Standard Swedish standard · SS-EN ISO 11608-1:2022

Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2022)

Status: Valid

Buy this standard

Standard Swedish standard · SS-EN ISO 11608-1:2022

Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2022)
Subscribe on standards - Read more Dölj
Price: 1 615 SEK
standard ikon pdf

PDF

Price: 1 615 SEK
standard ikon

Paper

Price: 2 584 SEK
standard ikon pdf + standard ikon

PDF + paper

Show more Show less
Preview this standard
Scope
This document specifies requirements and test methods for Needle-Based Injection Systems (NISs) for single-patient use intended to deliver discrete volumes (bolus) of medicinal product, which can be delivered through needles or soft cannulas for intradermal, subcutaneous and/or intramuscular delivery, incorporating pre-filled or user-filled, replaceable or non-replaceable containers.
This document applies in cases where the NIS incorporates a prefilled syringe. However, stand-alone prefilled syringes defined by ISO 11040-8 are not covered by this document (see exclusions below).
It is important to note that other functions and characteristics of the prefilled syringe, such as dose accuracy, are subject to the requirements (delivered volume) in ISO 11040-8 and not this document, unless the addition impacts the delivery function (e.g. a mechanism that intends to restrict or stop the plunger movement, which would limit the dose delivered). In that case, the system is completely covered by this document and applicable requirements of the ISO 11608 series.
Excluded from the scope are:
—    stand-alone prefilled syringes defined by ISO 11040-8 (with noted exceptions above);
—    NISs that provide continuous delivery and require a delivery rate clinically specified in the medicinal product labelling or determined by a physician based on clinical relevance (i.e. medication efficacy) as would be the case with insulin patch pumps or traditional infusion pumps (e.g. IEC 60601-2-24, ISO 28620) associated with continuous delivery of medicinal products (e.g. insulin);
—    NISs with containers that can be refilled multiple times;
—    requirements relating to methods or equipment associated with user filling of containers unless they are dedicated accessories (a component necessary for primary function, whether included in the original kitted product or not);
—    NISs intended for dental use;
—    NISs intended for different routes of administration (e.g. intravenous, ...

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 11608-1:2022

Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2022)
Subscribe on standards - Read more Dölj
Price: 1 615 SEK
standard ikon pdf

PDF

Price: 1 615 SEK
standard ikon

Paper

Price: 2 584 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-80035111

Edition: 4

Approved: 5/9/2022

No of pages: 84

Replaces: SS-EN ISO 11608-1:2015