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BS EN ISO 11608-1:2022 – TC:2023 Edition

BS EN ISO 11608-1:2022 – TC:2023 Edition

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Tracked Changes. Needle-based injection systems for medical use. Requirements and test methods – Needle-based injection systems

Published By Publication Date Number of Pages
BSI 2023 191
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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, intrathecal, intraocular). NOTE       These products that are excluded might benefit from elements in this document but might not completely fulfil the basic safety and effectiveness of such products.

PDF Catalog

PDF Pages PDF Title
1 30458841
105 A-30381875
106 undefined
109 European foreword
Endorsement notice
114 Foreword
116 Introduction
120 1 Scope
2 Normative references
121 3 Terms and definitions
124 4 Symbols
125 5 Requirements
5.1 General
126 5.2 System designations
127 5.3 Risk approach
5.4 Usability engineering
5.5 Uncertainty of measurement and conformance with specifications
128 5.6 General design requirements
130 5.7 Design verification
5.7.1 General
5.7.2 Primary functions requirements
131 6 Reagent and apparatus
6.1 General
132 6.2 Test liquid
6.3 Test surface for free-fall testing
7 Assessment of dose accuracy and other primary functions
7.1 General
7.2 Dose accuracy
7.2.1 General
133 7.2.2 Dosing regions
7.2.3 Dose settings
135 7.3 Sampling for other primary functions
7.4 Assessment
7.4.1 General
7.4.2 Determination of dose accuracy limits
137 7.4.3 Determination of last-dose error and last-dose accuracy limits (system designations A and C)
138 7.4.4 Calculation of dose delivery efficiency (system designations B1 and D1, user-filled)
7.4.5 Acceptance criteria
139 8 Preparation and operation of NISs
9 Test case matrix
141 10 Testing procedures
10.1 General
10.2 Normal/anticipated condition test cases
10.2.1 Cool, standard and warm atmosphere in-use testing
142 10.2.2 Last-dose accuracy testing (system designations A and C only)
10.2.3 Life-cycle testing (systems designations A and B only) — Preconditioning
10.3 Stressed/challenge condition test cases
10.3.1 Free fall testing – Preconditioning
144 10.3.2 Dry-heat storage – Preconditioning
10.3.3 Cold-storage – Preconditioning
145 10.3.4 Damp-heat testing (system designations A and B only) — Preconditioning
10.3.5 Cyclical testing (system designations A and B only) — Preconditioning
10.3.6 Vibration testing — Preconditioning
146 10.3.7 Transport – Preconditioning
10.3.8 Functional stability – Preconditioning
10.3.9 Fluid leakage (system designations A and B only) – Preconditioning
147 11 Inspection
11.1 General
11.2 Legibility of markings
11.3 Freedom from defects
148 12 Information supplied with the NIS
12.1 General
149 Annex A (informative) Testing rationale
154 Annex B (normative) One- and two-sided tolerance limit factors, k (for normally distributed data)
165 Annex C (informative) Biological evaluation according to ISO 10993-1
167 Annex D (informative) Functional stability
169 Annex E (normative) Instructions for use, marking and age warning
171 Annex F (informative) Rationale for recommended sample sizes
176 Annex G (informative) Considerations for assessing impact on primary functions due to exposure to or contact with medicinal product
178 Annex H (informative) Introduction of primary functions
187 Bibliography

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BS EN ISO 11608-1:2022 - TC
$280.87