BS EN ISO 11608-1:2022 PDF

Scope: 1 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 ...

BS EN ISO 11608-1:2022 Referenced Document

IEC 60068-2-6:2007 Environmental testing - Part 2-6: Tests - Test Fc: Vibration (sinusoidal)
IEC 60529 Degrees of Protection Provided by Enclosures (IP Code) (Edition 2.1 ***Applies to French text only***)*， 2024-04-21 Update
IEC 62366-1 Medical devices - Part 1: Application of usability engineering to medical devices*， 2024-04-21 Update
ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 14971:2019 Medical devices — Application of risk management to medical devices
ISO 16269-6 Statistical interpretation of data - Part 6: Determination of statistical tolerance intervals
ISO 23908 Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling

2022 BS EN ISO 11608-1:2022 Needle-based injection systems for medical use. Requirements and test methods - Needle-based injection systems
2015 BS EN ISO 11608-1:2015 Needle-based injection systems for medical use. Requirements and test methods. Needle-based injection systems
2012 BS EN ISO 11608-1:2012 Needle-based injection systems for medical use. Requirements and test methods. Needle-based injection systems
0000 BS EN ISO 11608-1:2001