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: \u2014 stand-alone prefilled syringes defined by ISO 11040-8 (with noted exceptions above); \u2014 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); \u2014 NISs with containers that can be refilled multiple times; \u2014 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); \u2014 NISs intended for dental use; \u2014 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.<\/p>\n
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| 1<\/td>\n | 30458841 <\/td>\n<\/tr>\n | ||||||
| 105<\/td>\n | A-30381875 <\/td>\n<\/tr>\n | ||||||
| 106<\/td>\n | undefined <\/td>\n<\/tr>\n | ||||||
| 109<\/td>\n | European foreword Endorsement notice <\/td>\n<\/tr>\n | ||||||
| 114<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
| 116<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
| 120<\/td>\n | 1 Scope 2 Normative references <\/td>\n<\/tr>\n | ||||||
| 121<\/td>\n | 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 124<\/td>\n | 4 Symbols <\/td>\n<\/tr>\n | ||||||
| 125<\/td>\n | 5 Requirements 5.1 General <\/td>\n<\/tr>\n | ||||||
| 126<\/td>\n | 5.2 System designations <\/td>\n<\/tr>\n | ||||||
| 127<\/td>\n | 5.3 Risk approach 5.4 Usability engineering 5.5 Uncertainty of measurement and conformance with specifications <\/td>\n<\/tr>\n | ||||||
| 128<\/td>\n | 5.6 General design requirements <\/td>\n<\/tr>\n | ||||||
| 130<\/td>\n | 5.7 Design verification 5.7.1 General 5.7.2 Primary functions requirements <\/td>\n<\/tr>\n | ||||||
| 131<\/td>\n | 6 Reagent and apparatus 6.1 General <\/td>\n<\/tr>\n | ||||||
| 132<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 133<\/td>\n | 7.2.2 Dosing regions 7.2.3 Dose settings <\/td>\n<\/tr>\n | ||||||
| 135<\/td>\n | 7.3 Sampling for other primary functions 7.4 Assessment 7.4.1 General 7.4.2 Determination of dose accuracy limits <\/td>\n<\/tr>\n | ||||||
| 137<\/td>\n | 7.4.3 Determination of last-dose error and last-dose accuracy limits (system designations A and C) <\/td>\n<\/tr>\n | ||||||
| 138<\/td>\n | 7.4.4 Calculation of dose delivery efficiency (system designations B1 and D1, user-filled) 7.4.5 Acceptance criteria <\/td>\n<\/tr>\n | ||||||
| 139<\/td>\n | 8 Preparation and operation of NISs 9 Test case matrix <\/td>\n<\/tr>\n | ||||||
| 141<\/td>\n | 10 Testing procedures 10.1 General 10.2 Normal\/anticipated condition test cases 10.2.1 Cool, standard and warm atmosphere in-use testing <\/td>\n<\/tr>\n | ||||||
| 142<\/td>\n | 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) \u2014 Preconditioning 10.3 Stressed\/challenge condition test cases 10.3.1 Free fall testing \u2013 Preconditioning <\/td>\n<\/tr>\n | ||||||
| 144<\/td>\n | 10.3.2 Dry-heat storage \u2013 Preconditioning 10.3.3 Cold-storage – Preconditioning <\/td>\n<\/tr>\n | ||||||
| 145<\/td>\n | 10.3.4 Damp-heat testing (system designations A and B only) \u2014 Preconditioning 10.3.5 Cyclical testing (system designations A and B only) \u2014 Preconditioning 10.3.6 Vibration testing \u2014 Preconditioning <\/td>\n<\/tr>\n | ||||||
| 146<\/td>\n | 10.3.7 Transport \u2013 Preconditioning 10.3.8 Functional stability \u2013 Preconditioning 10.3.9 Fluid leakage (system designations A and B only) – Preconditioning <\/td>\n<\/tr>\n | ||||||
| 147<\/td>\n | 11 Inspection 11.1 General 11.2 Legibility of markings 11.3 Freedom from defects <\/td>\n<\/tr>\n | ||||||
| 148<\/td>\n | 12 Information supplied with the NIS 12.1 General <\/td>\n<\/tr>\n | ||||||
| 149<\/td>\n | Annex A (informative) Testing rationale <\/td>\n<\/tr>\n | ||||||
| 154<\/td>\n | Annex B (normative) One- and two-sided tolerance limit factors, k (for normally distributed data) <\/td>\n<\/tr>\n | ||||||
| 165<\/td>\n | Annex C (informative) Biological evaluation according to ISO 10993-1 <\/td>\n<\/tr>\n | ||||||
| 167<\/td>\n | Annex D (informative) Functional stability <\/td>\n<\/tr>\n | ||||||
| 169<\/td>\n | Annex E (normative) Instructions for use, marking and age warning <\/td>\n<\/tr>\n | ||||||
| 171<\/td>\n | Annex F (informative) Rationale for recommended sample sizes <\/td>\n<\/tr>\n | ||||||
| 176<\/td>\n | Annex G (informative) Considerations for assessing impact on primary functions due to exposure to or contact with medicinal product <\/td>\n<\/tr>\n | ||||||
| 178<\/td>\n | Annex H (informative) Introduction of primary functions <\/td>\n<\/tr>\n | ||||||
| 187<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Tracked Changes. Needle-based injection systems for medical use. Requirements and test methods – Needle-based injection systems<\/b><\/p>\n |