal, intraocular);
—    materials that form the medicinal product contact surfaces of the primary container closure.
However, while this document is not intended to directly apply to these needle products, it does contain requirements and tests methods that can be used to help design and evaluate them.
NOTE       Needles provided by the manufacturer integrated into the fluid path or container are covered in ISO 11608-3, and hypodermic needles provided separately are covered in ISO 7864.

Subjects

Transfusion, infusion and injection equipment (11.040.20) Syringes, needles and catheters (11.040.25)


Buy this standard

Standard Swedish standard · SS-EN ISO 11608-2:2022

Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ended pen needles (ISO 11608-2:2022)
Subscribe on standards - Read more Dölj
Price: 1 320 SEK
standard ikon pdf

PDF

Price: 1 320 SEK
standard ikon

Paper

Price: 2 112 SEK
standard ikon pdf + standard ikon

PDF + paper

Show more Show less

Product information

Language: English

Written by: Svenska institutet för standarder

International title:

Article no: STD-80035112

Edition: 3

Approved: 5/9/2022

No of pages: 44

Replaces: SS-EN ISO 11608-2:2012